The pieces of tissue are often not evident to the naked eye, and are of concern to the FDA because they can compromise the entire sterilization process. The FDA said in the release that it is working with manufactures to determine the public health impact. Manufactures have notified their customers and reiterated the importance of following proper cleaning and sterilization procedures.
The FDA suggests the following steps to minimize any potential risks to patients:
- “Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer’s instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.”
- “Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3 mm video scope to inspect the channels of the shaver handpiece.”
Hospitals and practices that find pieces of tissue in their shavers after following the manufacturer-recommended cleaning instructions can file a voluntary report with MedWatch, contact MedWatch at 1-800-FDA-1088 or print out the online form and mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or fax it to 1-800-FDA-0178.
Read the FDA’s release about the ongoing safety review of arthroscopic shavers.
