Hill Democrats Blast Duodenoscope Firms, FDA
A report prepared by the Democratic staff of the Senate HELP Committee blasts Olympus and other duodenoscope manufacturers and FDA for cleaning problems with closed-channel duodenoscopes that sickened at least 250 patients worldwide in at least 25 different incidents of antibiotic-resistant infections between 2012 and spring 2015. The report charges that by early 2013, Olympus, which manufactures 85% of duodenoscopes used in the U.S., knew of two independent lab reports finding that the closed-channel scope would harbor and spread bacteria even after cleaning according to the manufacturer’s instructions. “Olympus never brought this information to the attention of FDA and did not alert hospitals, physicians, or patients in the U.S. to the risk of infection until 2/2015,” it says.
Investigators say they also found that Olympus as well as scope manufacturers Pentax and Fujifilm, and Custom Ultrasonics, the manufacturer of the automated cleaning machine used at many hospitals that experienced infections, failed to meet regulatory system obligations. Two of the manufacturers didn’t seek FDA clearance before marketing closed-channel duodenoscopes, all failed to adequately test whether the scopes could be cleaned reliably in real-world settings, and all failed to fully comply with adverse event reporting requirements.
“While FDA started investigating how closed-channel duodenoscopes cleaned according to manufacturers’ instructions spread infection in 9/2013,” the report says, “the agency took no action to alert hospitals, doctors, and the public to the risk posed by closed-channel duodenoscopes for 17 months. At least 68 patients in seven different hospitals in the United States were infected with antibiotic-resistant bacteria linked to duodenoscopes during this period.”
The report faults the agency for not having a way to seek independent information about adverse events linked to medical devices similar to the Sentinel system used to see drug adverse event signals. It says that because FDA did not have a good sense of the frequency and severity of infection outbreaks and was not aware of documentation by two independent European labs that the Olympus scope remained contaminated after repeated cleaning, it wasted time seeking cleaning data from manufacturers and trying to conclusively determine that cleaning mistakes by hospital staff were not responsible for the infections.
“The failure of FDA’s current medical device safety reporting system to rapidly identify duodenoscope-related antibiotic-resistant infections, including superbug infections, should serve as a warning that without a comprehensive postmarket device surveillance system that supplements self-reporting from hospitals and manufacturers, future device issues are likely to go undetected for far too long and with life-threatening consequences,” the staff report says.
The Democratic staff recommends these legislative and regulatory changes: Congress should require and promote that unique device identifiers be included in insurance claims, electronic health records, and device registries;FDA should evaluate whether modifications to the design of closed-channel duodenoscopes are necessary to prevent the spread of infection and if so, require manufacturers to rapidly implement any repairs through a phased recall to ensure that devices used by hospitals are safe for reuse;FDA should update its guidance to clarify when manufacturers are required to submit a notification to the agency for 510(k) clearance before marketing modified devices;FDA should move faster to provide information to healthcare providers when the agency becomes aware of information suggesting that patient safety might be compromised by a medical device;FDA should have clear authority to deny a 510(k) submission based on insufficient reprocessing validation data;Compliance with Medical Device Reporting requirements should be a Medicare Condition of Participation; andCongress should fully fund a national medical device evaluation system.