FDA Warns Three Scope Makers

The Food and Drug Administration sent warning letters to the three makers of a specialized medical device that has been linked to outbreaks of so-called superbug infections at U.S. hospitals.

The FDA conducted inspections of the manufacturing plants in the spring and said the companies either didn't adequately report infections or failed to provide sufficient evidence that its cleaning procedures work.

The device, known as a duodenoscope, is snaked down the esophagus into the top of the small intestine and is used in diagnostic and treatment procedures related to cancer and other conditions. The FDA has said the devices, which are cleaned and reused, have led to outbreaks of antibiotic-resistant infections even when hospitals followed manufacturers' cleaning instructions.

The three manufacturers, all headquartered in Japan, are Olympus Medical Systems Corp., Fujifilm Corp. and the Pentax division of Hoya Corp. The FDA's warning letters stemmed from inspections the agency conducted at manufacturing plants in Japan and the U.S., as well as from bacterial infection incidents.

Olympus said it is reviewing FDA correspondence before commenting.

Hoya's Pentax unit said it is "working closely with FDA to resolve the noted issues and ensuring that our devices meet the highest standards of safety and quality."

"We consider these issues to be of utmost importance," said Mark Koppel, chief medical officer of Pentax Medical Americas.

Fujifilm said it takes the issue seriously and is working closely with the FDA.

"Actions have been and will continue to be taken to ensure that our products and processes meet FDA requirements, and pose no risks to the health and safety of the public," Fujifilm said in a statement.

The scopes have been associated with infection outbreaks involving hundreds of people at U.S. hospitals in Seattle, Los Angeles and the Chicago area, as well as at hospitals overseas. The FDA has been grappling with the complex structure of the devices, which have proven to be extremely difficult to sterilize before being reused.

In a letter to Olympus, the FDA criticized the company for not notifying the agency in a timely fashion after it found that one of its devices "may have caused or contributed to a death or serious injury." FDA officials said the company became aware of an illness outbreak involving 16 patients in May 2012, but that FDA wasn't informed about illnesses until this year.

Hoya Corp. was criticized in a warning letter about a number of violations, including one for not notifying the agency within 30 days of the event, and for not notifying the agency of other events that could have resulted in death or serious injury to patients.

In the case of Fujifilm, the FDA found a range of violations related to manufacturing and complaint handling and said the agency "reviewed your firm's responses and concluded that they are not adequate."

Write to Thomas M. Burton at [e-mail]

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August 17, 2015 18:45 ET (22:45 GMT)

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