The intricate design of the specialized scopes, which have a movable “elevator” mechanism at one end that allows the instrument to maneuver into ducts and fix fluid-drainage problems, also makes it difficult for them to be disinfected and sterilized between uses.
The Food and Drug Administration, which over the past year has alerted hospitals and issued warnings to manufacturers about their failure to report and resolve these issues, signed off Friday on Olympus's plan. The company said that beginning in February, it would voluntarily recall all 4,400 of its TJF-Q180V model duodenoscopes in use around the country and replace the existing elevator mechanism with one designed to be less vulnerable to contamination. The company also said it will conduct annual inspections of each scope to monitor for wear and tear.
Olympus and FDA officials said health care facilities could continue to use a different Olympus model as long as they closely follow a detailed set of cleaning instructions.
The company's move comes days after the findings of a Senate investigation were released. Those showed that the number of patients harmed by contaminated medical scopes in recent years far exceeds federal regulators' previous estimates. Between 2012 and 2015, duodenoscopes were linked to more than two dozen outbreaks of antibiotic-resistant infections that sickened at least 250 patients in the United States and Europe, the inquiry found. Some patients died after battling an infection.
The report detailed a woefully inadequate warning system, in which manufacturers routinely failed to inform health officials of potential problems linked to their devices, hospitals neglected to alert federal regulators about outbreaks, and FDA was slow to identify problems and alert the public.
“Patients should be able to trust that the devices they need for treatment are safe and effective," said Sen. Patty Murray (D-Wash.), whose staff conducted the investigation. "Unfortunately, this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented."