Arthroscopic shaver safety review
This article was originally published in The Gray Sheet
Executive Summary
FDA is encouraging surgical facilities to evaluate the adequacy of their cleaning procedures for arthroscopic shavers after becoming aware of instances where pieces of tissue remain within shavers after cleaning in accordance with manufacturer instructions. Retained tissue can compromise the sterilization process for the devices, which are used for tissue resection and bone debridement. The agency advises hospitals to be sure that all personnel responsible for cleaning the products comply with the manufacturer's instructions, carefully inspect the devices following cleaning, and report any problems with retained tissue in arthroscopic shavers through FDA's MedWatch safety and adverse event reporting system. In the July MedSun newsletter, the agency notes that the hospital that brought the problem to its attention is effectively inspecting its shavers after cleaning by looking at the channels of the shaver hand piece with a 3 mm scope