FDA orders ‘scope makers to launch postmarket studies

The FDA today ordered a trio of Japanese duodenoscope makers to run post-market surveillance studies to evaluate how the devices are reprocessed in real-world conditions, after a deadly rash of so-called “superbug” outbreaks this year were linked to the devices.

The string of deadly infections were attributed to duodenoscopes made by Olympus (TYO:7733),  Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March, some of which led to patients’ deaths.

The 3 companies have 30 days to submit their post-market surveillance plans to the FDA, which warned them in August about violations found during spring inspections at plants in the U.S. and Japan, and provide specifics on how well healthcare providers follow the devices’ cleaning and disinfection instructions.

“This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used,” Dr. William Maisel, chief scientist at the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”

The outbreaks prompted the FDA to inspect 11 plants where the 3 companies make the endoscopes, leading to the August 12 warning letters to Olympus, Fujifilm and Pentax. The U.S. safety watchdog said it found numerous violations at the plants, ranging from inadequate quality controls to failures to report serious adverse events, including deaths. The violations turned up at plants in Japan, New Jersey, Pennsylvania and California, according to the FDA.

In March, hospitals in Los Angeles and Connecticut reported superbug outbreaks linked to the scopes. Cedars-Sinai Medical Center reported 4 infections and 67 more at-risk patients. coinciding with a hospital in Hartford, Conn., reporting a similar outbreak involving at least 5 infections and more than 280 potential exposures.

The Cedars-Sinai cases, like the larger number of infections and potential exposures reported in February at the UCLA Ronald Reagan Medical Center in Los Angeles, involved a family of germs called carbapenem-resistant Enterobacteriaceae. The bacteria identified in the Hartford Hospital outbreak was a drug-resistant strain of E.coli. Seven patients were infected with CRE during endoscopies at the UCLA teaching hospital between Oct. 3 and Jan. 28, and 2 died. Officials warned at the time that as many as 179 people may have been exposed to the so-called superbug.

Between 2012 and 2014, at least 32 patients at Virginia Mason Medical Center were infected with strains of multidrug-resistant E. coli bacteria spread through contaminated scopes that had been sterilized to the manufacturer’s guidelines, according to state health officials. At least 11 people eventually died, though the role of the superbug in their demise was unclear because all the patients were critically ill at the time of their infection, Washington state public health officials said.

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