the safe use of medical devices in 21st century by eng mohamed salah aouididi

ROYAL COMMISSION HEALTH SERVICES PROGRAM AT YANBU

THE SAFE USE OF MEDICALDEVICES IN THE 21st CENTURY

Prepared by:

Clinical Engineering ManagerEngr. Mohamed Salah Aouididi

(Masters Degree in BME/Germany)

For The 4th Medical Devices Scientific Forum12 - 15 April 2010

Medical devices and equipments

are used everyday by most healthcare professionals to support the care and

treatment of patients.

Professionals play a vital role in

ensuring that the equipment is

used safely and for the purpose

it was intended.

INTRODUCTION

AIMS OF THE ABSTRACT

The aims of this abstract are to:

Help nurses, midwives, health visitors, other health care professionals and support workers understand their role in the safe use, purchase and management of medical devices.

Provide managers with pointers to best practice for training, purchase and maintenance of medical devices.

Ensure that arrangements for purchase, use and maintenance of medical devices are firmly embedded within the local framework for clinical governance.

Raise awareness about the role of the SFDA and how it can provide advice and guidance to support the safe use of medical devices.

CHANGES IN TECHNOLOGY & CLINICAL PRACTICE (1)

Medical devices play an increasingly important role in

supporting patient care. However, they cannot replace the

need for the experience of nurses, doctors and other health

care professionals who assess, diagnose and deliver therapeutic care and who ensure that any device is functioning as it should.

Rapid changes in health care technology and clinical practice

present particular challenges. Increased throughput of

patients combined with more complex therapies are likely to

impact on the work pressures that health care professionals

experience.


As medical devices become more sophisticated and frequently

used, health professionals are committed to lifelong learning

and to developing their expertise.

Nurses and midwives will continue to need to expand their technical skills to use a growing range of medical devices, from the relatively simple to the complex

Patients will be increasingly knowledgeable about their health needs and treatment options as they access information from diverse sources, including the internet and TV channels.

The public will increasingly use self-screening devices, for example, blood pressure, cholesterol, blood sugar testing


Patients with chronic and/or life limiting illness will wish tomanage their own care and treatment regimes, for example, home intravenous therapy and dialysis.

This will require appropriate individually planned education, preparation and support from health care professionals.

To be shifted to

BLAME CULTURE

CULTUREOF

CORPORATE APPROCH

OPENNESS AT THE HEART OF THE QUALITY STRATEGY (1)

If adverse incidents are reported and if the chain of events leading up to and contributing to an adverse incident are analyzed, it will allow the individuals involved and the organization to identify where things went wrong. It is then possible to learn from the incident and to develop strategies which prevent the same thing happening again.

OPENNESS AT THE HEART OF THE QUALITY STRATEGY (2)

Effective clinical governance plans incorporate a shared

goal between the individual and the organization to minimize hazards related to the use of medical

devices and to ensure that everyone who needs to, is able to use medical devices safely and effectively.

This abstract is intended to provide the guidance needed by

healthcare professionals and to support workers and managers in order to minimize the risk of adverse

incidents resulting from the use of medical devices.

WHAT IS A MEDICAL DEVICE?

A medical device is any instrument,

apparatus, appliance, material or

health care product, excluding drugs,

used for a patient.

PURPOSE OF MEDICAL DEVICES

Medical Devices are used for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease.

Diagnosis, monitoring, treatment, or alleviation of, or compensation for, an injury or handicap

Investigation, replacement or modification of the anatomy or of a physiological process

Control of conception.

PERSONAL AND PROFESSIONAL

ACCOUNTABILITY

All healthcare professionals and support workers working in the public and private sector are accountable for ensuring that they use medical devices safely.

Occupational therapists, physiotherapists and other professional groups have professional standards/protocols with similar principles to guide their practice.

They should make sure they are familiar with the particular clauses of their own code.

It is important to be aware of the characteristics of :

The environment within which the equipment will be used.

The people who will be using it. The patient’s needs.

However, under the right circumstances and with

appropriate, individually tailored training, patients

can be supported using complex medical devices

such as a ventilator for long term or palliative care in

the home setting.

ENVIRONMENT IN WHICHMEDICAL DEVICES ARE USED

(1)


(2)Health care professionals and managers should consider

the following issues in managing the use of medical devices:

Knowledge of the individual’s medical condition and likely responses to treatment.

Assessment of need for particular medical devices and their availability.

Documentation of device used and monitoring undertaken (checking at specified intervals that the device is functioning as it should, for example, delivering a drug at the correct infusion rate).

Ability of the health care professional to interpret information provided by the device, for example, ECG trace, and identification of training needs.

Environment of care, for example, high tech, low tech or home setting

Skill mix and staffing levels, for example, the ratios of qualified to unqualified nurses, of nurse to patient and single patient user

Nurse/health care professional workload and ability to monitor patient and equipment within the care environment

Previous training and experience using similar type of devices, for example, infusion pumps, ventilators, patient hoists and prosthesis fitting.


(3)


(4)

When a health care professional selects medical devices

that will be operated by patients and/or carers, a number

of considerations must be taken into account:

General health and mental state of the patient and/ or carer: stressed, relaxed, rested, tired, affected by medication or disease.

Sensory capabilities: vision, hearing, touch…etc Co-ordination: manual dexterity. Cognitive ability and memory. Previous experience with medical devices.


(5) Patient/carer expectations about how the device

will operate Physical environment in which the medical device

will be used and others who might have access to it, for example, children

Patient and carer awareness of their responsibility to look after and monitor the equipment on completion of treatment

Personal responsibility of patients and carers for maintenance of equipment where devices have been purchased privately, for example, apnea alarms, nebulizers, TENS machines.

WRITTEN GUIDANCE FOR PATIENTS AND CARERS

Written Guidance should cover the following:

The name of the device

The operation and control of the device

Checking of the device while in use

Recognition of a device failure or fault

Action to be taken in the event of a device failure or fault

Individuals to be contacted in an emergency.

80%

20%

In any 100 Reports involving IV Pumps

User ErrorDevice Failure

PEOPLE MAKE ERRORS (1)

• Setup of the Infusion Rate (Overdoses: 20mL/h instead of 2mL/h)

• Failure in the Setup Buttons (numbers were bouncing, Alaris recall)

• Over-infusion of diamorphine (one Model of Syringe Driver mistaken for

another, staff familiar with one Model only – Equipment standardization is recommended).

PEOPLE MAKE ERRORS (2)

Adverse incidents due to user error occur for a variety of reasons. These include:

Devices used by those who have not been properly trained intheir use (Fetal US Monitors)

Devices used for a purpose other than that for which they were designed (Wooden tongue depressors used as limb splints in NICU, which caused potentially fatal fungal infections in four babies

Device is too complex for the user’s perceptual or physical capabilities. A patient fell from a two-piece sling and died two days later. Most suppliers of and slings advise that they are not suitable for certain people: those with extensor spasm, flaccid hemiplegia, confusion or those with painful shoulders. Therefore slings should be used carefully and selectively in accordance with the manufacturers’ instructions and that carers and users should receive full instruction in their use.

CHECKLIST:HOW SAFE IS YOUR

PRACTICE?Before using a medical device, ask yourself the following

questions:Do I know how to handle the medical devices in my unit?What preparation have I been given in how to use a particular medical

device, for example, an infusion pump? Was the preparation formalized and recorded or did I just pick it up as I went along?

How was my competency to use this equipment safely assessed?Am I familiar with the instructions on how to use this piece of

equipment and any warning labels?When was this equipment last serviced?Do my junior staff colleagues know how to use equipment?What is the cleaning and/or decontamination procedure for this device

and what are my responsibilities in this process?Do I know who is responsible for risk management in my

organization?Do I know how to report an adverse incident?Do I know who my SFDA Liaison Partner is?Do I have access to MDA Device Bulletins of relevance to my area of

practice and do I read and take note of Hazard and Safety Notices?

POINTERS TO BEST PRACTICE IN ORGANIZATIONAL RISK MANAGEMENT

(1)

In the context of the use of medical devices, the risk Management can help identify potential risk and

avoidadverse incidents. In the risk management process several steps are necessary:

Identify likely and unexpected hazards related to use

Identify situations and circumstances where these are most likely to occur

Develop strategies to minimize user-related adverse incidents

Demonstrate safe and effective device use.


(2)

Effective risk management is based on a partnership

between the organization and individual health care

professionals.

Formalized systems for procurement, training,documentation, communication of safety

warnings, reports of malfunctions and audit will help

minimize the incidence of device-related adverse

incidents.

This paper provides detailed guidance for clinical, technical and managerial staff in health care provider organizations.

It covers the following areas:

how to purchase the most appropriate device acceptance tests for newly delivered devices adequacy of instructions ensuring a client or patient is prescribed the best device maintenance and servicing record keeping training issues relating to medical devices in the community.


(3)

TRAINING (1)

Organizations must ensure that there are adequate

arrangements for training. Equally, all health care

professionals have a personal responsibility to ensure

that they are properly trained in the safe use of the

medical devices that they encounter.

Today’s Training

is on AED

Defibrillator

TRAINING (2)

Practical ‘on-the-job’ training from an experienced mentor

should be a prerequisite for all staff involved in the direct

care of patients where Medical devices are used to support

patient care.

Practical instruction on the use of medical devices commonly

in use within the unit, for example, infusion pumps, should

be incorporated into Induction programs and delivered to all

potential users, whatever their grade. It is essential that new

staff (including locums) should only operate devices after

they have received appropriate training.

TRAINING (3)

Each individual using complex medical devices such as

infusion systems should keep a training log.

Similar logs of the training of patients and/or carers

should also be kept.

Training manuals should be produced by trainers to

cover the needs of both staff and patient and carer

groups.

The training process in each unit should be audited.

MAINTENANCE AND REPAIR (1)

Medical devices are used in a variety of settings, including

hospitals, surgeries, nursing homes, and patients’ homes.

Arrangements must be in place for access to appropriate servicing facilities to maintain, service and repair

devices and to ensure that manufacturers’ recalls, updates and modifications are carried out. This requires accurate

record keeping.Unauthorized modification of devices is dangerous. Any modifications should only be authorized by the person

with overall responsibility for technical servicing, in

conjunction with manufacturers, to ensure that device safety is notcompromised.

In these circumstances, provision will be needed for alternative patient care by leasing/hiring or maintaining spare equipment.

MAINTENANCE AND REPAIR (2)

ADVERSE INCIDENT REPORTSAND SAFETY WARNINGS (1)

Healthcare Organization should establish

a system in place for: the prompt reporting of adverse

incidents through agreed channels

the rapid dissemination of safety warnings for equipment

maintenance of clear and concise records in a Device Register of adverse incidents and subsequent action taken

auditing adverse incidents and feeding back outcomes from investigations and audits to the organization.

ADVERSE INCIDENT REPORTSAND SAFETY WARNINGS (2)

Managers should identify an individual with responsibility

for ensuring that all device users are aware of local procedures for reporting adverse incidents.

They must also ensure SFDA safety warnings and bulletins

are disseminated throughout the organization.

SFDA has established Liaison Officers to undertake this role

For more details just go to the SFDA website:

www.sfda.gov.sa

THE ROLE & OBJECTIVES OF SFDA (1)

The Saudi Food and Drug Authority (SFDA) was established

on 07/01/1424 H, as an independent body corporate and has

as main objectives:

Observe the safety, security, and effectiveness of food and drug for humans and animal.

Observe the safety of complementary biological andchemical substances, cosmetics and pesticides.

Observe the safety of medical devices and its impact on public health.

Ensure accuracy and safety of medical and diagnostic devices.

Launch clear policies and procedures for food and drug, and plan to achieve and implement these policies.

Conduct research and applied studies to identify health problems in cooperative partnership with research bodies such as King Abdulaziz City for Science and Technology (KACST) and/or universities research centers.

Control and supervise licenses procedures for food, drugs and medical devices factories.

Disseminate and exchange information with local and international scientific and legal agencies, and setting up a database for food and drug.

THE ROLE & OBJECTIVES OF SFDA (2)

REFERENCES

Department of Health (1999) Making a Difference: Strengthening the nursing,midwifery and health visiting contribution to health and health care, DoH: London.

Department of Health (1998) A First Class Service: Quality in the New NHS, DoH:London.

Saudi Food and Drug Authority (Medical Devices Sector, A Guide for Healthcare Facilities on Reporting Medical Devices Problems), http://mdprc.sfda.gov.sa

Medical Devices Agency Device Bulletin (1998) Medical Device and Equipment

Management for Hospital and Community-based Organizations, MDA DB 9801 1998, MDA: London.

Medical Devices Agency Advice Leaflet (1997) Products you can have confidencein, MDA/CE 1997, MDA: London.

NHS Confederation (1999) The Pocket Guide to the New NHS, NHS Confederation: Birmingham.

United Kingdom Central Council for Nursing, Midwifery and Health Visiting (1992) Code of Professional Conduct, UKCC: London.

THE END

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the safe use of medical devices in 21st century by eng mohamed salah aouididi

Health & Medicine