FDA issues warning to medical device makers over failure to validate cleaning IFU

The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.

The devices, made by Olympus, Pentax, and Fujifilm, are used in hundreds of thousands of procedures each year. The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned. Olympus and Pentax were specifically cited for failing to relay to FDA reports that their devices ”may have caused or contributed to a death or serious injury” within 30 days of learning about the event. Pentax and Fujifilm were cited for failing to make sure their instructions for cleaning the scopes were valid.

Read the full FDA Final Guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Source: FDA.

Lawsuit Charges Pentax Negligence Led to Fatal Superbug Infection

September 1, 2015

Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the adult children of Renate Winkler as administrators of her estate have filed a wrongful death lawsuit against Pentax Medical, a division of Pentax of America, Inc., and Advocate Lutheran General Hospital, which is located in the Chicago suburb of Park Ridge, Illinois. Ms. Winkler died on December 7, 2013 from carbapenem-resistant Enterobacteriaceae or CRE, a bacteria that is highly resistant to antibiotics, following Endoscopic Retrograde Cholangiopancreatography or ERCP at Advocate Lutheran General Hospital. For the procedure, the hospital used a duodenoscope manufactured and sold by Pentax Medical.

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