The outbreak of deadly bacterial infections linked to contaminated medical scopes was worse than initially reported and due to numerous oversights and reporting failures by scope manufacturers, regulators and hospitals, according to a new U.S. Senate report.
The report revealed the outbreak was wider-spread than initially reported. Investigators determined there were a total of 25 outbreaks affecting 250 patients. They also determined that oversight gaps at the federal level continued to put patient safety at risk. Additionally, 17 months passed between hospitals in Seattle and Illinois detecting the scopes' risk of spreading antibiotic-resistant bacteria and the FDA's first warning to the public.
"Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented," Sen. Patty Murray (D-Wash.), who led the probe, told the Los Angeles Times.
The report also faulted the "passive" system the Food and Drug Administration (FDA) relies on to monitor patient safety problems; because the FDA must wait for providers to report safety issues, the agency could not identify the problem until it was brought to them. "Until a system is implemented that allows FDA to independently monitor, track, and assess the performance of devices, the agency will not be able to adequately identify risks to patient safety from particular devices like duodenoscopes and move quickly to address those risks," the report states.
Numerous affected hospitals, meanwhile, didn't follow proper reporting procedures; of the hospitals that discovered scope-linked superbug infections, 16 did nothing to notify manufacturers or the FDA, letting them know later than required, if at all, and often failing to notify affected patients. Last March, soon after the news of the contaminated scopes broke, FDA officials also faulted the manufacturers' testing process for recommended cleaning procedures. The federal agency, meanwhile, faced widespread criticism for its perceived slowness in issuing a warning about the risk, acting only after the infections killed two patients at UCLA's Ronald Reagan Medical Center, FierceHealthcare previously reported.
A spokesman for Olympus Corp., a manufacturer of the scopes, said in a statement to the press the company would "closely review" the report's recommendations, which include a staggered recall of devices that pose a threat, according to Bloomberg; similarly, FDA Spokeswoman Deborah Kotz told Bloomberg the agency is already working to implement many of the recommendations.