FDA sends warning letters to scope makers for failing to report infections

The U.S. Food and Drug Administration has sent warning letters to three duodenoscope manufacturers —Olympus, Pentax and Fujifilm — after discovering the two former companies failed to report patient infections to federal regulators within 30 days, according to The Washington Post.

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 CMO Mark Koppel, MD, said the company is working with the FDA, CDC and healthcare providers to address safety concerns linked to its duodenoscopes in a statement last week before the warning letters were sent, according to the report.

According to the Los Angles Times, the warning letters mark the federal agency's strongest action against the device makers since outbreaks of antibiotic-resistant bacteria linked to scopes at UCLA's Ronald Reagan Medical Center, Advocate Lutheran General Hospital in Chicago and Virginia Mason Medical Center in Seattle made headlines late last year and earlier this year.

Despite the risks, the FDA noted the importance of keeping these scopes on the market since there isn't a better alternative and patients can benefit from their use.

Jennifer Dooren, the FDA spokeswoman, told the Los Angles Times "removing these devices from the market would prevent thousands of patients from accessing this beneficial and often life-saving procedure."



More articles on scope-related infections:
3 reasons many scope-related infections go unreported
Scope-related infection estimates inaccurate and outdated, researchers say
Endoscopes and MDROs: How to avoid an outbreak

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