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Arthroscopic Shavers: Ongoing Safety Review
Audience: Orthopedic healthcare professionals, hospital risk managers, surgical services supervisors
FDA informed healthcare professionals of instances in which pieces of tissue have remained within arthroscopic shavers, a device used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Since retained tissue in these devices can compromise the entire sterilization process, FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients.
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.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA communication about the ongoing safety review, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
