Bloomberg Business (February 27, 2015; 11:38 am): “Superbug: Scopes in UCLA Case Linked to Florida Deaths Years Ago.”
From Bloomberg’s report published on-line earlier today: “Fifteen people died in an outbreak of drug-resistant infections spread by the same kind of medical device (ERCP endoscopes) six years ago.”
Quote
From this Bloomberg Business report: “It’s catastrophic. I’m stunned to hear it,” said Lawrence Muscarella, a patient safety consultant who has been tracking endoscope-related outbreaks.
Discussion
Interestingly, Alrabaa et al. (2013) reported a similar type of superbug outbreak also in Florida, also occurring between 2008 and 2009, also involving two hospitals, and also linked to the same type of gastrointestinal (GI) endoscope known as an “ERCP endoscope.”
But Alrabaa et al.’s (2013) CRE outbreak ostensibly occurred at a hospital located in a different county, in Tampa Bay (FL). In contrast, the outbreak reported by Bloomberg Business occurred at a hospital in Highlands County, in central Florida.
Further, Alrabaa et al. (2013) report that their outbreak involved 7 cases and 1 death, whereas the CRE outbreak described in Bloomberg Business’s report affected 70 patients, with 15 patients reportedly dying.
So, while an odd coincidence, the two outbreaks — the one reported by Bloomberg Business today and the one by Alrabaa et al. (2013) — are two distinct “CRE” outbreaks.
No matter, no reports in the FDA’s medical device reporting database, also known as the MAUDE database, documenting this outbreak could be identified.
Click here to read a related article by Dr. Muscarella discussing the Alrabaa et al. (2013) report in more detail.
(Note: Although Alraaba et al.’s report discusses a CRE outbreak that occurred between 2008 and 2009, their report was not published until 2013.)
An Update
On February 27, 2015, at 4:25 pm, Bloomberg Business “updated” its story to include the following statement:
[quote] The paper about Tampa cases (Alrabaa et al., 2013) “does partially describe” the Highlands County outbreak, Huard, the Florida health official, said in an email. He says Florida authorities reported the outbreak to the CDC in April 2009 and held a conference call with officials from the CDC and FDA in June 2009 “to discuss concerns about the role of endoscopes” in spreading CRE infections.[end quote]
Stay tuned.
References
1. Alrabaa SF, et al. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. American Journal of Infection Control 41 (2013) 562-4.
2. Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae (CRE) and related ‘superbugs’ during gastrointestinal endoscopy. World Journal of Gastrointestinal Endoscopy 2014 Oct 16;6(10):457-74 — click here.
3. Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography” Endoscopy 2010 Nov;42(11):957-9) — click here.
Posted: 2/27/2015, Rev C.
■ Serving as national counsel for a client sued in more than 300 cases, many alleging wrongful death, following the company’s recall of more than a dozen of its products. While dealing with public criticism from a federal agency and a nationally prominent teaching hospital — and concurrently with negative press coverage in a leading medical journal and The Wall Street Journal — Mr. Carroll was able to resolve nearly the entire docket of cases in less than two years. Dozens of the cases resulted in “no pay” dismissals because of strong motions practice, and the remainder were resolved at values acceptable to the client and its carriers. The litigation ended sooner — and cost less — than anticipated by the client.
http://www.carrollweiss.com/jameson-b-carroll/
The excerpt above is from Olympus’ legal champion, Jamie Carroll. Carroll brags on his website [and to my attorney, telling him my case would NEVER go to trial] of how he stifled the fall out from the design faulty bronchoscope despite JAMA, Johns Hopkins and others. FDA inspections in San Jose and Tokyo in response to Johns Hopkins and Vanderbilt’s independent inspections confirmed scopes were defective as designed, were purposely contaminated for the FDA inspection, revealing to the inspector that they could not be cleaned. I have a copy of that inspection. Yet here we are again. People still dying. Nothing done. This time it is another type scope but the scenario is the same. FDA KNEW, Olympus and others KNOW. They purposely blame hospital personnel to shut down complaints. However, I support your continued efforts to at least bring informed consent and transparency to bear on these companies and their FDA predicated rubber stamped instruments that are responsible for more infections than any of us can imagine.