News Feature | January 26, 2016

Olympus To Recall, Redesign Scopes In Wake Of FDA Report

Christine Kern

By Christine Kern, contributing writer

FDA Draft Guidance

Olympus pledges to prevent further superbug infections linked to their duodenoscopes.

As the emphasis on improving patient outcomes and safety records grows, Olympus has abandoned its previous denials of wrongdoing and is now pledging to take steps to help prevent further superbug infections linked to their duodenoscopes with recalls and redesigns, according to The Los Angeles Times.

Last February, the FDA issued a warning that duodenoscopes are difficult to clean, even when healthcare workers follow the manufacturers’ own care instructions. In March, the FDA issued a list of final recommendations for the cleaning and sterilization of such scopes.

The, in October, the FDA ordered manufacturers of endoscopic devices to conduct post market studies of their devices in healthcare facilities following a rash of outbreaks of life-threatening infections. At the heart of the investigations are the methods by which the scopes and cleaned and prepped for re-use in actual healthcare settings.

Now, the results from a January 18 report blame manufacturers, hospitals, and the FDA for infections involving at least 250 individuals worldwide since 2012, including dozens of deaths. The report, from Senator Patty Murray, demonstrates there are systemic weaknesses in the FDA approach to protecting the public from potentially harmful medical technology, according to Insurance Journal.

The voluntary recall and redesign by Olympus is significant. Olympus sells approximately 85 percent of all duodenoscopes used in the United States. The company has pledged to revamp an internal mechanism inside the reusable device, fixing the difficulties in disinfection.

The announcement follows closely on the release of the Murray report, which concluded that 25 outbreaks were conclusively linked to dirty scopes made by Olympus and two other manufacturers. The 310-page report says the manufacturers “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues. This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

The FDA has approved Olympus’ redesign plan, saying that until devices in question can be replaced, hospitals can continue to use the TJF-Q180V scope as long as they “meticulously follow” the cleaning instructions provided by the company.

The other two manufacturers cited, Pentax and Fujifilm, have not yet announced any redesign plans, and they have declined to comment to date.

The report — written by the minority staff of the Senate committee on health, education, labor and pensions — cited repeated failures by manufacturers, regulators, and hospitals to report outbreaks. The missteps in oversight allowed patients to remain at risk “with life-threatening consequences,” investigators concluded.

“The steps taken today are important,” Murray said in a statement, “but there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur.”