FDA Studying Cleaning Procedures for Arthroscopic Shavers (Sept. 2009)

FDA is investigating a situation in which pieces of tissue were found within certain arthroscopic shavers even after they were reportedly cleaned according to the manufacturer's instructions. Arthroscopic shavers are devices used in certain orthopedic surgical procedures. If these devices retain tissue after they are cleaned, the entire sterilization process could be compromised.

Multiple manufacturers of these devices have notified their customers about this situation and reiterated the importance of following proper cleaning procedures. FDA is continuing to work with the manufacturers to evaluate this situation and determine its potential public health impact. FDA will provide an update when more information is available.

In the meantime, facilities that use arthroscopic shavers should evaluate the adequacy of their cleaning procedures, and should ensure that the personnel who clean and sterilize these devices follow all the steps in the manufacturer's cleaning instructions prior to sterilization. They should also consider inspecting the inside of the devices after cleaning to ensure that they have been cleared of any tissue or fluids.

FDA is asking facilities that find tissue in these devices after they have been cleaned according to the manufacturer's instructions to file a report through FDA's MedWatch program.

Category:

Science & Technology

Tags:

• Cleaning Procedures
• Arthroscopic Shavers
• FDA
• Orthopedic Surgery
• Patient Safety