Arthroscopic Shavers: Ongoing Safety Review
FDA informed healthcare professionals that pieces of tissue have remained within arthroscopic shavers even after the manufacturer’s cleaning instructions were properly followed. Arthoscopic shavers are devices used in orthopedic surgical procedures. Retained tissue can compromise the entire sterilization process. FDA finds this tissue retention to be serious and is actively working with the device’s manufacturers to understand its potential public health impact. FDA encourages facilities to evaluate the adequacy of their cleaning procedures.
If tissue is found after cleaning, the FDA requests reports be made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.
The FDA can be contacted via:
- Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch,
5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
For more information please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm