we cannot afford to go back - j&j medical devices · mm.09.01.01 addresses antimicrobial...

36
Antimicrobial Stewardship We cannot afford to go back

Upload: others

Post on 20-Aug-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Antimicrobial StewardshipWe cannot afford to go back

Page 2: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Objectives

• What is antimicrobial stewardship?

• Why the concern over antibiotic resistance?

• Discuss the role and use of antibacterial medical devices decreasing the use of antibiotics.

Page 3: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Perspective

1994 1989 1974 1959 1945

First Smartphone. Time.com http://time.com/3137005/first-smartphone-ibm-simon/ Accessed 4/24/17History of the Web. World Wide Web Foundation. http://webfoundation.org/about/vision/history-of-the-web/?gclid=CN3EpN2R5NMCFQ9LDQodkJYFuw Accessed 4/24/17Invention of the PC. History.Com http://www.history.com/topics/inventions/invention-of-the-pc Accessed 4/24/17History of the seatbelt. Center for Auto Safety. http://www.autosafety.org/history-seat-belt-development/ Accessed 4/24//17Discovery and Development of Penicillin. American Chemical Society. https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/flemingpenicillin.html Accessed 4/24/17

Page 4: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Human Impact

Leading causes of U.S. deaths

Achievements in Public Health, 1900-1999: Control of Infectious Diseases. The Centers for Disease Control and Prevention. https://www.cdc.gov/Mmwr/preview/mmwrhtml/mm4829a1.htm Accessed 4/27/17 Life expectancy at birth, at 65 years of age, and at 75 years of age, by race and sex: United States, selected years 1900–2007. The Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/data/hus/2010/022.pdf Accessed 4/27/17Deaths: Preliminary Data from 2000. The Center for Disease Control and Prevention. https://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_12.pdf Accessed 4/27/17

20001900

0% 10% 20% 30%

SepticemiaNephritis

Alzheimer's diseaseInfluenza and pneumonia

Diabetes mellitusAccidents

Chronic lower resiratory diseasesCerebrovascular diseases

Malignant neoplasmsDisease of the heart

0% 5% 10%

DiptheriaSenilityCancerInjuries

Liver DiseaseStroke

Heart DiseaseDiarrhea and Enteritis

TuberculosisPneumonia

Life Expectancy 46.3Years

48.3Years

30.4% of all deaths were children under 5

74.1Years

79.5Years

1.4% of all deaths were children under 4

Page 5: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

What is it?

refers to coordinated interventions designed to improve and measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy, and route of administrationto reduce or avoid their use.

Promoting Antimicrobial Stewardship in Human Medicine. Infectious Disease Society of America. http://www.idsociety.org/stewardship_policy/ Accessed 4/24/17

Antimicrobial stewardship

Page 6: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Why the concern?

refers to microbes’ ability to changeand become less susceptible to drugs.

Antimicrobial Resistance. Infectious Disease Society of America. http://www.idsociety.org/Topic_Antimicrobial_Resistance/ Accessed 4/24/17

Antimicrobial resistance

The development of antimicrobial drugs (antibacterials [antibiotics], antivirals, antifungals and antiparasitics) to treat otherwise life-threatening infections has been one of the most notable medical achievements in human history.

The growing problem of resistance has undermined antimicrobials’ effectiveness resulting in the loss of countless lives and placing public health and national security at serious risk.

achievements in human history. one of the most notable medical

Page 7: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Some microorganisms of concern

Enterococci cause a range of illnesses, mostly among patients receiving healthcare, but include bloodstream infections, surgical site infections, and urinary tract infections.

Antibiotic Resistance Threats in the United States, 2013 CDC page 67

Page 8: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Some microorganisms of concern

Methicillin-resistant Staphylococcus aureus (MRSA) causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death. Staphylococcus bacteria, including MRSA, are one of the most common causes of healthcare-associated infections.

Antibiotic Resistance Threats in the United States, 2013 CDC page 77

Page 9: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Some microorganisms of concern

Streptococcus pneumoniae (S. pneumoniae, or pneumococcus) is the leading cause of bacterial pneumonia and meningitis in the United States. It also is a major cause of bloodstream infections and ear and sinus infections.

Antibiotic Resistance Threats in the United States, 2013 CDC page 79

Page 10: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Some microorganisms of concern

Clostridium difficile (C. difficile) causes life-threatening diarrhea. These infections mostly occur in people who have had both recent medical care and antibiotics. Often, C. difficile infections occur in hospitalized or recently hospitalized patients.

Antibiotic Resistance Threats in the United States, 2013 CDC page 51

Page 11: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Antibiotic introduction and resistance development

Antibiotic Resistance Threats in the United States, 2013 CDC page 28

Antibiotic Resistance Identified

Antibiotic Introduced

1950Tetracycline

1972Vancomycin

1996Levofloxacin

1996Levofloxacin

1950 1960 1970 1980 1990 2000 - Today

1959Tetracycline

1968Erythromycin

1988Vancomycin

1962Methicillin

1953Erythromycin

1960Methicillin

Page 12: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Antibiotic introduction and resistance developmentAn even bigger concern…

The number of new antibiotics developed and approved has steadily decreased in the past 3 decades, leaving fewer options to treat resistant bacteria

Antibiotic Resistance Threats in the United States, 2013 CDC page 44

Number of Antibacterial New Drug Application (NDA) Approvals vs. Year Intervals*

1980-1984 1985-1989 1990-1994 1995-1999 2000-2004 2005-2009 2010-2012

*Intervals from 1980-2009 are 5-yr intervals; 2010-1012 is a 3-yr interval. Drugs are limited to systemic agents. Data courtesy of FDA’s Center for Drug Evaluation and Research (CDER)

NDA

Page 13: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

“Voluntary”Antibiotic StewardshipPrograms in the US

Page 14: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Mandatory Antibiotic Stewardship InitiativesThe Joint Commission recently announced a new Medication Management (MM) standard for hospitals, critical access hospitals, and nursing care centers. Standard MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017.

September 29, 2016 Center of Medicaid and Medicare Service (CMS) finalized improvements in care, safety, and consumer protections for long-term care facility residents.

Updating the long-term care facility’s infection prevention and control program, including requiring an infection prevention and control officer and an antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.

CMS is in the process of developing a Condition(s) of Participation (CoP) on antimicrobial stewardship for hospitals.New Antimicrobial Stewardship Standard. Joint Commission. https://www.jointcommission.org/assets/1/6/New_Antimicrobial_Stewardship_Standard.pdf Accessed 4/24/17CMS finalizes improvements in care, safety, and consumer protections for long-term care facility residents. Center for Medicare and Medicaid Services. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-09-28.html Accessed 4/24/17

Page 15: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

So what can we do?

Page 16: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

https://www.cdc.gov/vitalsigns/protect-patients/

Page 17: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Breaking the Chain of Infection

Infectious Agent

SusceptibleHost

Portal of Entry

Reservoirs

Portal of Exit

Means of Transmission

Microorganism (bacteria, virus, fungi)

Host which allows the microorganism to live, grow and multiply

Path for microorganism to escape from host (ex. Blood, respiratory tract, skin, etc.)

Vehicle to carry to other hosts

Path for microorganism to

enter new host

Person susceptible to the

microorganism

Page 18: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Interesting study 47% relative reduction in the CAUTI rate

observed with silver-alloy hydrogel catheter compared to standard

catheter when both the old and the most recent CDC CAUTI definitions

were used

Antimicrobial days for CAUTIs decreasedfrom 1165

(standard catheter period)

to 406(silver-alloy

hydrogen period)

Lederer J, Jarvis W, Thomas L, Ritter, J. Multicenter cohort study to assess the impact of a silver-alloy and hydrogel-coated urinary catheter on symptomatic catheter-associated urinary tract infections. Journal of Wound Ostomy Continence Nursing. 2014 Sep-Oct;41(5):473-80

Those of you who participate in the National Healthcare Safety Network’s voluntary Antimicrobial Use and Resistance module and track antimicrobial days may find data like this extremely relevant.

Page 19: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Most Bloodstream Infections and Surgical Site Infections are caused by bacteria from patients own skin

HAIs – Major Site of Infections Estimated No.

Pneumonia 157,500

Gastrointestinal illness 123,100

Urinary tract infections 93,300

Primary bloodstream infections 71,900

Surgical site infections from any inpatient surgery 157,500

Other type of infections 118,500

Estimated total number of infections in hospitals 721,800

Reducing Surgical Site Infections: A Review. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2812878/ Accessed 4/24/17Catheter-related bloodstream infections. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093967/ Accessed 4/24/17HAIs at a Glance. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/surveillance/index.html Accessed 4/27/17

Page 20: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Skin Colonization

Portal Exit

Infectious Agent

Reservoir

Pre-PrepBacteria colonies exist not only on the surface, but below the surface as well, particularly within the hair follicles and sebaceous glands

Post-Prep (immediately following antiseptic application)

Prepping the skin reduces colony counts of bacteria from the surface only – it never completely sterilize the skin

Page 21: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Skin Colonization

Portal of

entrySusceptible

host

Means of Transmission:Central Venous Catheter

Means of Transmission:Surgical Incision

Susceptiblehost

Portal of entry

Page 22: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017

Recommendation Classification

Administer preoperative antimicrobial agents only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made.

Category IB

Administer the appropriate parenteral prophylactic antimicrobial agents before skin incision in all cesarean section procedures. Category IA

In clean and clean-contaminated procedures, do not administer additional prophylactic antimicrobial agent doses after the surgical incision is closed in the operating room, even in the presence of a drain.

Category IA

Do not apply antimicrobial agents (i.e., ointments, solutions, or powders) to the surgical incision for the prevention of SSI. Category IB

Application of autologous platelet-rich plasma is not necessary for the prevention of SSI. Category II

Implement perioperative glycemic control and use blood glucose target levels less than 200 mg/dL in patients with and without diabetes Category IA

Maintain perioperative normothermia. Category IA

For patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation, administer increased FIO2 during surgery and after extubation in the immediate postoperative period.

Category IA

Advise patients to shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day Category IB

Perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated. Category IA

Application of a microbial sealant immediately after intraoperative skin preparation is not necessary for the prevention of SSI. Category II

The use of plastic adhesive drapes with or without antimicrobial properties is not necessary for the prevention of SSI. Category II

Consider intraoperative irrigation of deep or subcutaneous tissues with aqueous iodophor solution for the prevention of SSI. Category II

Do not withhold transfusion of necessary blood products from surgical patients as a means to prevent SSI. Category IB

In prosthetic joint arthroplasty, recommendation 1E applies: in clean and clean-contaminated procedures, do not administer additional antimicrobial prophylaxis doses after the surgical incision is closed in the operating room, even in the presence of a drain.

Category IA

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Network. http://jamanetwork.com/journals/jamasurgery/fullarticle/2623725 Accessed 4/27/17

Page 23: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Triclosan Coated Sutures Recommendations“Consider the use of triclosan-coated sutures for the prevention of SSI.”CDC Guideline for the Prevention of Surgical Site Infections 2017*

Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.JAMA Surg. http://jamanetwork.com/journals/jamasurgery/fullarticle/2623725 Accessed 4/25/17

* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

Page 24: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Triclosan Coated Sutures Recommendations“Triclosan antibacterial suture use is recommended for wound closure in clean and clean-contaminated abdominal cases when available”American College of Surgeons & Surgical Infection Society (ACS & SIS) Surgical Site Infection Guidelines*

* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

Journal of the American College of Surgeons. DOI: http://dx.doi.org/10.1016/j.jamcollsurg.2016.10.029. Accessed 4/24/17

Page 25: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Triclosan Coated Sutures Recommendations“The panel suggests the use of triclosan-coated sutures for the purpose of reducing the risk of SSI, independent of the type of surgery”World Health Organization (WHO) Global Guidelines for the Prevention of Surgical Site Infection*

* The CDC, WHO, ACS & SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.

Infection prevention and control. World Health Organization website. http://www.who.int/infection-prevention/publications/ssi-guidelines/en/ Accessed 4/24/17

Page 26: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Prospectively planned meta-analyses of randomized control trials were performed on the use of suture containing triclosan to lower SSI rates

Page 27: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Significance of the recommendation

Three new evidence-based SSI prevention guidelines were published inpeer-reviewed medical literature. The ground-breaking news across all of these guidelines is that for the first time, the choice of a wound-closure device is being recognized as an evidence-based component within a bundle of interventions aimed at addressing risk factors for SSI.

Page 28: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Reducing Colonization

Antibacterial Sutureshown in vitro to inhibit

bacterial colonization of the suture for 7 days or more

The petri dish image is for illustrative purposes only, zone of inhibition testing results can vary.

Page 29: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Recommendations for CLABSIreduction practices from Healthcare Infection Control Practices Advisory Committee of Centers for Disease Control and Prevention

RECOMMENDATION CLASSIFICATION

Hand hygiene prior to catheter insertion Category IB

All inclusive catheter carts or kits Category IB

Maximal sterile barrier precautions Category IB

Chlorhexidine for skin anti-sepsis Category IA

Antimicrobial catheters Category IA

Subclavian vein insertion Category IB

Disinfect hubs and needle-less connectors Category IA

Remove non-essential CVCs Category IA

Chlorhexidine cleansing Category II

CVC (transparent film) dressing Category IA

Chlorhexidine impregnated sponge dressing Category 1B

Topical antibiotic use (dialysis) Category IB

Antibiotic or anti-infective “locks” Category II

Educational interventions Category IA

Catheter bundles or “checklists” Category IB

Use of specialized CVC insertion teams Category IAPrevention of Central Line-Associated Bloodstream Infections: Brief Update Review. US National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK133364/ Accessed 4/25/17

Page 30: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Revised CHG Impregnated Dressings Recommendation

1. For patients aged 18 years and older:a. Chlorhexidine-impregnated dressings with an FDA-cleared

label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated bloodstream infection (CABSI) are recommended to protect the insertion site of short-term, non-tunneled central venous catheters. (Category IA)

2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections. CDC.gov. https://www.cdc.gov/infectioncontrol/guidelines/pdf/guidelines/c-i-dressings.pdf Accessed 11/7/17

Page 31: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Some of the evidence cited by the CDC support the recommendation

Page 32: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Areas of Opportunity

Central Venous

Catheters

DialysisCatheters

ArterialCatheters

PICC Lines

Peripheral IVs

Mid Lines EpiduralCatheters

Implanted Venous Ports

External FixatorPins

Drains

Rebaselining

HAI Progress Report – FAQ. Centers for Disease and Control website. www.cdc.gov. Accessed 11/8/17

Page 33: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Interesting case study

Methodist Hospitals of Northwest Indiana aligned their Peripheral IV (PIV) policy to INS Standards of Practice, moving from the routine replacement of PIVs to clinically indicated replacement of PIVs. They proactively protected the lines by implementing a PIV bundle (education, Protective Disk with CHG, securement dressing, alcohol impregnated caps, integrated closed IV catheter system and sterile gloves) and tracked their data for 12 months to understand the impact of these changes. The hospitals realized a:

37% reduction in house-wide laboratory confirmed bloodstream infections

19% reduction in peripheral IV-related BSIs

68% fewer CLABSIs than predicted via NHSN

2 Years Post Implementation

Sustained

Sustained

6% Further Reduction

DeVries M, Valentine M. Mancos P. Protected Clinical Indication of Peripheral Intravenous Lines: Successful Implementation. Journal of Vascular Access. June 2016. Volume 21, Issue 2, Pages 89–92

Page 34: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Summary• Antibiotics have become an integral part of healthcare and have

had a tremendous impact on our very existence• Antibiotic resistance poses a real threat to the treatment of disease

as we know it• We can take steps to break the chain of infection to help mitigate

the problem

Page 35: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Summary• Antibiotics have become an integral part of healthcare and have

had a tremendous impact on our very existence• Antibiotic resistance poses a real threat to the treatment of disease

as we know it• We can take steps to break the chain of infection to help mitigate

the problem

Prevent infections

from catheters and after surgery

Prevent bacteria from

spreading

Reduce or eliminate

antibiotic use+ =

Break the chain of infection with the use of evidenced

based products

Follow good clinical practice

Page 36: We cannot afford to go back - J&J Medical Devices · MM.09.01.01 addresses antimicrobial stewardship and became effective January 1, 2017. September 29, 2016 Center of Medicaid and

Questions?

© 2018 Ethicon US, LLC . 086412-171231