Further Information on the Safety of Linvatec Surgical Handpieces Manufactured by ConMed Linvatec, Largo, Florida- Notice to Hospitals

Date: 2005-12-28

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NOTICE TO HOSPITALS
Health Canada Issued further Information on the Safety of
Linvatec Surgical Handpieces Manufactured by ConMed Linvatec, Largo, Florida

December 28, 2005

To: Hospital Chief of Medical Staff

Please distribute to staff of Operating Rooms, Surgery, Central Processing and Biomedical Engineering Departments and other involved professional staff and post this NOTICE in your institution.

Subject: Cleaning and Sterilization of Linvatec PowerPro Surgical Handpieces

On September 19, 2005, Health Canada advised hospitals of concerns that Linvatec PowerPro battery-powered surgical handpieces may be permeable to body fluids during surgery, and that these fluids cannot be easily removed during cleaning. Models affected included the PRO5200 and the PRO5300. These handpieces are designed to be autoclaved after use, but are not intended to be opened for cleaning.

Health Canada has now received problem reports from six Canadian health facilities. Three of these reports were for a liquid material leaking from the handles after cleaning. Three hospitals have opened the devices and reported finding foreign material inside resembling fresh and dried blood. There have been no reports of patient infection or of viable microorganisms found inside the device after autoclaving.

Health Canada asked the manufacturer, ConMed Linvatec, to provide evidence that the handpieces will be clean and sterile when reprocessed according to the manufacturer's instructions. Also, the Ontario Hospital Association obtained the services of an independent microbiology laboratory to conduct sterility testing of used handpieces submitted by hospitals. Health Canada has now reviewed the manufacturer's evidence and the results of the OHA-sponsored study. The results of this evaluation are as follows:

The PowerPro handpieces are permeable to fluid ingress under the side panels of the handle, and residual debris under the side panels may not be easily removed during cleaning. However, both the manufacturer's evidence and the independent studies have demonstrated that the recommended sterilization procedures will render any residual debris on the device, even under the side panels, sterile. No cases of viable micro-organisms were found in any of the units tested after autoclaving. Therefore, Health Canada concludes that the risk of patient infection from residual debris on Linvatec handpieces to be negligible, and that hospitals may continue to use these devices provided they reprocess them according to the manufacturer's instructions.

Nevertheless, the issue of residual debris, common to a large number of reusable surgical instruments, continues to be a risk management concern to health care facilities. Health Canada will consult with its Scientific Advisory Panel on Reprocessing Medical Devices (SAP-RMD) and device manufacturers to address this concern. Information on the SAP-RMD is posted at http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/saprmd-gcsrmm-eng.php.

Health Canada depends on health care professionals to report adverse incidents involving medical devices to Health Canada at the following address: