The US Food and Drug Administration (FDA) has become aware of instances in which pieces of tissue have remained within certain arthroscopic shavers, a device used in some orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Reports submitted to FDA suggested that the tissue retained was not evident to the naked eye.
Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures.
FDA is concerned about this because retained tissue in these devices can compromise the entire sterilization process. It is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. As the FDA obtains more information that better defines the situation and determines whether there are specific risks, the agency will provide that information to facilities, health care providers and the public.
The FDA encourages 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 FDA’s attention uses a 3mm video scope to inspect the channels of the shaver handpiece.
FDA asks that surgical facilities that discover retained tissue in arthroscopic shavers after following the manufacturer-recommended cleaning procedures file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program online. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.