FDA, CDC Issue Health Advisory for Device Reprocessing
The FDA and Centers for Disease Control and Prevention have advised healthcare facilities to strictly adhere to manufacturers’ instructions for reprocessing medical devices, as reports of improperly cleaned instruments continue to surface.
In a health advisory issued last month, the agencies recommended that healthcare facilities work with an expert to ensure that employees follow proper medical device reprocessing procedures. Facilities also should train all personnel involved in reprocessing at the time of hire or before they provide services at the facility. Personnel must demonstrate competency before being allowed to perform procedures independently.
Further, employees should receive updated training at least once a year and when new devices or protocols are introduced.
The agencies also advised facilities to monitor and document adherence to cleaning, disinfection, sterilization and device storage procedures. Protocols should be put in place to ensure employees can easily identify devices that have been properly reprocessed and ready for patient use.
The advisory comes after reports of notifications going out to patients, warning them that they may be at increased risk as a result of inadequate cleaning, disinfection and sterilization of medical devices.
The FDA issued a separate safety notice explaining ways that healthcare facilities can reduce the risk of transmitting antibiotic-resistant infections through the proper reprocessing of flexible bronchoscopes, which are used in about 500,000 procedures in the U.S. each year.
An FDA investigation found that the agency received 109 MDRs of infections or contamination associated with flexible bronchoscopes between January 2010 and June 2015. The agency was moved to further investigate the issue after receiving 50 MDRs that mentioned infections or device contamination specifically associated with reprocessed flexible bronchoscopes.
“A small number of these reports indicate persistent device contamination despite following the manufacturer’s reprocessing instructions,” according to the notice.
In March, the FDA unveiled final guidance strengthening controls on reprocessing. At the time, it said bronchoscopes can pose a greater risk to patients if reprocessed improperly. However, the FDA has acknowledged the risk of infection transmission is lower with bronchoscopes than with duodenoscopes. Olympus, Pentax and Fujifilm, the three manufacturers taken to task in recent FDA warning letters for inadequate MDR procedures related to their duodenoscopes and endoscopes, also market bronchoscopes.
Stay up to date on regulatory stories like this one by subscribing to The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and the Quality Systems Regulation.