April 01, 2004

By: Alicia Orlowicz
Website: http://www.1st-in-wellness.com

AOMM encourages Health Canada to take leadership role regarding the reuse of single use medical devices

The Association of Ontario Medical Manufacturers has reviewed the recent Health Canada survey concerning the widespread reuse of single use medical devices by hospitals across Canada and the association is concerned that this practice can pose a serious risk to the safety of patients.

Many single use medical devices are used in complex medical procedures and are not designed for reuse in additional patients. Furthermore, many of these devices cannot be redesigned as a reusable device due to limitations in current technology. Logically, reusing such a device can compromise its function and integrity, and it will also expose patients to the risk of biological contamination. Medical device manufacturers must obtain a licence from Health Canada prior to selling a single use device in Canada. The licence application must contain evidence and validated data regarding the safe and effective one time use of the device.

Moreover, medical manufacturing is one of the world’s most regulated industries, with strict government regulatory controls and conformance to international quality systems standards that are audited by independent agencies. Therefore, the AOMM is also very concerned that third parties that reprocess such devices for reuse are currently operating in an unregulated environment with no guarantee that the reprocessed device can meet its original performance specifications.

Advancements in medical technology will lead to new devices for the cost-effective treatment of serious diseases. Many of these new products will be in the form of complex and intricate single use devices. The economic arguments by healthcare providers for the reuse of devices fail to consider the full costs of reprocessing and overlooks the impact that this practice has on the manufacturer’s investment in the research and development of new technologies. Such economic reasons are not in the best interest of patient safety.

To protect public safety, the AOMM will continue to encourage Health Canada to provide leadership in finding solutions that will ensure all single use medical devices are used in accordance with the manufacturers recommendations.

About The Author:

Alicia Orlowicz is a successful author and regular contributor to http://www.1st-in-wellness.com.  Obtaining and keeping good health through healthy living, natural healing, great mental health and healthy finances.