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Reuse of single use medical devices in Canada: Clinical and economic outcomes, legal and ethical issues, and current hospital practice

Published online by Cambridge University Press:  01 October 2008

David Hailey ,
Philip D. Jacobs ,
Nola M. Ries  and
Julie Polisena
David Hailey
Affiliation:
University of Calgary and Institute of Health Economics
Philip D. Jacobs
Affiliation:
University of Alberta and Institute of Health Economics
Nola M. Ries
Affiliation:
University of Alberta
Julie Polisena
Affiliation:
Canadian Agency for Drugs and Technologies in Health
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Abstract

Objectives: The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada.

Methods: A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals.

Results: Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism.

Conclusions: There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.

Keywords

Medical devicesEquipment reuseSafetyCost-effectivenessEthicsProfessional
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 24 , Issue 4 , October 2008 , pp. 430 - 436
Copyright
Copyright © Cambridge University Press 2008

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