Unprotected lead wires: ban and performance standard proposed by FDA.
This article was originally published in The Gray Sheet
Executive Summary
DEVICES WITH UNPROTECTED PATIENT LEAD WIRES WOULD BE BANNED under an FDA proposed reg slated to be published the week of June 19. The proposal would ban medical devices that do not incorporate features designed to prevent the connection of patient lead wires directly to AC electrical power sources and would establish a mandatory performance standard requiring leads to include the safety features.