Arthroscopic Shavers Subject of FDA Safety AlertJul 8, 2009 | Parker Waichman LLP
Arthroscopic shavers, devices that are used in some orthopedic surgical procedures, are being subjected to a Food & Drug Administration (FDA) safety review. According to the agency, there have been reports of instances in which pieces of tissue have remained within certain arthroscopic shavers, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions.
According to an agency statement, reports have suggested that the tissue retained in arthroscopic devices was not evident to the naked eye. The FDA said it is concerned about this because retained tissue in these devices can compromise the entire sterilization process.
The agency is actively working with the manufacturers of arthroscopic shavers to gather more data about this situation and to understand its potential public health impact. The FDA said that as it obtains more information that better defines the situation and determines whether there are specific risks, it will provide that information to facilities, health care providers and the public.
According to the FDA, multiple manufacturers of arthroscopic shavers recently informed their customers of this situation and reiterated the importance of proper cleaning procedures. The FDA is encouraging facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures. Hospitals should consider taking the following steps to minimize any potential risk 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 3mm video scope to inspect the channels of the shaver handpiece.
Finally, the agency is asking health care professionals to file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program if retained tissue is discovered in an arthroscopic shaver.