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Deadly Superbug Outbreaks Result in FDA Warning Letters for Duodenoscope Manufacturers

Aug 25, 2015

A series of superbug outbreaks in hospitals across the country has resulted in FDA warning letters to Olympus Medical Systems, Pentax Medical, and Fujifilm from the Food and Drug Administration (FDA).

In the letters, the FDA cited failure to report infections in a timely manner and problems with the devices including difficulties in sterilizing the scopes properly between uses, the Washington Post reports.

In recent years, duodenoscopes have been linked to outbreaks of difficult-to-treat carbapenem-resistant Enterobacteriaceae (CRE). At least two people died in an outbreak at Ronald Reagan UCLA Medical Center in Los Angeles and many other patients were potentially exposed to the dangerous bacteria. Four patients at Cedars-Sinai Medical Center in Los Angeles were infected by a superbug during duodenoscope procedures, according to the Post. And a Connecticut hospital reports that it has contacted nearly 300 patients who might have been exposed to drug-resistant E. coli during duodenoscope procedures. Since 2012, 44 scope-related infections occurred at Advocate Lutheran General Hospital near Chicago, and at the Virginia Mason Medical Center in Seattle, at least 32 patients became ill and 11 died. Prompted by these incidents, the FDA issued an alert earlier this year to doctors and hospitals, warning that duodenoscopes can be difficult to sanitize between uses and "may facilitate the spread of deadly bacteria," according to the Post.

About 700,000 duodenoscope procedures are done in the U.S. each year. A variety of conditions, including cancers and bile duct blockages, can be detected and in some instances treated with the duodenoscope. The device is a flexible scope equipped with a tiny camera that is inserted through the patient's esophagus into the top of the small intestine. The devices are intended to be reused after cleaning and sterilization but have been found to harbor dangerous bacteria even when the manufacturer's cleaning instructions are carefully followed, according to the Wall Street Journal.

FDA officials inspected scope manufacturing facilities in the U.S. and Japan and the warning letters cited violations observed during the inspections. Pentax and Olympus were cited for failing to inform the FDA that their scopes might have "caused or contributed to a death or serious injury" within 30 days of learning about the incidents, as regulations require. Pentax and Fujifilm were cited for failing to validate their instructions for cleaning the scopes, the Post reports. Olympus, which has the largest share of the market for duodenoscopes in the U.S., is facing lawsuits as a result of superbug infections. The company has issued detailed new cleaning instructions for the devices.

Doctors consider duodenoscopes an important tool in detecting and treating a variety of medical problems early and in a minimally invasive way. The FDA has said that in many instances, there is no better alternative available. Regulators and industry officials have argued that the benefits of duodenoscopes outweigh the risks, according to the Post. At this time, the FDA is not recommending that they be pulled from the market.

The FDA gives companies 15 business days from receipt of a warning letter to respond in detail about how they have addressed the violations and how they plan to ensure such violations do not occur again.

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