FDA sends warning letters to 3 manufacturers of superbug-linked scopes

The Food and Drug Administration has sent warning letters to three major manufacturers of specialized medical scopes linked to deadly "superbug" outbreaks at hospitals.


Olympus, Pentax and Fujifilm did not properly report problems with the devices--known as duodenoscopes, as required by law and in some cases, didn't ensure that they could be cleaned properly between uses, the FDA said last week in the warning letters.

The scopes have been associated with outbreaks of serious bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.

The FDA wrote that Pentax and Olympus didn't inform the regulator that their scopes might have "caused or contributed to a death or serious injury" within 30 days of learning about the incidents. Indeed, the reason that superbug outbreaks linked to medical scopes continue to rise is because cases of the deadly infections often go unreported, FierceHealthcare reported earlier this month.

In an e-mail to the Washington Post, an Olympus spokesman said the company is "reviewing the FDA's warning letter so that we can provide the required response in a timely manner." Pentax and FujiFilm also told the publication that they take patient safety seriously and will work closely with the FDA to meet regulatory requirements.

The industry has focused much attention on antibiotic-resistant infections linked to reusable duodenoscopes, which clinicians use in endoscopic retrograde cholangiopancreatograph (ERCP) procedures, after tests revealed contaminated devices were the source of illnesses and patient deaths in Seattle, Chicago and Pittsburgh. But USA Today reported that federal officials just learned of two more scope-related infections in Indiana that were not disclosed previously.

Olympus Corp. warned hospitals in Europe about the risk of patient infections associated with a certain type of gastrointestinal scope two years before the devices were linked to a deadly superbug outbreak in California, FierceHealthcare previously reported.

To learn more:
- read The Washington Post article
- here's the FDA letter to Olympus
- read the FDA letter to Fujifilm
- see the FDA letter to Hoya Corp. (Pentax Life Care Division)

Related Articles:
Medical scopes and superbugs: Infection risk greater than previously thought
Olympus waited to alert U.S. hospitals of scopes' superbug risk
True extent of scope-related superbugs unknown
DOJ investigates manufacturer of superbug-linked scopes
CRE superbug spreads to North Carolina, kills two