The FDA, which conducted facility inspections in the spring, has sent warning letters to the 3 manufacturers of duodenoscopes, citing all 3 for failing to adequately report infections related to their scopes and/or for failing to prove that their recommended reprocessing instructions are adequate.

Olympus, which has the largest market share, was cited for failing to notify the FDA within 30 days after becoming aware that its scope "may have caused or contributed to death or serious injury." Olympus, it says, knew of an outbreak that affected 16 people in May 2012, but didn't report it until 2015.

Hoya Corp., the parent company of Pentax, was cited for various transgressions, including testing sterilization instructions on models other than the model currently being marketed, failing to maintain procedures for implementing corrective and preventive actions, and failing to timely notify the FDA after becoming aware that its scope may have caused or contributed to death or serious injury.

Fujifilm also came under fire for a wide range of perceived shortcomings, including failing to adequately test cleaning procedures; and failing to develop, conduct, control and monitor production processes to ensure that its device meets all specifications.

Duodenoscopes, which are used for endoscopic retrograde cholangiopancreatography (ECRP) procedures, have been linked to numerous deadly outbreaks in recent years, and their complex design makes them extremely challenging to sterilize. Along with being criticized for failing to develop and disseminate adequate reprocessing instructions, manufacturers have been accused of withholding information about their dangers.

Both the FDA and Olympus have issued updated reprocessing instructions this year. The Association for the Advancement of Medical Instrumentation also recently updated its guidelines for endoscope reprocessing.

In June, an FDA-convened panel of doctors, health experts and consumer representatives concluded that current duodenoscope designs aren't safe, but agreed that banning their use would harm the public more than it would help.

Olympus says "we are reviewing the FDA's warning letter so that we can provide the required response in a timely manner." Representatives from all 3 companies tell the Wall Street Journal that they take the warning letters very seriously.

Jim Burger