More scrutiny for Japanese duodenoscope makers on notification failures

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

The U.S. FDA has slapped Japan's Olympus with a warning letter after the discovery of new cases of infections linked to a deadly "superbug" that were not reported in proper time or procedure, press reports and the agency said.

Olympus did not report 16 infections in patients who underwent procedures with the company's scope in 2012 until this year, the FDA said in a warning letter released on Monday.

The New York Times noted that medical device manufacturers need to file reports on serious problems within 30 days of discovery, adding that the FDA found the company did not have such a procedure in place.

"We are reviewing the FDA's warning letter so that we can provide the required response in a timely manner," Olympus said in response to the letter, according to The New York Times.

Last week, the agency last week sent letters as well to Japan firms Pentax and Fujifilm which also failed to report problems with scopes in a timely fashion, according to a separate report from Bloomberg.

All three companies manufacture duodenoscopes used in colonoscopies and upper gastrointestinal tract examinations. The devices are complex and require specialized maintenance for sterilization and use.

According to a June story in the Wall Street Journal, one reason for improper sterilization may have been because ethylene oxide used by workers for the process was toxic if exposed to skin and ingested or inhaled, increasing the burden on the makers and the hospitals to conduct the procedure carefully.

- here's the FDA letter
- and a story from The New York Times
- and one from Reuters