FDA Warns of Retained Tissue in Arthroscopic Shavers

Orthopedics

By: OSD Staff

Published: 7/7/2009

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Agency urges facilities to evaluate cleaning processes and report problems.


Certain arthroscopic shavers used in orthopedic surgery have been found to retain pieces of tissue even after being cleaned according to the manufacturers??? instructions, reports the Food and Drug Administration. The discovery has raised concerns that the retained tissue in the shavers could compromise the sterilization process and pose a risk to public health.

As it conducts a safety review of the shavers with the products??? manufacturers, the FDA is urging surgical facilities that use these devices take the following steps:

  • "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."

    If you discover tissue retained in your arthroscopic shavers after cleaning them according to manufacturer guidelines, the FDA asks that you file a voluntary report with its MedWatch reporting system either by calling (800) FDA-1088 or filling out a form and sending it to the agency by mail or fax.

    —Irene Tsikitas

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