Survey of Disposable-Device Reuse in Canadian Hospitals Provokes Mixed Response

Originally Published MDDI December 2001

Survey results indicating that up to half of Canadian healthcare institutions engage in reuse of single-use devices have sparked responses in both Canada and the United States. Health Canada, the federal department responsible for medical device regulation, sent the survey of reuse to 741 Canadian acute-care health institutions containing more than 80 beds.

The questionnaire presented a list of disposable medical devices and asked respondents to indicate which ones their respective institutions reused. Other survey questions asked respondents about existing device reuse procedures, committees, and guidelines. Among the disposable devices identified on the survey were electromyography needles, cardiac electrophysiology catheters, gastrointestinal snares, and hot gastrointestinal biopsy forceps.

Of the 422 infection-control professionals and CEOs who returned the questionnaires, only 43 (10%) indicated they had a specific reuse committee in place in their facilities. According to the survey summary, "many" disposable devices are reused more than 20 times in Canadian healthcare institutions before being discarded, and "there are no written reuse protocols [in place] for the majority of the cited single-use devices."

Medical Devices Canada (MEDEC), Canada's trade association for the medical device industry, is citing these findings to support its condemnation of reuse. In a press release dated August 24, 2001, MEDEC expressed support for Health Canada's investigation into the reuse of disposable devices; the release restates MEDEC's position that reuse "could pose serious risks to the safety of patients."

Among those taking the opposite view are Dan Vukelich, deputy executive director of the Association for Medical Device Reprocessors (AMDR) in the United States, and Pamela Furman, AMDR's executive director. In response to Health Canada's survey results, Furman and Vukelich argue that the reprocessing and reuse of disposable devices is generally safe, so long as those doing the reprocessing are "adamant" about selecting devices for reuse. "There are test methods used by reprocessors that allow them to determine if a device originally marked for single use is amenable [to reprocessing]," Vukelich says. Speaking for the third-party reprocessors represented by AMDR, he says that of all the devices marked for single use, only a very small percentage of those tested meet criteria for reprocessing. "We think validation is critical," he adds.

Kevin Murray, MEDEC's vice president of regulatory affairs, responded to AMDR's comments in an e-mail to MD&DI: "If AMDR has evidence of safe reprocessing of single-use devices, we would be interested to see it," he said. "And if some devices are not suitable for reuse, then it follows that very rigid criteria must be established to justify reprocessing the remaining types of devices. This 'criteria' should be no less than what industry would be required to provide to government regulators."

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