January 15, 2015 — More than a dozen outbreaks of “CRE” and their related superbugs have been recently linked to contaminated gastrointestinal (GI) endoscopes, several in the U.S. just since 2012.

Associated with patient injury and death, these outbreaks are codified in the peer-reviewed article by Dr. Muscarella entitled, “Risk of transmission of carbapenem-resistant Enterobacteriaceae and related ‘superbugs’ during gastrointestinal endoscopy.”

CRE are so named, because they are resistant to most antibiotics including those of “last resort” called carbapenems. And, whereas other types of bacteria transmitted during GI endoscopy can typically be eradicated with one or more types of antibiotics, some strains of CRE are resistant to all types of antibiotics (i.e., they are pan-resistant).

Most troubling, the mortality rate of patients infected with CRE can be as high as 50%.

Whether these several recently identified outbreaks of CRE, even just since 2012, could be categorized as a type of “national epidemic” is debatable.

Is an FDA action forthcoming?

To date, the FDA has not issued a statement, safety notice or advisory publicly acknowledging these superbug outbreaks and providing guidance for the prevention of CRE transmissions during GI endoscopy.

Each of these outbreaks has been directly linked to GI endoscopes. Indeed, these instruments, like the automated devices routinely used by hospitals to clean and disinfect them — commonly known as “AERs” (i.e., automated endoscope reprocessors) — are regulated medical devices subject to the FDA’s oversight and rules.

It is surprising that the FDA has not yet issued such a statement or public notice.  Not only are these outbreaks of CRE and their related superbugs significant in number, having been identified in several states and U.S. regions, but also several have been associated with patient deaths, with at least one CRE outbreak identified in Washington — refer to Dr. Muscarella’s related article:7 More Deaths Linked to GI Endoscopes in Washington: Part of a National Epidemic?” for more details — reportedly having a mortality rate of 50% (i.e., 7 patient deaths).

That said, the FDA is reputed to be releasing a safety or health advisory in early 2015 discussing the risk of these types of infections following GI endoscopy. Whether it will provide any specific recommendations for the prevention of these outbreaks is unclear.

This possibility of the FDA issuing such an advisory is discussed in more detail in Dr. Muscarella’s article, “Superbugs, Contaminated Gastrointestinal Endoscopes, and a Growing Number of Hospital Infections: Is an FDA Action Imminent?” — click here.

Lessons being taught … Are they being learned?

These many recent outbreaks of CRE and their related superbugs linked in the U.S. (and globally) to the inadequate reprocessing of GI endoscopes — and possibly to other contributing factors, too, including the complex design of those unique models used to perform endoscopic retrograde cholangiopancreatography, or “ERCP” — provide a number of important lessons, including:

First, that ERCP and endoscopic ultrasound, or “EUS,” both of which are performed using a GI endoscope that features a complex and difficult-to-clean forceps elevator mechanism at its distal tip, have been linked to multiple patient infections and deaths due to transmission of CRE and their related superbugs;

Second, that, despite the significant number of patient deaths associated with recent outbreaks of CRE in the U.S., the risk of infection posed by contaminated ERCP (and EUS) endoscopes appears not to have received the publicity or national attention it necessarily warrants. Checks and balances inherent to the prevention of these types of medical errors are seemingly inadequate, if significantly lacking.

For example, one recent outbreak of CRE and related superbugs in Seattle (WA) linked to contaminated GI endoscopes, and, too, to a mortality rate of 50%, with 7 associated deaths — this may be the most significant CRE outbreak ever recorded — has not, to date, been reported in the local Washington press;

Third, that CRE outbreaks linked to contaminated GI endoscopes may not be promptly reported to the FDA via its “MAUDE” database, but may be reported as many as 18 months later, or longer. And, some outbreaks are not reported publicly to the FDA at all (unpublished data), despite not only federal regulations requiring prompt filing, but also the importance of documenting these reports to data trending, surveillance optimization, and other quality and safety activities.

For example, no filed medical device report, or MDR, associated with the recent CRE outbreak linked to contaminated GI endoscopes in Pittsburgh (PA) could be identified in the FDA’s MAUDE database (see: Sidebar);



Sidebar: With the filing of a medical device report with the FDA’s MAUDE database can come increased regulatory scrutiny, the risk of litigation, and unwanted publicity for the hospital and the device’s manufacturer.

Yet, on the flip side, the lack of transparency associated with a manufacturer or hospital not filing a MAUDE report can also beget complacency, a lack of accountability, the delay of important corrective actions necessary to prevent the outbreak’s recurrence, and, therefore, an increased risk of patient harm.

That better oversight designed to improve the prompt and complete filing of MAUDE reports might demonstrably reduce the risk of healthcare-associated infections and their associated costs can certainly be argued.



Fourth, GI endoscopes appear to pose a risk of transmitting these types of superbugs no matter the manufacturer. Reports filed in the FDA’s medical device report database, known as “MAUDE,” include those from all three of the primary manufacturers of the models of GI endoscopes sold in the U.S. and used to perform ERCP or EUS. Whether the design of one manufacturer’s GI endoscope is more prone to CRE transmission has not been published;



Legal Reviews for Consumers, Hospitals, Manufacturers:  Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.



Fifth, that reports of CRE outbreaks in the U.S. are not routinely publicized by a state’s department of health, which is surprising. This inattention misses an important opportunity and could interfere with improvements in the quality of health care;

Sixth, that the risk of infection from CRE (and other infectious agents) following GI endoscopy, and particularly ERCP (as well as EUS and presumably some other types of medical procedures), may be significantly higher than publicly reported;

Seventh, that the mortality rate of patients infected with CRE following ERCP in some instances is as high as 50%; and

Eighth, the FDA may not at times be the primary source to rely on for prompt notification of public safety concerns involving regulated medical devices.

Recommendations

Ideally, the FDA’s forthcoming advisory will give important guidance to healthcare practitioners and the public, and will provide specific recommendations for the prevention of CRE outbreaks following GI endoscopy (rather, possibly, than just expressing a general concern about this risk).

A review of the FDA’s advisory, once it is published, is urged.

Additional recommendations for the prevention of the transmission of CRE and their related superbugs during GI endoscopy are provided in a number of Dr. Muscarella’s articles, including:

  • Risk of transmission of carbapenem-resistant Enterobacteriaceae and related ‘superbugs’ during gastrointestinal endoscopy” (October, 2014) — click here; and
  • Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography, or ERCP” — click here.

Additional recommended reading

  1. Muscarella LF. Alert: Association of GI Endoscopy with Two Patient Deaths in 2013 — click here.
  2. Muscarella LF. Overlooked Outbreaks of “CRE” Following GI Endoscopy: A “Superbug” Epidemic in Our Midst? — click here.
  3. Muscarella LF. Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography, or ERCP — click here.
  4. Muscarella LF. Superbugs, Contaminated Gastrointestinal Endoscopes, and a Growing Number of Hospital Infections: Is an FDA Action Imminent? — click here.
  5. Muscarella LF. Risk of Transmission of Carbapenem-Resistant Enterobacteriaceae and Related “Superbugs” during Gastrointestinal Endoscopy. World J Gastrointest Endosc 2014 October 16; 6(10): 457-474 — click here.
  6. Webpage: Superbugs and Endoscopyclick here.
  7. Centers for Disease Control and Prevention (CDC). New Delhi Metallo-β-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated With Exposure to Duodenoscopes. Journal of the American Medical Association. October 8, 2014 — click here.
  8. Centers for Disease Control and Prevention (CDC). Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013. Morbidity and Mortality Weekly Report January 3, 2014;62(51); 1051-1051 — click here.
  9. Medscape. CDC Confirms Superbug Transmission via Endoscopy. January 3, 2014.

By: Lawrence F Muscarella, PhD; posted: 12/24/2014; updated: 1/15/2015, Rev B.

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