Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in premarket notification submissions.
The list comes thanks to the 21st Century Cures Act (section 3059), which requires FDA to identify and publish a list of reusable device types that are required to include such "instructions for use" and "validation data" regarding cleaning, disinfection and sterilization in 510(k) notifications.
"FDA believes that a majority of manufacturers for the reusable devices listed below are already conducting validation of their reprocessing instructions because FDA already has provided recommendations for reprocessing validation in relevant FDA documents," Thursday’s Federal Register notice said. Sponsors of new 510(k) notifications for reusable devices identified in the lists must also include validation data regarding cleaning, disinfection and sterilization, in addition to all the other required elements of a 510(k), beginning in the next two months.
"FDA believes arthroscopes, laparoscopic instruments, and electrosurgical instruments, and their respective accessories with specific design features, identified in table 2, may pose a challenge to adequate reprocessing. 510(k) notifications for such devices that incorporate any of the design features listed in table 2 must include validated reprocessing instructions and reprocessing validation data reports, and if such are determined to be inadequate, FDA will find the device not substantially equivalent,"
A reusable medical device is one intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing steps between uses.
One type of these devices, known as duodenoscopes, made headlines in early 2015 after Carbapenem-resistant enterobacteriaceae (CRE) outbreaks at Virginia Mason Medical Center in Seattle, WA and UCLA Ronald Reagan Medical Center in Los Angeles were traced to them.
FDA in February 2015 issued a safety communication regarding the cleaning of certain duodenoscopes, but a Senate report on the issue, released in January 2016, raised concerns about FDA’s post-market surveillance system for tracking devices.
In recent years, FDA noted that there have been significant changes in the "knowledge and technology" involved in reprocessing reusable medical devices. But there’s also been a push toward more complex reusable medical device designs that are more difficult to clean, disinfect and sterilize.
FDA said it believes that the devices included in its list "currently have the greatest risk of infection transmission and inadequate performance if not adequately reprocessed," and the agency may reevaluate or revise the list In the future.
FDA also pointed companies to guidance from 2015 on Reprocessing Medical Devices in Health Care Settings, which contains information on the validation processing methods necessary to be reported in a 510(k) submission. Appendix E of this guidance has been updated to include all device types listed in Thursday’s Federal Register notice, FDA added.