January 7, ,2014 — The largest outbreak of a superbug – “CRE” – in U.S. history has been confirmed at a hospital outside of Chicago (IL; USA).

The hospital – Advocate Lutheran General Hospital – linked these critical patient infections of carbapenem-resistant Enterobacteriaceae, or CRE, to the gastrointestinal (GI) endoscopic procedures, namely, to “ERCP.”

More about this outbreak is discussed in the Chicago Sun-Times newspaper article, dated January 6, 2014 — click here — “Largest outbreak of dangerous bacteria in U.S. tied to Park Ridge hospital.”

What is ERCP? ERCP, or endoscopic retrograde cholangiopancreatography, is a type of upper GI endoscopic procedure that uses fluoroscopy and an ERCP endoscope (or, duodenoscope) to diagnose and treat certain disorders and aliments of the biliary and pancreatic ductal systems.

CRE’s mortality rate: This outbreak involving the infections of 38 patients with CRE following ERCP are concerning for a number of reasons, including because superbugs, such as CRE, are very resistant to antibiotics.

Two examples of CRE are NDM-producing Escherichia coli and KPC-producing Klebsiella pneumoniae.

Whether any of Advocate Lutheran General Hospital’s patients expired as a result of this outbreak has not yet been reported. But, according to the January 10, 2014, issue of the Chicago Tribune (click here), of the 243 patients who had undergone ERCP between January and September of 2013 and were notified by hospital officials of their increased risk of CRE infection, 114  (almost 50%) were tested.

Of these 114 patients, 38 were either infected or colonized with CRE (16% of the total number of patients that underwent ERCP), with 28 patients (the majority of those tested) being colonized with CRE (i.e., that is, harboring CRE, but did not displaying symptoms of infection) and the remaining 10 patients being infected, some of them critically, with infections of the blood, urine or in wounds. CRE infections of the blood are associated with a mortality rate of as high as 50%.

Alert: A December 27, 2013, report in the Daily Herald newspaper (click here) discloses that, while 105 of its notified patients had returned to Advocate Lutheran General Hospital, so far, to be tested for CRE infection, a total of 243 patients underwent ERCP at this hospital during the time of its outbreak (i.e., between January and September, 2013) and, therefore, 138 additional patients, considered by health officials to be at risk of CRE infection, have not returned to the hospital for screening.

Notably, the CDC reports that 44 people, in total, were infected or colonized with CRE in northeastern Illinois, 38 of whom, as previously discussed,  were patients of Advocate Lutheran General Hospital and underwent ERCP between January and September, 2013.

Whether any of these remaining 6 people infected with CRE — none of whom reportedly were patients of, and underwent ERCP at, Advocate Lutheran General Hospital — had been in direct or indirect physical contact with one or more of this hospital’s 38 infected or colonized patients, demonstrating, possibly, community-transmission of CRE, is unclear but important to determine.

Many of Dr. Muscarella’s perspectives about this hospital’s CRE outbreak are provided in a recent article published by the renown medical source MedscapeClick here (note: registration is free) to read his comments and recommendations in Medscape’s important article “CDC Confirms Superbug Transmission via Endoscopy.”

Also not reported is whether patients considering treatment at this hospital between January and September, 2013 – the time of the superbug’s spread at this hospital – were informed of this outbreak.

Click here to read an article in the Washington Post in 2012 that discusses an outbreak of multidrug-resistant Klebsiella spp. at a hospital in Maryland.

CDC’s MMWR, comments:  According to the federal Centers for Disease Control and Prevention (CDC) – click here to read its report in Morbidity and Mortality Weekly Report (MMWR):

1.  “After manual cleaning and high-level disinfection in an automated endoscope reprocessor, cultures were obtained from the ERCP endoscope used on five of the case-patients. NDM-producing Escherichia coli and KPC-producing Klebsiella pneumoniae were recovered from the terminal section (the elevator channel)”;

Attention Healthcare Facilities: Could your GI endoscopy unit be harboring CRE?  Click here to read about an safety/auditing program specifically designed by Dr. Muscarella – this article’s author – to prevent infection-control breaches and disease transmission during ERCP and other GI endoscopic procedures.

2.  “Previous studies have shown an association between ERCP endoscopes and transmission of multidrug resistant bacteria; the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection”; and

3.  “In September 2013, as a result of the investigation, (the hospital) changed ERCP endoscope reprocessing from automated high-level disinfection to gas sterilization with ethylene oxide; no new cases with exposure to a gas-sterilized ERCP endoscope have been identified.”

Attention Medical Device Manufacturers:  Could your reusable medical device be harboring CRE?  Click here to read about a quality program designed by this article’s author – Dr. Muscarella – to improve the design of reusable medical instruments and to minimize the likelihood of their association with CRE transmission.

FDA databases: A review of an FDA’s database shows that the following two medical devices were involved in Advocate Lutheran General Hospital’s CRE outbreak: (i) at least one manufacturer’s duodenoscope (click here); and (ii) at least one manufacturer’s automated endoscope reprocessor, or AER (click here).

Recommendations: Dr. Muscarella’s blog “Discussions in Infection Control” features a number of his articles that, in addition to discussing this outbreak at Advocate Lutheran General Hospital, provide recommendations to prevent disease transmission during GI endoscopy, in general, and during ERCP, in particular.

This articles include:

  1. Muscarella LF. “Overlooked Outbreaks of the Superbug “CRE” Following Gastrointestinal Endoscopy: An Epidemic in Our Midst?” Click here.
  2. Muscarella LF. “Investigation and Prevention of Bacterial Outbreaks during Endoscopic Retrograde Cholangiopancreatography (ERCP).” Click here.

Attention Patients, Healthcare Facilities: Contact Dr. Muscarella in strict confidence – click here – if you have any questions about a possible outbreak of bacteria linked to a contaminated endoscope. (Read more about Dr. Muscarella’s auditing program by clicking here.)

Recommended reading: The following articles are also recommended reading:

  • Muscarella LF. “Growing National Concerns about Carbapenem-Resistant Enterobacteriaceae, or CRE.” Click here.
  • Endoscopy: Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957–9.

Article by: Lawrence F Muscarella, PhD, president and owner of the think-tank quality and safety company “LFM Healthcare Solutions” — click here for a list of its services. Article posted 1/7/2014; updated 1/13/14, Rev A.

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