The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.
Specifically, because of challenges with cleaning these devices for reprocessing and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps.
The FDA has released final guidance addressing reporting and record-keeping requirements for medical device manufacturers in the event of device-related adverse events and malfunctions. “The goal is to detect and correct problems in a timely manner,” the FDA wrote in the final guidance document, which supersedes the draft published in 2013 and the guidance from 1997.
The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.