safe injection practices iap

Guide Book on Safe Injection Practices

Developed in Technical Collaboration with Becton Dickinson, India

Indian Academy of Pediatrics

Editorial Board :

Advisors:

Editors: Dr. A Parthasarathy, Dr. T.U. Sukumaran, Dr. S.S. Kamath, Dr. Anil Mishra

First Edition: September, 2004

Second Edition: December 2006

Third (Current) Edition : May 2012

Publication:The Indian Academy of PediatricsKailas Darshan, Kennedy Bridge (Nana Chowk)Mumbai 400007 (India)Phone (022) 23887906, 23887922, 23889565Fax: (022) 23851713 Email: [email protected]: www.iapindia.org

Society Regn.No.BOM 127/1963 GBBSDPublic Trust Regn.No. F-1166 (BOM)

Technical Collaboration and Educational Grant Support: Becton Dickinson, India

National Convenor’s Address:Dr. S. Sachidananda Kamath, National ConvenorIAP National Task Force on Safe Injection PracticesWelcare Hospital, Vyttila, Cochin 682 019Ph : 0484-2307897Email : [email protected]

Published by: IAP National Publication House, Gwalior, MP

Designed and Printed by:

Printek Ways:

149, DSIDC Complex, Okhla Industrial Area, Phase-I, New Delhi -110020

Dr. Rohit Agrawal, Dr. C.P. Bansal, Dr. Sailesh Gupta, Dr. Pravin J. Mehta

IAP Guide Book on Safe Injection Practices

IAP GUIDE BOOK ONSAFE INJECTION PRACTICES

Advisors:

Dr. Rohit Agrawal

Dr. C.P. Bansal

Dr. Sailesh Gupta

Dr. Pravin J. Mehta

Editors:

Dr. A Parthasarathy

Dr. T.U. Sukumaran

Dr. S.S. Kamath

Dr. Anil Mishra

Editorial Board

Technical Collaboration and Educational Grant SupportFrom Becton Dickinson, India

Published by:IAP Publication House,Gwalior,MP,

India

Dr. ROHIT AGRAWALMD, DCHPresident IAP-2012Consultant PediatricianChandrajyoti Children's Hospital, MumbaiKohinoor Hospital, Mumbai603/4 Vindyachalneelkanth Valley

th7 Road,Rajawadi,Ghatkopar (East) Mumbai 400077e-mail [email protected], Mobile 9821096353

Dr. T.U. SUKUMARANPresident IAP-2011Professor of PediatricsPIMS, Thiruvalla, Keralae-mail; [email protected]

Dr. C.P. BANSAL MD, FIAP, PGDAP, FICMCHDirector, Shabd Pratap Hospital, Gwalior 474 012President Elect- IAP-2013e-mail; [email protected]

Dr. SAILESH GUPTAMD, FIAPHon. Secretary General -2012Ashna Children's Hospital, Uttara ApartmentsJan Kalyan Nagar, Malad West, Mumbai-400095e-mail [email protected] 9819042213

Dr. S.SACHIDANANDA KAMATH MD,DCH, FIAP,DHHM,PGDAPConvenor, National Task Force on Safe Injection Practices,Consultant Pediatrician, Welcare Hospital,S A Road, Vyttila, Cochin - 682019

Dr. A. PARTHASARATHYDistinguished Professor of Pediatrics, The Tamil Nadu Dr. MGR University & Retd. Professor of Pediatrics, Madras Medical College & Deputy Superintendent, Institute of Child Health & Hospital for Children,Chennai, TN. Mobile 91 90422 60053, email: [email protected]

Contributors' List

Dr. SHIVANANDADirector Professor and HOD PediatricsIndira Gandhi Institute of Child HealthSouth Hospital Complex, Bangalore - 560023 Mobile: 094484 66562e-mail; [email protected]

Dr. M.INDRA SHEKHAR RAO. M.D.(Paed.)D.C.H.,NEO(USA)FIAP Senior Pediatric Consultant, Basant Sahney Children's Hospital, Secunderabad,Former Medical Superintendent & HOD Pediatrics,Institute of Child Health, Niloufer Hospital, Hyderabad, A.P.Residence: "Indraprastha", 106, Abhinava Nagar, Padmarao Nagar, Secunderabad, AP - 500 025.e-mail; [email protected]

Dr. RAJU C. SHAHMD, D Ped, FIAPProfessor and HOD, Dept of Pediatrics, GCS Medical college, Ahmedabad.National President IAP (2005)Chairman, Injection Safety Task Force, IAP(2004-7)Ankur Institute of Child Health,B/H Ciyu Gold Cinema, Ashram Road,Ahmedabad 380009, Gujarat.Phone: (079) 26583067.e-mail; [email protected]

Dr. BALDEV S. PRAJAPATIM.D.(PED.) GOLD MEDALISTD. PED. FIAP, MNAMS, FICMCH.Professor, GCS Medical College,Hospital & Research Centre, AHMEDABAD.EBM Central IAP (5 Terms)Member& Trainer,Safe Injection Practices(2005- 2007)MEMBER, IAPCOI,2009-2011Aakanksha Children Hospital,Nava Vadaj Road, AHMEDABAD.PHONES: (079) (H) 27559179, 27559667(R) 27680256(M) 09824039376email: [email protected]

IAP Guide Book on Safe Injection Practices i

Dr. ARUN SHAHMD DCH FIAP FIAMSAssociate professor NMCHBrahampura, Muzaffarpur, BIHARe-mail: [email protected]

Dr. ALOK GUPTA MDPediatrician & CounselorJaipur, India.+91 94140 62700+91 94610 03070e-mail; [email protected]

Dr. M.A MATHEW MD,DCH London FIAP Professor Of Pediatrics M.O.S.C Medical College Kolenchery 682311Kerala State Coordinator for SAFE-I Program office : 04843055262Res:04846494556Mobile:9447234554e-mail; [email protected]

Dr. ANIL MISHRARegional Technical Advisor-Infection ControlBECTON DICKINSON, INDIABoomerang, A - Wing, Unit No- 310, Third Floor, Chandivali Farm Road, Chandivali, Near Powai, Andheri - (E), MUMBAI - 400072Telephone: 022- 32221318-19. 022- 28582430-32Mobile: 09669696306e-mail: [email protected], [email protected]

DR. BHASKAR J SONOWALTechnical Advisor- Infection Control and Patient SafetyBECTON DICKINSON, INDIA6th Floor, Signature Tower B, South City 1, Gurgaon, Haryana 122001 Indiatel: +91-124-3088333 cell: +91-9999501159 fax: +91-124-2383224/5/6e-mail: [email protected] Website: www.bd.com

Dr. OM PRAKASH KANSALAdvisor-Injection SafetyBECTON DICKINSON, INDIA6th Floor, Signature Tower B, South City 1, Gurgaon, Haryana 122001 India tel: +91-124-3088333 cell: +919910555964 fax: +91-124-2383224/5/6E-mail: [email protected]

K. RAJESH NAIRSenior ASM – TenderBECTON DICKINSON, INDIASouth Regional Office - Keralae-mail: [email protected]:09745603110

Logistics

GANESH MEDHEBECTON DICKINSON, INDIABoomerang,A-Wing,Unit No.310,Chandivali Farm Road,Mumbai, IndiaPin-400072Tel- +91-22-33241600e-mail: [email protected] Mobile:08291135670

MANOJ CHAUBEYBECTON DICKINSON, INDIABoomerang,A-Wing,Unit No.310,Chandivali Farm Road,Mumbai, IndiaPin-400072Tel- +91-22-33241600e-mail: [email protected]: www.bd.com

ANU KHANNABECTON DICKINSON, INDIA6th Floor, Signature Tower B, South City 1,Gurgaon, Haryana 122001 India e-mail: [email protected]

IAP Guide Book on Safe Injection Practicesii

It is indeed a matter of pleasure and pride that IAP in partnership with BD India is making sincere efforts to address the issue of unsafe injections in India, which remains an important public health scourge, even in these times of technology advancements.

Out of the injections which are administered in day to day practice of medicine, a significantly high percentage has been found to be unsafe. These unsafe injections will continue to add to the disease burden and loss of life, if the problem is not addressed on urgent basis. I am sure that our efforts will effectively address the issue of unsafe injections, which is a major public health challenge.

This guidebook on injection safety will try to address the problem of unsafe injections by serving as a treatise on injection safety. It has been ensured that the key issues which are of relevance to different cadres of medical practitioners are addressed through this book and the basic essential knowledge and skills do not become a hindrance in achieving optimum standards of safety in its entirety. IAP and BD have planned state wise release of this book and will work to address the state specific concerns of injection safety by developing a contextual strategy in partnership with respective state governments.

I highly appreciate the efforts of all the experts from IAP and the technical team of BD India, who have worked hard to ensure that the present edition of the guidebook presents all facts and information which are of practical importance to a wide spectrum of medical practitioners, undergraduates, post graduates and nursing cadre as well, in a way that is simple and easy to understand.

Dr. Rohit Agrawal

National President-IAP, 2012

Foreword

IAP Guide Book on Safe Injection Practices iii

rdI am immensely pleased to see that the revised and updated 3 edition of the guide book on safe injection practices, which is a joint academic project of IAP and BD India is available to all of us for use towards improving standards of injection safety. As you all know, Safe Injection Practices has been a focus area of IAP and we continue to move forward in this direction with valuable support from all of you.

Injection safety is of paramount importance in Indian context, if we wish to abide by the ethical value of doing no harm to the patients. The concept of Safe Injection Practices in India was conceived in 2004 during the Presidency of Dr. MKC Nair and has become an important part of IAP's action plan. BD also works in different parts of the globe on improving injection safety standards and has been partnering with IAP since the inception of the project on Injection Safety. I am confident that this joint work of IAP and BD will have the desired impact towards reducing unsafe injection practices in India.

This guide book will be helpful for the entire spectrum of healthcare staff, i.e. for doctors, nurses, laboratory technicians, other categories of Health care workers and for the registered medical practitioners. The structure, content and language have been kept simplified so as to suit the needs of all categories of healthcare providers in various settings. New chapters on 'Prevention of re-use of syringes 'and' Newer technologies in injection delivery systems' in the present edition will be of immense practical utility to the readers. Chapters on injection techniques, best practices, Healthcare worker safety, Patient safety, waste disposal etc. have been extensively revised.

I sincerely thank Dr. SS Kamath for leading this initiative and to all the expert group members from IAP and BD India who have contributed in developing this guide book. I also thank BD India for providing the educational grant for this project.

Dr. T. U. Sukumaran

National President, 2011, IAP

Message

IAP Guide Book on Safe Injection Practicesiv

Dear IAP Colleague,

Injection Safety has been an area of high focus for the Indian Academy of Pediatrics. The subject has been accorded priority in successive IAP Action plans, every year. Experts in IAP have deliberated on ways to address the issue of unsafe injection practices in India. One of the strategies in the multipronged approach is, to address the knowledge barrier among the healthcare practitioners. As part of this strategy, IAP, in technical collaboration with Becton Dickinson India has developed this guide book on Safe Injection Practices. The objective while planning this book was to provide maximum practical usefulness for healthcare professionals, therefore the structure of the contents is simple and illustrative

We are confident that after the book is released and when trainings for the zonal level and district level are rolled out, we will be able to impact the knowledge , skills and practices of healthcare professional and the same would reflect through reduced percentage of unsafe injections in India. It will help us abide by the ethical principle of doing no harm to the patients.

We look forward to the stage when we will achieve the highest possible standards of injection safety. I am confident that the joint efforts of IAP and BD will replace the unsafe injections practices in India with safe and ethical practices.

Dr Sailesh Gupta,

Hon. Secretary General-2012

Message

IAP Guide Book on Safe Injection Practices v

Becton Dickinson Company (BD), in pursuance with its mission of Helping All People Live Healthy Lives, besides producing high quality medical technology products, has developed many initiatives across the globe to deliver direct benefits to the patients, healthcare workers and to the people in general.

In India, BD's joint work with the Indian Academy of Pediatrics (IAP) to address the issue of Injection safety is one of such initiatives. As a part of this strategy, IAP and BD jointly worked to develop this training module on Injection safety as the first step. Subsequently, this guidebook will be used as the basis of training of the healthcare professional on Injection Safety.

A team of highly experienced experts from IAP and technical team members from BD have carried out in-depth discussions to develop this guidebook which provides all necessary information to the practitioners in a very simple but illustrative way.

I am confident that this joint effort of IAP and BD, India will work to effectively address the problem of unsafe injections, a critical public health need in India.

Manoj Gopalakrishna,

Managing Director, BD India

Message

IAP Guide Book on Safe Injection Practicesvi

It is well known that prevention is always better than cure. Infections still form a major part of under five mortality in a developing country like ours. Vaccines are the most cost effective tools in the hands of pediatricians to prevent morbidity and mortality.

As more and more immunizations are being given, one has to bear in mind the rising incidence of diseases transmitted by unsafe injection practices. On one hand we are immunizing to prevent diseases and on the other hand if we do not follow the safe injection practices we will also be instrumental in transmission of diseases. Hence it is very important for all of us to be aware of what are safe injection practices and best injection techniques so that we do not cause any harm while aiming to do good.

Injections are a must when we have to give injectable vaccines but are we justified in giving so many injections in the curative section? We need to have rational prescription habits and reduce the unnecessary injections. The lesser the injections we give, lesser will be the risk of transmission due to unsafe practices.

One way of making the injections safer in the immunization sector is the use of AD syringes as recommended by WHO. The Indian Academy of Pediatrics has always taken the lead to come out with IAP recommendations in national issues related to child health by conducting workshops which bring out a consensus document.

A workshop on safe injection practices was organized in New Delhi in June 2004 by Dr. S.S. Kamath and Dr. Swati Bhave. There was representation of various stakeholders in this meeting, including the Ministry of Health, UNICEF, WHO, IMA, TNAI etc. The Secretary of Health and Family Welfare was kind enough to spend a lot of time to give his comments during the two days. The recommendations brought out have been published in the Indian Pediatrics, as well forwarded to all partners working in the field of child health.

One of the recommendations of the workshop was that IAP should form a National Task Force on Safe Injection Practices to propogate the message to the members and in the community. In June 2004 Executive Board meeting, this task force was formed with Dr. Raju C. Shah, the President Elect, as Chairperson, Dr. S.S. Kamath as the Convenor and Dr. Swati Y. Bhave as Scientific Coordinator. It was decided to bring out the IAP Guide Book on Safe Injection Practices and conduct workshops all over the country in the year 2005 with a set of slides and the Guide Book.This is a part of the Presidential Action Plan of 2005.

Preface To The First Edition

IAP Guide Book on Safe Injection Practices vii

A master trainers' workshop was organized in March 2005 at Cochin.Here a peer review was done of the scientific material and slides which were painstakingly prepared by Dr. Swati Bhawe with a lot of technical inputs and help from Dr. Saurabh Sharma. We are thankful to him and M/s Becton Dickinson India Pvt. Ltd. who have given an educational grant for publication of the guide book and conduction of workshops.

All the members of the task force worked hard to give their inputs but special mention must be made of Dr. Parthasarathy, Dr. Indra Shekhar Rao and Dr. Shivananda.

We thank Mr Narayanan of Pixel Studio, Cochin for designing and printing under able guidance of Dr. S.S. Kamath.

We sincerely hope that this publication will be useful to all pediatricians who care for the wellbeing of children.

Dr. S.S. Kamath

Dr. Swati Bhave

Dr. Raju C. Shah

IAP Guide Book on Safe Injection Practicesviii

This guide book on safe injection practices has been developed to strengthen the area of injection safety in India, which remains a major public health concern and is accountable for a significant share of deaths, morbidity and productivity losses. With highly encouraging responses received about the usefulness of the earlier editions, form practicing pediatricians and family physician from all over the country we decided to extensively revise this book and make it of more practical utility for the practitioners. We are immensely pleased to hand over this book to the medical and paramedical community in India. We also urge all medical practitioners to accord highest priority to safe injection practices.

This Guidebook is of significant value in helping all categories of Health Care Providers to reduce the risk of spread of blood born infections which are transmitted through unsafe injections including re-use of needles and syringes, needle stick injuries and unsafe disposal of the used injection devices and sharps. The book has made sincere efforts to address the issue of safety in its entirety, i.e. safety of patients, of healthcare providers and of the community at large.

The content and structure of this Guide Book is so designed as to present the basic facts related to injection safety in a manner which can be well understood by diverse target groups like nurses, undergraduate medical students, interns, post-graduates, students of laboratory technology, as well as practicing general physicians, specialists and super-specialists, with equal degree of ease. This guide book will also serve as a ready reckoner for all classes of professionals.

Special addition in this guidebook is the chapter on Re-use of syringes, which is posing a major risk to the health of people in India. IAP and BD are jointly making efforts to address this problem in India. We hope that orientation of health care providers including Medical practitioners towards the need to put an effective check on the problem of re-use and improving overall standards of injection safety will deliver lasting benefits to the public health in India.

It is our fervent hope that this guide book will serve as an important aid to all cadres of health workers in delivering safe injections.

Dr. A Parthasarathy

Dr. S.S. Kamath

Dr. Anil Mishra

Preface

IAP Guide Book on Safe Injection Practices ix

The current Guide Book on Injection Safety has been jointly developed by IAP and BD India, with the objective of re-orienting the medical practitioners and other health care providers towards this critical aspects of Injection Safety, which is an essential part of day to day medical care. It has been observed that medics and paramedics, keeping their focus on the expected outcome of medical care i.e. cure of the patient and his/her return to normalcy, often overlook needed attention that is required to be paid to the minute details of Injection safety, and this results in serious harm- either to the patient, or to the care giver, and quite often to the community in general.

The Content and structure of this Guide Book has been so designed , as to be effective for the larger community of medical practitioners, which includes specialists, general practitioners, Registered Medical Practitioners (Including alternative streams of medicine) , as well for the nursing , paramedical and laboratory staff who frequently deliver injections either for diagnostic or for therapeutic purposes or for both. This Guide Book will be of immense benefit to guide the graduating medical students and nursing students also on issues related to Injection safety, and will help in creating a solid understanding of the issue and also of the behavior and practices required to be adopted for achieving highest levels of injection safety in medical practice, and thereby abiding with the ethical principle of “ doing no harm to the patients”.

IAP and BD India , in order to maximize the utility of this Guide Book as an effective training guide on Injection Safety, carried out multiple rounds of discussion on the content and structure of the book. Current knowledge and key gaps amongst the practitioners has been given due consideration in arriving at the final shape.

It is expected that this Guide Book will be the most comprehensive and informative practical guide and will serve as 'Desk top reference' on matters of injection safety. The book has given due emphasis on critical areas like, Healthcare worker safety from sharps injury and other exposures, and patient safety from re-use of syringes and needles. It also deals with the safety of the community at large, which faces disastrous effects of improper disposal of bio-medical waste- specifically sharps and used syringes, which are picked up for resale. As stated above, in order to have an understanding of the prevailing knowledge, attitude and practices (KAP) of a small sample of injection providers/medical practitioners on injection safety, a quick assessment was carried out. It was later decided that for ensuring completeness of the information which is being provided on injection safety in this Guide Book, each and every area needs mention,

Target Audience, Expected Impact and Methodology

IAP Guide Book on Safe Injection Practicesx

IAP Guide Book on Safe Injection Practices xi

irrespective of the understanding of medical practitioners around that particular area. This will also make the guidebook suitable for the practitioners who were not a part of the sampling universe, and thus would make it replicable in true sense.

In the current scenario in medical practice and day to day medical care, re-use of syringes and needles is a major threat for the patients in reference to spread of blood born pathogens like HCV, HBV and HIV. The same risk is faced by the healthcare workers through Needle Stick Injuries which they sustain in the process of providing care to the patients, and consider it an unavoidable part of their profession. Expert members from IAP and BD strongly felt that these two topics need special emphasis in the book, as they contribute towards spread of blood born pathogens, the investigations and management of which impose a financial burden on the health system, as well as these infections contribute towards productivity losses which again have a financial bearing.

As mentioned above, IAP and BD constituted a Technical Expert group, comprising of the members who have worked on specific aspects of the Injection safety, and have taken help of their deep insight into the matter, for developing the structure and content of this guide book. The Individual chapters have also been drafted by the members of this expert team , which were subsequently reviewed by a smaller team of experts.

The Technical Expert Group comprised of following experts from IAP and technical team members from BD India:

1. Dr. Rohit Agrawal

2. Dr. T.U. Sukumaran

3. Dr. A. Parthasarathy

4. Dr. Sailesh Gupta

5. Dr. S.S. Kamath

6. Dr. Raju C Shah

7. Dr. C.P. Bansal

8. Dr. Arun Shah

9. Dr. Shivananda

10. Dr. Baldev S Prajapati

11. Dr. M Indra Shekhar Rao

IAP Guide Book on Safe Injection Practicesxii

12. Dr. Alok Gupta

13. Dr. M.A. Mathew

14. Dr. Anil Mishra ( BD India)

15. Dr. Bhaskar J. Sonowal ( BD India)

16. Dr. Om Prakash Kansal (BD India)

The Group of Experts got fully apprised to the recent advances and updates on given topics and sub-topics, to ensure that updates on these areas are available for the readers. However, the readers are recommended to continue updating their knowledge on given topics and sub-topics as this is a dynamic field and the advances in technology which can reinforce safety are necessary to be thoroughly understood.

Dr. A. Parthasarathy

Dr. S.S. Kamath

Dr. Anil Mishra

IAP Guide Book on Safe Injection Practices xiii


Table of Contents

Chapter - 1.1 Achieving Comprehensive Safety through a Safe Injection Environment 1-5

Chapter - 1.2 Importance of Injections and Injection Safety; Creating The Safe Environment 6-11

Chapter - 1.3 Rational Use of Injections 12-16

Chapter - 2 Best Practices to Ensure Injection Safety 17-25

Chapter - 3.1 Methods of Injection Delivery 26-35

Chapter - 3.2 Phlebotomy 36-47

Chapter - 3.3 IV Cannulation : A Process Oriented Approach 48-65

Chapter - 4.1 Injection Safety- Slicing The Problem of Reuse of Syringes 66-71

Chapter - 4.2 Healthcare Workers Safety 72-88

Chapter - 4.3 Injection Waste Disposal 89-97

Chapter - 5 Newer Technologies available in India to ensure Injection Safety 98-117

Chapter - 6 Surveillance mechanisms to understand Injection Safety 118-122

Chapter - 7 IAP Recommendations on Injection Safety 123-128

Evolution of Syringes-a pictorial journey 131

Resources and Links on Injection Safety 132

Points for Surveillance on Safe Injection Practices 133

IAP Plan of Action on Safe Injection Practices 134

Annexure - I WHO Fact Sheet on Injection Safety 129-130

Annexure - II

Annexure - III

Annexure - IV

Annexure - V

Chapter Page No.Title

Injection is one of the most common healthcare interventions globally. WHO estimates that at least 16 billion (1600 crores) injections are delivered annually throughout developing and transitional countries. It is also reported that 90-95% of all injections are in the curative sector for routine care, not for immunization. The INCLEN (International Clinical Epidemiology Network) report of Assessment of Injection Practices in India, 2004 found that approximately 6 billion injections are given in this country every year; however it has also been reported by industries that only 3 billion syringes are actually manufactured. This clearly spells out the huge magnitude of reuse of syringes in India. This definitely needs to be addressed urgently to avoid incidents such as those of Modasa (Gujarat) and Fatehabad (Haryana) where hundreds of people lost their lives due to improper reuse of syringes. Reuse of syringes can easily be prevented by using appropriate devices such as Reuse Prevention (RUP) syringes and following best clinical practices for injection safety.

Sharps waste management is another area that should be considered as an important area that needs urgent attention. Healthcare workers, housekeeping staff and the general community are often at risk of infection due to accidental needlesticks when sharps are not appropriately contained. Varied sharps management practices occur throughout India, some of which have been scientifically proven as being potentially harmful to human health. However, due to lack of understanding, awareness and will, several such approaches are still being adopted. Needle burners, often used to blunt the sharp tips of needles, have been shown to cause fumes, aerosol spread of infections, blood and medicine splatter and have been discontinued in developed countries, but their usage in India is still rampant posing a threat to the health of the healthcare workers. Puncture-resistant sharps containers, which have been recommended by the United States CDC (Center for Disease Control and Prevention) are not being universally adopted due to the recurrent costs and inadequate infrastructure at the Combined Waste Treatment Facility (CWTF) to deal with autoclaving and shredding these containers. This lack of adoption helps propagate outdated practices like needle burning.

Above all, injection Safety is compromised on several occasions in our healthcare settings, due to the lack of awareness. Injection Safety is not a high focus component of healthcare workers training (doctors, nurses paramedical workers etc) and most of the understanding on injections is by the simple rule of on the job training. Therefore, if a

Chapter - 1.1Achieving Comprehensive Safety through a

Safe Injection Environment

IAP Guide Book on Safe Injection Practices 1

1.1


wrong practice is adopted by the person who is followed by healthcare workers all the healthcare workers learn the same mistakes and thus the effects are multiplied manifold in actual practice. There is therefore a need for a training module that can help address this most common intervention in healthcare – Injection Safety.

The concept of Injection safety can be easily understood if we consider the science behind this. It can be thought of as an roadmap where different actions work in tandem, all aligned to create a “Safe Injection Environment”.

Figure: The model on Safe Injection Environment (courtesy: Becton Dickinson)

Explaining the Safe Injection Environment (SIE):

The Safe Injection Environment aims to combat the spread of bloodborne pathogens and avoid clinical complications associated with unsafe injection practices through comprehensive solutions across the continuum of care. Injection safety is not only about a syringe with a needle inserted into a human body to deliver a medication safely. It has several components that go on to make a program in itself, a program that seeks to improve not just the individual practice, but also the environment in which injections are given.

The critical step towards ensuring a SIE is to ensure that the devices that are meant to be used for injections are affordable (especially in resource constrained settings), that they

Safe InjectionEnvironment

Safe DisposalSystems

Affordability, Accessibility and Availability

ASafe InjectionEnvironment

Policy & Compliance

Aspiration

Enablers:

Foundation:

IT & Info. DeliveryCapability

OptimizedWorkflow

Risk Assess. / Surveillance

Alternate / NewTechnologies

OptimizedProduct Array

On-going HCWEducation &

Training

Green Solutions / Landfill Diversion

IAP Guide Book on Safe Injection Practices2

1.1


are accessible (it makes no sense if the affordable injection equipments are not accessible to the provider) and available to the user

Box-1: Optimized Product Array

The foundation for the SIE happens to be that such devices that are affordable, accessible and available have an optimized product array. For example, while reconstituting medications, a standard injectable needle should not be used because – 1. Using an injectable needle can cause an accidental needlestick injury to the person doing the reconstitution & 2. Such needles do not provide for glass particles to be filtered out, which may then be injected to the recipient. In such situations using a blunt filter needle may be helpful and more clinically appropriate. Another example is that while drawing blood in an emergency situation it is highly possible that due to the rush in patients, there could be inadvertent placement of sharps in places where there may be high chances of accidental needlestick injuries. Moreover in such situations the HIV status of the patients may not be known. To help the healthcare workers in such a situation it is prudent to use safety devices (safety shielded needles) instead of conventional. It is necessary to have an appropriate array of products to build a safer injection environment.

Box - 2: Ongoing healthcare workers Education and Training

Healthcare workers are a respectable and sometimes limited resource that should be protected while carrying out their healthcare delivery responsibilities. Moreover these healthcare workers should be kept engaged and updated on the ways in which to treat patients as well how to take care of themselves. The high turnover of such healthcare resources, often leads to situations where training and education becomes paramount. Through education and training programs, it can be ensured that Injection Safety can be practiced – through processes that are safe to the patient, safe to the healthcare worker and safe for the community.

Box - 3: Safe Disposal Systems

Biomedical waste is amongst the most dangerous of any waste that is generated, primarily because of the numerous contaminants that could cause potentially life- threatening illnesses if any person were to inadvertently get exposed to untreated biomedical waste. Sharps waste, generated from needles and cannulae, are amongst the most dangerous of the biomedical waste due to the risk of transmission of blood-borne pathogens.

To ensure the safety of the community as well as the environment, it becomes necessary to ensure that the right products and processes are adopted for collection, storage, transportation, disinfection and treatment of such biomedical waste. Injection safety


1.1


can never be fully achieved if a modern, reliable and scientifically sound system of handling biomedical waste is not available.

Box - 4: Green Solutions / Landfill diversions

With the growing importance being laid on developing a greener planet and reducing the carbon footprint, some companies have been taking measures to help reduce the environmental impact of healthcare delivery. International companies have invested tremendous R&D resources in developing unique programs that reduce the amount of plastic used to make injection devices, while retaining required performance attributes. Moreover certain programs have been introduced to ensure that sharps disposal containers and all contents therein can be appropriately shredded and recycled, preventing plastic waste from accumulating in landfills.

Box - 5: Optimized workflow

It is important to ensure that the processes and protocols are available for healthcare workers to optimize their workflow. Rational use of injections and standardization of best practices for injection safety helps to limit clinical variability. When variability is reduced and workflow is optimized, healthcare can be delivered more effectively and efficiently, leading to higher healthcare worker and patient satisfaction.

Box - 6: Risk Assessment / Surveillance

A critical step towards an SIE, is to ensure that appropriate data is captured in a reliable and consistent manner to monitor progress and improvement. Such data would help the decision makers of the hospital or policy makers in taking the right steps to ensure patient and healthcare workers safety. The data collected should be uniform and complete, so that it is comparable and adequate correction measures in safety can be taken.

A uniform software format like EPINet (Exposure Prevention Information Network) developed by the University of Virginia, can help collect information on needlestick injuries and blood and body fluid exposures. Data collected through this system helped change the policy on sharps in the United States. In December 2000, President Bill Clinton signed the historic act that mandates the use of Safety Engineered Devices in US healthcare facilities. This was due in large part to data that demonstrated the high incidence of needlestick injuries, the risks of bloodborne disease transmission and the importance of protecting healthcare workers from such injuries.

Box - 7: Alternate / New Technologies

Companies are working continuously to develop products that cater to the unmet needs of patients, healthcare workers and the community. Such new technologies are being developed after prudent R&D to ensure that the technology is continuously


1.1


upgraded to meet the challenges of the new healthcare needs. Adopting such proven technology is always a positive step towards ensuring comprehensive injection safety.

Box - 8: IT & Information delivery capability

IT has revolutionalized the world and has shortened distances. In healthcare, adoption of IT and using IT to enhance patient & healthcare workers benefits is apt to keep pace with the ever-changing medical world. Surveillance processes can get immediate feedback, which can help decision makers to take the right steps on safety. Benchmarking against industry standards and comparing available information helps healthcare organizations know exactly where they stand. Outbreaks can easily be identified and acted upon. Such steps only help healthcare get ready to meet newer challenges.

Box - 9: Policy and Compliance

For any decision to be taken, it is prudent that the decision maker is armed with data-driven information that can demonstrate the impact of certain healthcare interventions on improving delivery of care. The SIE framework could help influence local, state or even national policies on comprehensive injection safety by demonstrating wins and positive measures that make a large public health impact. Adoption of this framework would definitely help in ensuring Injection Safety across healthcare settings.

However, even after a policy is developed to adopt SIE, adherence to the protocols is important so that there is no reversal of the gains made. Continuous monitoring of the activities is important and so is the feedback that is provided. This leads to an environment of continuous improvement. Behaviour change would only happen if habits are concretely formulated. This would help healthcare organizations in reaching the aspired goal of a Safe Injection Environment leading to comprehensive safety across the continuum of care. The current initiative of IAP attempts to address all dimensions of safety as stated above for achieving highest standards of injection safety for the benefit of people, the patients and the healthcare professionals.


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Injection is the commonest procedure carried out by the health care providers all over the world. Over 22 billion (2200 crore) injections are given in the world, of which16 billion (1600 crore) injections are given every year across the developing countries. Majority of these injections, over 95%, are given for therapeutic purpose. only 3% are used for immunization activity and over 2% are used in laboratory work.

Rational use of injection is a highly important subject that is needed to be emphasized, as nearly70% of injection that are being administered are actuary unnecessary.

WHY PEOPLE PREFER INJECTIONS?

People prefer injections because

• They believe injections act fast.

• Some Doctors regard injections as the best form of treatment

Doctors prescribe injections to satisfy the patients, even though by counseling they can avoid giving these unnecessary injection. Some practitioners do it for commercial gains which is not an ethical practice.

WHAT IS A SAFE INJECTION?

A safe injection does no harm to the patient, health care giver and to the community. If injections are not delivered in a safe manner, it exposes people to dangerous and deadly infections.

Millions are exposed to serious infections due to unsafe injection practices like re use of syringes.Studies in many countries have shown that more often injections are given by dipping the syringes in boiling water in the sterilizer. The study done by INCLEN in INDIA has shown that 66% of injections are unsafe. Reuse of syringes is rampant to the extent o f 40 -60%. Industry trends indicate that 5.8 injections are received by an individual on an average annually.

Poor collection and disposal of injection waste practiced in many situations, in private and public sector both, not only expose the health workers but also the community to the hazard of needle stick injuries and thereby to the risk of contracting life threatening infections.

Improper disposal of injection waste has other dimension of resale of used syringes and needles and intravenous line tubings. These are rerouted to the health care settings for mere commercial gains.

Chapter - 1.2Importance of Injections and Injection Safety;

Creating The Safe Environment


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DISEASES ASSOCIATED WITH UNSAFE INJECTION PRACTICES

It is estimated that each year 13 Lac new deaths are attributed to UNSAFE INJECTIONS. and about 2700 million Rupees are spent as medical cost, to treat resulting infections.

Unsafe injections are known to transmit blood borne pathogens like bacteria, virus and parasites, particularly, potentially lethal and dangerously morbid diseases like Heptitis B, Hepatitis C, HIV, Malaria and other local and systemic bacterial infections.

Nearly 22 million people are infected each year representing 33% of new HBV infections 42% of new HCV infections and 2% of all new HIV infections that are attributable to unsafe injections.

WHAT NEEDS TO BE DONE TO CHANGE THIS SCENARIO

Safe and appropriate use of infections is the only way and injection safety and basic infection control practices are central to patient safety of saving the man kind from deadly diseases which can be achieved by 3 ways:

• Behavioural change of health care providers.

• Availability and sustained supply of injection equipments.

• Safe and appropriate management of injection waste.

Of late it has been observed that in many countries consumers are demanding the safe and quality injection equipments and and are concerned about safe disposable methods.

There is an urgent need to ensure availability and sustained supply of safe injections equipments like disposable syringes with safety features to prevent re-use, both at curative and preventive settings to enable the health care workers to use them and to meet the demand of consumers, The supply of disposables and waste disposable should be available as bundle to facilitate the health care givers to practice appropriately.

Many countries are adopting the national policy on hospital waste management. Health care providers at all level of care both in private and public settings are oriented in safe injection practices however this is not happening in small care establishments.

A comprehensive system of implementation, creation of awareness and training of health workers as per the local need to be developed.

WHO through safe injection global network, SIGN, provide technical advice through policy guidelines, decision making, management and advocacy tools to help member countries implement the system of safe injection practices by providing the affordable equipments, capacity building of HCWs and materials to promote rationle use of injections. SIGN also developed specific standard for AD syringes for use in immunization and curative sector.


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To ensure rational use of injections WHO urges its member countries to develop national drug policy which is essential for appropriate use of drugs and injections. It will also help in removal of unnecessary injectable medicines from essential drug list.

WHO developed guiding principles to ensure injection device security by emphasizing the need of sustained supply chain of injection equipments to each health facility in the public health system.

Center Of Disease Control and Prevention (CDC, Atlanta) has also emphasized the need of safe injection practices through use of technology, trainings and appropriate policy frameworks.

APIC RECOMMENDATIONS

The APIC (Association for Professionals in Infection Control and Epidemiology (APIC) full) strongly supports adherence to the following safe injection, infusion and medication vial practices .

• Perform hand hygiene (handwashing with soap and water or by application of a 60% or greater alcohol-hand sanitizer rub that is allowed to dry) before accessing supplies, handling vials and IV solutions and preparing or administering medications.

• Use aseptic technique in all aspects of parenteral medication administration, medication vial use, injections and glucose monitoring procedures.

• Store and prepare medications and supplies in a clean area on a clean surface.

• Never store needles and syringes unwrapped because sterility cannot be ensured.

• Discard all opened vials, IV solutions and prepared or opened syringes that were involved in an emergency situation.

• Avoid contacting sterile drugs and sterile areas of devices and containers with non-sterile objects and/ or secretions and particles shed from personnel.

IV SOLUTIONS

• Never use IV solution containers (eg, bags, bottles) to obtain flush solutions or for any other purpose for more than 1 patient.

• Never use infusion supplies, such as needles, syringes, flush solutions, administration sets, or IV fluids, on more than one patient.

• Disinfect IV ports and vial stoppers by wiping with sterile 70% isopropyl alcohol.

FLUSHING

• Use single-dose containers for flush solutions, when ever possible.


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• If a multi-dose vial must be used, use it for only one patient and then discard it. Each entry into the multi-dose vial (dedicated to that patient) must be made with a new, unused sterile needle and a new, unused sterile syringe.

SYRINGES

• Remove the sterile needle/cannulas and/or syringe from the package immediately before use.

• Never use a syringe for more than one patient even if the needle has been changed between patients. Changing the needle but not the syringe is unacceptable.

• Use a new syringe and a new needle for each entry into a vial or IV bag.

• Utilize sharps safety devices whenever possible. Discard syringes, needles and cannulas immediately after use.

• Dispose off used needles/syringes at the point of use in an approved sharps container.

• Do not prepare medication in one syringe to transfer to another syringe.

• Never store or transport syringes in clothing or pockets.

• Prepare syringes as close to administration as possible.

VIALS

• Always follow the manufacturer's instructions for storage and use.

• Use single-use or single-dose vials whenever possible.

• Cleanse the access diaphragm of vials using sterile 70% isopropyl alcohol.

• Discard single-dose vials after use. Never use them again for another patient.

• Discard any vial that has been placed on a contaminated surface or a used procedure tray or that has been used during an emergency procedure.

• Dedicate multi-dose medication vials for a single patient. Access all vials using a new sterile syringe and new needle/cannula adhering to aseptic technique.

• Never store or transport vials in clothing or pockets.

• Never leave a needle, cannula, or spike device (even if it has a 1-way valve) inserted into a medication vial rubber stopper because it leaves the vial vulnerable to contamination.

• Do not use expired drugs.


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• All vials used during an emergency should be discarded because sterility cannot be guaranteed.

BLOOD GLUCOSE MONITORING DEVICES

• Assign a glucometer to each individual patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients.

• Use single-use lancets that permanently retract after puncture.

• Never reuse finger stick devices and lancets.

• Thoroughly clean all visible soil or organic material (eg, blood) from the glucometer before disinfection.

SOME GENERAL POINTS

• Provide the HBV vaccination series to all previously unvaccinated health care personnel whose activities involve contact with blood or body fluids.

• Immediately report body fluid exposures and needle-stick/sharps injuries.

• Ensure that staff preparing or administering injections or other parenteral medications are competent to perform these tasks aseptically.

• Periodically assess compliance with safe injection practices by observing and evaluating all personnel performing these procedures.

Phlebotomy, hepatic procedures, dialysis, endoscope settings are the risky areas for Health Care Workers (HCW) and patients. Catastrophic outbreaks have been reported in these settings due to unsafe injections practices and these areas are known for unrecognized transmission

CONCLUSION

Health care providers everywhere need to spend time along with their colleagues to review injection practices and other issues of care to ensure the safe injection practices are understood and followed to save themselves, patients and community. Safe injection practices are also critical to prevent microbial contamination of products administered to patients.

Different reports of HBV and HCV transmission and outbreaks of bacterial infections from different regions indicate that much more is needed to ensure that preventive practices are being scrupulously followed in all health care settings.

HCWs and their managers must understand and practice these procedures safely. Administrators of medical facilities must be aware of safe injection practices and ensure that employees have the knowledge, training and equipment to safely implement these procedures.


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Continuing education efforts should be aimed at practicing safe injection practices. It is critical that injectable medications, IV delivery systems and blood glucose monitoring devices are used safely in all health care settings.

We have an obligation to reiterate and ensure that safe injection, infusion and medication vial practices are the absolute standard of care throughout various health care settings and across the continuum of care. We must take a lead in promoting adherence to these safe Injection practices by Health care Providers to protect the health and safety of the patients under our care.

POINTS TO REMEMBER

• Health care providers should prioritize improving their knowledge and skills on injection safety.

• Ensuring injection safety as a preventive practice, should be followed in all health care settings.

• Administrators of medical facilities should understand safe injection practices and ensure skill building and compliance at the facility level.

• Continuing education efforts aimed at improving injection safety standards should be accorded high priority.

References:

1. Safe injection practices to prevent transmission of infections to patients CDC2007 guidelines

2. AJIC Injection Practces Among Clinicians of United States Health Care settings 2010

3. WHO SIGN MEETING PROCEEDINGS 2010

4. WHO Injection Safety Guidelines

5. BD Safe Injection Practice Coalition FEB2009

6. CDC PREVENTION OF UNSAFE INJECTION PRACTICES


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BACKGROUND

Medically inappropriate, ineffective and economically inefficient use of pharmaceuticals is commonly observed in health care systems throughout the world, especially in developing countries. However, various forms of inappropriate prescribing often remain unnoticed by those who are involved in health sector decision making or delivery of health services. This problem will usually come to the attention of health decision makers or managers when there is an acute shortage of pharmaceutical budget that requires action for cost-efficiency or there is a resistance to a particular drug.

Promoting appropriate use of drugs and Injections in the health care system is needed because of

a) Financial reasons with which policy makers and managers are usually most concerned.

b) An essential element in achieving quality of health and medical care for patients and the community.

Actions or intervention programs to promote the appropriate use of drugs and injections should, therefore, be continuously implemented and systematically incorporated as an integral part of the health care system.

Defining Rational Use of Drugs (including injections)

People may have different perceptions and meanings regarding rational use of drugs, or more specifically regarding rational prescribing. However, the Conference of Experts on the Rational Use of Drugs, convened by the World Health Organization in Nairobi in 1985, defined rational use as follows:

Rational use of drugs requires that patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time and at the lowest cost to them and their community.

Injections are a form of drug administration and choosing this form of administration for the patient needs utmost caution.

The requirements for rational use will be fulfilled if the process of prescribing is appropriately followed. This process includes steps in defining a patient's problems (or diagnosis); in defining effective and safe treatments (drugs and non drugs); in selecting

Chapter - 1.3Rational Use of Injections


1.3


appropriate drugs, dosage and duration; in writing a prescription; in giving patients adequate information; and in planning to evaluate treatment responses.

The definition implies that rational use of drugs and injections, especially rational prescribing, should meet certain criteria as follows:

• Appropriate indication. The decision to prescribe drug(s) is entirely based on medical rationale and the chosen therapy is an effective and safe treatment.

• Appropriate molecule. The selection of molecule for a patient is based on efficacy, safety, suitability and cost considerations.

• Appropriate patient. No contraindications exist, the likelihood of adverse reactions is minimal and the drug is acceptable to the patient.

• Appropriate patient information. Patients are provided with relevant, accurate, important and clear information regarding their conditions and the medication(s) that are prescribed.

• Appropriate evaluation. The anticipated and unexpected effects of medications are appropriately monitored and interpreted.

Unfortunately, in the real world, prescribing patterns do not always conform to these criteria and can be classified as inappropriate or irrational prescribing. Irrational prescribing may be regarded as "pathological" prescribing when the above-mentioned criteria are not fulfilled. Common patterns of irrational prescribing may, therefore, be manifested in the following forms:

• The use of drugs when no drug therapy is indicated, e.g., antibiotics for viral upper respiratory infections.

• The use of correct drugs with incorrect administration, dosages and duration, e.g., the use of IV metronidazole when suppositories or oral formulations would be appropriate.

• The use of injections due to patient's request or commercial gains.

• The use of the wrong drug for a specific condition requiring drug therapy, e.g., tetracycline in childhood diarrhea requiring ORS.

• The use of drugs with doubtful or unproven efficacy, e.g., the use of antimotility agents in acute diarrhea.

• The use of drugs of uncertain safety status, e.g., use of dipyrone (Baralgan, etc.).

• Failure to provide available, safe and effective drugs, e.g., failure to vaccinate against measles or tetanus, or failure to prescribe ORS for acute diarrhea.


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The use of unnecessarily expensive drugs, e.g. the use of a third generation, broad-spectrum antimicrobial when a first-line, narrow spectrum agent is indicated.

Some examples of commonly encountered inappropriate prescribing practices in many health care settings include:-

• Overuse of antibiotics and antidiarrheals for nonspecific childhood diarrhea.

• Indiscriminate use of injections, e.g., in malaria treatment.

• Multiple or over-prescription.

• Excessive use of antibiotics for treating minor ARI.

• Multivitamins and tonics for malnutrition.

• Unnecessary use of expensive antihypertensives.

The drug use system is complex and varies from country to country. Drugs may be imported or manufactured locally. The drugs may be used in hospitals or health centers, by private practitioners and often in a pharmacy or drug shop where over the counter preparations are sold. In some countries all drugs are available over the counter. Finally, the public includes a very wide range of people with differing knowledge, beliefs and attitudes about medicines. Consumers may have a very different perspective of what is rational.

Factors Underlying Irrational Use of Drugs and Injections

Many different factors affect the irrational use of drugs. In addition, different cultures view drugs in different ways and this can affect the way drugs are used.

The major forces can be categorized as those deriving from patients, prescribers, the workplace, the supply system including industry influences, regulation, drug information and misinformation and combinations of these factors.

Patients - Drug misinformation

- Misleading beliefs

- Patient demands/expectations

Prescribers - Lack of education and training

- Inappropriate role models

- Lack of objective drug information

•


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- Generalization of limited experience

- Misleading beliefs about drugs efficacy

Workplace - Heavy patient load

- Pressure to prescribe

- Lack of adequate lab capacity

- Insufficient staffing

Drug Supply System - Unreliable suppliers

- Drug shortages

- Expired drugs supplied

Drug Regulation - Nonessential drugs available

- Informal prescribers

- Lack of regulation enforcement

Industry - Promotional activities

- Misleading claims

All of these factors are affected by changes in national and global practices. For example, the frequent use of injections is declining in many African countries because of the fear of AIDS. In some countries, however, the use of injectables remains high due to false assumption of prescribers that injections will improve patient satisfaction and that they are always expected by the patients.

Impact of Inappropriate Use of Drugs

The impact of this irrational use of drugs can be seen in many ways:

• Reduction in the quality of drug therapy leading to increased morbidity and mortality.

• Waste of resources leading to reduced availability of other vital drugs and increased costs.

• Increased risk of unwanted effects such as adverse drug reactions and the emergence of drug resistance, e.g., malaria or multiple drug resistant tuberculosis.


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Psychosocial impacts, such as when patients come to believe that there is “a pill for every ill.” This may cause an apparent increased demand for drugs.

Hospital Problems

Drug use in hospitals has been a neglected area. However in both developed and developing countries, the misuse of antibiotics, particularly for surgical prophylaxis, has been widely reported. More so, the hospitals choose injectable form than oral medications in such scenarios. Hospitals have been able to improve antibiotic use through the use of formularies.

Points to Remember

• Never use injections due to patient's request or commercial gains.

• Appropriate indication. The decision to prescribe injections is entirely based on medical rationale and the chosen therapy is an effective and safe treatment. Analyze patients condition and then only prescribe injections if at all required.Prefer oral medications if patients'scodition permits.

• Appropriate molecule. The selection of suitable molecule for a patient is based on the disease condition, drug's efficacy, safety, suitability and cost considerations.

• Appropriate patient. No contraindications exist, the likelihood of adverse reactions is minimal and the drug is acceptable to the patient.

• Appropriate patient information. Patients are provided with relevant, accurate, important and clear information regarding their conditions and the medication(s) that are prescribed. Discourage them to unnecessarily ask for injections.

• Appropriate evaluation. Monitor the patient for anticipated and unexpected effects of medications given through injections.

References:

Laing RO. Rational drug use: an unsolved problem. Trop Doct. 1990; 20:101–3.

Avorn J, Harvey K, Soumerai, SB et al. Information and education as determinants of antibiotic use. Rev Infect Dis. 1987; 9(S3):S286–96.

Vance MA, Millington WR. Principles of irrational drug therapy. Int J Health Serv. 1986;16(3):355–61.

Quick JD, Foreman P, Ross-Degnan D, et al. Where Does the Tetracycline Go?: Health Center Prescribing and Child Survival in East Java and West Kalimantan, Indonesia. Boston: Management Sciences for Health, October 1988.

Ross-Degnan, D, Laing RO, Quick, JD et al. A strategy for promoting improved pharmaceutical use: The International Network for Rational Use of Drugs. Soc Sci and Med. 1992 35 (11) 1329–41.

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Background

In transitional and developing countries where unnecessary injections are common, the

average number of health care injections per person was estimated to be 3.7 per year

(this includes all health care injections, including those given to diabetics for

administering insulin). Many injections, as well as being unnecessary, are also unsafe.

Each year, the reuse of injection equipment may cause 20 million infections with

hepatitis B virus (HBV), 2 million infections with hepatitis C virus (HCV) and 250 000

infections with human immunodeficiency virus (HIV) worldwide. These chronic

infections lead to a high burden of morbidity and mortality.

No evidence-based guidelines are available to guide injection providers through the

steps they should follow to prevent injection-associated infections. IAP with the

objective of addressing the issue in reference, have worked to develop guidelines and

recommendations which are based on the WHO framework. This chapter would throw

light on vital aspects of this.

Potentially Critical Issues

An injection is a procedure that introduces a substance into the body by piercing the skin

or a mucosal membrane and thus carries the risk of introducing disease causing agents

from outside to inside the body, Therefore some vitally important precautions should

always be practiced by the injection providers. The potentially critical issues which carry

a risk of causing infections amongst the recipient, the providers and the community in

general as well, are listed in the table below

Chapter - 2Best Practices to Ensure Injection Safety


2


Potential Source of contamination and stages of occurrece

Use of sterile injection equipment

The most important infection control measures for preventing infection among injection recipients is the use of a sterile syringe and needle for each injection and to reconstitute each unit of medication (for medications that require a diluent). In many

countries, the practice of reusing injection equipment in the absence of sterilization is

common and such practices have been associated with infections.

Use of a new, single-use syringe and needle provides the highest level of safety to the

recipient. However, unreliable and insufficient supplies might lead to the equipment being reused. Even though boiling injection equipment for 20 min does not sterilize it, the use of pans to boil single-use injection equipment is common in developing and transitional countries. In many instances these pans are used as containers of tepid

water where injection equipment is simply rinsed and soaked between injections Also, it

is necessary to use injection equipment that has been inspected for breaches in barrier

Potential source of Stage at which contamination Potentially critical issuescontamination or exposure or exposure might occur

Preventing infection amonga injection recipients

Injection equipment Sterilization 1. Sterilization of injection equipmentStorage 2. Duration and conditions of storageHandling 3. Handling of injection equipment

Injected substance Before opening 4. Type of medication5. Medication and vial check

During opening 6. Swabbing of vial stopper/neck7. Filing and breaking of ampoules and vials

After opening 8. Handling of multi-dose vialsSkin of the recipient Introduction of the needle 9. Site of injection administration

10. Skin preparationEnvironment Injection preparation 11. Injection preparation area

12. Aseptic techniquesHands of the provider Injection preparation and administration 13.Hand Hygiene

Preventing infection amongb injection providers

Exposure to the injection recipient’s During injection administration 14. Preparation and/or restraint of patientblood through needle-stick injury Handling of injection equipment 15. Needle recapping

after use 16. Needle removal17. Needle cutting18. Rising and dissembling sterilizable equipment

Collection of contaminated equipment 19. Use of sharps containers20. Improper disposal of sharps21. Quality of sharps containers

Sharps waste management 22. Removal of containers used to collect sharps

Preventing infectionbin the community

Exposure to the injection recipient’s Sharps waste management 23. Storage of containers used to collect used SharpsBlood through needle-stick injury 24. Terminal disposition of sharps waste

a Contamination.b Exposure.


2


integrity and to discard it if it is punctured, torn, or damaged. By inspecting the packaging of individual syringes,we can also have an idea about the completeness of process of sterilization using Ethylene Oxide (ETO), which is carried out by the manufacturers.. In the ribbon packs one should observe for presence of a paper strip with perforations, which allow the ETO to enter and diffuse out. ETO sterilizes the injection equipment and this effect is long lasting. Excess of residual ETO has carcinogenic effects. If the packaging says that the syringe is ETO sterilized and the paper used in not medical grade paper (flow wrap and blister packs) or there is no paper strip with perforations (ribbon packs), then the quality of sterilization is doubtful.

Preventing contamination of injection equipment and medication

Work environment. It is important to prepare injections in a clean designated area, where the risk of contamination by blood or body fluids is low. HBV persists for up to seven days on surfaces, which can potentially lead to environmental contamination. Environmental contamination is a potential source of HBV infection in settings where chronic haemodialysis is performed.

Factors that might facilitate HBV transmission among patients receiving chronic haemodialysis include a high prevalence of HBV infection among patients, an environmental contamination with blood, a high frequency of percutaneous procedures and the presence of patients with high levels of viraemia. These factors might also be found in other health care settings because of following features:-

• High HBV endemicity

• Limited implementation of standard precautions

• Overuse of injections

• The presence of people in whom the HBV replicates actively (e.g. children)

In Romania, for example, where some of these conditions were present, HBV infection was associated with injections in 1998. However, a review of injection practices in Romania suggested that HBV transmission was probably related to the preparation of injections in environments that were potentially contaminated with blood or body fluids. The preparation of injections in contaminated environments might also lead to bacterial infection.

Multi-dose vials. It is important to use single-dose vials rather than multi-dose vials whenever possible. Although preservatives reduce the survival of bacteria, multi-dose vials remain prone to bacterial contamination and the use of multi-dose vials has been reported to be a potential source of infections in number of studies. Needles left in the septum of multi-dose vials might encourage the use of the same syringe to repeatedly draw medications for one patient, a practice that may lead to vial contamination and


2


infections among subsequent patient,. Thus, if multi-dose vials must be used, it is essential that the person administering the injection pierces the septum with a separate sterile needle and it is important not to leave any needle in place in the stopper.

A vial showing a needle in Septum

Breaking vials and ampoules. Injuries to injection providers can be another source of infection. While opening glass ampoules, providers may lacerate their hands, which can bleed and may cause infections. Thus, it is important to use pop-open ampoules and vials rather than that need to be opened using a metal file. If a metal file is to be used, the fingers should be protected using a clean barrier (e.g. small gauze pad).

Compromised packaging. Cracks and leaks in vials are a potential source of contamination. Although it is not known how effective a visual examination of the vial is in preventing infections, it is important to inspect the vial for and discard medications with visible contamination or breaches of integrity (e.g. cracks or leaks) and to follow product-specific recommendations for use, storage and handling.

Aseptic techniques. Medical devices might become contaminated with bacteria if touched. Thus, a needle that has touched any non-sterile surface must be discarded.

Provider's hand hygiene and skin integrity. Washing or disinfecting hands is a standard procedure that is carried out before preparing injection material. The need for hand hygiene between each injection will vary depending on the setting and on whether the health care worker has had contact with soil, blood, or body fluids. Injections have been administered in the absence of hand-washing. Skin lesions and skin irritation are associated with bacterial contamination. Thus, it is necessary to avoid giving injections if skin integrity is compromised by local infection or other skin conditions (e.g. weeping dermatitis) and to cover any small cut. This has been described in details in the chapter on injection methods.


2


Swabbing vial tops Cotton balls and gauze stored wet in antiseptics might become

contaminated and have contributed to infections among patients, particularly when

benz-alkonium chloride was used. Thus, if swabbing with an antiseptic is selected for

use, an isopropyl alcohol swab must be used. Cotton balls stored wet in a multi-use

container must not be used.

Skin preparation of patient before injection. While the benefit of skin preparation is

unclear, unsafe skin preparation protocols may be harmful. Thus, if swabbing with an

antiseptic is selected for use, an isopropyl alcohol swab must be used. Cotton balls

stored wet in a multi-use container must not be used.

Prevention of needle-stick injuries to the provider

Best infection control practices for preventing infections among injection providers

address the prevention of movements of patients, the prevention of unsafe recapping of

needles and the collection of contaminated sharps in puncture-proof and liquid-proof

containers.

Movement of patients. Needle-stick injuries to providers when administering

injections are usually attributable to the abrupt movement of patients during the

procedure. Thus, it is important that providers anticipate and take measures to prevent

sudden patient movement during and after injection. In some instances, physical

assistance from other health care workers or family members might help to ensure that

the procedure is carried out under appropriate circumstances.

Recapping. Avoiding recapping of needles and other hand manipulations of used

needles is essential for preventing needle-stick injuries. A high proportion of needle-

stick injuries are attributable to recapping.

Sharps collection. It is important to collect and properly contain syringes and needles

at the point of use in a sharps container that is resistant and leak-proof and that is sealed thbefore it is full up to 3/4 level. Unsafe sharps waste collection causes between 5% and

28% of needle-stick injuries as per NIOSH. Puncture and liquid-proof containers

designed for the collection of contaminated sharps are associated with a lower risk of

needle-stick injuries than regular cardboard boxes. The presence of sharps containers

close to the point of use reduces the incidence of recapping and of recapping related

needle-stick injuries. Interventions that combine the provision of sharps containers and

risk communications reduce the total number of needle-stick injuries.


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Other practice issues

Engineered technologies. Current hypodermic needles and syringes with safety features for preventing needle-stick injuries require a provider-dependent activation step. Their effectiveness is unclear. None are able to protect the provider when giving an injection because the safety feature is only activated after use. Reports on the effectiveness of other, safer needle-bearing devices (e.g. intravenous catheters, phlebotomy needles) to protect health care personnel from needle-sticks are encouraging. Thus, whenever possible, devices designed to prevent needle-stick injury that have been shown to be effective for patients and providers are preferable.

Preventing infections in the community

Contaminated sharps are a potential source of biohazard to the community at large. To prevent people being exposed to contaminated sharps, it is important to seal sharps containers for transport to a secure area in preparation for disposal. After closing and sealing, sharps containers must not be opened, emptied, reused, or sold.

In South Asia, used injection equipment is sought for recycling, mostly for the plasticware industry Such practices might lead to needle-stick injuries among waste pickers and can lead to illegal repackaging of syringes for reuse in hospitals and clinics. Finally, it is important to manage sharps waste in an efficient, safe and environment-friendly way. Contaminated sharps were observed in the immediate surroundings of a high proportion of health care facilities in developing countries. Such unsafe sharps waste management exposes the community to needle-stick injuries.

Use of new single use equipment


2


Summary of best infection control practices for intradermal, SC and IM needle

injections

• Eliminating unnecessary injections is the highest priority in preventing injection-

associated infections.

• When injections are medically indicated, they should be administered safely.

• These best practices are measures that have been determined through scientific

evidence or expert consensus most effectively to protect patients, providers and

communities.

1. Use sterile injection equipment

• Use a sterile syringe and needle for each injection and to reconstitute each unit of

medication.

• Use a new, single-use syringe and needle.

• Inspect packaging for breaches in barrier integrity.

• Discard a needle or syringe if the package has been punctured, torn, or damaged.

2. Prevent contamination of injection equipment and medication

• Prepare each injection in a clean designated area, where contamination from

blood or body fluid is unlikely.

• Use single-dose vials rather than multi-dose vials.

• If multi-dose vials must be used, always pierce the septum with a separate sterile

needle.

• Do not leave a needle in place in the stopper of the vial.

• Select pop-open ampoules rather than ampoules that need to be opened by

using a metal file. If an ampoule that requires a metal file is used, protect fingers

with a clean barrier (e.g. small gauze pad) when opening the ampoule.

• Inspect for and discard medications with visible contamination or breaches of

integrity (e.g. cracks, leaks).

• Follow product-specific recommendations for use, storage and handling.

• Discard a needle that has touched any non-sterile surfaces.


2


3. Prevent needle-stick injuries to the provider

• Anticipate and take measures to prevent sudden movement of patient during and after injection.

• Do not recap needles and do not manipulate needles manually.

• Collect used syringes and needles at the point of use in an enclosed sharps thcontainer that is puncture-proof and leak-proof and that is sealed before it is ¾

full.

4. Prevent access to used needles

• Seal sharps containers for transport to a secure area in preparation for disposal. After closing and sealing sharps containers, do not open, empty, reuse, or sell them.

• Manage sharps waste in an efficient, safe and environment-friendly way to protect people from accidental exposure to used injection equipment.

5. Other practice issues

• Engineered technology. Whenever possible, use devices that have been designed to prevent needle-stick injury and have been shown to be effective for patients and providers. Auto-disable (AD) syringes are increasingly available to prevent the reuse of injection equipment in selected settings, including immunization services.

• Hand hygiene and skin integrity of provider. Perform hand hygiene (i.e. wash or disinfect hands) before preparing injection material and giving injections. The need for hand hygiene between each injection will vary depending on the setting and whether there was contact with soil, blood, or body fluids. Avoid giving injections if skin integrity is compromised by local infection or other skin condition (e.g. weeping dermatitis). Cover any small cuts.

• Gloves. Single-use gloves may be indicated if excessive bleeding is anticipated.

• Swabbing vial tops or ampoules. If swabbing with an antiseptic is selected for use, use a clean, single-use swab and maintain product-specific recommended contact time. Do not use cotton balls stored wet in a multi-use container.

• Skin preparation of patient before injection. Wash skin that is visibly soiled or dirty.. If swabbing with an antiseptic is selected for use, use a clean, single-use swab and maintain product-specific recommended contact time. Do not use cotton balls stored wet in a multi-use container.


2


References:

Hauri AM, Armstrong GL, Hutin YJF. Contaminated injections in health care settings. In: Ezzati M, Lopez AD, Rodgers A, Murray CJL, editors. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors. Geneva: World Health Organization; 2003.

Best infection control practices for intradermal, subcutaneous,and intramuscular needle injectionsYvan Hutin,1 Anja Hauri,2 Linda Chiarello,3 Mary Catlin,4 Barbara Stilwell,2 Tesfamicael Ghebrehiwet,5Julia Garner,2 & the Members of the Injection Safety Best Practices Development Group

Hauri AM, Armstrong GL, Hutin YJF. Contaminated injections in health care settings. In: Ezzati M, Lopez AD, Rodgers A, Murray CJL, editors. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors. Geneva: World Health Organization; 2003.

Dicko M, Oni AQ, Ganivet S, Kone S, Pierre L, Jacquet B. Safety of immunization injections in Africa: not simply a problem of logistics. Bulletin of the World Health Organization 2000;78:163-9.

Sopwith W, Hart T, Garner P. Preventing infection from reusable medical equipment: A systematic review.BMC Infectious Diseases 2002;2:4. Available from:URL: http://www.biomedcentral.com

Centers for Disease Control. Recommendations for preventing transmission of infections among chronic hemodialysis patients. Morbidity and Mortality Weekly Report 2001;50(RR05):1-43.

Hutin YJF, Craciun D, Ion-Neldelcu N, Mast EE, Alter MJ, Margolis HS. Using surveillance data to monitor key aspects of the epidemiology of hepatitis B virus (HBV) infection in Romania. Abstract presented at the annual meeting of the Infectious Diseases Society of America (IDSA). Denver (CO), November 1999. Dentinger CM, Hutin YJF, Pasat L, Mihilescu I, Mast EE, Margolis HS. Knowledge and practices of nurses regarding injection safety and use of universal precautions, Vilcea district, Romania. Abstract presented at the annual meeting of the Society for Healthcare Epidemiology of America (SHEA). San Francisco (CA), April 1999 (Abstract S 42).

Centers for Disease Control. Recommendations for preventing transmission of infections among chronic hemodialysis patients. Morbidity and Mortality Weekly Report 2001;50(RR05):1-43.

Simon PA, Chen RT, Elliot JA, Schwartz B. Outbreak of pyogenic abscesses after diphtheria and tetanus toxoids and pertussis vaccination. Pediatric Infectious Disease 1993;12:368-71.

Phillips G, Fleming LW, Stewart WK. The potential hazard of using multipledose heparin and insulin vials in continuous ambulatory peritoneal dialysis. Journal of Hospital Infection 1989;14:174-7.

Krause G, Whisenhunt S, Trepka M, Katz D, Nainan O, Wiersma S, et al. Patientto- patient transmission of hepatitis C virus associated with use of multidose saline vials in a hospital. Presentation given at the 49th Annual EpidemicIntelligence Service (EIS) Conference. Atlanta (GA), 2000.

Simon PA, Chen RT, Elliot JA, Schwartz B. Outbreak of pyogenic abscesses after diphtheria and tetanus toxoids and pertussis vaccination. Pediatric Infectious Disease 1993;12:368-71.

Phillips G, Fleming LW, Stewart WK. The potential hazard of using multipledose heparin and insulin vials in continuous ambulatory peritoneal dialysis. Journal of Hospital Infection 1989;14:174-7.

Sheth NK, Post GT, Wisniewski TR, Uttech BV. Multidose vials versus singledose vials: a study in sterility and cost-effectiveness. Journal of Clinical Microbiology 1983;17:377-9.

Parker MR. The use of protective gloves, the incidence of ampoule injury and the prevalence of hand laceration amongst anaesthetic personnel. Anaesthesia 1995;50:726-9. Bulletin

Ross RS, Viazov S, Gross T, Hofmann F, Seipp HM, Roggendorf M. Transmission of hepatitis C virus from a patient to an anesthesiology assistant to five patients. New England Journal of Medicine 2000;343:1851-4.


2


METHOS OF INJECTION DELIVERY

Commandments of Right Injection Delivery:

The right vaccine, right drug, to the right child, at the right age, at the right site, in the right dose, in right dose, right interval, by the right procedure at the right age is the best and cheapest investment a health-care system of any country can make for the positive health of its people.

To make sure that the entire process of administering an injection is safe, the equipments used, techniques applied and processes involved should be handled in an utmost safe and hygienic manner.

It is also known that skin and the environment contain microorganisms which may be commensals, but on the first opportunity can become pathogenic. Unsafe injections can spread pathogens more easily than by inhalation, swallowing or sexual activity, as they introduce them directly into the blood stream. As health care professionals, it is our responsibility to ensure that all healthcare interventions are safe for beneficiaries, the health care workers and the community at large.

HAND WASHING

Hands are the principal route by which cross-infection occurs.

Hand-washing is one of the most important standard precautions for preventing the spread of diseases. Hand decontamination is a simple and effective way in which Health Care Workers or Professionals (HCW/HCP) can prevent the transmission of infection between patients and protect themselves leading to a reduction in patient morbidity & mortality.

Hands must be decontaminated before and after every step of care that involves direct contact with patients' skin, their food, invasive devices or dressings. Effective hand decontamination can significantly reduce infection rates leading to a reduction in patient morbidity and mortality. The current spread of antibiotic-resistant organisms can be attributed, at least in part, to a failure of HCW/HCP to perform hand hygiene either as often, or as efficiently as the situation requires.

Skin provides an environment that is acidic, arid, limited in nutrients and is constantly shed and renewed. Micro-organisms present on the skin can be classified as “resident”

Methods of Injection Delivery

Chapter - 3.1


3.1


or “transient”. Resident microorganisms are commonly termed normal flora. They live deeply seated within the epidermis – in skin crevices, hair follicles and sweat glands and beneath fingernails. Their function is to protect the skin from invasion from more harmful micro-organisms. These organisms do not readily cause infection and are not easily removed. However, they may establish an infection following surgery or invasive procedures. Transient microorganisms are located on the surface of the skin and beneath the superficial cells of the stratum corneum. They are termed transient because direct contact with other people, equipment and other body sites all result in the transfer of these microorganisms to and from the hands.

Effective hand washing technique involves three stages; preparation, washing and rinsing & drying. Preparation requires wetting hands under tepid running water before applying liquid soap or an antimicrobial preparation. The hand-wash solution must come in contact with all the surfaces of the hand. The hands must be rubbed together vigorously for a minimum of 10-15 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands should be rinsed thoroughly prior to drying with pre-sterilized and clean towels or allowed to air dry. Apply an emollient hand cream regularly to protect skin from the drying effects of regular hand decontamination.

Picture demonstrating hand washing techniques


3.1


Six basic steps

SITE SELECTION

It varies according to the age of the recipient and the vaccine/drug effect may be enhanced / diminished. All complications of injections viz nerve injury, muscle contractures are also site dependant. The preferred sites for injections in pediatric patients are antero-lateral aspect of thigh and the deltoid region. Vaccines should never be given in the gluteal region, to prevent injury to the sciatic nerve and as gluteal fat retards absorption, thus affecting antibody titers.

Antero-lateral Thigh

This is the preferred site for IM injection in children. The target muscle is Vastus Lateralis. The injection is given on antero-lateral aspect of thigh, middle third portion between greater trochanter and lateral femoral condyle. The rectus femoris muscle (which is anterior on the thigh) should not be used.

Vastus Lateralis Relaxed Area


3.1


Deltoid Muscle

This is the alternate site for children above 2-3 years. The injection is given 3-5 cm below the acromian process or midway between acromian process and deltoid insertion. The muscle space is adequate for low volume injections. If not positioned properly there is a potential for injury to axillary and radial nerves and posterior circumflex humeral vessels.

Triceps muscle should never be used since radial, brachial and ulnar nerves and profunda brachii artery is under the muscle.

POSITIONING

This is important to ensure that the pain is minimum and also there is no injury to the provider and the patient.

Thigh: Child may be laid supine or be held on adult's (mother's) lap & restrained.

Deltoid: Child may be held on adult's lap & restrained or may sit with little restrain, if willing.

The part should be completely exposed and the child positioned & restrained such that the target muscle is fully relaxed.

IM Injection deltoidDeltoid Muscle Area

IM Injection antero-lateral thighPositioning the child for IM injection


3.1


CLEANSING

Cleaning the injection site before giving injection is:

• Good Clinical Practice.

• Decreases number of microorganisms present in the skin.

• Reduce the risk of abscess.

If swabs are used to clean the skin they should be used in an inside out semicircular movement, or, top to bottom without returning to the site. In most cases though the recipient may be asked to wash the site prior to injecting. If Alcohol is used for cleaning, it should be allowed to dry before injection is given.

Site cleaning

DO NOT TOUCH PARTS

Preventing contamination of injection equipment is as important as having a clean site. Any part of the syringe that comes in contact with the Injectable drug and human anatomy should NOT be touched. If accidentally any of these parts are touched, the syringe and needle are NOT sterile and needs to be discarded immediately in the appropriate container and new sterile syringe and a sterile needle should be used.

The site is cleaned/washed with clean water/soap and water/alcohol wipes and allowed to dry. Routine disinfection of skin is not necessary for Immunization. Wipes impregnated with medicated chemicals may interfere with live vaccines like measles. Avoid pre-wetted cotton swabs (Kept in bottles/bowls) for fear of contamination.

Do Not Touch Parts


3.1


SIZE & BORE OF THE NEEDLE

Needle length depends upon the site, age of child and muscle mass.

Intra-Dermal Injection:

BCG: 26/27G x 16mm (2/3 inch)

Intra-Muscular Injection:

1) Most infants & children: 23G x 25mm (1 inch) needle.

2) Preterm/small babies (<2m): 26/27G x 16mm (2/3 inch)

3) Very obese children: 23G x 38mm (1½ inch)

SC Injection:

Measles, MMR etc vaccines: 26G x 16mm (2/3 inch) needle

Needle Bore (gauge): Wider the lumen of the needle, less injury will be caused by the 'jet effect' while injecting. 26/27 and 23 G needles are appropriate for most vaccines.

TECHNIQUE OF INJECTION ADMINISTRATION

1. WHO Recommended Techniques

Intra-dermal Injections0Needle inserted at an angle parallel to long axis (at approx.150 ) for about 2 mm, so that

entire needle bevel penetrates the skin and the injected solution raises a small bleb. There is no need to aspirate before injecting in immunization. The vaccine should be injected at a moderate rate of around 1ml/10 sec.

Intra-muscular Injections0Stretch the skin flat and push the needle down at 90

Subcutaneous Injections

Pinch up the skin between thumb and forefinger so as to lift the adipose tissue and then 0push the needle in the pinched up tissue at a 45 .Posterior skin fold of the Triceps muscle

in the arm is the ideal site because of the loose skin available for pinching before insertion of the needle, compared to thigh, though other sites are also recommended.

Illustration showing techniques of IM, SC and ID Injection

Sites on the Body Wherea Subcutaneous Injection

Can be Given


3.1


2. ACIP Recommended Techniques

Intra-dermal Injections

Intra-dermal injections are generally administered on the volar surface of the forearm, except for human diploid cell rabies vaccine (HDCV) for which reactions are less severe when administered in the deltoid area. With the bevel facing upwards, a 3/8 to 3/4 inch, 26 or 27gauge needle can be inserted into the epidermis at an angle parallel to the long axis of the forearm. The needle should be inserted so the entire bevel penetrates the skin and the injected solution raises a small bleb. Because of the small amounts of antigen used in intra-dermal injections, care must be taken not to inject the vaccine subcutaneously because it can result in a suboptimal immunologic response.

Subcutaneous Injections

Subcutaneous injections are usually administered into the posterior skin fold of the arm /lateral aspect of thigh of infants and in the deltoid area of older children and adults. A 5/8- to 3/4”, 26/27- gauge needle should be inserted into the tissues below the dermal layer of the skin.

Intramuscular Injections

• The preferred sites for intramuscular injections are the antero-lateral aspect of the upper thigh and the deltoid muscle of the upper arm.

• Generally, gluteal area should not be used routinely for active vaccination of infants, children or adults because of the potential risk of injury to the sciatic nerve.

• In addition, injection into the gluteal area has been associated with decreased immunogenicity of certain immunogens like Hepatitis B and Rabies vaccines, presumably because of inadvertent subcutaneous injection or injection into deep fat tissue.

• If the gluteal area is used for passive immunization when large volumes are to be injected or multiple doses are necessary (e.g. large doses of immune globulin [IG]), the central region should be avoided; only the upper, outer quadrant should be used and the needle should be directed anteriorly (i.e. not inferiorly or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve.

• For all intramuscular injections, the needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue, but not so long as to endanger underlying neurovascular structures or bone. Vaccinators should be familiar with the structural anatomy of the area into which they are injecting vaccine.


3.1


• An individual decision on needle size and site of injection must be made for each

person based on age, the volume of the material to be administered, the size of

the muscle and the depth below the muscle surface into which the material is to

be injected.

Infants (<12 months of age):

Among most infants, the antero-lateral aspect of the

thigh provides the largest muscle mass and is therefore

the recommended site. However, the deltoid can also be

used with the thigh; for example, when multiple

vaccines must be administered at the same visit. In most

cases, a 7/8- to 1inch, 22 to 24 gauge needle is sufficient

to penetrate muscle in the thigh of a 4-month-old

infant. The free hand should bunch the muscle and the

needle should be directed inferiorly along the long axis

of the leg at an angle appropriate to reach the muscle

while avoiding nearby neurovascular structures and

bone.

Toddlers and Older Children:

The deltoid may be used if the muscle mass is adequate. The needle size 22 to 24 gauges

and from 5/8 to 1¼ inches, based on the size of the muscle. As with infants, the antero-

lateral thigh may be used, but the needle should be longer—generally ranging from 7/8

to 1¼ inches.

Adolescents & Adults:

The deltoid is recommended for routine intramuscular vaccination

among adolescents & adults, particularly for Hepatitis B vaccine. The

suggested needle size is 23G x 1”. They are more prone to fainting

attacks and therefore injecting in a supine position will be a better

option in susceptible people.

Post Injection Precautions:

After emptying medication, wait for 10 seconds before withdrawing the syringe.

Withdraw the needle with a smooth and steady movement. Apply gentle pressure with

a gauze for a few seconds. Do not rub the area for site cleaning and post injection. Do

not use alcohol/spirit swab which may cause burning sensation.

IM Injection antero-lateral thigh

IM Injection in deltoid


3.1


Multiple Injections

Use separate syringe and needle for each injection: If more than one preparation is administered or if vaccine and an immunoglobulin preparation are administered simultaneously, it is preferable to administer each in two different limbs. It is also preferable to avoid administering two intramuscular injections in the same limb, especially if DPT is one of the products administered. However, if more than one injection must be administered in a single limb, the antero-lateral aspect of thigh is usually the preferred site because of the greater muscle mass; the injections should be sufficiently separated (i.e. at least 2.5 cm or 1 inch apart) so that any local reactions are unlikely to overlap & enough dendrite network is available for each vaccine to be carried to the local lymph nodes.

POST INJECTION CARE & ANTICIPATORY GUIDANCE

The child should be observed for 15 minutes. The parents should be explained to look out for adverse events: immediate and late,Instruct parents regarding management of adverse events.

Always keep emergency and resuscitation equipment ready. Management of anaphylaxis is to be done as per standard protocol.

EMERGENCY MANAGEMENT

1. Adverse events should be reported immediately to the concerned agencies.

2. Follow the standard procedures of ABC.

3. Shift the patient to emergency room for further appropriate management.

POINTS TO REMEMBER

1. Hand-washing before and after procedures including injections and examining patients is a good clinical practice

2. Site selection is important. It is also age dependant. All immunization, except BCG, should be given on the antero-lateral aspect of thigh or Deltoid

3. Different sites and/or limbs, as for as possible, should be used if more than one injection is given at the same visit.

4. If the same site is used under extraordinary conditions the second injection should be given at least one inch apart.

5. Cleaning of injection site reduces the risk of infection

6. Needle size and bore are dependent on the consistency of liquid to be injected (viscous vaccines like DPT and Hepatitis B require longer needles with larger bore


3.1


to deposit them slowly into the muscle mass) IAP recommends the use of Auto-disable / Reuse prevention syringes in all health care settings

7. WHO/ACIP techniques are recommended for giving injections.

8. Anticipatory Guidance: Parents should be educated on the probable post- injection complications and the actions they are required to take if they ever happen.

References:

1. Safety of injections in immunization programs. WHO recommended policy. Global Program for vaccines and immunization, 1998, WHO/EPI/LHIS/96.05 Rev 1.

2. WHO Expanded Program on Immunization country reports (including special studies of injection safety), Geneva, World Health Organization, 1998 (unpublished document).

3. Guideline for Hand Hygiene in Health-Care Settings - Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/ APIC/IDSA, Hand Hygiene Task Force, MMWR Recommendations and Reports, October 25, 2002 Vol. 51 No. RR-1.

4. Lakshman M, Nichter M. Contamination of medicine injection paraphernalia used by registered medical practitioners in south India: an ethnographic study. Soc Sci Med 2000; 51: 11-28.

5. Needle Length and Injection Technique for Efficient Intramuscular Vaccine Delivery in Infants and Children Evaluated Through an Ultrasonographic Determination of Subcutaneous and Muscle Layer Thickness. José Groswasser, MD André Kahn, MD, PhD Beatrice Bouche, MD Sylviane Hanquinet, MD Noémi Perlmuter, MD Department of Pediatrics and Radiology Queen Fabiola Children's Hospital Luc Hessel, MD Pasteur Mérieux Connaught Department of Medical Affairs Pediatrics Vol. 100 No. 3 September 1997, pp. 400-403.

6. Royal College of Pediatrics and Child Health, Position Statement on Injection Technique, March 2002.

7. Best infection control practices for intradermal, subcutaneous and intramuscular needle injections. Yvan Hutin, Anja Hauri, Linda Chiarello, Mary Catlin, Barbara Stilwell, Tesfamicael Ghebrehiwet, Julia Garner & the Members of the Injection Safety Best Practices Development Group Bulletin of the World Health Organization 2003, 81 (7).

8. Lala K R, Lala MK. Intramuscular injection: Review and guidelines. Indian Pediatrics 2003; 40: 835-845.

9. General Recommendations on Immunization - Recommendations of the Advisory Committee on Immunization Practices (ACIP); MMWR January 28, 1994. Vol. 43, No. RR-1.

10. Office Preparedness for Pediatric Emergencies Provider Manual Developed in collaboration with the North Carolina Office of Emergency Medical Services, the North Carolina Chapter of the American Academy of Pediatrics, the North Carolina Association of Pediatric Nurse Practitioners, the North Carolina Academy of Physician's Assistants and the North Carolina Academy of Family Practice Physicians.


3.1


Drawing blood by venepuncture is a complex process that requires adequate knowledge and skills to perform it properly.Each healthcare worker should establish a routine and practice that is comfortable to him or her. Here are some essential steps, that are critical to ensure a proper venepuncture and these should be given due attention and importance

1. Selection of a suitable site for venepuncture

2. Preparation of the equipment, the patient and the puncture site

3. Each venepuncture should involve the use of

a. Gloves

b. Tourniquet

c. Alcohol swabs/disinfectants

d. Cotton balls

e. Bandage / Gauge pads

f. Evacuated blood collection tubes/ sterile tubes with required additives

g. Evacuated blood collection needles, holders, syringe

h. Laboratory request slips

i. Marking pens, labels,

j. Sharps container

Safety during venepuncture

1. Observe universal (standard) safety precautions. Observe all applicable isolation procedures.

2. PPE's will be worn at all time.

3. Wash hands in warm, running water with the chlorhexidine gluconate hand washing product (approved by the Infection Control Committee), or if not visibly contaminated with a commercial foaming hand wash product before and after each patient collection.

4. Gloves are to be worn during all phlebotomies and changed between patient collections. Palpation of phlebotomy site may be performed without gloves providing the skin is not broken.

Chapter - 3.2


3.2


Phlebotomy

5. A lab coat or gown must be worn during blood collection procedures.

6. Needles and hubs are single use and are disposed of in an appropriate 'sharps' container as one unit.

Needles are never recapped, removed, broken, or bent after phlebotomy procedure.

7. Gloves are to be discarded in the appropriate container immediately after the phlebotomy procedure. All other items used for the procedure must be disposed of according to proper biohazardous waste disposal policy.

8. Contaminated surfaces must be cleaned with freshly prepared 10% bleach solution. All surfaces are cleaned daily with bleach.

9. In the case of an accidental needlestick, immediately wash the area with an antibacterial soap, express blood from the wound and contact your supervisor.

Performing the venepuncture

Tourniquet Application

• It is important for making the veins prominent and palpable, which is essential for venepuncture

• Tourniquet should be 3-4 inches above the puncture site

• It should be just adequately tight so as to to stop the blood flow in veins and NOT in arteries

• Duration for which a tourniquet is applied should not be more than 1 minute (otherwise resulting hemo-concentration might not give us the actual investigation findings)

• If you are tying tourniquet for preliminary vein selection, then release it and reapply after 2 minutes

Visible veins after tying tourniquet


3.2


• Tourniquet should be released as soon as the blood starts coming in the tube

• Torniquet should be removed before removing the needle

Cleansing the venepuncture site

• Recommended to be done with 70% isopropyle alcohol

• Clean the site using circular movement of alcohol swabs, starting from the center and moving out towards periphery

• Allow the site to dry (30-60 seconds)

• Do not touch the puncture site after cleaning

Performing venepuncture

First attempt should always be made in the vein which is obviously prominent in the selected extremity

Venepuncture using butterfly wing set and syringe

• Most HCWs prefer using syringe needle technique, (however, closed collection system should always be preferred)

• The devices used are 25 or 23 Gauge needle (bevel up) with syringe attached

• Disposable needle of 21/ 22 guage should be preferred as it ensures rapid blood flow (Please refer to chapter 5 on newer technologies – Thin Walled needles)

• Clean the site using standard techniques

• Apply tourniquet

• Perform venepuncture entering the vein, keeping needle's bevel up

• Grasp the syringe barrel firmly and pull the plunger until required quantity of blood is drawn

Needle Insertion in to the vein Photograph Showing Needle Insertion in to the vein


3.2


• Through plunger apply only gentle and gradual suction so that the vein does not collapse

• Remove tourniquet as soon as the blood is drawn

• Remove needle through a gentle pull

• Apply direct pressure on the site to stop blood from coming out

• Ask the patient to keep the arm fully extended, elevate arm and with the other hand apply gentle pressure on the puncture site

• Check the site for bleeding, if it is there continue applying direct pressure

• Once bleeding completely stops, apply bandage over the guage pad placed on venepuncture site and advice patient to leave that on for 15 minutes

Venepuncture using evacuated blood collection system

The Clinical Laboratory Standards Institute (Formerly NCCLS) recommends evacuated blood collection system as a preferred devise over the needle and syringe collection as the former helps in directly collecting the blood specimen from the vein into the stetile evaluated tubes.

The system comprises of three basic components

• A sterile blood collection needle

• Evacuated tubes which are sterile from inside and contain pre-measured vacuum and pre-measured additives

• A holder which is used to secure both, the needle and the evacuated tobe

Holder with tubing and wingset

Holder with needle Evacuated tubes


3.2


• Attach the appropriate needle to the hub by removing the plastic cap over the small end of the needle and inserting into the hub, twisting it tight.

• Remove plastic cap over needle and hold bevel up.

• Pull the skin tight with your thumb or index finger just below the puncture site.

• Holding the needle in line with the vein, use a quick, small thrust to penetrate the skin and enter the vein in one smooth motion.

• Holding the hub securely, insert the first vacutainer tube following proper order of draw into the large end of the hub penetrating the stopper. Blood should flow into the evacuated tube.

WITH SAFETY FEATURE

Putting Evacuated tubes in holder Filling multiple tubes

Wing Set with Holder


3.2


• After blood starts to flow, release the tourniquet and ask the patient to open his or her hand.

• When blood flow stops, remove the tube by holding the hub securely and pulling the tube off the needle. If multiple tubes are needed, the proper order of draw to avoid cross contamination and erroneous results is as follows:

• Blood culture vials or bottles, sterile tubes

• Coagulation tube (light blue top) (Routine PT/PTT may be performed if blue top is first tube collected. It may be desirable to collect a second tube for other coagulation assays.)

• Serum tube with or without clot activator or silica gel (Red or Gold)

• Heparin tube (Green top)

• EDTA (Lavender top)

• Glycolytic inhibitor (Gray top)

Mixing

Most tubes contain an additive. Regardless of the additive type, all tubes should be gently inverted to ensure thorough mixing of the blood with the additive. Tubes with anticoagulants such as EDTA, heparin etc., must be mixed to ensure that the specimen does not clot. For example insufficient mixing could lead to platelet clumping in EDTA tubes. Tubes with a clot activator Serum Tubes must also be mixed or the specimen may not clot completely in the recommended time.

Venipuncture procedure using a syringe:

• Place a sheathed needle or butterfly on the syringe.

• Remove the cap and turn the bevel up.

• Pull the skin tight with your thumb or index finger just below the puncture Site.

• Holding the needle in line with the vein, use a quick, small thrust to penetrate the skin and vein in one motion.

• Dr.aw the desired amount of blood by pulling back slowly on the syringe stopper.

• Release the tourniquet.

Mixing the sample collected


3.2


• Place a gauze pad over the puncture site and quickly remove the needle. Immediately apply pressure. Ask the patient to apply pressure to the gauze for at least 2 minutes.When bleeding stops, apply a fresh bandage, gauze or tape.

• Transfer blood drawn into the appropriate tubes as soon as possible using a needleless Vacutainer Blood Transfer Device, as a delay could cause improper coagulation. Gently invert tubes containing an additive 5-8 times.

• Dispose of the syringe and needle as a unit into an appropriate sharps container.

Infant/Child Phlebotomy

• Confirm the patient's identification

• Secure patient to Papoose apparatus for stabilization if child is unable to sit upright on their own.

• Assemble the required supplies

• Select the collection site and proceed as routine phlebotomy. If the child is old enough, collect blood as in an adult.

Please refer to the chapter on best practices to ensure injection safety

Blood collection by Skin Puncture

Skin puncture is particularly useful when venipuncture is difficult or when very small quantity of blood is required. It is a useful technique for neonates infants and children. Capillary blood collection is the preferred method of blood specimen collection for newborns and infants. Clinical Laboratory Standards Institute (CLSI) recommends capillary blood collection via heelstick for infants less than one year of age.1 For children older than one year, capillary blood collection via fingerstick should be considered, where appropriate.

Capillary blood collection may also be used for adults under certain circumstances including:

• Patients with fragile, superficial or difficult to access veins

• Patients where multiple unsuccessful venipunctures have already been performed, especially if the test(s) requested requires only a small volume of blood

• Patients with burns or scarring in venous blood collection sites

• Extremely obese patients

• Patients requiring frequent blood tests


3.2


• Patients receiving IV therapy in both arms or hands

• Patients at risk for serious complications associated with venipuncture, venous thrombosis, or deep venous puncture (e.g. deep vein puncture in infants, thrombophlebitis)

• Patients requiring only one blood test for which a capillary specimen is appropriate

• Patients whose veins are 'reserved' for intravenous therapy or chemotherapy

• Point-of-care testing where only a few drops of blood are needed

Capillary blood collection is inappropriate for:

• Severely dehydrated patients

• Patients with poor circulation

• Coagulation studies requiring plasma specimens

• Tests that require large volumes of blood (i.e. Erythrocyte Sedimentation Rate (ESR) and blood cultures)

• It is important to understand that there are differences between some analytes in capillary blood as compared to venous or arterial blood specimens. Glucose, potassium, total protein and calcium have been reported to show statistically and/or clinically important differences. With the exception of glucose, the concentration of these analytes is lower in capillary blood.

There are two methods which are used for obtaining blood from infants and children

• Finger puncture

• Heel punctureBlue shaded area for finger prick

Blue Shaded area for Heel prick


3.2


Procedure for skin puncture

A. Fingerstick:

• Correctly identify and reassure the client. Explain the procedure and verify that the client is free of latex allergies (if latex gloves are used).

• Position the client in a chair suitable for capillary puncture. If the client is an infant or small child, instruct the parent how best to support the child and restrain excessive movement.

• Obtain the sample from the third or fourth (middle or ring) finger Choose a site that is on the side of the fingertip, midway between the edge and midpoint of the fingertip. The puncture should be made perpendicular to the fingerprint ridges.

• Thoroughly wash hands with warm soapy water.

• It may be necessary to warm the skin puncture site to increase blood flow to the site. A warm, moist towl (or other warming devices) at a temperature no higher

othan 42 C may be used to cover the site for three to five minutes. This technique increases blood flow to the site up to sevenfold, does not burn the skin and does not result in significant changes for routinely tested analytes.

• Thoroughly cleanse the chosen site with 70% isopropyl alcohol. Allow the skin to air-dry. Wet alcohol remaining on the skin causes rapid hemolysis, will sting the client and may dilute the sample.

• Perform finger puncture. Use a sterile, OSHA approved, blood lancet and press firmly. Press the trigger to make a deep puncture (1.5 mm) at the chosen site (figure 2). The blood will form a bead and make collection easier. A puncture parallel to the ridges tends to make the blood run down the ridges and will hamper collection.

Correct way of placing a lancet


3.2


• A deep puncture is no more painful that a superficial one, gives a much better flow and makes it unnecessary to repeat the procedure.

• Using a dry gauze, wipe away the first drop of blood, making certain the area is completely dry. The first drop is most likely to contain excess tissue fluid.

• Apply moderate pressure, approximately 1 cm behind the site of the puncture to obtain a drop of blood. Blood flow from the puncture is enhanced by holding the puncture site downward and gently applying intermittent pressure to the finger. Do not use strong repetitive pressure (milking) on the finger!

• Release this pressure immediately to allow recirculation of the blood.

• Collect the blood sample in a collection device appropriate for the test to be performed.

• Repeat steps 10 & 11 until sufficient blood has been collected.

• Apply a piece of gauze, (or cotton ball), to the puncture site, using slight pressure until the bleeding has stopped. For older children and adults, offer a band-aid.

• Immediately dispose of contaminated lancet into a sharp's container

B. Heelstick

• Clean the infant's heel with 70% isopropyl alcohol (use only rubbing alcohol).

• Warming the skin-puncture site with a warm moist cloth, or a heel warming device, for 3 minutes can increase blood flow through the site.

• Allow the heel to air dry.

• Using a lancet, or heel incision device and wearing gloves, perform the puncture on the plantar surface of the heel (the shaded area in figure 3). The puncture should be made to a depth of less than 2.0 mm with a sterile lancet or incision device.

Heel area to be used for piercing Placing the lancet for piercing heel


3.2


• Gently wipe off the first drop of blood with sterile lint-free gauze. The initial drop contains tissue fluids that may dilute the sample.

• Wait for the formation of a large blood droplet; apply gentle pressure with the thumb and ease the pressure intermittently as drops of blood begin to form.

• Do not use excessive pressure or heavy massaging because the blood may become diluted with tissue fluid or hemolysis of blood cells may occur.

• Collect blood in the specimen collection device specific for the test being performed.

• After blood collection is complete, elevate the infant's foot above the body and apply pressure using sterile gauze until bleeding has stopped. Do not apply adhesive bandages.

Procedure Notes

• Hemolyzed specimens may cause inaccurate results.

• Hemolsis may occur in skin puncture blood for the following reasons:

i There is residual alcohol at the skin puncture site.

ii Patients have increased red blood cell fraglity and high packed cell volume (e.g., newborns and infants).

iii Milking of the puncture site.

iv Excessive and aggressive mixing of the specimen in the tube after collection.

• Skin puncture blood is a mixture of undetermined proportions of blood from arterioles, venules, capillaries and interstitial and intracellular fluids. The arterial portion can be increased by warming the site prior to collection. This increases the blood flow as much as sevenfold.

• When heelsticks are performed, take the following precautions:

1. Do not puncture deeper than 2.0 mm.

2. Do not puncture through previous puncture sites.

Points to remember

Follow all universal precautions of safety

Before preferring capillary blood draw, please check its suitability in relevance to investigations to be conducted

Follow sharps disposal protocols for automated lancets also


3.2


References:

Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture;Approved Standard Fifth Edition. NCCLS document H4-A4 [ISBN 1-56238-382-5]. Clinical Laboratory Standards Institute, 940West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 1999.

Blood Collection on Filter Paper for Neonatal Screening Programs. National Committee for Clinical Laboratory thStandards, Vol. 23. No. 21 Approved standard – 4 Edition, NCCL Document LA4-A4. Clinical Laboratory Standards

Institute, 940West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2003.

http://www.michigan.gov/documents/RL_135815_7.04.01_Specimen_Collection_Blood_by_Finger_Puncture.doc

http://www.bd.com/vacutainer/labnotes/Volume20Number1/

CLSI H4-A6. Procedures and Devices for the Collection of Diagnostic Blood Specimen by Skin Puncture; Approved Standard'Sixth Edition, Vol. 24, No. 21, 2008.

Shah V, Taddio A, Kulasekaran K, et al. Evaluation of a new lancet device (BD QuikHeel') on pain response and success of procedure in term neonates. Arch Pediatr Adolesc Med 2003;157:1075-1078.

Bloodborne Pathogens and Needlestick Prevention. Occupational Safety & Health Administration. Available at: www.osha.gov/SLTC/bloodbornepathogens/index.html

Product literature. BD Microtainer' Contact-Activated Lancet. Becton, Dickinson and Company, 2006.

Product literature. BD Quikheel' Safety Lancet.

Mc Call RE, Tankersley CM. Phlebotomy Essentials. Lippincott Williams & Wilkins, Philadelphia, PA: 2007:384.

Ernst D. Minimum blood volume for CBC tubes. Medical Laboratory Observer, 2005.

http://www.uams.edu/clinlab/venipuncture.htm

www.bd.com

www.rcn.com

www.cdc.gov


3.2


INTRODUCTION

Intravenous catheterizations are one of the most common invasive procedures performed in acute care hospitals. Almost over 70% of the patients in a hospital receive an intravenous infusion as part of their treatment and this is almost invariably administered via a catheter placed in a peripheral vein of the upper limb. This intravenous infusion or therapy has numerous purposes, some of which are:

1 Fluid and/or electrolyte replacement

2 It provides a route for drug administration

3 It provides a route for nutritional support

4 Transfusion of Blood and blood products

5 Provides venous access diagnostic blood draws

PERIPHERAL VENOUS ANATOMY AND PHYSIOLOGY

Superficial veins of the upper limbs are usually selected for peripheral cannulation. Cannulation of the lower limbs is associated with an increased risk of venous thromboembolism.

IV Cannulation : A Process Oriented Approach

Chapter - 3.3

Cephalic vein

Lateral antibrachialcutaneous

nerve

Accessorycephalic vein

Cephalic vein

Basilic vein

Vena medianacubiti

Basilic vein

Medial antibrachialcutaneous nerve

Medial antibrachial vein

Basilic

Cephalic

Dorsal venousnetwork

DorsalMetacarpals

Venous arch


3.3


The wall of a vein is composed of three layers:

• The Tunica adventitia (the outer layer):

• The Tunica media (the middle layer.

• The Tunica intima (the inner layer):

Skin is composed of two main layers:

• Epidermis (skin surface):

• Dermis (beneath the epidermis):

Selecting a Vein

When choosing an appropriate vein for venipuncture, many factors are considered, including:

• The patient's medical history

• Patients age, body size and weight, general condition and level of physical activity

• The condition of his veins

• The type of I.V. fluid or medication to be infused

• The expected duration of I.V. therapy

• Venipuncture skills of the Health care professional

Short peripheral catheters are indicated

1. When the therapy lasts 6 days or less

2. Fluids and medications -pH between 5 and 9

3. Osmolarity is less than 500 mOsm/liter.


3.3


Microscopic Anatomy of VeinTunica adventitia

Tunica mediaValves

EndotheliumBasement Membrane

Tunica intima

If therapy is expected to last less than 6 days, start with the most distal site in the upper extremities and move up as necessary.

1. Digital veins of the fingers

2. The metacarpal veins

3. Dorsal venous arch -radial end and ulnar end

The cephalic vein is large, easily stabilized and accessible

The median cubital vein runs diagonally across the antecubital fossa connecting the basilic and the cephalic veins.

A cannula should not be placed in areas of

1. Localized oedema,

2. Dermatitis,

3. Cellulitis,

4. Arteriovenous fistulae,

5. Wounds,

6. Skin grafts,

7. Fractures,

8. Stroke,

9. Planned limb surgery and

10.Previous cannulation.

Veins that are tender thrombosed or hard should be avoided.

Valves and cannulation:

Valves are most plentiful in the veins of the limbs and occur more frequently at junctions where veins converge.

Careful observation may reveal valves (small bulges) within the peripheral veins, which should be confirmed by palpation.

Valves may prevent blood withdrawal and cannula advancement and, therefore, should be avoided.

Palpation also allows differentiating between arteries and veins. Arteries are pulsatile and should be carefully avoided.


3.3


Cross section of vein showing a valve that prevents backflow

Venous valves prevent reverse blood flow.

Veins in the wrist should not be used -because of

1. Their close proximity to nerves

2. Pain and damaging nerves,

3. Preventing movement at these sites may be impossible, Increasing the risk of complications.

Leg veins:

Although used in infants, veins of the legs, feet and ankles shouldn't be used in adults.

The superficial veins of the legs and feet have many connections with the deep veins.

Catheter complications can lead to

1. Thrombophlebitis,

2. Deep vein thrombosis and

3. Embolism.

But if there is no choice during an emergency, the dorsum of the foot and the saphenous vein of the ankle can be used until central venous access is obtained. The foot vein can be stabilized by plantar flexion. Cannulas in the lower extremity should be removed as soon as possible.

• Other sites to avoid include:

• Veins below a previous I.V. infiltration

• Veins below a phlebitic area

• Sclerosed or thrombosed veins

• Areas of skin inflammation, disease, bruising, or breakdown

• An arm affected by a radical mastectomy, edema, blood clot, or infection?

• An arm with an arteriovenous shunt or fistula.

Sites in Pediatric patients:

In Infants and children -

1. Antecubital Fossa

2. Dorsum of hand or foot

3. Saphenous vein in lower leg

4. Scalp veins


3.3


In Adolescents:

1 As Adults

Site selection should be routinely initiated from “Distal to Proximal”

Cannulation should not be performed in the same extremity if it is unable to place the cannula proximal to the previous site. It has to be ensured that Bifurcation does not exist between two veins. It is advised to use opposite extremity if infiltration of a vesicant has occurred.

Cannula Selection

It is important to select the correct vascular access device, which is suited for patient's specific clinical situation and has the greatest likelihood of surviving anticipated length of therapy.

There are three types of IV cannulae:

1. Over-the-Needle plastic cannula: A plastic cannula mounted over a needle. After the venipuncture is made, the cannula is guided off the needle and into the vein. This is the most commonly used venous access device.

2. Through-the-needle cannula: After the venipuncture is performed, a cannula is threaded through the needle into the vein.

3. In lying cannula: A plastic cannula that is introduced by means of a cut-down, a minor surgical procedure.

Modern peripheral IV cannulae are usually made of polyurethane, softer, cause less intimal damage and are kink resistant which reduces the incidence of cannula failure.


3.3


Good Quality Catheter Tip

Poor Quality Catheter Tip

Older cannulae are made of polyvinyl chloride (PVC) or Teflon®, more rigid and higher incidence of thrombophlebitis.

Most peripheral cannulae contain a 'flashback chamber'. This provides the practitioner with an immediate visual indication that the cannula has entered the vein.

Generally, the smallest gauge of cannula should be selected for the prescribed therapy.

1. Prevent damage to the vessel intima and ensures that there is adequate blood flow past the cannula

2. Provide a sufficiently high flow rate to deliver most therapies and

3. Reduce the risks of mechanical and chemical phlebitis.

Blood flow is slow in small peripheral vessels. If the cannula is too large, blood flow is impeded and drugs remain in prolonged contact with the vein wall resulting in chemical phlebitis

Types of Peripheral Over the Needle IV Cannula

An over-the-needle catheter and a closed I.V. catheter system with attached tubing are ideal choices for veins of the hand or forearm. Most over-the-needle and closed system cannulas range from 0.5 inch to 2 inches; the diameters of these cannulas range from 14 to 26 gauge.

For Pediatric usage the recommended length is 0.56 inch to 0.75 inch; with 24-26-gauge size.

Flashback

Comparison between Teflon and Vialon material (Showing Kinking of Catheter)

Vialon Teflon


3.3


Steel butterfly-type needles should be avoided except for short-term duration (1 to 4 hours) or injections of one-time doses. An inflexible steel needle greatly increases the risk of vein injury and infiltration. Never use these devices for any medication that would cause tissue necrosis if it extravasated.

Two types of Cannulas are available commercially and these are ported cannula and Non-ported catheters:

Depending on the vein used, the I.V. cannula should usually be 0.5 inch to 2 inches long. For Pediatric patients the appropriate length is 0.56 inch to 0.75 inch.

To reduce the risk of phlebitis

The catheter should be as small in diameter as possible so it takes up less space in the vein. This allows better blood flow around the catheter, lessening the risk of phlebitis. Using the smallest-gauge cannula in the largest vein possible will reduce the mechanical and chemical irritation to the vein wall.

These general guidelines can be kept in mind:

• 26 to 24 gauge for Infants and children

• 24- to 22-gauge for children and elderly patients

• 24- to 20-gauge for medical patients and postoperative surgical patients

• 18-gauge for surgical patients and for rapid blood administration. Blood can be infused through smaller gauge catheters, but the flow rate will be slower.

• 16-gauge for trauma patients and those requiring large volumes of fluid rapidly.

• Before inserting any needle or cannula, carefully inspect it for imperfections, such as problems with the catheter tip.

Ported CannulaNon - Ported Catheters


3.3


Parts of a cannula

As a principle, always use the smallest gauge and shortest catheter length appropriate for therapy.

SITE PREPARATION

1. Select vein.

2. If the site is excessively hairy, the hair should be clipped, the site should not be shaved because this causes microabrasions.

3. Visibly dirty skin should be cleaned with soap and water.

4. Then an approved antimicrobial solution should be used.

Chlorhexidine gluconate solution is the preferred agent, according to the Centers for Disease Control and Prevention (CDC); tincture of iodine 2%, 10% povidone-iodine, 70% isopropyl alcohol and combination povidone-iodine/alcohol preparations are also acceptable agents. Aqueous benzalkonium-like compounds or hexachlorophene should not be used to prepare the site.

The procedure that used to apply an antimicrobial solution for site preparation is crucial. If chlorhexidine is being used, apply in a back and forth motion, which increases the friction and allows the antiseptic solution to penetrate the lower layers of the epidermis.

If using another agent, use a circular inside out motion. Although the surface area for preparation depends on the size of the extremity, in most adult patients an area 2 to 3 inches (5 to 7.5 cm) in diameter is acceptable. Excess solution should never be blotted at the insertion site. The solution should be allowed to air-dry completely.

Needlegrip

Different parts of cannula


3.3


1. Chlorhexidine gluconate achieves its antimicrobial action within 30 seconds.

2. Povidone-iodine requires at least 2 minutes to kill organisms on the skin.

70% isopropyl alcohol should not be applied after a 10% povidone iodine preparation because this may irritate the skin and it interferes with povidone's germicidal action. If a patient is allergic to iodine, the preparing solution of choice is chlorhexidine gluconate or 70% isopropyl alcohol. When using 70% isopropyl alcohol, it should be applied with friction for at least 30 seconds or until the final applicator is clean.

(Please refer to the chapter on methods of injection delivery for further details)

CANNULA PLACEMENT

Equipment required

1 Tourniquet

2 Gauze squares

3 Adhesive tape

4 Clear permeable dressing

5 Site label (to record time of insertion)

6 IV sets (As required)

7 IV bottles (As required)

8 Examination gloves

9 Sterile drapes

10 Surgical scissors

11 Antiseptic

12 Swabs

13 I.V. Catheter

The patient's left arm should be assessed first to allow him to use his dominant hand freely.

A Maximum of Two attempts at venipuncture should be taken in non-life threatening situations. Cannula should be inspected for product integrity before use and discarded if it is found defective, needle should never be reinserted into a cannula. Only one cannula should be used for each cannulation attempt and standard precautions should be adhered to.


3.3


Applying a tourniquet

The tourniquet is applied 2 to 3 inches above the intended venipuncture site. Peripheral veins in a well-hydrated patient should distend within a few seconds.

It should be tight enough to trap venous blood in the lower arm's veins without interfering with arterial flow.

If pulse is not felt below the tourniquet (or if the patient complains of discomfort), it's too tight.

As the occluded veins distend, the skin below the tourniquet will become slightly darker from venous congestion.

Apply tourniquet as shown in the figures below:

When the tourniquet is in place, the patient should be asked to open and close his fist several times. This will encourage venous distension. After identification of a desirable vein, it can be encouraged to enlarge with a light tap of finger. (Patting and hitting it too hard will cause vasoconstriction.) The vein should become as engorged as possible to create a bigger target and improve the chances of success. The vein should be palpated gently to see if it feels soft and bouncy. When it is depress and release an engorged vein, it should spring back to a filled state.

Some clinicians prefer to use a blood pressure cuff instead of a tourniquet, especially for elderly patients, whose fragile veins are more likely to rupture when engorged if a tourniquet is applied too tightly. In such cases the cuff is inflated, then deflated to just below the patient's diastolic pressure to make the vein visible without engorging it excessively.

If the vein won't distend sufficiently, remove the tourniquet and let the vessels refill. Sometimes veins fill better on the second try because of a rebound effect.

Method of tying a tourniquet Prominent veins


3.3


Techniques to dilate the veins:

• Position the arm below heart level or hang the arm down to encourage capillary filling.

• Instruct the patient to open and close the hand several times. (Make sure the hand is relaxed during venipuncture.)

• Gently rub or stroke the arm to warm the skin.

• Cover the entire arm with moist compresses for 10 to 15 minutes to trigger vasodilation by increasing blood flow to the area.

Vein Stabilization

Maintaining the vein in a taut, distended, stable position. Hand veins are generally easier to immobilize than upper arm veins. Hand veins may also be easier to cannulate because they're usually surrounded with less fatty tissue. It is important to remember that there's a greater chance of nerve injury in the hand and wrist.

The following techniques can be used to immobilize hand and arm veins:

• The Healthcare professional should use his thumb to stretch the skin down over the knuckles to stabilize the vein. The grip has to be kept firm throughout venipuncture.

• To stabilize a vein on the forearm, the left arm of the health care professional is used to encircle the patient's arm and the thumb used to pull downward on the skin below the venipuncture site.

Approaching the vein

An I.V. cannula can be inserted in several ways.

The choice depends on

1. Cannula length,

2. Vein location and

3. Individual health care professional's preference.

No matter which method is used, the cannula should enter the skin at such an angle that the needle punctures the vein wall and enters the lumen without piercing the opposite wall.

There are three ways to do this:

• Approaching the vein from the top: Cannula is inserted at a 5- to 15- degree angle, depending on vein depth; for example, a 5- to 10-degree angle will be used for a superficial hand vein


3.3


• Approaching the vein from the side: This method reduces the risk of piercing the vein's back wall.

• Approaching a vein that's palpable and visible for only a short segment: This cannulation technique may help in cannulating a vein that extends into deeper tissues, where it can't be seen or felt. The cannula is inserted about 1 to 2 cm below the vein's visible segment and then the cannula is tunneled through the tissue to enter the vein. This Tunneling may reduce trauma to the vein wall on insertion.

• Venipuncture should be avoided in areas where valves are palpable or where two veins bifurcate. The insertion site should be proximal to a valve or a bifurcation.

Inserting the Cannula

Before performing venipuncture, the vein should be stretched and immobilized. The vein should be pressed lightly to check for rebound elasticity and to get a sense of its depth and resilience. To insert the cannula, follow the steps given here.

• The right hand should be used to grasp the cannula or the cannula's wings (if using an over-the-needle butterfly) and proceed at once with venipuncture.

• The cannula should be inserted at a 10 to 30 degree angle, depending on the vein's depth. The cannula should be inserted bevel up to reduce the risk of piercing the vein's posterior wall.

Cannula insertion technique Way of holding

Photograph showing entry into the vein


3.3


• The fingers are positioned such that blood backflow in the flash chamber or extension tubing can be seen. Some cannulas and closed cannula systems are designed to provide early or continuous flashback of blood, which improve the chances of success on the first attempt.

• The vein is kept immobilized and the cannula advanced through the skin and vein with one quick motion.

• Popping or giving-way sensation may not always be felt.

• The blood backflow in the cannula tubing or hub should be observed as it signifies that the cannula is in the vein lumen.

• Backflow may occur briefly if the stylet passes through the lumen and out the opposite wall. But the blood flow will stop when the stylet leaves the vein lumen.

• An alternative is to enter the skin and pause slightly to position the cannula tip over the vein wall. Then insert at least one-fourth of the length of the cannula into the vein.

• Once the backflow has been observed, the cannula is lowered almost parallel to the skin and advanced slightly to ensure the cannula tip is in the lumen of the vein. As the vein is being immobilized, the catheter is pushed off the stylet and advanced completely into the lumen of the vein.

• If the initial insertion isn't successful, repositioning of the cannula can be tried as long as the stylet has not been pulled back or the cannula tip removed from the skin.

• A deeper or more superficial approach to the vein may work, but the area should not be excessively probed, as this could damage the nerve

• If still unsuccessful, the cannula should be removed and tried again with a new catheter at a new site—preferably on the opposite arm.

• Stylet should never be reinserted back into a cannula. This can shear off a piece of the plastic.

• Same cannula should never be reused as it can lead to catheter-related infection. The infusion is started or cannula flushed with normal saline or heparinized saline.

• Once the cannula is totally advanced into the vein the tourniquet is released and digital pressure is applied beyond the cannula tip and the hub stabilized.


3.3


Securing and dressing the cannula

Tape placed under a transparent dressing should be clean, preferably strips of tape from a fresh roll.

The administration set or extension set is attached to the cannula hub.

A 1D 2- inch-wide strip of tape is placed across the cannula hub; it shouldn't cover the puncture site.

Then a 1D 2-inchwide strip of tape is placed under the cannula hub, adhesive side facing up.

The tape strip is folded around the cannula hub. If a catheter hub with wings is being used, the tape strip is folded across the wings rather than the hub.

The venipuncture site and catheter hub is covered with the dressing; the hub-tubing junction is not covered.

A 2x2 gauze pad is folded in half and covered with a 1-inch-wide tape strip. It is placed under the cannula hub-tubing junction. This prevents skin breakdown from tubing taped directly to the skin. Finally, the tubing is curled to the side.

A 1-inch-wide tape strip is placed over the tubing directly on top of the tape under the hub.

A transparent dressing insures observation of the insertion site for phlebitis, infiltration and infection without disturbing it. Also, because it's waterproof, it need not be replaced routinely unless it's loosened or soiled. It is applied directly to the site without stretching it (which may make the patient's skin itch). It should cover the cannula and part of the hub

Catheter securement devices are available commercially and have been demonstrated to reduce complications and increase the cannula dwell time. Stretch netting can also be used to cover the entire I.V. site. It prevents accidental dislodgment while allowing easy site access.

Dressing at cannula site


3.3


Flushing IV Cannula

Regular flushing is required. Until recently heparin diluted in sodium chloride 0.9% was used, however heparin is no longer routinely used

Goode et al (1991) concluded that NaCl 0.9% was as effective as heparin in maintaining patency.

In most instances, 5ml of sodium chloride 0.9% is sufficient

• 2ml before and 3ml after administering the drug

• If more than one drug is used more will be needed

The frequency of flushing, in order to maintain patency varies widely between and even within institutions

The current literature supports flushing before and after every drug administration, to check patency and to ensure there is no mixing of drugs in the cannula with possible adverse reactions When no infusions are being administered - Flushing should be done every 6 hourly to maintain the patency of the catheter

Care of The Cannula

• Documentation

• Site Inspection

• Termination of Infusion Therapy

• Post removal

• Complications OF IV Cannulation

• Phlebitis

Flushing IV Cannula


3.3


Sr. No. Signs Picture Action

0 No pain or signs Continue to observe

1 Pain/rednessaround insertionsite

Remove &replace cannulaobserve site

2 Pain, swelling,rednesspalpable venouscord

Remove &replace cannulaObserve & treatsite

3 Pain, Swellng,induration,rednessPalpable venouscord above 3cmsPresence of pus

Remove, sendtip for C&SImplementTreatment plan

4 All the abovePresence of tissue damage

Remove, send tip for C & SImplementTreatment planCompleteclinicalin cidence form

Detection and advice Scale for Peripheral Phelbitis


3.3


Transfixation

Skin Vein Wall

Extravasations

Infiltration

• Infiltration occurs when the infusate enters the subcutaneous tissue rather than the vein

Vein Wall

Haematoma

Infiltration

Complications


3.3


Catheter colonization

When organizations get lodged to the catheter and multiply there

Points to remember

Intravenous catheterization is one of the most common invasive procedure performed in acute care settings, therefore train healthcare staff meticulously, on the safe practices

Pay due attention to selection of suitable site, proper selection of cannula with due consideration of the patients condition

In infant and children antecubital fossa, dorsum of hand or foot, saphenous vein in lower limb or scalp veins are preferred

Preferred sizes

• 26-24 Gauge in infants and children

• 24-22 gauge in children and elderly patients

• 24-20 gauge in critical patients including post-operative surgical patients

• 18 gauge in surgical patients and for rapid blood transfusion. If slow infusion rate is needed then smaller gauge catheters can also be used

• 16 gauge for serious trauma patients requiring large volumes of fluid rapidly

FOLLOW all universal precautions as described in previous chapters

Once the cannula is placed, secure it by proper dressing with a transparent dressing

Flushing of cannula with normal saline (0.9%) is as effective as heparin in maintaining the patency

Keep observing cannula insertion site and take steps when any complication is noticed

Change cannula in accordance with indwelling time related instructions.

Give due attention to sharps disposal

Report immediately any Needle Stick injury sustained

References: H Gray's text book of Anatomy

Survival Medicine # 18: Starting an IV

www.bd.com

www.vascular-web.com

www.wikipedia.com


3.3


BACKGROUND

Reuse of syringe-needle without sterilization is not unheard of at hospitals with working sterilizers. Misconceptions about injection safety that lead to reuse without sterilization arise from the structure of injection technology and were widespread in high income developed countries less than 20 years ago. Reuse without sterilization usually occurs when health workers mistakenly believe that

1. it is safe to reuse a syringe after changing the needle.

2. it is safe to reuse a needle or syringe on the same patient, re-entering a multi-dose vial or saline bag with a used needle or syringe.

3. it is safe to reuse a needle or syringe when accessing an IV port separated from the patient by intervening lengths of IV tubing with heparin locks or valves.

The global burden of disease from unsafe medical injections has been estimated for the year 2008 by the World Health Organization from a probabilistic model. In total unsafe medical injections led to 340,000 HIV infections, 15 million HBV infections, 1 million HCV infections, 3 million bacterial infections and 850,000 injection site abscesses in 2008. These infections accounted for 14% of HIV infections, 25% of HBV infections, 8% of HCV infections and 7% of infections with bacteraemia worldwide and accounted for 28 million disability adjusted life years, a metric of the years of life lost to death and disability from AIDS, acute hepatitis, liver cancer, end-stage liver disease and fatal sepsis.

One in four HIV infections and half of HBV and HCV infections in India result from unsafe medical injections. (Source: Hutin 2004). As per the findings of joint study conducted by INCLEN and Government of India, which were published in 2005, 62 percent injections given in India are unsafe and nearly 27 percent out of these indicate towards possibility of re-use.

Chapter - 4.1

Characteristic of unsafe injection: Govt. Health Facility

Unsafe

QuestionableSterility

Reuse

Wrong Habits of Injection givers

68.6%

29.6%

17.2%

56.9%

61.3%

20.8%

11.3%

52.7%

84.1%

46.9%

27.9%

66.4%

Assessment of injection Practices in India: An IPEN Study

Total Plastic Glass


4.1


Injection Safety- Slicing The Problem of Reuse of Syringes

As Re-use of syringes and needles is unethical practice and all of us should make every possible effort to put a check on this. Therefore, it is of paramount importance to understand key details related to re-use, which are given in the following pages.

RE-USE AND ITS TYPES

Re-use of syringes can be classified into two main types

1 Intentional Re-use

2 Down stream Re-use

Intentional Re-use

There can be following reasons for this category of re-use

• When a health worker knows that re-using needles and syringes is harmful, even then he/she uses the syringe/needle that has been used once (and needed to be discarded)- for limiting the cost

• When a health worker does not know that reusing syringe/ needle that has been used once, on the same or other patient, is HARMFUL

• When a health worker feels that re-using syringe needle on the same patient is not harmful

• When health workers mistakenly believe that

• it is safe to reuse a syringe after changing the needle,

• it is safe to reuse a needle or syringe on the same patient, re-entering a multi-dose vial or saline bag with a used needle or syringe,

• it is safe to reuse a needle or syringe when accessing an IV port separated from the patient by intervening lengths of IV tubing with heparin locks or valves.

(SOURCE-CDC)


4.1


Downstream Re-use

When syringes /needles are not properly disposed off, people pick them up and resale it. Mainly, the desire to get lucrative gains out of selling an otherwise useless product is the responsible reason.

Dangerous use of syringes

The absence of a sound health care waste management system, the risks linked to re-use of waste sharps from healthcare waste and the environmental impact of improper disposal are major concerns. There is thus an urgent need to find solutions. Due to lucrative resale value of disposable syringes in the market, the problem is magnified. With India's growing urbanization, this becomes much more concerning There is a potential risk of illegal reuse, posing a risk to the entire community. The process of re-use of syringes involves a chain of recovery of intact and un-mutilated syringes, cursory cleaning in appearance, in some cases repacking and reentrance into the user chain.

Preventing Re-use

Re-use takes place primarily because of two reasons- misconceptions and greed for monitory gains. In order to address this issue, thus, a three pronged strategy is needed

• Proper training of healthcare staff

• stringent acts and appropriate policy measures

• use of technology in terms of re-use prevention feature enabled injection devices

IMPACT OF RE-USE

Effect on Individual level

1. Unsafe medical injections due to re-used syringes often result in spread of blood born pathogens like HCV, HBC and HIV. The resultant illnesses lead to financial burden of the patient for getting the condition properly diagnosed and treated (if they are not reporting to the public health system).

(Photo credit CMJ)


4.1


2. The illnesses lead to productivity losses and thus have a negative bearing on the finances for the family.

3. Can also result in death or permanent disability for the individual affected.

Effect on the health system

1. Infections so spreading add to the disease burden in the society. Further spread from these cases in the community can also happen

2. Expenditure on investigations and management of the disease condition pose a heavy cumulative financial burden on the health system

3. Credibility goes down when a incident story surfaces

WHY RUP TECHNOLOGY

• The global incremental cost effectiveness ratio of introducing reuse prevention syringes for all medical injections is 0.0187, indicating that this intervention would be cost-saving.

• This cost-effectiveness assessment suggests that the incremental cost of introducing reuse prevention syringes for all medical injections is outweighed by the societal benefit in all world regions.

• In the study by W.H.O., in all sub-regions analyzed, the cost of each DALY averted through national policies for the safe and appropriate use of injections is considerably less than one year of average per capita income, which is the threshold for an intervention being highly cost-effective proposed recently by the WHO Commission on Macroeconomics and Health

• Even indirect syringe reuse can transmit HIV from one patient to four others. (Source: Shields 1994)

• 39.3% of developing world injections are given with re-used syringes. (Source: Anja M Hauri, Gregory L Armstrong and Yvan J F Hutin)

• One in four HIV infections and half of HBV and HCV infections in India result from unsafe medical injections. (Source: Hutin 2004)

Cost Effectiveness

• The average cost of a policy by which single-use syringes and needles are used for all injections amounts to less than Rs 25 per person per year.

• Also, cost differential between a normal syringe and an AD syringe is only around a rupee, where as the cost of undergoing the treatment is not only expensive but unbearable.

• Implemented jointly with interventions to reduce injection use, injection safety interventions can prevent more death and disability while remaining a sound investment in public health.


4.1


• In addition, policies for the safe and appropriate use of injections can lead to savings in the cost of injectable medicines.

• These savings could be redirected to finance injection equipment for injectable medicines that are essential.

• Thus, introducing re-use prevention syringes in curative segment is a logical investment in public health, considering its positive impacts the health systems, the community at large and that too in a cost effective manner.

IAP RECOMMENDATIONS

State Government

• Training of healthcare workers on Injection safety to be reinforced.

• State to develop a policy on Injection Safety and Re-use prevention

• Device mechanisms to have strict vigil on infection control measures,

• Use of safety engineered devices in curative setting as 95 % of injections are given for therapeutic and diagnostic purposes and infection load is also higher

• Standards of infection control and safety to be made applicable to all levels of public health facilities (District hospitals, CHCs, PHCs, Sub Centers.

• Accreditation of private facilities based on infection control and safety standards

• Develop and put in place mechanisms to prevent re-use at RMP/ Rural Practitioner level

• Make strict acts and strict penalties for non-conformance

Private Institutions

• Train entire cadre of healthcare staff on Infection control and injection safety and conduct periodic reinforcement trainings

• Make sure to display SOPs on infection control and injection safety in each ward / injection room

• Set standards on infection control and ensure strict conformance to these (Healthcare worker Safety, Patient Safety and Community Safety)

• Sensitize entire staff (including waste handlers) on harms of re-use

• Give special attention to proper disposal of bio-medical waste

• Take support from Professional Bodies like IAP on achieving these standards

• Shift to Re-use prevention injection devices for therapeutic and diagnostic purposes


4.1


Individual Health care staff

• Make sure to abide by safety standards always

• Ensure there are SOPs displayed in your clinic

• Continue referring the guide book on Injection safety regularly

• Give special attention to proper disposal of biomedical waste generated from your clinic

• Shift to Re-use prevention injection devices for therapeutic and diagnostic purposes

POINTS TO REMEMBER

• Never administer medications from the same syringe to multiple patients, even if the needle is changed or the injection is administered through an intervening length of intravenous tubing

• Do not reuse a syringe to enter a medication vial or solution

• Do not administer medications from single-dose or single-use vials, ampoules, or bags or bottles of intravenous solution to more than one patient

• Do not use fluid infusion or administration sets (e.g., intravenous tubing) for more than one patient

• Dedicate multi-dose vials to a single patient whenever possible.

• If multi-dose vials will be used for more than one patient, they should be restricted to a centralized medication area and should not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle)

• Dispose of used syringes and needles at the point of use in a sharps container that is closable, puncture-resistant and leak-proof.

• Adhere to IAP/National Guidelines on Injection safety, Pollution Control Board Guidelines on waste disposal

References:SIGN 2010 Annual Meeting of the Safe Injection Global Network:Meeting Report; 9 to 11 November 2010 Dubai, United Arab Emirates

Report INCLEN/GOI 2005

The cost-effectiveness of policies for the safe and appropriate use of injection in healthcare settings :G Dzieken et al: Bulletin of the World Health Organization 2003, 81 (4)

Guide To Infection Prevention In Outpatient Settings: Minimum Expectations for Safe Care

National Center for Emerging and Zoonotic Infectious Diseases,Division of Healthcare Quality Promotion CDC Atlanta


4.1


Effective measures to prevent infections from occupational exposure of healthcare workers to blood and body fluids include immunization against HBV; eliminating unnecessary injections; implementing Universal Precautions; eliminating needle recapping and disposing of the sharp into a sharps container immediately after use; use of safer devices such as needles that sheath or retract after use, provision and use of personal protective equipment and training workers in the risks and prevention of transmission.

Hepatitis C (HCV) and HIV, the virus that causes AIDS, are two of the most serious of the 20 blood-borne pathogens that healthcare workers are exposed to in their daily work caring for the world's health. Hepatitis B virus (HBV) is the most common bloodborne infection and the only one of the three serious viral infections for which an immunization exists. Other infections transmittable through needlesticks include syphilis, malaria and herpes.

The healthcare workforce, 35 million people worldwide, represents 12% of the working population. The occupational health of this significant group has long been neglected both organizationally and by governments. The misconception exists that the healthcare industry is “clean” and without hazard, when in fact the chemical and blood-borne exposures encountered can be career- and life-ending.

Needle Stick Injuries (NSI)

Globally, NSIs are the most common source of occupational exposures to blood and the primary cause of blood-borne infections of HCWs.

The two most common causes of NSIs are recapping and the unsafe collection and disposal of sharps waste.

Determinants of NSIs

Determinants of NSIs include:

• Overuse of injections and unnecessary sharps

• Lack of supplies: disposable syringes, safer needle devices and sharps-disposal containers

• Lack of access to and failure to use sharps containers immediately after injection

Chapter - 4.2


4.2


Healthcare Workers’ Safety

• Inadequate or short staffing

• Recapping of needles after use

• Lack of engineering controls such as safer needle devices

• Passing instruments from hand to hand in the operating theatre

• Lack of awareness of hazard and lack of training

Determinants of Transmission of Infection

The risks of transmission of infection from an infected patient to the HCW following a NSI are:

Hepatitis B 3–10%

Hepatitis C 3%

HIV 0.3%

Factors that increased risks of transmission of HIV include

• a deep wound

• visible blood on the device

• a hollow-bore blood-filled needle,

• use of the device to access an artery or vein and

• high-viral-load status of the patient.

Taken together, these factors can increase the risk of transmission of HIV from a contaminated sharp to 5%. In developing countries, the risk of occupational transmission is increased by the excessive handling of contaminated syringes.

What is needed for control measures to be effective

• An effective exposure control program should have a responsible person assigned to head the program and a committee (such as an infection-control or health and safety committee) that

• It should include representatives from front-line patient care providers to evaluate the hazards, compile the injury data and make recommendations for prevention.

• The committee and staff responsible for infection control should regularly review and analyze data and take remedial measures.

• The committee should assure appropriate follow-up and post-exposure prophylaxis as determined by the nature of the injury and source patient.


4.2


Control Measures

The most effective means of preventing the transmission of blood-borne pathogens is to prevent exposure to NSIs. Primary prevention of NSIs is achieved through the elimination of unnecessary injections and needles; implementation of education; Universal Precautions; elimination the practice of needle recapping; and use of sharps containers for safe disposal have reduced NSIs by 80%. Additional reductions are possible through the use of safer needle devices. Control measures to prevent NSI following the traditional hierarchy of controls from most effective to least effective include.

Elimination of hazard—

• Substitute injections by administering medications through another route, such as tablet, inhaler etc wherever possible.

• Remove sharps and needles and eliminate all unnecessary injections.

Engineering controls—

• Such as needles that retract, sheathe, or blunt immediately after use. (These devices, after a decade of technologic advances, are widely available in North America and Europe and required by law in the United States.)

Administrative controls—

• policies and training programs aimed to limit exposure to the hazard. Examples include Universal Precautions (see below),

• allocation of resources demonstrating a commitment to HCW safety,

• initiatives such as -a needle stick prevention committee, an exposure control plan and consistent training.

Work practice controls—

Examples include no re-capping, placing sharps containers at eye level and at arms' reach, checking sharps containers on a schedule and emptying them before they're full and establishing the means for safe handling and disposing of sharps devices before beginning a procedure.

Personal protective equipment (PPE)—

These are barriers and filters between the worker and the hazard. Examples include eye goggles, face shields, gloves, masks and gowns.


4.2


Universal Precautions

The concept of universal precautions came into being in 1985 as the AIDS epidemic worldwide raised awareness about the occupational hazard of exposure to blood-borne pathogens. Universal Precautions is an administrative control measure that calls for the implementation of practices and equipment to protect the HCW whenever the potential exists for exposure to blood. Every patient is considered to be infected with a blood-borne pathogen regardless of the known sero-status.

Testing of patients for HIV on admission to a healthcare setting is widespread in some countries and regardless of the ethical implications of not obtaining informed consent, a negative test provides a false sense of security to healthcare workers. Sero-conversion to HIV or HCV positive can be delayed up to nine months following infection, so a negative test does not necessarily mean that the individual is not infected. In addition, medical treatment of emergency patients and provision of first aid do not provide any opportunity for testing prior to treatment.

Cost Effectiveness of Safety Measures

A common reason for neglecting to implement disposable syringes, sharps containers and PEP is cost.

While cost-effectiveness data regarding HCW health and safety in general and NSI in particular are generally lacking, the WHO Safe Injection Global Network demonstrated the cost effectiveness of safe injections for the patients and community.

The state of California projected a savings of more than $200 million from prevention of occupational HIV and hepatitis transmission following the implementation of a revised standard to protect workers from blood-borne pathogens by using safer needle devices.

POST-EXPOSURE MEASURES

Follow-up

• Every HCW who sustains a NSI should have access to post-exposure prophylaxis (PEP), as appropriate, within hours of the injury, along with counseling, confidential testing and follow-up.

• Failure to report NSIs may compromise appropriate post-exposure management, including PEP for HIV and hepatitis B virus and assessment of occupational hazards and preventive interventions.


4.2


• The absence of PEP, lack of knowledge of the efficacy of PEP for prevention, an attitude that HCWs are careless or to blame for their own injuries and lack of follow-up and workers' compensation are all reasons HCWs do not report injuries.

• Health care institutions and HCWs should assess reasons for underreporting and eliminate barriers to reporting to encourage an effective exposure-control program.

Prophylaxis

When any HCW sustains a needle-stick injury or other potential exposure to a blood-borne pathogen, the site should be washed with soap and water; mucous membranes should be flushed with water.

• Evaluation of the injury for the appropriate use of PEP should be initiated immediately.

• The decision to initiate PEP is based upon the nature of the NSI, severity of exposure and source patient sero-status and medication regimen if known.

• Testing of source patients requires informed consent in most institutions. Ethical issues must be considered prior to testing of source patients or workers.

• Guidelines for PEP can be found on the CDC Web site and also on NACO web site

• Immune globulin and antiviral agents are not recommended for PEP of hepatitis C.

Unnecessary injections pose unnecessary risks to the patient and the worker and increase the cost of health care. The marginal savings realized through the reduction of unnecessary injections can offset the cost of sharps containers (also known as safety boxes), especially if locally produced in developing countries.

The costs avoided will then include the costs of infection, disease, death and workers' compensation and most of all the human cost of suffering for workers' families.

Important points for assessing exposuresType of exposure

• Percutaneous injury

• Mucous membrane exposure

• Nonintact skin exposure

• Bites resulting in blood exposure to either person involved


4.2


Type and amount of fluid/tissue

• Blood

• Fluids containing blood

• Potentially infectious fluid or tissue (semen; vaginal secretions; and

cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids)

• Direct contact with concentrated virus

Infectious status of source

• Presence of HBsAg

• Presence of HCV antibody

• Presence of HIV antibody

Susceptibility of exposed person

• Hepatitis B vaccine and vaccine response status

• HBV, HCV and HIV immune status

Points to be considered for evaluation of occupational exposure source

Known sources

• Test known sources for HBsAg, anti-HCV and HIV antibody

• Direct virus assays for routine screening of source patients are not

recommended

• Consider using a rapid HIV-antibody test

• If the source person is not infected with a bloodborne pathogen, baseline

testing or further follow-up of the exposed person is not necessary

• For sources whose infection status remains unknown (e.g., the source person

refuses testing), consider medical diagnoses, clinical symptoms and history of

risk behaviors

• Do not test discarded needles for bloodborne pathogens

Unknown sources

• For unknown sources, evaluate the likelihood of exposure to a source at high risk for infection

• Consider likelihood of bloodborne pathogen infection among patients in the exposure setting


4.2


Management of Exposures to HBVFor percutaneous or mucosal exposures to blood, several factors must be considered when making a decision to provide prophylaxis, including the HBsAg status of the source and the hepatitis B vaccination and vaccine-response status of the exposed person. Such exposures usually involve persons for whom hepatitis B vaccination is recommended.

• Any blood or body fluid exposure to an unvaccinated person should lead to initiation of the hepatitis B vaccine series.

• The hepatitis B vaccination status and the vaccine-response status (if known) of the exposed person should be reviewed.

• A summary of prophylaxis recommendations for percutaneous or mucosal exposure to blood according to the HBsAg status of the exposure source and the vaccination and vaccine-response status of the exposed person is included in this report (Refer Enclosure 1).

• When HBIG is indicated, it should be administered as soon as possible after exposure (preferably within 24 hours). The effectiveness of HBIG when administered >7 days after exposure is unknown.

• When hepatitis B vaccine is indicated, it should also be administered as soon as possible (preferably within 24 hours) and can be administered simultaneously with HBIG at a separate site (vaccine should always be administered in the deltoid muscle).

• For exposed persons who are in the process of being vaccinated but have not completed the vaccination series, vaccination should be completed as scheduled and HBIG should be added as indicated (Refer Enclosure 1).

• Persons exposed to HBsAg-positive blood or body fluids who are known not to have responded to a primary vaccine series should receive a single dose of HBIG and reinitiate the hepatitis B vaccine series with the first dose of the hepatitis B vaccine as soon as possible after exposure.

• Alternatively, they should receive two doses of HBIG, one dose as soon as possible after exposure and the second dose 1 month later.

• The option of administering one dose of HBIG and reinitiating the vaccine series is preferred for nonresponders who did not complete a second 3-dose vaccine series.

• For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred.


4.2


Management of Exposures to HCVIndividual institutions should establish policies and procedures for testing HCP for HCV after percutaneous or mucosal exposures to blood and ensure that all personnel are familiar with these policies and procedures.

The following are recommendations for follow-up of occupational HCV exposures:

• For the source, perform testing for anti-HCV.

• For the person exposed to an HCV-positive source

• perform baseline testing for anti-HCV and ALT activity; and

• perform follow-up testing (e.g., at 4–6 months) for anti-HCV and ALT activity (if earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4–6 weeks).

• Confirm all anti-HCV results reported positive by enzyme immunoassay using supplemental anti-HCV testing (e.g., recombinant immunoblot assay [RIBA™])

Health-care professionals who provide care to persons exposed to HCV in the occupational setting should be knowledgeable regarding the risk for HCV infection and appropriate counseling, testing and medical follow-up.

IG and antiviral agents are not recommended for PEP after exposure to HCV-positive blood. In addition, no guidelines exist for administration of therapy during the acute phase of HCV infection. However, limited data indicate that antiviral therapy might be beneficial when started early in the course of HCV infection. When HCV infection is identified early, the person should be referred for medical management to a specialist knowledgeable in this area.

Management of Exposures to HIV

Step 1: First aid in management of exposure

For skin — if the skin is broken after a needle-stick or sharp instrument:

• Immediately wash the wound and surrounding skin with water and soap and rinse. Do not scrub.

• Do not use antiseptics or skin washes (bleach, chlorine, alcohol, betadine).

After a splash of blood or body fluids on unbroken skin:

• Wash the area immediately

• Do not use antiseptics


4.2


For the eye:

• Irrigate exposed eye immediately with water or normal saline. Sit in a chair, tilt head back and ask a colleague to gently pour water or normal saline over the eye.

• If wearing contact lens, leave them in place while irrigating, as they form a barrier over the eye and will help protect it. Once the eye is cleaned, remove the contact lens and clean them in the normal manner. This will make them safe to wear again

• Do not use soap or disinfectant on the eye.

For mouth:

• Spit fluid out immediately

• Rinse the mouth thoroughly, using water or saline and spit again. Repeat this process several times

• Do not use soap or disinfectant in the mouth

• Consult the designated physician of the institution for management of the exposure immediately

Don'ts

• Do not panic

• Do not put pricked finger in mouth

• Do not squeeze wound to bleed it

• Do not use bleach, chlorine, alcohol, betadine, iodine or any antiseptic or detergent

Step 2: Establish eligibility for PEP

The HIV sero-conversion rate of 0.3% after an AEB (for percutaneous exposure) is an average rate. The risk of infection transmission is proportional to the amount of HIV transmitted, which depends on the nature of exposure and the status of the source patient. A baseline rapid HIV testing of exposed and source person must be done for PEP. However, initiation of PEP should not be delayed while waiting for the results of HIV testing of the source of exposure. Informed consent should be obtained before testing of the source as per national HIV testing guidelines.

First PEP dose within 72 hours

A designated person/trained doctor must assess the risk of HIV and HBV transmission following an AEB. This evaluation must be quick so as to start treatment without any


4.2


delay, ideally within two hours but certainly within 72 hours; PEP is not effective when given more than 72 hours after exposure. The first dose of PEP should be administered within the first 72 hours of exposure. If the risk is insignificant, PEP could be discontinued, if already commenced

Assessing risk of transmission

Exposure is defined under three categories based on the amount of blood/fluid involved and the entry port. These categories are intended to help in assessing the severity of the exposure but may not cover all possibilities.

Categories of exposure

Category Definition and example

Mild exposure mucous membrane/non-intact skin with small volumes E.g.: a superficial wound (erosion of the epidermis) with a plain or low calibre needle, or contact with the eyes or mucous membranes, subcutaneous injections following small-bore needles.

Moderate exposure mucous membrane/non intact skin with large volumes OR percutaneous superficial exposure with solid needle E.g. : a cut or needle stick injury penetrating gloves

Severe exposure percutaneous with large volume e.g.: an accident with a high calibre needle (>18 G) visibly contaminated with blood; a deep wound (haemorrhagic wound and/or very painful); transmission of a significant volume of blood; an accident with material that has previously been used intravenously or intra-arterially.

The wearing of gloves during any of these accidents constitutes a protective factor. Note: In case of an AEB with material such as discarded sharps/needles, contaminated for over 48 hours, the risk of infection is negligible for HIV, but still remains significant for HBV. HBV survives longer than HIV outside

the body.

Assess exposed individual

The exposed individual should have confidential counselling and assessment by an experienced physician. Exposed individuals who are known or discovered to be HIV positive should not receive PEP. They should be offered counselling and information on prevention of transmission and referred to clinical and laboratory assessment to determine eligibility for antiretroviral therapy (ART). Besides the medical assessment, counselling exposed HCP is essential to allay fear and start PEP.

Step 3: Counselling for PEP

Exposed persons (clients) should receive appropriate information about what PEP is about and the risk and benefits of PEP in order to provide informed consent for taking PEP. It should be clear that PEP is not mandatory.


4.2


Psychological support

Many people feel anxious after exposure. Every exposed person needs to be informed about the risks and the measures that can be taken. This will help to relieve part of the anxiety. Some clients may require further specialised psychological support.

Document exposure

Documentation of exposure is essential. Special leave from work should be considered initially for a period of two weeks. Subsequently, it can be extended based on the assessment of the exposed person's mental state, side effects and requirements.

Practical application in the clinical settings

• For prophylactic treatment the exposed person must sign consent form.

• Informed consent also means that if the exposed person has been advised PEP, but refuses to start it, this needs to be recorded. This document should be kept by the designated officer for PEP.

• An information sheet covering the PEP and the biological follow-up after any AEB must be given to the person under treatment. However, this sheet cannot replace verbal explanations.

Step 4: Prescribe PEP

Deciding on PEP regimen

There are two types of regimens:

• Basic regimen: 2-drug combination

• Expanded regimen: 3-drug combination

The decision to initiate the type of regimen depends on the type of exposure and HIV serostatus of the source person.

HIV PEP Evaluation

Exposure Status of Source

HIV+ andAsymptomatic Clinically

symptomatic

Mild Consider 2-drug PEP Start 2- drug PEP Usually no PEP or consider 2-drug PEP

Moderate Start 2-drug PEP Start 3- drug PEP Usually no PEP or consider 2-drug PEP

Severe Start 3-drug PEP Start 3- drug PEP Usually no PEP or consider 2-drug PEP

HIV+ and HIV status unknown


4.2


• In the case of a high risk exposure from a source patient who has been exposed to

or is taking antiretroviral medications, consult an expert to choose the PEP

regimen, as the risk of drug resistance is high. Refer/consult expert physician.

Start 2-drug regimen first.

Seek expert opinion in case of

• Delay in reporting exposure (> 72 hours).

• Unknown source

• Known or suspected pregnancy, but initiate PEP

• Breastfeeding mothers, but initiate PEP

• Source patient is on ART

• Major toxicity of PEP regimen.83

Step 5: HIV chemoprophylaxis

Because post-exposure prophylaxis (PEP) has its greatest effect if begun within two

hours of exposure, it is essential to act immediately. The prophylaxis needs to be

continued for four weeks. Exposure must be immediately reported to designated

authority and therapy administered. Never delay start of therapy due to debate over

regimen. Begin with basic 2-drug regimen and once expert advice is obtained, change

as required.


4.2


Dosage of drugs for PEP

Medication 2-drug regimen 3-drug regimen

Zidovudine (AZT) 300 mg twice a day 300 mg twice a day

Stavudine (d4T) 30 mg twice a day 30 mg twice a day

Lamivudine (3TC) 150 mg twice a day 150 mg twice a day

Protease Inhibitors 1st choice

Lopinavir/ritonavir (LPV/r)

400/100 mg twice a day or

800/200 mg once daily with meals

2nd choice

Nelfinavir (NLF)

1250 mg twice a day or

750 mg three times a day with empty stomach

3rd choice

Indinavir (IND)

800 mg every 8 hours and drink 8–10 glasses (1.5 litres) of water daily

Note: If protease inhibitor is not available and the 3rd drug is indicated, one can consider using Efavirenz (EFV 600 mg once daily).

Monitoring should be instituted for side effects of this drug eg CNS toxicity such as nightmares, insomnia etc.

* Fixed Dose Combination (FDC) are preferred, if available. Ritonavir requires refrigeration.

PEP regimens to be prescribed by Health Centres

Preferred Alternative

2-drug regimen Zidovudine (AZT) + Lamivudine (3TC) Stavudine (d4T) + Lamivudine (3TC)

(basic PEP regimen)

3-drug regimen (consult expert opinion for starting 3 drug eg LPV/r, NLF or IND regimen)

Not recommended ddI + d4T combination

NNRTI such as Nevirapine should not be used in PEP

More information on alternative schedules is available in the latest update USPHS guidelines issued 30 September 2005. (http://www. cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm)


4.2


Selection of PEP regimen when the source patient is on ART

The physician should consider the comparative risk represented by the exposure taking in view exposure source's history of and response to antiretroviral therapy based on clinical response, CD4 cell counts, viral load measurements (if available) and current disease stage (WHO clinical staging and history). If the source person's virus is known or suspected to be resistant to one or more drugs considered for the PEP regimen, exposed person needs to be given alternate PEP drug regimen and referred for expert opinion.

Changes in the PEP regimen can be made after PEP has been started. Re-evaluation of the exposed person should be considered within 72 hours post-exposure, especially as additional information about the exposure or source person becomes available.

ARV drugs during pregnancy

Data regarding the potential effects of antiretroviral drugs on the developing foetus or neonate are limited. There is a clear contraindication for Efavirenz (first 3 months of pregnancy) and Indinavir (pre natal).

For a female HCP considering PEP, a pregnancy test is recommended in case of a doubt. Pregnant HCP are recommended to begin the basic 2-drug regimen and if a third drug is needed, Nelfinavir is the drug of choice.

Side-effects and adherence to PEP

Studies have indicated more side effects, most commonly nausea and fatigue, among HCP taking PEP than PLHAs taking ART. These side-effects occur mainly at the beginning of the treatment and include nausea, diarrhoea, muscular pain and headache. The person taking the treatment should be informed that these may occur and should be dissuaded from stopping the treatment as most side-effects are mild and transient, though possibly uncomfortable. Anaemia and/or leucopenia and/or thrombocytopenia may occur during the month of treatment.

Adherence information and psychological support are essential. More than 95% adherence is important in order to maximise the efficacy of the medication in PEP. Side effects can be reduced through medications. A complete blood count and liver function tests (transaminases) may be performed at the beginning of treatment (as baseline) and after 4 weeks.

Step 6: Follow-up of an exposed person

Whether or not post-exposure prophylaxis is started, a follow up is needed to monitor for possible infections and to provide psychological support.


4.2


Clinical follow-up

In the weeks following an AEB, the exposed person must be monitored for the eventual appearance of signs indicating an HIV seroconversion: acute fever, generalized lymphadenopathy, cutaneous eruption, pharyngitis, non-specific flu symptoms and ulcers of the mouth or genital area. These symptoms appear in 50%-70% of individuals with an HIV primary (acute) infection and almost always within 3 to 6 weeks after exposure. When a primary (acute) infection is suspected, referral to an ART centre or for expert opinion should be arranged rapidly.

An exposed person should be advised to use precautions (e.g., avoid blood or tissue donations, breastfeeding, unprotected sexual relations or pregnancy) to prevent secondary transmission, especially during the first 6–12 weeks following exposure. Condom use is essential.

Drug adherence and side effect counselling should be provided and reinforced at every follow-up visit. Psychological support and mental health counselling is often required.

Laboratory follow-up

Exposed persons should have post-PEP HIV tests. HIV-test at 3 months and again at 6 months is recommended. If the test at 6 months is negative, no further testing is recommended.

(Refer Antiretroviral Therapy Guidelines for HIV-infected Adults and Adolescents including Post-exposure Prophylaxis, May 2007, NACO, Ministry of Health and Family Welfare, Government of India for details on exposure prevention and essential information to be provided to exposed person.)

PEP for HCV

In the absence of PEP for HCV, recommendations for post-exposure management are intended to achieve early identification of chronic disease and, if present, referral for evaluation of treatment options.

POINTS TO REMEMBER

• Anticipate and take measures to prevent sudden patient movement during and after injection.

• Avoid recapping and other hand manipulations of needles.

• Collect used syringes and needles at the point of use in an enclosed sharps container that is puncture- and leak-proof

th• Ensure that the sharp container is sealed before it is 3/4 full.


4.2


• Seal sharps containers for transport to a secure area in preparation for disposal.

• After closing and sealing sharps containers, do not open, empty, reuse, or sell them.

• Manage sharps waste in an efficient, safe and environment-friendly way to protect people from voluntary and accidental exposure to used injection equipment.

• Engineered technology. Whenever possible, use devices designed to prevent needle-stick injury that have been shown to be effective for patients and providers

• Encourage health staff to report needle stick injuries and ensure strict adherence to PEP protocols from NACO and Ministry of Health and Family Welfare, Government of India.

Enclosure 1


4.2


References:

Preventing Needlestick Injuries among Healthcare Workers: A WHO–ICN collaboration: SUSAN Q. WILBURN, BSN, MPH, GERRY EIJKEMANS, MD

Centers for Disease Control and Prevention. Guidelines for infection control in health care personnel. Infect Control Hosp Epidemiol. 1998;19:445.

Centers for Disease Control and Prevention, Division of Healthcare Quality Promotion. Surveillance of Healthcare Personnel with HIV/AIDS, as of December 2001. 2003 http://www.cdc.gov/ncidod/hip/BLOOD/hivpersonnel.htm>.

World Health Organization. The World Health Report. Geneva, Switzerland: WHO, 2002.

Lipscomb J, Rosenstock L. Healthcare workers: protecting those who protect our health. Infect Control Hosp Epidemiol. 1997;18:397-9.

Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health (NIOSH) NIOSH Alert: Preventing Needle stick Injuries in Health Care Settings, 1999. Publication No. 2000-108. <www.cdc.gov/niosh/2000-108.html>.

World Health Organization. Aide-Memoire for a Strategy to Protect Health Workers from Infection with Bloodborne Viruses. Geneva, Switzerland: WHO, November 2003.

Pruss-Ustun A, Rapiti E, Hutin Y. Sharps injuries: global burden of disease from sharps injuries to health-care workers. Geneva, Switzerland: World Health Organization, 2003 (WHO Environmental Burden of Disease Series, No. 3).

Cardo D, et al. A case control study of HIV seroconversion in health care workers after percutaneous exposure. N Engl J Med. 1997;337:1485-90.

Ippolito G, Puro V, Heptonstall J, Jagger J, De Carli G, Petrosillo N. Occupational human immunodeficiency virus infection in health care workers: worldwide cases through September 1997. Clin Infect Dis. 1999;28:365-83.

Centers for Disease Control and Prevention. Guidelines for infection control in health care personnel. Infect Control Hosp Epidemiol. 1998;19:445.

WHO/UNAIDS/International Council of Nurses (ICN): HIV and the workplace and Universal Precautions, Fact sheets on HIV/AIDS for nurses and midwives. Geneva, Switzerland: WHO, 2000.

International Labor Office. An ILO code of practice on HIV/AIDS and the world of work. Geneva, Switzerland: ILO, 2001.

South African Law Commission: Aspects of the law relating to AIDS (Project No. 85): Universal workplace infection control measures (Universal Precautions). 1997.

Dziekan G, et al. Cost effectiveness of policies for injection use. Bull WHO, 003;81:(4).

Ca l i forn ia Depar tment of Hea l th Serv ices . The Sharps In jury Contro l Report , 2001. http://www.dhs.cahwnet.gov/ohb/sharps/

Vol. 50 / No. RR-11 MMWR 21


4.2


Objective:

The world Health Organization's (WHO) Safe Injection Global Network (SIGN) has delineated three primary components of behavior change, provision of safe injection supplies and implementation of sharps waste management systems to achieve injection safety.

WHO estimates that contaminated syringes and needles caused HBV, HCV and HIV infections which lead to significant morbidity and mortality and result in substantial costs for families, communities and nation.

The Challenge:

The risks associated with sharps waste are particularly high in developing countries because few systems for the waste management have been established. Injuries from sharps of all types in the clinics, health centers and hospitals are is an important hazard to all the categories of health personnel and waste handlers. The persons most at risk are doctors and nurses in clinics and other health providers in the hospital. In the institutions, the sharp waste not only causes injury to all the categories of staff but also poses risks of nosocomial infection in patients from poor infection control. In our scenario in India, rag pickers, scavengers and municipal workers are at serious risk.

Attention needs to be paid to keep the hazardous sharp waste generated at clinics and hospitals. They need to be secured and prevented from access.

a) They can be achieved by bringing about awareness among health workers, community about potential hazards of sharps waste,

b) Minimizing, segregating, decontaminating (disinfecting) the hazardous waste at the site of generation.

c) Destroying (mutilating) used items to prevent their reuse.

The real challenge is that there is very little information regarding the incidence of diseases directly related to the improper management of sharps in our country. However injuries by sharps are a common occurrence. There is an increasing incidence of HBV infection among hospital staffAdd magnitude of NSIs, refer to ICMR study, AFMC study and a similar study from Chennai.. As per the study conducted in a teaching hospital of

Chapter - 4.3


4.3


Injection Waste Disposal

Armed Forces in India healthcare staff received

At present there is no well established system of segregating hazardous sharp waste in many clinics and hospitals. Very few waste processing technologies are available for remote locations with no infrastructure and further health workers have not been universally trained to follow standard policies and practices. Even in the presence of health care waste management rules framed by the government.

Present way of Sharp management: Sharp waste is frequently dumped along with the municipal garbage. Large hospitals are having incinerator for all sharps, some hospitals are segregating, disinfecting and mutilating and disposing off in pits whichever is appropriate. Some cities in India have common health care waste management facilities. These facilities collect health care waste from the hospitals/nursing homes/clinics on a charge based on per bed or per kg. At the same time in some small towns and villages and even in some cities, proper facilities for health care waste management do not exist. Most of the waste both hazardous/non hazardous are dumped in municipal garbage drums or thrown in vacant plots of land.

BIOMEDICAL WASTE MANAGEMENT RULES

Government of India under the provisions of the Environmental Act,1988 notified the BMW Rules in 1998, which regulates the disposal of all biomedical waste with an objective to ensure safety of health/ environment.

WHAT IS NEEDED?

All health care facilities are required to segregate, disinfect, transport and dispose off the biomedical waste in an environmental friendly manner. Biomedical waste shall not be mixed with other wastes.

Classification of hospital waste

Radioactive discarded from general waste, chemical Cytotoxic, Incinerator

31.43% of percutaneous exposure by NSIs) while providing care to the patients.

Classification of hospital waste

Non hazardous80%

Hazardous20%

15% infectious other hazardous 5%

Non sharpsharp

Plastic disposables

Tissues

Radioactivediscarded fromgeneral waste

chemicalCytotoxicIncinerator


4.3


WHAT ARE WASTE SHARPS?

As per the Schedule I, Rule 5 of BMW Rules, sharp wastes are classified in Category 4, which says, sharp wastes means needles, syringes, scalpel blades, glass etc., that may cause puncture and cuts. This includes both used and unused sharps, which should be treated

COLOR CODING

As per Schedule II, color coding of the container for disposal of sharps is a must. Blue/white translucent colored puncture proof container has to be used and disposed as per schedule (as above). Please refer to the revised guidelines from the Central Pollution Control Board of India.

CPCB POLICY on BMW mangagement

Section 4 of the BMWRules act has given a policy statement.

The following steps should be followed:

1 Minimization

2 Segregation

3 Handling

4 Storage of hospital waste

5 Disposal

SHARP WASTE MINIMIZATION

As far as possible minimize the use of sharps. Emphasis the rational use of injections in the treatment of illness. The use of disposable syringes/needles have increased considerably generating potentially infectious waste with limited options for treatment and disposal. The use of plastic disposables should be limited as far as possible because plastic are not de-gradable, not necessarily legally produced and more likely to cause reuse.

Right way of disposing sharps


4.3


SEGREGATION OF SHARPS

Sharps should be segregated at source. The clinical staff is responsible for segregating the waste at source. Awareness programme is essential and posters for segregating should be placed at the site. Appropriate and different types of waste containers have to be placed at different points as per the Act e.g., in the Ward, OT, ICUs, Clinics.

WHERE ?

Blue/white translucent puncture proof containers should be placed at strategic and easily accessible locations. Sharps include syringes and needles, scalpel blades, catheters stylette, used slides and broken glasses. ! Needles should not be recapped, removed and transported by hand ! Sharps should be disinfected. Hubcutters/needle and syringe destroyer should be used at the site of generation :

a) to reduce the bulk

b) to disinfect

c) to prevent reusing

HANDLING

HANDLING OF SHARPS

Sharps containers should be picked up and carried by the handle provided. They should not be supported at the bottom.

Sharps containers should not be carried on back and they should not be dropped/ thrown.

• Containers should be labeled.

• Vehicles used to transport sharps containers should be authorized and labeled with signage written boldly on the vehicle.

CONTAINERS

Sharps Decontaminating Units (SDU) for syringes and needles are made of plastic and are puncture proof, they can be foot-operated with an inner perforated container with secured handles.

• Should be filled 1/3 with 1% (10 g bleaching powder mixed in one liter of water) hypochlorite solution.

• Sharps in inner containers after treatment with hypochlorite solution should be transferred to puncture proof containers for shredding. (Please refer to the recent guidelines about use of sodium hypochlorite – it was found to serve as a medium for organism to grow and hence the guidelines are being revised)


4.3


• Should be labeled as sharps only.

• Fiber board boxes, discarded plastic cans or metal tins can be used alternatively for transport in absence of proper containers.

MUTILATION/DESTRUCTION/SHREDDING

This will reduce the bulk of the waste. Types of waste required to be mutilated are:

• Needles/syringes

• Plastic disposables

• Needle/syringe destroyers, hub cutters, shredders (mechanical/electrical) are available and they should be used.

SHREDDERS

• Equipments to cut the waste into small pieces to reduce the volume.

• Must have safety provisions to prevent contamination.

• Must be placed in a separate room.

• Waste must be properly disinfected before feeding into shredder.

• Preferably shred all types of materials – plastic, glass, metal etc.

• The quality and grade of cutting blades is critical.

TREATMENT & DISPOSAL

It is necessary to treat certain wastes before disposal to prevent hazards to human health and environment. Onsite treatment is preferred than offsite. Chemical disinfectants like 1% Hypochlorite solution can be used to treat the sharp wastes. Immediately after use, syringe with needle should be dropped into SDU (Sharp Decontaminating Unit), so that both parts are completely immersed in Disinfectant. When SDU is 1/3 full – after contact time of 30 minutes the inner perforated container contents are drained into puncture-proof containers for shredding. Hub cutter /needle and syringe destroyer can be used. The separated/ destroyed needles are collected in puncture-proof containers where they are disinfected by immersing in 1% Hypochlorite or any other disinfectant.

HEAT DISINFECTION

Sharps are collected in a heat resistant container, which when full, should be placed in autoclave/hot air oven. Autoclave is done for 30 minutes at 121oc dry heat for one hour or by boiling at 100oc for 20 minutes in steam sterilizer.


4.3


ENCAPSULATION

Sharp containers when full with sharp wastes are encapsulated by filling with cement clay and plastic foam. The container is sealed and buried in a landfill.

SMELTING

This is suitable for metal sharps, scalpel and lancets. The metal sharps are collected in puncture proof containers which are sealed and smelted in a furnace to recycle.

BURIAL

Sharps can be buried in a land fill after encapsulation or in a special pit only for sharps.

INCINERATION

Used in the absence of safe land, puncture proof containers with waste sharps are placed in incinerator. Metal sharps are incompletely destroyed and will be present in the incinerator ash. GOI Biomedical Waste Management Rule does not allow incineration of plastic waste which includes disposable syringes.

IMPLEMENTATION

Human element is more important than technology. It requires well trained and well motivated staff to implement proper waste management than the sophisticated technology without motivated persons.

WASTE CHAIN

Management requires a chain of diligent, responsible and careful people from nurses/doctors through porter, labourer/ward boy to technician/mechanic who keep the system in good condition.

AWARENESS

The education of general public is also important. The general public who comes to the hospital and also in the community should know the medical risks of hospital waste so that they keep away from risks and also to demand the proper care, services from the hospital/clinic.

SCALE-UP :

To accelerate the uptake of safe injection and disposal practices and to scale-up the awareness and knowledge, establishment of model injection centers at referral hospitals or medical colleges will prove as useful step forward. Such center was established in association with PATH at Niloufer hospital for children at Hyderabad, A.P. and found to be a successful program.


4.3


The model injection center is aimed to:

Rationalize and reduce the number of curative injections.

Increase access to safe injections.

Demonstrate safe injections including safe sharps disposal practices.

• Prevent and reduce needle stick injuries to providers.

• Educate nursing and medical professionals and students on the importance of safe injections.

• Create a permanent learning center.

• Build awareness of injection safety within the community.

The model injection center serves as an ongoing training facility for medical and nursing students as well as visiting physicians and private providers.

TEAM CARE AND RESPONSIBILITY:

All the staff including handlers in waste disposal should have a regular medical checkup and also reorientation about procedures and precautions to

• Minimize

• Segregate

• Treat and handle

• Transport

• Dispose

• Educate and create awareness

Each hospital should have waste management team. Each hospital should apply for authorisation for handling waste and :

• Should be responsible for implementation.

• Should be responsible for segregation, treatment and transport.

• Responsible for annual report.

DO'S OF SHARPS WASTE MANAGEMENT

• Do segregate infectious sharps (e.g. hubcutter).

• Do collect in a blue/white transparent colour coded container.

• Do decontaminate all sharps and plastic waste.

• Do use shredder.

• Do use recyclable/reusable consumables.

• Do immunize all Health Care Professions/Workers/Waste Handlers.

• Do create awareness.

• Do monitor the health waste management activities.


4.3


DON'T'S OF SHARPS WASTE MANAGEMENT

•

• Don't disconnect the needle from syringe by hand.

• Don't mix the infectious and non-infectious wastes.

• Don't throw sharps in the trash/ non-puncture proof containers.

• Don't use open buckets for infectious waste/sharps.

GUIDELINES FOR CLINICS AND CONSULTANTS

The steps that need to be taken for health waste management at clinics are :

• Minimize the use of injections.

• Segregate at source.

• Disinfect with freshly prepared 1% Hypochlorite solution.

• Transport.

All health clinics should have proper health waste management. The doctors, nurses and attenders should have awareness and motivation to follow the guidelines to prevent health hazard.

Don't recap the needle.

Flow Chart -III Steps of DisposalInjection Related Waste

Wrapper, Needle Cap/Empty vialsnot ampoules

Black Bag

Clean the injection site with swab &Give Injection

Cut Hub

Fresh Syringes & Needle Injection vials / ampoules

Blue BagSyringe after the Hub has been cut

GlovesTubes like IV Sets etc.

Puncture proof box-Used Needle, ampoules & athar

Sharp

Yellow BagUsed Swabs

Unused/partially used expired vials

Flow Chart -II Steps of DisposalInjection Related Waste

Wrapper, Needle Cap/EmptyVials not ampoules

Black Bag

Clean the site of injection withSwab & give injection

Cut Hub

Fresh syringes & Needles Vial/Ampoules

Red Bag-Syringes cuter hub cuttingGloves/used swabs/ all other vials

Tubes like IV sets

Puncture proof box- usedNeedle, ampoules & other

Sharps

Blue Bag

Flow Chart -I Disposal of Injection Related Wastes at the Health Facility

Disposal of injection Related Wastes

Wrapper/needle cap/empty vial

SwabsNeedle/brokenampoules /cutter

Sharps

Syringes afterhub cut, gloves

IV set

OR

ORBlack Bag White TranslucentPuncture proof

Container Yellow Bag

Municipalwaste Disinfectant /

Autoclaving/Shredding/Recycling

DisinfectantAutoclaving/Shredding/Recycling

/

DisinfectantAutoclaving/

Recycling

/ Incineration/ Burial

Red Bag


4.3


HUBCUTTER/NEEDLE DESTROYER

Hub cutter/needle and syringe destroyer can be used at clinics to segregate/destroy sharps/needles at source. They should be transported and disposed by an authorized agency who uses closed transport system and disposes as per health care waste management rules.

ORGANISE

In small towns/cities/ villages, all clinicians/consultants should organize themselves to have local medical waste management system for proper management of waste disposal for the safety of themselves as well as community. They should organize reorientation classes on Medical Waste Management.

POINTS TO REMEMBER

– Unsafe Injection practices lead to heavy burden of morbidity and mortality in the community

– Implementation of sharps waste management systems will ensure injection safety and practice it in letter and spirit.

– Creation of awareness, behavior change and effective team building will give success.

– Health care workers responsibility,

Do No Harm to yours self and to the community

References:1) IAP Safe Injection Practices Module, 2005

2) IAP work shop on safe injection practices. Indian Pediatrics, Vol.42, Feb 2005

3) Health care Infection control practices 2007

4) Injection practices in Southern part of India, Rajashekharan etal. Public Health 2003

5) Sharp Waste Disposal practices among genreral practitioners, Gomal Journal of Medical Sciences Jan-June, 2005, Vol.3, No.1

6) Injection safety and Waste Management Building a model - PATH Dec, 2004

7) Med Cdt BR Sangwan., Col Atul Kotwal, SM., Brig AK Verma: Occupational Exposure to Blood and Body Fluids amongst Health Care Workers in a Teaching Hospital of the Armed Forces: MIMI, W,l. 67, No. I, 20ll


4.3


Background of the importance of adopting technology:

WHO states that - A contemporary health system relies on the contribution of human resources and health technologies. Medical devices, one aspect of health technologies, equip health care providers with tools to perform their functions effectively and efficiently. Although medical devices provide an opportunity for a better service, the lack of a national system for selection, procurement, use and management may lead to a disproportionate escalation in health care delivery costs.

It goes on to say that - The majority of the world's population is denied adequate, safe and reliable access to appropriate medical devices within their health systems.

Since the Declaration of Alma-Ata in 1978, WHO has highlighted the importance of appropriate technology and has called for better standardization of health and medical

thtechnologies. In May 2002, the 55 World Health Assembly emphasized the importance of improving patient safety and quality of health care by strengthening the science-based systems used to assess and monitor medical equipment and technology. Subsequently, a follow-up report by the secretariat to the 113th Session of the Executive Board in January 2004 concluded that countries need to develop national regulations, systems for quality assurance, procedures for procurement and risk assessment. These provided a useful foundation and reference for health care technology policy formulation and implementation.

(Adapted from WHO - Technical discussions - The role of medical devices and equipment in contemporary health care systems and services)

Importance of selecting proper technology

With increasing understanding about the importance of Injection safety and its role in avoiding accidental spread of harmful blood born pathogens, more and more technological advances are being applied into the science of injections. Selecting the right products help healthcare organizations take adequate measures to address patient the issues around safety, healthcare workers safety and community safety. However, technology should not be viewed as independent of adequate handholding measures and processes. The combination of products and appropriate quality training go a long way to address safety and thereby help build better healthcare systems. In reference to the injection device following key technologies are available to us

Chapter - 5


5


Newer Technologies available in India to ensure Injection Safety

A. To address patient safety

• Devices to address safety in Immunization - Auto-Disable (AD) syringes for fixed dose immunization – ISO 7886-3, 2005

• Devices to address safety in Curative Sector - Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 1, Type B)

• Devices to address safety in Curative Sector – Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 2, Type B)

• Devices to address safety in Curative Sector – Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 1, Type A)

• Prefilled Injection devices to ensure patient safety – specific vaccines

• Devices that ensure patient safety in the laboratories – Ensuring Safe blood draw

• Devices that ensure patient safety with correct handling of blood – Ensure a safe pre-analytical phase for correct laboratory results

• Devices that prevent contamination with foreign particles – needles for reconstitution

• Devices that ensure proper care in the ICU – Safety syringes

B. To address Healthcare workers safety

• Devices to prevent needlestick injury – safety engineered syringes and cannula

C. To address Community safety

• Sharps collection devices

D. Importance of choosing the correct needle technology – ensuring a smooth patient experience

A. Elaboration of Technologies that promote patient safety

1. Devices to address safety in Immunization - Auto-Disable (AD) syringes for fixed dose immunization – ISO 7886-3, 2005

ISO 7886-3,2005 states that the AD feature is one that automatically activates upon administration of the intended fixed dose to prevent subsequent reuse of the syringe and needle. No secondary or additional action on the part of the user shall be required.

AD syringes are disposable syringes with a metal clip that lock once the medication has been injected and hence physically cannot be reused. Since these syringes prevent reuse, they present the lowest risk of patient to patient transmission of bloodborne pathogens. These are available as prefixed 0.05, 0.1, 0.5 and 1ml syringes for immunization.


5


Auto-Disable Syringes with different mechanisms are commercially available. These can be broadly divided into two types of auto-disable mechanisms:

Active Mechanism

• Requires the user to “actively” disable the syringe/device after use.

• Disadvantage: Chances of reuse if mechanism is not activated.

Passive Mechanism

• The device is disabled as soon as the drug is fully injected out. The user has no control over the mechanism.

• No chance of reuse as user has no control over mechanism.

WHO-UNICEF-UNFPA joint statement issued in 1999 on the use of Auto- Disable Syringes in immunization services has urged countries to use only AD Syringes for immunization after 2003. Various studies have been done comparing the AD Syringes to the Normal Disposable Syringes and it has been found that besides ensuring injection safety, it minimizes vaccine wastage so as to provide extra doses of vaccine.

Also it was preferred by the Health Care Professionals delivering vaccination as it could be used safely and properly with minimal amount of training.

AD Syringes were introduced into the country EPI by UNICEF, GAVI funded Hep B Pilot Project and Govt. of Andhra Pradesh / Gates Foundation Partnership project. Govt. of India in a major step to make immunization safer, took a decision to introduce AD syringes in EPI from 2005.

AD syringes for Fixed Dose Immunization (0.5 ml and 0.1 ml)


5


2. Devices to address safety in Curative Sector - Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 1, Type B)

These have followed the immunization AD and are available both with active and passive disabling mechanisms. The active disabling mechanisms are generally for use in general curative and have a clinician controlled mechanism in which the mechanism is manually activated by the clinician to disable the syringe from being reused after completion of the injection.

The syringes can be used for a multitude of tasks including variable volumes and a number of plunger movements during a single use. These syringes can be used for more common, routine type of procedures including IM injections, IV infusions, reconstitution and blood and other fluid aspirations, which are typically performed in the health care sector.

These syringes require no change in injection technique and minimal additional education. They have standard luer fittings and thereby making it compatible with standard needles and can combine with needle-based safety devices.

The passively disabling syringes (shown below) are more like the immunization AD and allow limited plunger movements. They are intended to be used in primary health care settings or in places where multiple plunger movement is not a necessity. This category of RUP syringes falls under the ISO specifications 7886:4, 2006 (Type 1, Type B)

Passive RUP Syringe


5


3. Devices to address safety in Curative Sector – Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 2, Type B)

There is another variety called the Active Reuse Prevention syringe, which is under the specifications of ISO 7886:4, 2006 (Type 2, Type B). This syringe provides multiple plunger movement and requires the healthcare worker to actively lock the syringe after it's intended single use.

Active RUP syringe

4. Devices to address safety in Curative Sector – Reuse Prevention Syringes (RUP) for curative segment – ISO 7886-4, 2006 (Type 1, Type A)

These RUP syringes operates automatically during or upon completion of intended single use. It is used for single aspiration and injection. Such procedures where single plunger movements are required are relatively rare in the curative segment.

RUP syringe Type 1, Type A


5


5. Prefilled Injection devices to ensure patient safety – specific vaccines and medications only

UNIJECT: Uniject Prefill Injection Device is a cost-effective, high quality, nonreusable injection device for intramuscular and subcutaneous injections. Uniject is a prefilled injection device, not a syringe, since it does not have a plunger and, therefore, functions in a unique way.

Uniject was developed starting in 1987, by the Program for Appropriate Technology in Health (PATH) under projects funded by the United States Agency for International Development (USAID), the Australian Agency for International Development (AusAID) and the International Development Research Centre (IDRC) of Canada.

It is available in 0.25, 0.5, 1.0 and 2ml volumes. This has been extensively used in mass immunization campaigns for Maternal and Neonatal Tetanus in Africa and also for birth dose of Hepatitis B in Indonesian EPI which is now being extended to all doses of Childhood Hep B doses in EPI. The device is also now available in the private market with Hep B vaccine prefilled.

Prefilled vaccine delivery devices like Uniject ensures safety by :

• Protecting the integrity and sterility of the dose until the moment of administration,

• Introducing non-reusable devices, thus minimizing the risk of needle stick injury,

• Guaranteeing the availability of sterile injection devices with the vaccine dose,

• Simplifying distribution and eliminating vaccine wastage,

• Minimizing the volume of contaminated material to be disposed off.

Uniject


5


Uniject thereby has all the attributes to reach immunization right to the doorsteps of the beneficiary even if delivered by semi-trained vaccinators. These newer technologies in immunization will go a long way in increasing the coverages of all antigens without compromising the patient or Health Care Worker safety.

Prefilled Syringes

Some medications and vaccines are also provided in a prefilled form that ensures that the delivery becomes easy and saves precious time, especially for the physician who is flooded with patients. It has specific storage requirements, which the manufacturer provides. At the end of the injection process, the prefilled device is disposed off.

Prefilled syringes

6. Devices that ensure patient safety in the laboratories – Ensuring Safe blood draw

A safe blood draw can only be ensured, if the needle insertion experience is smooth. Moreover, those that require blood draw may already be compromised with some illness due to which the blood draw may be required. To prevent multiple insertions of the needle, while collecting the adequate sample size, is critical in today's healthcare delivery.

These needles are double-pointed needle coupled with a plastic holder.

Multisample needle Holder of the multisample needle


5


7. Devices that ensure patient safety with correct handling of blood – Ensure a safe pre-analytical phase for correct laboratory results

It is known that 68% of all laboratory errors are due to the fact that the sample collection (pre-analytical phase) has been compromised. Preanalytical phase also compromises about 60% of the entire test time. It is therefore critical that samples are collected by procedures that does not compromise patient safety due to erroneous results.

Quality controlled and passed evacuated blood collection devices provide the answer to ensure patient safety with proper results. They are available in the following

a) Plain

b) Gel

c) Citrate

d) EDTA

e) Fluoride

f) Heparin

The colours indicate the type of additives (some tubes have no additives!).

Blood collection using the evacuated tube collection system produces the best blood samples for analysis by the laboratory and they are safe and easy to use — the patient's blood flows directly into the appropriate test tube. Either by manually covering it protects the blood drawing needle or it is self-retracting into the barrel.

Evacuated Blood collection tubes


5


For pediatric blood collection, a smaller and simpler process is required, especially since the veins are fragile and sometimes not found.

Capillary Blood collection tubes

Contact-Activated Automated Lancets

8. Devices that prevent contamination with foreign particles – needles for reconstitution

It is proven by electron microscopy that ampoules that are either cut or broken throw glass particles into the medication. These particles behave like foreign particles when injected into the patient.

To prevent such contamination of the medication with glass particles, needles that are blunt and have filters in them have been devised. The aspect that it is blunt also provides healthcare workers safety

Blunt needles for reconstitution & Blunt Filter needles


5


9. Devices that ensure proper care in the ICU – Safety Syringes

ICUs have patients where minimal changes could be life saving or threatening. In order to ensure that medication delivery is safe and constant, Luer Lok syringes have been devised. They ensure a smooth and a constant delivery of life saving medications and also prevent accidental slippage.

Safety Syringes for Critical Care settings

B. To address Healthcare workers safety-

Devices to prevent needlestick injury – safety engineered syringes and cannula

Data from the CDCs National Surveillance System for Healthcare Workers (NaSH) show that Nurses, Physicians and Laboratory Technicians sustain the highest number of percutaneous injuries.

st1 EPINet (using Exposure Prevention Information network (EPINet) which is the database created by International Healthcare Worker Safety Research and Resource Center, University of Virgini), study in India which was published in December 2010 in the Indian Journal of Medical Sciences. Data ranging from 6 to 26 months were collected from these 4. hospitals.


5


The results: Two hundred and forty-three sharp injuries and 22 incidents of blood or body fluid exposure were encountered in the cumulated 50 months of the study. The incidence of SIs was the highest among nurses (55%) of all the HCWs, akin to the global data. However a new category which is not available in western countries is the category called house keepers.

Where did the injury occur?


5


Healthcare workers reported injuries with sharps

Original purpose of the sharps item

Most of these injuries can be prevented by the usage of Safety Engineered Medical Devices (SEMD).

Needle stick injury prevention devices

These are basically devices, which sheath the needle after usage thereby protecting the healtah care worker from accidental needle stick injuries. The needle requires to be manually sheathed or is withdrawn into the barrel after intended use. USA was the first country to legislate that NSI Prevention Devices to be made available with needle/sharps.

Several devices are available that can protect the healthcare workers

a. Shielded needles with syringe – The shield can be pushed by the finger to cover the needle after usage

Safety glide needles Safety shield needles Safety Lok syringe


5


b. Safety Cannulas – These cannulas prevent the occurrence of Needle stick injuries by automatically developing a plastic sheath upon withdrawal of the stellate.

Safety Cannulas

c. Safety Blood Collection devices

Safety Blood Collection Needle

• Built-in safety shield in alignment with the bevel of the needle

• The safety shield permanently locks into place, significantly reducing the risk of needlestick injuries

Blood Collection needle

Push Button Blood Collection Set

• Provides split-second protection against needlestick injuries

• In-vein activation irreversibly retracts the needle in a split second, locking it safely out of harm's way


5


Push Button blood collection set

Blood Collection Set

• Single-handed safety activation with irreversible locking

• Mechanism, confirmed with an audible click

Safety Lok blood collection set

C. To address Community safety – Sharps collection devices

National Institute of Occupational Safety and Health (NIOSH) states that “As many as 1/3

of all sharp injuries” are disposal related. Appropriately placed Sharps Collectors can

reduce NSI's related to recapping of Sharps by as much as 80%. “Sharps disposal

containers are an important safety engineering control to be considered (with needle

safety devices) as part of a comprehensive needle stick injury prevention program”.

Safety


5


Devices for safe containment of sharps

Phlebotomy collectors

Hub cutters

Sharps collectors


5


D. Importance of choosing the correct needle technology – ensuring a smooth patient experience

For all the categories of devices as listed above, the most important cross cutting aspect is the Needle quality, use of non toxic materials in making syringes stoppers, plungers and also the process of sterilization.

The Needle

The hypodermic needle was invented independently by Charles Gabriel Pravaz in France and by Alexander Wood in England in 1853.1 Since then, needles have become the most widely used medical device, with an estimated 16 billion injections administered worldwide.2 Currently, needles are available in a wide range of lengths and gauges (i.e., diameters) either to enable delivery of drugs, vaccines and other substances into the body or for extraction of fluids and tissue

Electron Microscope photographs of (a) 21 gauge, (b) 27 gauge and (c) 31 gauge needles

Some factors in needle design

To mitigate pain from hypodermic injections, the effect of needle geometry on pain has been investigated. Needle gauge has been shown to significantly affect the frequency of pain during needle insertion into the skin of human subjects.9 For example, insertion of a 27- or 28-gauge needle (Figure 1b above) had an approximately 50% chance of being reported as painful, which was significantly greater than insertion of a 31-gauge needle (Figure 1c above), which had a 39% chance of causing pain.


5


Gauge, Inner Diameter and Flow Rate

The 'gauge' of a needle indicates its thickness – the higher the gauge, the thinner the needle. Maintenance of the flow rate with the thinner 29G/5-bevel needle is made possible by technological improvements that allow the inner diameter of the 29G/5-bevel needle to be the same as that for the 27G/3-bevel needle, although the outer diameter is reduced. Maintenance of the inner diameter also means that the same pressure is required to inject fluid once the skin has been penetrated.

Bleeding and Needle thickness

The likelihood of bleeding was also observed to decrease with decreasing needle diameter. Increasing needle length is also expected to increase pain, although to our knowledge the literature does not contain formal studies specifically demonstrating this effect.

Pain reduction and needle technology

In addition, the mechanics of needle insertion has been found to significantly affect pain. Both the force and the mechanical workload (i.e., area under the force displacement curve) of hypodermic needle insertion have been found to positively correlate with the frequency of pain,. Thus, needle tip sharpness and other factors, such as lubrication, which can reduce the force of insertion and mechanical workload, are important parameters that can be optimized to reduce pain from needle insertions.

Needle Selection Criteria

• Right gauge of the needle.

• Right length of the needle.

• Needle geometry.

• Polishing of the needle.

• Lubrication of the needle.

Right Gauge of the needle:-

• (Gauge corresponds to external diameter of the needle)

• Thicker needle will cause more pain,however viscous medicine like oil based, need higher gauge.

• Option of thin wall needle can be considered.

• Need to have understanding of optimum needle gauge required against type of medicine and site of injection

• Thin wall Technology enables us to have wider internal lumen without need of going for increasing gauge, for achieving better flow rate


5


Right length of the needle.

• Optimum needle length requirement vary according to site of injection, age of patient, BMI of the patient and type of medication

• ID/SC- (1/2 ” or less) length needle

• IM – (I”/ 1.25” /11/2” /2”) -according to BMI of the patient (kg/m2)

• IV- 1”Needle

• Pediatric –(1/2” to 1”) Needle

• Medicine to be given deep IM- (11/2” /2”) Needle.

Tri bevel tip geometry

Regular Bevel

• Designed to penetrate with low penetration. force and minimal drag.

• Used for intramuscular & subcutaneous injections.

Regular Wall

Thin Wall


5


Short bevel

• Designed to minimze unwanted injection depth.

• Used for speciallity. applications e.g. Arterial blood gas sampling and nerve blocks.

Intradermal bevel

• Allows shallow & low angle insertion.

• Primarily used for allergy tests.

Needle finishing

The end result is that trauma to the patient's tissue will be minimized due to lesser metal scrapping on a needle with good quality finishing.

Comparison between good and bad finishing

Good Finshing Bad Finishing


5


Information on Syringe materials

Syringe –Barrel and Plunger- why polypropylene is superior

Rubber stopper- Non toxic/ TPE -benefits

Packaging – types of packaging, how to check quality of packaging

Sterilization- briefly about how it is done- how to check the packaging to see whether the sterilization had been proper or not (perforations for ETO to pass etc)

POINTS TO REMEMBER

• Auto-disable and reuse prevention syringes minimize the risk of transmission of Blood borne pathogens.

• Passively disabling AD syringes are preferred for Immunization and actively disabling Re use prevention syringes for acute care curative settings.

• Use of safety devices in health care has been proven to be highly cost effective, as it helps reducing a part of disease burden (infection due to blood born pathogens) on health systems.

• The use of Auto-disable/Re-Use prevention syringes for Immunizations and other injections is recommended.

• Use of closed system IV cannulas minimizes exposure to blood.

• Use of evacuated blood collection systems minimizes risk of Needle stick Injury and exposure to blood.

• Needle stick injury prevention devices are helpful in preventing occupational exposures to blood borne pathogens.

• Sharps containers prevent accidental needle stick injuries.

References:

Arendt-Nielsen L, Egekvist H, Bjerring P. Pain following controlled cutaneous insertion of needles with different diameters.Somatosens Mot Res. 2006 Mar-Jun;23(1-2):37-43.

Egekvist H, Bjerring P, Arendt-Nielsen L. Pain and mechanical injury of human skin following needle insertions. Eur J Pain. 1999 Mar;3(1):41-49.

Schneider LW, Peck LS, Melvin JW.Penetration characteristics of hypodermic needles in skin and muscle tissue. Phase I Appendices B-E).Final report.Highway Safety Research Institute, Ann Arbor, MI; 1978. Persistent URL http://hdl.handle.net/2027.42/614


5


Monitoring and Surveillance Mechanisms to strengthen Safe Injection Environment

Monitoring

Monitoring is the regular observation and recording of activities taking place in a project or programme. It is a process of routinely gathering information on all aspects of the project.

To monitor is to check on how project activities are progressing. It is observation; ─ systematic and purposeful observation.

Monitoring also involves giving feedback about the progress of the project to the donors, implementors and beneficiaries of the project.

Reporting enables the gathered information to be used in making decisions for improving project performance

Surveillance

Surveillance is data collection for action. It is defined as “systematic collection, analysis, interpretation and dissemination of data about an event or a disease and factors influencing the event behavior”. The information so collected is used as a basis for planning, implementing and evaluating the event or disease prevention and control activities.

In harmony with the essence of Safe Injection Environment (SIE), the surveillance opportunities are at various levels

Level Issue

No harm to Patient New sterile syringes freshly opened from a new pack and then used.

No harm to Provider Did the provider recap the needle after use; Is there any needle stick injury.

No harm to community Has the plunger of the syringe been broken, how has the needle been destroyed Are used injection equipments and other wastes disposed off as per the guidelines?

Chapter - 6


6


Surveillance mechanisms to understand Injection Safety

Why is it needed?

It is imperative that each and every health facility, whether public or private, irrespective of its size, should monitor the injection safety with a strict vigil. The monitoring and surveillance so set should be focusing on providing feedback for corrective action

In a healthcare delivery/ vaccination/ laboratory setting, as we all understand injection with therapeutic/ preventive / investigative purposes is a very common practice carried out on hour to hour, day to day basis.Any omission or commission of negligent act will result into a wide harm.

Surveillance framework to strengthen safety

As we know unsafe injections pose a major and direct risk to the patients, of contracting unwanted infections during the process of care or investigations. These infections can have potentially serious effects and can result into productivity losses frequently and are also lethal at times.

Similarly, unsafe injection practices result into harm to the injection providersalso. One of such most common incidents is needle stick injury (NSI). In India many healthcare workers have contracted infections like HBV, HIV and HCV through NSIs.

Unsafe disposal of injection waste results in to harm (spread of infection) to the general population.

Key Issues which directly harm patients

• Injecting medications which are actually not required- unnecessary injections

• Not using proper aseptic techniques while providing injections

• Using injection equipment which are unsterile/ or already used on some other patient.

Key issues for healthcare workers (Injection providers)

• Not using personal protection (e.g.gloves, eye protection etc) can result into unwanted and dangerous exposure to blood/ body fluids

• Use of injection equipments without safety shield mechanisms, coupled with faulty attempts to recap used needles result into NSIs

• Vaccination against Hepatitis B is mandatory

• Post exposure prophylaxis in case of accidental exposures


6


Key issues which jeopardize community safety

Improper disposal of bio-medical waste- specially sharps

• Unsafe handling of biomedical waste by waste handlers / rag pickers etc

• Re-entry of used syringes in healthcare system

Comprehensive framework

• Every healthcare institution should put in place a comprehensive system of monitoring and surveillance covering all three dimensions of safety.

• For healthcare worker safety, such a framework will help the facility achieve following objectives-

•?Identify injuries that may be prevented with safer medical devices.

• Share and compare information and successful prevention measures with other institutions.

• Evaluate the efficacy of new devices designed to prevent injuries.

• Target high-risk devices and procedures for intervention.

• Analyze injury frequencies by attributes like jobs, devices and procedures. Prepare monthly, quarterly and annual exposure reports

For the patient safety framework it is important to focus on prevention of reuse and other precautions of injection safety (aseptic technique for doing no harm to the patient)

Following areas are important and are to be considered for monitoring

• Training of health workers on injection safety – coverage as well as quality

• ?Orientation of health workers on harmful effects of re-use

•?Essential practice of safe injection techniques across all units and sub-units

•?Monitoring availability of supplies at all points of time – e.g. required sizes of gloves, hand wash, soap and running water, alcohol preps (site cleaning), all required sizes of needles and syringes, re-use prevention syringes, sharps containers, sodium hypochlorite solution (1%), color coded plastic bags and bins for waste disposal,

• Display of injection safety protocols in all injection delivery points

• Complete coverage of health workers with Hepatitis B vaccine.

• Display of pollution control board guidelines in all units which generate healthcare waste

•


6


•waste handlers

• Regular system of waste collection and disposal

• System of identification for HIV, HCV and HBV positive cases admitted in the ward (for healthcare staff)

• Guidelines displayed for post-exposure prophylaxis

• Recording, reporting and follow up system for all cases of NSIs and other body fluid exposures

• Crosschecking number of injections given and syringes indented by a particular ward / department

In a hospital setting the Hospital Infection Control Committee(HICC) is potential framework which can strengthen the injection safety status in a given health facility. The HICC, considering the status of training of health staff on injection safety, their understanding and practices related to the issue, can design an effective monitoring and surveillance mechanism and ensure that it remains operational at all points of time.

There are institutions in differents of the world and in India as well, which have put in place available softwares of Exposure Prevention Information Network (EPI Net- a vuable

tool for research in this area) as an important component of larger surveillance mechanism. This software helps recording and reporting of exposures of healthcare workers through NSIs or Body fluid exposure.The software is available free of cost. BD provides necessary technical support for putting in place EPI Net surveillance system.

The final design of a monitoring and surveillance system depends upon the individual institutions needs, but it should essentially capture finer details related to following broad areas

• Training of healthcare workers on Injection safety

• Vaccination of healthcare workers for Hepatitis B

• Needle Stick Injuries-occurrence and reasons

• Body fluid exposures –occurrence and reasons

• Injection related complications-occurrence and reasons

• Adequacy of sharps containment system

• Functioning of bio-medical waste disposal system

• Any suspicion on syringe/needle re-use

• Availability and regularity in supply of all essential items

• Post-exposure prophylaxis -coverage

Availability and use of personal protective equipments by health workers and


6


The institution should preferably have monthly figures analysed and accordingly take corrective actions in the quickest possible time.It is important to understand here that any such monitoring and surveillance system is for the benefit of the institution, the healthcare workers and the patients, provided timely corrective actions are initiated.

POINTS TO REMEMBER

The information that the institution desires to collect should be discussed in details with the clinical /para-clinical staff

The purpose of collecting this information should be explained to them

In what way the monitoring and surveillance system will benefit the staff should be clearly explained

Importance of correctness and completeness of information should be explained

Every institution/ facility should nominate a nodal person entrusted with the responsibility of ensuring complete and correct information is sent at required frequency from all units/subunits in the institution

Corrective actions needed under different circumstances (related to injection safety) should be well explained to the healthcare staff

ReferenceCommunity Empowerment Collective, article by Phil Bartle, PhD cec.vcn.bc.ca/cmp/

CDC Atlanta;Workbook for Designing, Implementing and Evaluating Sharps Injury Prevention Program

http://www.bd.com/safety/epinet/

Jagger J, Cohen M, Blackwell B. EPINet: A tool for surveillance and prevention of blood exposures in health care settings. In: Charney W, editor. Essentials of Modern

Hospital Safety. Boca Raton, FL: CRC Press Inc; 1995. p. 223-39.

http://www.healthsystem.virginia.edu/pub/epinet/about_epinet.html

Concerned with the reuse of syringes and needles inadvertently in some clinical


6


situations and at times for routine immunization purposes with the standard glass

syringes and some times with disposable syringes too, which are re-sterilised and re-used unhygeinically without safety precautions, The Indian Academy of Pediatrics in association with BD India, as deliberated in an extensive National Consultative Meet

with experts have come out with the following recommendations for Public and Private

Health Facilities:

Equipment related

The health systems and all categories of health facilities (public and private) should have

a system of ensuring no re-use of syringes and needles in their Health Facilities. There

should be proper monitoring of biomedical waste disposal at all levels.

It is recommended that Re-use prevention technology should be encouraged – specifically for the curative sector since Pilot studies conducted by INCLEAN, INDIA have

clearly established several Health hazards following re-use.

Safe injection practices

1. Introduction of effective preservice and inservice curricula on injection safety

(a) Conducting periodic, hands on training with emphasis on practical orientation on the subject of Injection safety,including use of newer technologies, in the training programs for nurses, laboratory technicians and doctors from all streams of medicine)

(b) Creation of Centers of Excellence on Injection Safety in all teaching and training centers should also be a part of the policy).

(c) Orientation workshop should be imparted through a coalition comprising of professional organization like IAP, IMA and MoHFW.Other organization having

expertise in this fiels should also be included)

2. Setting up Injection safety as an important quality criteria

Accreditation of private facilities based on infection control and safety standards

Chapter - 7


7


IAP Recommendations on Injection Safety

3. Healthcare worker safety

States to work out policy regulations and recommendations on the safety of healthcare workers from healthcare acquired infections (specifically the blood stream infections).

(a) Enforce adherence to NACO recommended guidelines on Post exposure prophylaxis

(b) All health care workers should be immunized with 3 doses of Hepatitis B vaccine. Ensure due availability of HBV VACCINE AND IMMUNOGLOBULIN

(For safeguarding healthcare workers against Hepatitis B exposure's effect, all health care set-ups should have the availability of Hepatitis B vaccine and Hepatitis B immune globulin)

(c) Strict adherence to NACO and GoI guidelines on PEP guidelines on HIV, Hepatitis B and other infections as relevant.

(d) Take appropriate measures to increase awareness, REPORTING and understanding of the significance of timely post exposure prophylaxis among different cadres of healthcare workers in public as well as private settings

(e) Switch over to needle stick injury prevention technology enabled devices in a phased manner for injections and infusions.

(f) Establish surveillance mechanism to collect data on NSI in the country and widely disseminate the data for awareness.

(g)Information regarding reporting of NSI, getting counseling and treatment should be widely disseminated.

(h) special insurance provisions for the healthcare workers who contract dangerous blood stream infections due to occupational accidental exposures, to cover cost of investigations, treatments, follow ups, loss of wages, as well as for the loss of life

4. Essential supplies affecting injection safety

(a) Reinforce supply chain to ensure all time availability of essential items, of all required sizes such as, gloves, alcohol hand rub, soap for hand wash, skin disinfectants, syringes and needles (all required volumes and gauges), sharps containers, sodium hypochlorite solution, hub cutters, etc

(b) All essential trainings and supplies to healthcare workers for first hand management of adverse reactions following certain injections

(c) Make a system of quality checks for assessing the technical quality on all items which are used during the process of injection administration.


7


5. Best injection techniques

(a) Establish standard operating procedures (SOP) for safe injections through Model INJECTION Centers set up in teaching and tertiary care hospitals.

(b) Ensure compliance of such standards across the states in all health care delivery points, where injections are administered

(c) All the state governments through the National Government should examine and adapt the guide book on Injection safety jointly developed by IAP and BD India as the first step towards creating a culture of injection safety in healthcare

(d) Create centers of Excellence in every district, which could serve as the practical demonstration site for all health care workers of a given district (public and private both). Make special resource provisions for setting of these centers

6. Rational injection practices

(a) Measure to reduce unnecessary injections in medical care should be adapted on an urgent basis. The steps towards achieving reduction in unnecessary injections could be

• Defining effective and safe treatment protocols.

• Promoting minimal essential injection practices.

• Promoting rational drug/injection therapy.

• Reduction in procurement of injectable drugs at health facilities.

• Encouraging prescription-auditing at all health facilities in both public and private health facilities.

• Community awareness on harmful effects of injections.

• All health facilities should have Model Injection Rooms.

7. Patient Safety

(a) Encourage use of safety engineered devices in curative setting as 95 % of injections are given for therapeutic and diagnostic purposes and infection load is also higher. This will prevent re-entry of used syringes in the system and the resultant harm to the patients.

• Develop and put in place mechanisms to prevent re-use at Governmentt/Semi Government institutions and clinics/ Private practitioners including RegistredMedicalPractitoioner/ Rural Practitioner level


7


Monitor strictly Biomedical waste disposal at all the levels


(b) DOs And DON’Ts Safe Injection Practice Posters Should Be Availble And Placed In All The Places Where Injections Are Given

(c) Reinforce following neglected dimensions of re-use and injection safety in all classes of health facilities

• NEVER administer medications from the same syringe to more than one patient, even if the needle is changed.

• CONSIDER a syringe or needle contaminated after it has been used to enter or connect to a patient's intravenous infusion bag or administration set.

• DO NOT enter a vial with a used syringe or needle

• NEVER use medications packaged as single-use vials for more than one patient.

• ASSIGN medications packaged as multi-use vials to a single patient whenever possible.

• DO NOT use bags or bottles of intravenous solution as a common source of supply for more than one patient.

• FOLLOW proper infection control practices during the preparation and administration of injected medications.

• Infection Control Committees to monitor the adherence to Safe Injection Practices

8. Community safety

(a) Disposal of syringes and sharps

The existing law of the land on health care waste management should be followed. Hence, the waste disposal strategies must conform to central pollution control board guidelines. The state governments should make provisions and impose heavy penalty and punishments to address non-conformance

The logistical difficulties faced by ANMs and health care workers at sub-district levels should be kept into consideration. 'Think globally and Act locally' should be the objective in implementing these guidelines.

Reinforce supply chain for uninterrupted delivery of adequate quantities of all supplies needed for bio-medical waste disposal

•


7


Containment of the injection waste especially sharps in temper resitant, puncture proof

containers, at the point of use (by using a method best suited for the health care setup) is

essential. This should be followed by terminal disposal using methods, which are most

feasible, economical, legal and environment friendly.

Encourage involvement of voluntary sector, technical institutions like IITs and

commercial waste management companies including existing networks of waste

collectors in both rural and urban areas to identify locally feasible solutions.

Make arrangements for district wise dissemination of revised guidelines of the Central

Pollution Control Board and ensure strict compliance

(b) Integrated communication and social mobilization strategy for safe

injection practices

Communication strategy for promoting injection safety should target both the health

service providers as well as the community.

At least 15-20% of the total program budget for injection safety should be kept for

communication and social mobilization campaigns.

To be effective the communication strategy would need to take into account socio-

cultural beliefs and local sensitivities. Hence, it will be necessary to work with NGOs,

community and local influencers. The objective of developing communication strategy

will be to establish product branding. This can be done as a partnership exercise.

Medical professionals should give technical inputs/contents. Communication/ media

experts should develop and design strategy and implementation. Audience research

methods need to be employed.

9. IAP's immediate plan of action on safe injection practices

1. Work for strengthening the Coalitions to support Injection safety at the state and

National level

2. Release the guidebook on injection safety in select states and advocate with the

government for its adoption in training curricula of health workers (first step to

create safe injection environment)

3. Work in partnership with central and state governments, NGOs and other

professional organizations to promote safe injection practices with the over all

aim of ensuring that every injection given in this country is rational and safe and

injection related waste is appropriately disposed.


7


Some specific recommendations:

State Government

•

• State to develop a policy on Injection Safety and Re-use prevention

• Device mechanisms to have strict vigil on infection control measures,

• Use of safety engineered devices in curative setting as 95 % of injections are given for therapeutic and diagnostic purposes and infection load is also higher

• Standards of infection control and safety to be made applicable to all levels of public health facilities (District hospitals, CHCs, PHCs, Sub Centers.

•?Accreditation of all facilities based on infection control and safety standards (including Safe Injection Practices)

• Develop and put in place mechanisms to prevent re-use at RMP/ Rural Practitioner level


Private Institutions

• Train entire cadre of healthcare staff on Infection control and injection safety and conduct periodic reinforcement trainings

• Make sure to display (Standard Operating Procedures) SOPs on infection control and injection safety at the point of use in each ward / and injection room

• Set standards on infection control and ensure strict compliance to these (Healthcare worker Safety, Patient Safety and Community Safety)

• Sensitize entire staff (including waste handlers) on harms of re-use

• Give special attention to proper disposal of bio-medical waste

• Take support from Professional Bodies like IAP and others on achieving these standards

• Promote Re-use prevention injection devices for preventive, therapeutic and diagnostic purposes

Individual Health care staff

• Make sure to abide by safety standards always

• Get youself immunized against Hepatitis B

• Ensure there are SOPs displayed in your clinic

• Continue referring to the guide book on Injection safety regularly

• Give special attention to proper disposal of biomedical waste generated from your clinic

• Shift to Re-use prevention injection devices for preventive, therapeutic and diagnostic purposes

Training of healthcare workers on Injection safety to be reinforced.


7


A safe injection does not harm the recipient, does not expose the health careworker to any risk and does not result in waste

that is dangerous for the community

Annexure - I


I



I


Annexure - II

Evolution of Syringes-a pictorial journey

Metal Syringe Metal Syringe

Metal Syringe Syringes with different shapes

Glass SyringeMetal and Glass Syringe

Plastic Syringe Auto Disable (AD) Syringe

RUP Syringe with breakable plunger Plastic syringe with safety needle


II


Annexure - III

Resources and Links on Injection Safety

“Safe Injection Global Network" (SIGN) http://www.who.int/injection_safety/sign/en/

WHO has a dedicated website http://www.who.int/injection_safety/en/ for more resources on the issues related to Injection Safety. The resources include

1. WHO best practices for injections and related procedures toolkit

2. WHO Guidelines on drawing blood: best practices in phlebotomy

3. G u i d i n g p r i n c i p l e s t o e n s u r e in j e c t i o n d e v i c e s e c u r i t y

Revised Injection Safety assessment tools

4. WHO/UNICEF/UNFPA joint statement on use of AD Syringes in Immunization

(available in Annexure)

5. Key WHO Recommendations on Injection Safety

The Centers for Disease Control, Atlanta, USA also has numerous resources on Injection Safety. Please refer to http://www.cdc.gov/injectionsafety/ for further technical information.

CDC works with numerous partners to conduct a range of activities to improve injection safety and prevent transmission of bloodborne pathogens and other infectious diseases. Below are some of CDC's current injection safety activities.

• Promotion of Safe Injection Practices

• Development of Infection Control Guidelines

• Improved Basic Infection Control through Collaborations with CMS

• Improved Safety through Collaborations with FDA

• Improved Healthcare Personnel Protections from Sharps Injuries

• Responding to Outbreaks in Healthcare Settings

• Identification and Promotion of Best Practices for Patient Notification

• Efforts to Improve Injection Safety through Collaborations with Industry

• Improved Capacity in State Health Departments

• Expansion of the HHS Action Plan to Prevent HAIs in Outpatient Healthcare Settings

U n i v e r s i t y o f V i r g i n i a - I n t e r n a t i o n a l H e a l t h c a r e W o r k e r S a f e t y C e n t e r (http://www.healthsystem.virginia.edu/pub/epinet/home.html)

http://www.cdc.gov/niosh/docs/2003-108/

Safe Injection Practices Coalition http://www.bd.com/press/newsroom/sip.asp

http://www.bd.com/press/pdfs/PRIMER-Safe-Injection-Technologies.pdf

The World Bank

http://siteresources.worldbank.org/INTPHAAG/Resources/AAGInjectionSafety9-03.pdf

http://www.unicef.org/media/media_59053.html


III


Annexure - IV

Points for Surveillance on Safe Injection Practices

1. Is the Hospital/Clinic offering Injections either preventive or curative?

2. Have the entire Professional, paramedical and ancillary staff been immunized against Hepatitis B? Have the record been checked by senior administrative officer?

3. Is the hospital/clinic using the products which are designed to prevent reuse. e.g Auto Disable syringe or Reuse Prevention feature syringe?

4. What was the last date of sensitization session on Safe Injection Practices undertaken in the hospital for all staff and professionals? Who took the session and was it interactive?

5. How many staff/doctors have had any Needle Stick Injuries (NSIs) in the last six months?

6. Is there Post Exposure Protocols displayed at strategic points for accidental exposure cases?

7. Who is the designated focal point for clinic/hospital to treat Needle Stick Injuries?

8. What practice does the hospital/clinic follow to prevent reuse of the needle?

9. What practice does the hospital/clinic follow to prevent reuse of the syringe?

Instructions for filling up this format:

a) The Hospital/Clinic Incharge may fill this format first time immediately after receiving a copy. Thereafter, it is intended to be filled up every six months.

b) The filled format may be summarized and the whole staff and doctors may be briefed upon in the subsequent sensitization sessions on the Safe Injection Practices.

c) If the Hospital has multiple departments, then one format may be filled for each department.

NB: This is a simple adaptation for basic quick surveillance of the Safe Injection Practices. For detailed surveillance, the user is encouraged to use the Epinet Software.


IV


Annexure - V

IAP Plan of Action on Safe Injection PracticesIn order to work towards achieving the required standards of Injection Safety in India, the Indian Academy of Pediatrics has following activities planned to be done in a phased manner

1. Release of the Safe Injection Practices Guide book in two states of India.

2. Developing training modules based on the Guide book on Injection Safety . These modules will be developed through a national consultative process as was done for finalizing the Guide book on Safe Injection Practices.

3. Conducting a National workshop on Training of Trainers.

4. Conducting four Regional workshops for training of trainers (ToT) using the modules developed on safe injection practices (1 each for West, North, South zones, and one for Central and North East zone combined). The trainers here would be those trained through the National ToT

5. Conducting District level workshops in selected cities (15-20 workshops), where the trainers trained through Regional ToTs will impart trainings to IAP members, as well as to some of the members from other professional organizations.

6. For all district level workshops impact of training would be assessed using pre and post training questionnaires.

7. IAP would continue to highlight issues related to unsafe injection practices through articles and publications in the bulletins of Central IAP and other publications as relevant.

8. IAP would include Injection Safety as an issue for discussion in all major forums based on thematic relevance. Efforts will be made to include the subject in Pre-conference workshop during conferences of IAP, based on feasibility.

9. IAP would continue to advocate with the Government and Private sector healthcare systems to sharpen focus on injection safety.

10. IAP will support institutions and public health systems in setting up monitoring and Surveillance System on Safe Injection Practices and Waste Disposal practices for ensuring conformance with the laid-down guidelines.


V



1.1


AD-Active Mechanism, 100AD-Passive Mechanism, 100Antero-Lateral Thigh, 28APIC Recommendations, 8Applying A Tourniquet, 57Approaching The Vein, 58ARV Drugs During Pregnancy, 85Aseptic Techniques, 20Auto-Disable Syringes, 99Best Practices, 17Biomedical Waste Management Rules, 90Blood Collection By Skin Puncture, 42Blood Glucose Monitoring, 10Breaking Vials, 20Burial, 94Butterfly Wing Set, 38Cannula Placement, 56Cannula Selection, 52IV Cannulation, 48Capillary Blood Collection, 42Care Of The Cannula, 62Classification Of Hospital Waste, 90Cleansing, 30Cleansing The Venepuncture Site, Clinical Follow-Up, 86Color Coding, 91Complications, 64Compromised Packaging, 20Contamination, 9,10,18,19Deltoid Muscle, 29Determinants Of NSIs, 72Devices For Safe Containment Of Sharps, 112Do Not Touch Parts, 30Downstream Re-Use, 68Emergency Management, 34Encapsulation, 94Evolution Of Syringes, 131Exposures To HBV, 78

Exposures To HCV, 79Exposures To HIV, 79Fingerstick, 44Flow Rate, 114Flushing, 8Flushing iv Cannula, 62Gauge, Inner Diameter, 114Green Solutions, 2, 4Hand Washing, 26Handling Of Sharps, 92Healthcare Workers Safety, 72Heat Disinfection, 93Heelstick, 45Hubcutter, 97IAP Plan of Action, 134IAP Recommendations, 123Impact Of Re-Use, 68Inappropriate Use Of Drugs, 15Incineration, 94Infant/Child Phlebotomy, 42Injection Delivery, 26Injection Waste Disposal, 89Inserting The Cannula, 59Intentional Re-Use, 67Intradermal Bevel, 116Intra-Dermal Injection, 31Intra-Muscular Injection, 31 29, 33Irrational Use, 14ISO 7886-3, 2005, 99ISO 7886-4, 2006 (Type 1, Type A), 102ISO 7886-4, 2006 (Type 1, Type B), 101ISO 7886-4, 2006 (Type 2, Type B), 102Laboratory Follow-Up, 86Leg Veins, 51Mixing Of Samples, 41Multi-Dose Vials, 19Multiple Injections, 34Mutilation, 93

INDEX


1.2


Needle Bore, 31Needle Design Factors, 113Needle Finishing, 116Needle Length, 31Needle Selection Criteria, 114Needle Stick Injuries, 72Needle Stick Injury Prevention Devices, 109Needle-Stick Injuries, 21, 24 Needle Technology, 113New Er Technologies, 98Newer Technologies, 98Parts Of A Cannula, 55PEP, 80-83Performing The Venepuncture, 37Peripheral Phelbitis Scale, 63Peripheral Venous Anatomy, 48Phlebotomy, 36Positioning, 29Post Injection Care, 34Post Injection Precautions, 33Post-Exposure Measures, 75Prefilled Syringes, 104Preventing Contamination, 19Preventing Re-Use, 68Procedure For Skin Puncture, 44Procedure Notes, 46Prophylaxis, 76Rational Use Of Injections, 12Resource Link 132, Reuse Of Syringes, 66Reuse Prevention Syringes, 101Risk Of Phlebitis, 54RUP Technology, 69

Safe Disposal Systems, 3Safe Injection Environment, 1 Safety Devise For Boold Colloction, 40Safety During Venepuncture, 36SC Injection, 31Securing And Dressing The Cannula, 61Segregation Of Sharps, 92Selecting A Vein, 49Short Bevel, 116Short Peripheral Catheters, 49Shredders, 93Site Preparation, 55Site Selection, 28Sites In Pediatric Patients, 51Size & Bore Of The Needle, 31Skin Integrity, 20Smelting, 94IV Solutions, 8Subcutaneous Injections, 31, 32Surveillance, 2, 4, 5, 107, 118, 119, 133Surveillance - Injection Safety, 118Surveillance Framework, 133Swabbing Vial, 21, 24Technique Of Injection Administration, 31Tourniquet Application, 37Tri Bevel Tip Geometry, 115Valves And Cannulation, 50Vein Stabilization, 58Venepuncture Using Evacuated Blood Collection System, 39Waste Chain, 94Waste Sharps, 91Who Fact Sheet, 129

INDEX

Contact Address:Hon. Secretory GeneralThe Indian Academy of PediatricsKailas Darshan, Kennedy Bridge (Nana Chowk)Mumbai 400007 (India)Phone (022) 23887906, 23887922, 23889565Fax: (022) 23851713 Email: [email protected]: www.iapindia.org