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2004 March Report of the Auditor General of Canada
Exhibit 2.11—Canada does not have a position on the reuse of single-use devices
The U.S. regulations for reprocessing of medical devices are quite recent, and to date, only a few devices have been granted pre-market approval. Critical-contact single-use devices (see margin definition on page 26) are among those that have not yet been approved. Canadian hospitals are interested in having devices, including critical-contact devices, reprocessed by American reprocessors. However, before the U.S. will allow shipment of any "unapproved" reprocessed devices out of the U.S. and back to Canadian hospitals, it needs a letter from Health Canada stating that the device "...complies with the laws of that country" (as required by the U.S. Food and Drug Administration Export Reform and Enhancement Act of 1996).
As a result, Health Canada has prepared a "Letter of No Objection" for reprocessors that may want to import reprocessed devices into Canada. To date this letter has not been used. The letter states that Health Canada is aware that the reprocessor has reprocessed devices belonging to the Canadian health care facility. It further states that Health Canada is aware that these devices have not been approved by the U.S. Food and Drug Administration for reprocessing. And finally, the letter notes that the shipment of the reprocessed devices does not contravene Canadian law. In essence, the letter is not stating that Health Canada agrees with the practice but rather that the practice is not breaking Canadian law. Thus, devices that have not yet been approved for reprocessing by the U.S. Food and Drug Administration could be reprocessed and imported to Canadian hospitals.
Source: Health Canada, the U.S. Food and Drug Administration, and other sources