Fujifilm, Pentax Medical swept up in U.S. DOJ subpoenas on duodenoscopes

Two more Japanese manufacturers of specialized medical scopes linked to a "superbug" outbreak were subpoenaed by the U.S. Department of Justice (DOJ) this week, reports said, as Olympus already faces related regulatory scrutiny and lawsuits.

Fujifilm Holdings Corp and Pentax Medical, a unit of Hoya, were said to have received the subpoenas, according to a report in USA Today, citing two sources familiar with the investigation.

All three companies manufacture what are known as duodenoscopes used in colonoscopies and upper gastrointestinal tract examinations. The devices are complex and require specialized maintenance.

In May, the DOJ subpoenaed Olympus Medical Systems to investigate cases that pointed to its duodenoscopes as a source for the spread of deadly bacteria trailing back years because of the postprocedure cleaning process.

In a related development, a U.S. FDA advisory panel asked last month that the agency require sterilization after each use of a duodenoscope, directly affecting products by the three Japan makers.

According to a story in The Wall Street Journal, ethylene oxide used by workers for sterilizing 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 story from Reuters