Reusing Single-Use Medical Devices

Recommendations from a CADTH health technology assessment (HTA) report on the reprocessing of single-use medical devices are being incorporated into pan-Canadian practices.

For at least two decades, patient safety concerns have surfaced about the reprocessing and reuse of single-use (medical) devices (SUDs). While those concerns have led some countries to regulate hospital and third-party activities on reprocessing or ban SUD reuse altogether, in some Canadian jurisdictions the practice still occurs with little or no regulation.

With the issue in front of federal and provincial governments, regional health authorities, hospitals, and health care associations, Health Canada proposed that CADTH conduct an HTA to explore the issue of reprocessing SUDs.

In February of this year, CADTH published a two-part report that is helping decision makers at many levels understand current reprocessing practices in Canada and the clinical, economic, ethical, and legal ramifications of reprocessing.

At the federal level, the report was shared with a federal/provincial/territorial working group established to draft a pan-Canadian framework on the reuse of SUDs. The framework, which has been reviewed by the provincial and territorial health ministries and regional health authorities, refers to the CADTH study as a basis for its recommendations.

It should be pointed out that a number of provincial and territorial jurisdictions have already developed their own policies or advisories on SUDs, the most stringent being that of the Northwest Territories which, in 2005, banned the reuse of any device labelled as single use.

For the Ontario Hospital Association (OHA), the survey portion of the CADTH report provided new data on SUD reprocessing practices in acute-care hospitals in Canada, including specific data for Ontario. The OHA had issued a position paper in 2004 recommending that hospitals stop reprocessing SUDs in their facilities within two years. A 2001 survey indicated that 40% of Canadian hospitals reused SUDs, and OHA was keen to know if that number had changed.

Although the survey statistics show that SUD reprocessing is on the decline, 28% of the survey respondents still reuse SUDs; and larger hospitals and academic centres were significantly more likely to do so. Of the 28% that do reprocess, most do so in-house. This practice may not be supported by jurisdictional directives, which mostly state that critical and semi-critical SUDS should not be reused unless reprocessed by a third-party reprocessor licensed by a regulatory authority.

Reprocessing Single-use Medical Devices: National Survey of Canadian Acute-Care Hospitals. CADTH, 2008: http://cadth.ca/index.php/en/hta/reports-publications/search/publication/800