The FDA today published warning letters it sent earlier this month to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan.
The inspections followed a string of deadly “superbug” infections 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 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.