Antibiotic Resistant Superbug Outbreaks
In its March 9, 2015 issue the Los Angeles Times reported that four patients at the Cedars-Sinai hospital had been infected with a multi-resistant microbe linked to a contaminated medical scope. 67 others may have been exposed. A similar outbreak was being investigated at UCLA’s Ronald Reagan Medical Center where seven patients had been infected, two of whom died and up to 179 patients may have been exposed.2, 3, 13
The story received significant attention worldwide.
An accident waiting to happen?
Federal lawmakers, consumer advocates and patients’ families have criticized both the regulators and manufacturers for failing to act sooner.
Biofilm risk in reusable endoscopes
Implementation of microbiological surveillance of endoscope reprocessing is appropriate to detect early colonization and biofilm formation in the endoscope and to prevent contamination and infection in patients after endoscopic procedures.
On March 12, 2015 the U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectiousagents between usages.4, 5, 15
2-day seminar hosted by FDA
Since then the FDA has issued a new guidance on reprocessing of medical devices, hosted a 2-day seminar discussing the transmission of infection associated with endoscopes, issued warnings to duodenoscope manufacturers for lack of filing MDR reports, as well as issued a safety communication on the infection associated with reprocessed flexible bronchoscopes.15
Committee meeting on infections associated with use of endoscopes
Postmarket surveillance studies on duodenoscopes required
Warnings to duodenoscope manufacturers
Safety communication on bronchoscopes
The stakes are higher with
More nosocomial infection and pseudo-infection outbreaks have been linked to contaminated endoscopes than to any other medical device.6
Intensivists, hygiene nurses and others involved in infection control have been aware of the risk of contamination and infection of patients under medical care for many years. The arrival of Multi-Drug Resistant Organisms (MDRO) such as CRE or multidrug resistant Pseudomonas aeruginosa constitutes a new challenge when it come to the risks involved for patients, physicians, hospitals and clinics.
CRE contributes to the cause of death in up to 44% of infected patients
Bronchoscopes pose a particular challenge
Flexible bronchoscopes are difficult to clean and disinfect due to the long and narrow channel. The question is whether it is possible to ensure 100% disinfection of each scope. Despite following cleaning instructions persistent device contamination has been seen, and failure to meticulously follow cleaning instructions is likely to lead to contaminated scopes.1, 15
Routine cleaning is not enough
The true incidence of cross-contamination and infection during flexible bronchoscopy is likely under-recognized due to underreporting and inadequate or no surveillance.1, 7
In an overview of infections associated with flexible bronchoscopy from 20131, 50 studies were identified. In 30 out of the 50 studies published the same contaminant was found in the patient as well as in the bronchoscope. A total of 569 contaminated patients and 115 infected patients (20.21%) could be directly related to contaminated bronchoscopes.1
Routine cleaning does not effectively remove biofilm from endoscope channels. Biofilm was present in 13 out of 13 endoscopes despite appropriate cleaning procedures being followed in the channels of 12/13 instruments.8
An independent expert panel, using the Delphi method, revealed a 3% mean risk of cross-contamination from bronchoscopes.12 This is in alignment with findings in another study, where 10 (4%) out of 251 patient-ready bronchoscopes were contaminated despite cleaning.14
As the majority of patients contaminated from bronchoscopes suffer from pneumonia1, 11 costs linked to ventilator associated pneumonia ($24.500) are used as the clinical impact in the calculation of costs. Combining the 3% risk of cross-contamination with the 20,21% infection risk, the overall costs associated with cross-contamination can be calculated. See calculations in figure below.
200 x 0.03 x 0.2021 x 24,500 = $29,700
200 bronchoscopies times the 3% risk of a cross-contamination13, 15 times the risk of an infection (calculation based on Kovaleva et al.1) times the cost of a ventilator-associated pneumonia $24,50013.
In a recent Pseudomonas outbreak, the health-care costs directly related to the diagnosis, treatment, and hospitalization of the six affected patients were estimated to be $243.000 or $40.500 per patient.16
Sterility straight from the pack
Outbreaks have led physicians to question the safety of bronchoscopy. Endoscopes, including bronchoscopes, are the medical devices most frequently associated with outbreaks of nosocomial infections.9
The risk of cross-infection with multi-resistant microbes in the ICU during bedside bronchoscopy procedures can be significantly reduced by using a sterile single-use bronchoscope.
Ambu’s single-use aScope™ 3 minimizes the risk of cross-contamination in the ICU by ensuring sterility straight from the pack, thus avoiding residual biofilm caused by inadequate automatic endoscope reprocessing.
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- 1 Kovaleva J1, Peters FT, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol
Rev. 2013 Apr;26(2):231-54. doi: 10.1128/CMR.00085-12.
- Los Angeles Times. March 9, 2015.
- Fierce Medical Devices. March 5, 2015. New superbug outbreak tied to endoscope devices surfaces amid FDA scrutiny. March 5, 2015.
- FDA News Release. FDA releases final guidance on reprocessing of reusable medical devices. March 12, 2015.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff.
FDA. March 17, 2015.
- Seoane-Vazquez E et al. Exogenous endoscopy-related infections, pseudo-infections, and toxic reactions: clinical and economic burden.Current Medical
Research and Opinions, Vol 22, No. 10, 2006, 2007-2012.
- Mughai MM et al. Reprocessing the Bronchoscope: The Challenges, Seminars in Respiratory and Critical Care Medicine/volume 25, number 4,
p. 443-449, 2004.
- Pajkos et al. Is biofilm accumulation on endoscope tubing a contributor to the failure of cleaning and decontamination? Journal of Hospital Infection
- Srinivasan A, Wolfenden LL, Song X, Mackie K, Hartsell TL, Jones HD, et al. An Outbreak of Pseudomonas aeruginosa Infections Associated with Flexible
Bronchoscopes. The New England Journal of Medicine, 2003; 348;221-7.
- Falaga ME, Tansarli GS, Karageorgopoulos DE et al. Deaths attributable to carbapenem-resistant Enterobacteriaceae infections. EmergInfect Dis. 2014
- R. Douglas Scott II, The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention, Division of Healthcare
Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention
- 2015 Expert Panel estimation using the Delphi method, data on file in Ambu.
- New lawsuits filed against scope maker in deadly UCLA superbug outbreak, Los Angeles Times, March 17, 2015
- Michelle Alfa Ph.D., Endoscope Reprocessing Verification Testing, Presentation, Meeting Materials Non-FDA Generated, FDA Committee Meeting, May
14-15, 2015 - See more
- Go to article: Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication
- Kovaleva J Buss A, Usefulness of Bacteriological Monitoring of Endoscope Reprocessing, Therapeutic Gastrointestinal Endoscopy, www.intechopen.com,
Chp 9, pp 141-162, 2011