Survey Introductions Dr. Atul Mehta, Professor of Medicine at - - PowerPoint PPT Presentation

Survey

Introductions

• Dr. Atul Mehta, Professor of Medicine at Lerner

College of Medicine is a staff physician at the Cleveland Clinic’s Department of Pulmonary Medicine of Respiratory Institute. He also holds the first Buoncore Family Endowed Chair in Lung

• Transplantation. Dr. Mehta is founder and president
• f the American Association for Bronchology, and is

Senior Editor of The Journal of Bronchology and Interventional Pulmonology

Atul Mehta, M.D.

Introductions

Founder of LFM Healthcare Solutions LLC, Lawrence F. Muscarella, PhD, has authored more than 200 articles on the topics of disinfection, sterilization, instrument reprocessing, risk management, and both the causes and prevention of healthcare-associated infections (HAIs). His current research focuses on infection transmission during bronchoscopy, gastrointestinal endoscopy, and open-heart-surgery.

• Dr. Muscarella’s articles have been published in: The

American Journal of Infection Control, Gastrointestinal Endoscopy, Chest, Endoscopy, Infection Control and Hospital Epidemiology, The Journal of Hospital Infection, and the World Journal of Clinical Infectious Diseases, among others. In 2013, he founded the blog, “Discussions in Infection Control.” Lawrence F Muscarella, PhD

Bronchoscope Cross-Contamination

Is it a real issue?

• True entity yet, under recognized.
• Physicians play an important role in prevention

Agenda

In this hour we will cover:

• Recent published outbreaks involving bronchoscopes
• Trends involving contaminated bronchoscopes
• Risk factors for disease transmission
• Recommendations to prevent bronchoscope infections
• The most relevant guidelines
• Which prevention measures are most important for M.D.s
• Why bronchoscope related infection is under recognized
• How to identify / evaluate Epidemics & Pseudo-epidemics
• Q&A

Recent Published Outbreaks

• Contaminated flexible endoscopes are associated with more

healthcare–associated infections than any other medical device.

• Bronchoscopes and gastrointestinal (GI) endoscopes are examples.
• For example, we learned last year that several

U.S. hospitals since 2012 had linked deadly “superbug” outbreaks to contaminated duodenoscopes.

• Duodenoscopes feature a complex forceps

elevator mechanism and recessed areas that are difficult to clean, according to the FDA.

Recent Published Outbreaks

• These U.S. hospitals include:
• Pasadena’s Huntington Memorial Hospital, which in 2015 linked a

deadly outbreak of antibiotic-resistant Pseudomonas aeruginosa – a type of “superbug” -- to contaminated Olympus duodenoscopes

• Philadelphia's Fox Chase Cancer Center, which in 2015 linked 3

patients infected with carbapenem-resistant Klebsiella pneumoniae – also “CRE” -- to a contaminated FujiFilm duodenoscope

• Illinois’s Advocate Lutheran General Hospital, which in 2013 linked a

deadly outbreak of carbapenem-resistant E. coli – or, “CRE” -- to contaminated Pentax duodenoscopes

Image credit: CDC/ Melissa Dankel Plates have antibiotic disks (small white circles). Plate on the left contains bacteria that is susceptible to antibiotics and can not grow near discs. Plate on right contains CRE.

• But these types of outbreaks are not limited to duodenoscopes.
• Contaminated bronchoscopes have also been linked to

“superbug” outbreaks.

• To identify some recent outbreaks, I reviewed:
• the peer-reviewed medical literature;
• news reports; and
• the FDA’s medical device (“MAUDE”) database.
• While peer-reviewed studies are more scientific, the FDA’s

MAUDE database provides more timely data.

Recent Published Outbreaks

Recent Published Outbreaks

• My review identified a number of peer-reviewed reports linking

contaminated bronchoscopes to superbug outbreaks.

• Zweiger et al. (2014)* reported that 8 patients were infected with

CRE following bronchoscopy (in Germany).

• Two bronchoscopes tested “+” for the superbug.
• Defects in the internal surfaces of the two

bronchoscopes’ working channels were found.

• These bronchoscopes reportedly transmitted the

CRE despite their being reprocessing as recommended by their manufacturer.

* Zweiger J, et al. Am J Infect Control2014;42:935-40. [Letter]

Scanning electron micrographs of a suction channel showing surface defects such as cracks, grooves and pits. 1

Pajkos, et al. Journal of Hospital Infection

Recent Published Outbreaks

• Almost 15 years earlier, Sorin et al. (2001)* reported that 18

patients tested “+” for imipenem-resistant P. aeruginosa.

• While not CRE, these bacteria are a related superbug because they’re

also resistant to carbapenems - the “last resort” antibiotic.

• This may be the 1st reported case in the U.S. of a bronchoscope

infecting patients with carbapenem-resistant Pseudomonas.

• The CDC published a report about this outbreak in MMWR.**
• This outbreak was caused by the improper connection of the

bronchoscope to the automated endoscope reprocessor, or “AER”.

* Sorin M, et al. Infect Control Hosp Epidemiol 2001; 22: 409-413. ** Centers for Disease Control and Prevention (CDC). MMWR July 09, 1999;48(26);557-560.

Recent Published Outbreaks

• Other peer-reviewed reports describe bronchoscopes infecting patients with:
• Stenotrophomonas maltophilia: The cause? → a bronchoscope’s

contaminated suction valves*

• Serratia marcescens: The cause? → A loose, contaminated biopsy port

caused by a manufacturing defect** (the bronchoscope was recalled)

• Atypical mycobacteria: The cause? → Contaminated rinse water
• Mycobacterium tuberculosis: The causes? → (A) Use of an AER not

designed for the hospital’s bronchoscope;*** (B) A defective bronchoscope (that was recalled); and (C) an undetected leak, due to not performing a leak test.****

* Guy M, et al. Euro Surveill 2016 Jul 14;21(28). ** Kirschke DL, et al. N Engl J Med 2003 Jan 16; 348(3):214-20. *** Larson JL, et

• al. Infect Control Hosp Epidemiol 2003 Nov;24(11):825-30. **** Ramsey AH, et al. Chest 2002 Mar;121(3):976-81.

News Reports of Outbreaks

• Last June, a news source reported that a nurse had filed a lawsuit alleging

that an Ohio hospital had linked bronchoscopes to an outbreak of multidrug-resistant bacteria.

• More than 24 patients were infected in 2015, the suit alleges.
• The bronchoscopes remained contaminated despite being cleaned and

disinfected according to the device’s labeling, the suite also claims.

• I identified the specific medical device report (MDR) that the

bronchoscope manufacturer filed with the FDA recording this outbreak.

• The MDR states the hospital began using ethylene oxide (EtO) gas

to sterilize potentially contaminated bronchoscopes.

• The cause of this outbreak is unclear at this time.

Image: Stenotrophomonas maltophilia. CDC/ Dr. William A. Clark

FDA MAUDE database

• I also reviewed the FDA’s MAUDE database to identify recent outbreaks linked

to contaminated bronchoscopes.

• On June 24 2016, a hospital informed the FDA that an “EBUS”* bronchoscope

may have infected patients with Enterobacter bacteria.

• The bronchoscope tested “+” for this bacteria despite being cleaned and

disinfected according to the device’s labeling.

• If resistant to carbapenems, these bacteria are CRE.
• At least two patients were infected, one died.
• The hospital reported that the complex design of EBUS bronchoscopes is

a risk factor for infection, just like duodenoscopes.

* “EBUS” refers to endobronchial ultrasound.

FDA MAUDE database

• Four months earlier, in February 2016, a manufacturer filed a report notifying

the FDA that 13 patients may have been infected (in 2008) with multidrug- resistant Pseudomonas and Stenotrophomonas during bronchoscopy.

• The hospital reported that the bronchoscope’s biopsy port was loose and

could be twisted off and removed.

• A third party repair company had replaced the bronchoscope’s biopsy

channel a year earlier.

• The repair company used “non-OEM”* parts to repair the

bronchoscope.

(Continued)

* “OEM” refers to the original equipment manufacturer (e.g., Olympus).

FDA MAUDE database

• Further, the manufacturer reported that the hospital:

x didn’t pre-clean the bronchoscope at bedside x didn’t immediately clean and disinfect the bronchoscope after use x didn’t properly leak test the bronchoscope x didn’t suction detergent through the bronchoscope’s suction channel during manual cleaning (performed in the reprocessing room), and x didn’t rinse the bronchoscope with clean water to remove detergent after washing it.

FDA MAUDE database

• A year earlier, in December 2014, a manufacturer notified the FDA that

14 patients had tested “+” for CRE following bronchoscopy.

• The bronchoscopes tested “+” for this superbug despite being

reprocessed per the manufacturer’s instructions (as others have similarly reported).

• The bronchoscopes had been repaired by a third party company.
• The cause of these possible infections is unclear.
• This report appears to be the first MAUDE report linking a

contaminated bronchoscope to a CRE outbreak.

FDA Safety Alert

• In response to this December 2014 FDA report, I wrote an article in July

2015 that I recommend the audience read:

• “Contaminated Bronchoscopes Linked in 2014 to A Potential

'Superbug' Outbreak: An Under-recognized Risk?”

• My article publicized for the first time that bronchoscopes, too,

can transmit CRE. (Visit my website: https://www.lfm-hcs.com/)

• Two months later, the FDA published the safety alert “Infections

Associated with Reprocessed Flexible Bronchoscopes” (Sept 2015)

• This alert notified the public that improperly reprocessed

bronchoscopes can pose a high risk of infection.

FDA MAUDE database: Trends

• Reports in the FDA’s MAUDE database provide us with timely trending

data that suggest:

• CRE can be transmitted by contaminated bronchoscopes too.
• Enhanced focus on bronchoscope reprocessing is crucial to improve safety

and prevent superbug infections.

• Bronchoscopes repaired by (un-regulated) third-party (non-OEM) companies

may pose an under-recognized risk of transmitting superbugs.

• The FDA hosted a public workshop last month to discuss whether

regulation of third-party repair companies is warranted to improve safety.

Image: Damaged working channel. Mehta, Et al. The High Price of Bronchoscopy.

Risk Factors for Contamination

• My reviews of these and other reports found risk factors for

contaminated bronchoscopes to transmit infections to include:

• Improper reprocessing of bronchoscopes
• Inadequate training of reprocessing staff
• Failure to pre-clean bronchoscopes immediately after their use
• Poor maintenance, servicing and repairing of bronchoscopes
• Terminally rinsing bronchoscopes with contaminated water
• Faulty leak testing

(Continued)

Risk Factors for Contamination

• Risk factors (continued):
• The complex designs of some bronchoscope models (EBUS), which may

hinder thorough cleaning and disinfection

• Using AERs that have not been validated for the effective reprocessing of

certain bronchoscope models

• Improper connection/adaptation of the AER to the bronchoscope
• Inconsistent reprocessing instructions provided by the bronchoscope and

AER manufacturers

• Storing bronchoscopes in moist, poorly-ventilated areas

Recommendations

• Based on my research, I provide the following recommendations for

managers to reduce the risk of bronchoscopes infecting patients:

• Establish a comprehensive safety program for reprocessing

bronchoscopes.

• Meticulously follow the manufacturer’s instructions for reprocessing

bronchoscopes.

• Review the brochure I wrote for Ambu to resolve

discrepancies between the AER and bronchoscope manufacturers’ reprocessing instructions.

• Periodically audit reprocessing staff to ensure

compliance with manufacturers’ instructions.

(Continued)

Recommendations (continued)

• Use a certified company to service and repair bronchoscopes.
• Ask the manufacturer for a written maintenance schedule to service

the bronchoscope and avoid costly repairs.

• As warranted, consider adopting one of more of the following:
• Disinfect complex bronchoscopes twice after each reuse
• Use EtO gas to sterilize these bronchoscopes whenever feasible, and
• Periodically culture (and quarantine) these bronchoscope for CRE.
• Ensure the AER is validated for reprocessing all of the bronchoscope

models in inventory.

• Review the literature, news reports, and the FDA’s MAUDE database.

Guidelines

• The following guidelines and alerts provide important information for

preventing bronchoscopes from transmitting infections:

• SGNA’s 2016 “Standards of Infection Prevention in Reprocessing Flexible

Gastrointestinal Endoscopes”

• AORN’s 2016 “Guideline for processing flexible endoscopes.” (In: Guidelines

for Perioperative Practice. Denver, CO: AORN, Inc.)

• ANSI/AAMI’s 2015 “Flexible and semi-rigid endoscope processing in health

care facilities” (ST91)

• FDA’s “Infections associated with Reprocessed Flexible Bronchoscopes”

(September 17, 2015)

(Continued)

Guidelines (continued)

• FDA’s “Supplemental Measures to Enhance Duodenoscope

Reprocessing: FDA Safety Communication” (August 4, 2015)

• CMS’s “Alert Related to Outbreaks of CRE during GI endoscopy,

particularly ERCP.” (April 3, 2015)

• ASGE’s (2011). “Multi-society guideline on reprocessing flexible

gastrointestinal endoscopes, 2011.”

• FDA, CDC and VA: “Preventing Cross-Contamination in Endoscope

Processing: FDA Safety Communication” (November 19, 2009)

• CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities”
• Consensus statement:* “Prevention of flexible bronchoscopy-associated

infection: 2005.” (Dr. Mehta et al. Chest 2005;128(3):1742-55.)

* American College of Chest Physicians and American Association for Bronchology Consensus Statement

Survey

Summary

• Inadequate reprocessing, leak testing, servicing and storage of

bronchoscopes poses a significant risk of infection.

• Bronchoscopes can infect patients with CRE despite being reprocessed

according to the manufacturer’s instructions.

• Outbreaks caused by contaminated bronchoscopes are under-

recognized.

• Tap water is an overlooked “medical device” that poses a risk of infection,

including for patients undergoing bronchoscopy.

• Supplemental measures including the EtO gas sterilization of certain

bronchoscope models may occasionally be warranted.

Biofilm and Bronchoscopes

• Definition: Collection of microorganisms

attached to a surface & embedded in a matrix (protein, polysaccharide, nucleic acid)

• Mode of microbial growth (Bacteria, Fungi,

Virus, Protozoa)

• Causes 60% of all microbial infections (NIH)
• Recalcitrant to antimicrobial agents
• Rx: Inhibitors of adherence, Immune

antagonists

Seminars in Resp & Crit Care Med 2003; 24(6):663

“Scanning electron micrographs of a suction Channel… showing soil and various types of microorganisms, many surrounded by exopolysaccharides”1 Pajkos, et. al., 2004

Pitfalls

• Unfamiliarity with guidelines
• Ineffective dissemination of information
• Inadequate emphasis during training
• Unfamiliarity with user’s manual
• Domain of ancillary staff?

Increasing Risk of FB Associated Infections?

• Procedure: Lengthier, Invasive
• Population of Immunocompromised pt
• Virulence of organisms: MDR-TB, CRE, Hepatitis
• Use of AERS
• Miniaturization of FB & accessories
• Vigilance!

Factors for Under-recognition

• Sign/symptoms masked by pt’s 1° condition
• Latent infection
• Interpretation of cultures difficult
• Inadequate surveillance
• Lack of information on pattern of infection
• Under-reporting

Identifying and Evaluating Epidemics and Pseudo-epidemics

Requires Team Work:

• Bronchoscopist, Anesthesiologist
• Pulmonary Fellow
• Bronchoscopy Assistant*
• Microbiology Lab
• Statistician

Identifying…cont.

Components:

• On going education of all involved
• Data collection*
• Prevention of complications
• Infection control
• Maintenance of instrument

Q&A