Superbug Outbreak Prompts FDA To Seek Data From Devicemakers
FDA has asked manufacturers of ERCP medical endoscopes to provide evidence that their recommended disinfection protocols work to reduce contamination risks after an outbreak of a superbug at a California hospital caused the death of two patients, Modern Healthcare reports.
The announcement was made by FDA Chief Scientist Stephen Ostroff, who will become acting FDA commissioner at the end of March when current Commissioner Margaret Hamburg steps down (Ross Johnson, Modern Healthcare, 2/26).
California health officials are working to track down as many as 179 patients who were treated at the University of California-Los Angeles' Ronald Reagan Medical Center between October 2014 and January and may have been exposed to a drug-resistant superbug known as CRE from contaminated medical endoscopes. So far, seven patients have been confirmed to have CRE infections, two of whom died (California Healthline, 2/23). The medical center said it switched to a gas sterilization method after the outbreak and that no patients have been exposed to infections from the devices since the implementation of the new method (Terhune, Los Angeles Times, 2/26).
Ostroff said, "Institutions appear to have been doing the recommended procedures, and doing them extremely well." However, FDA has said that correctly following the recommended procedures for reprocessing might not be sufficient to avoid infection risks (Modern Healthcare, 2/26).
FDA last week issued a general health warning to providers about the ERCP endoscopes, which are also called duodenoscopes (California Healthline, 2/20). According to Modern Healthcare, FDA has since updated the warning to say that it is conducting "reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the [U.S.] -- FUJIFILM, Olympus and Pentax."
In addition, FDA said it is working with CDC on looking at other steps that can be taken to reduce infection risks (Modern Healthcare, 2/26).
Devicemaker Faces Lawsuits
In related news, a family of a patient who died from a CRE infection and a patient currently hospitalized with the CRE superbug have filed separate suits against Olympus Corporation of the Americas, the manufacturer of the duodenoscope device used by the UCLA Medical Center, the AP/Washington Times reports.
Aaron Young on Monday sued Olympus, accusing the company of negligence and fraud. Young, a high school student, is hospitalized from the superbug infection at the medical center (AP/Washington Times, 2/26).
On Wednesday, the family of Antonia Torres Cerda -- who died on Nov. 8 after being exposed to a contaminated duodenoscope made by Olympus -- filed a separate suit against the devicemaker, claiming fraud, negligence and wrongful death.
The suit claims that the company promoted a "defective" scope and that it did not provide an "effective and validated reprocessing protocol" when it released a redesigned version of a duodenoscope in 2014. The suit alleges that Olympus gave providers decontamination instructions for an older model, which led to users not being able to effectively clean the new model (Los Angeles Times, 2/26).
The family is seeking unspecified punitive and exemplary damages.
Both lawsuits were filed on the plaintiffs' behalf by attorney Pete Kaufman in Los Angeles County Superior Court (AP/Washington Times, 2/26).
Kaufman said that UCLA and the University of California regents could be added to the cases as defendants as more details come out about the incidents (L.A. Biz, 2/26).
According to the AP/Washington Times, more patients are expected to file suit in relation to the superbug outbreak (AP/Washington Times, 2/26).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.