The FDA today issued new guidance for makers of reusable medical devices like the endoscopes linked to a rash of deadly "superbug" infections.
The new guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," is aimed at helping medtech makers develop safer devices, the federal safety watchdog said.
"Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and healthcare providers should know that the risk of acquiring an infection from a reprocessed medical device is low," according to Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. "This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective."
The FDA also said today that an advisory panel is slated to discuss the transmission of "superbug" infections through endoscopy procedures in U.S. hospitals.
A top Los Angeles hospital, Cedars-Sinai Medical Center, said last week that 4 patients had been infected with bacteria from a contaminated scope and 67 more were at risk, weeks after UCLA Ronald Reagan hospital reported 7 patients were similarly infected and scores more potentially exposed. Across the country in Connecticut, Hartford Hospital has also reported a similar outbreak involving at least five infections and more than 280 potential exposures.
Between 2013 and 2014, the FDA said it received reports of 135 possible microbial transmission from reprocessed duodenoscopes. The federal safety watchdog has been under pressure to review current protocol of sterilizing the instruments after a string of superbug outbreaks at hospitals across the country.
Although the FDA said Olympus put its TJF-Q180V duodenoscope on the market without the agency’s clearance, Olympus claimed that, based on the FDA’s policy, a modified version of its previously approved scope did not require a new marketing approval.
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