The widespread reuse of single-use medical devices (SUDs) within Canadian hospitals is unsafe and needs to be regulated, delegates attending a February conference were told. The conference, sponsored by the Ontario Hospital Association, was held 2 months after the $27.5-million settlement of a case involving a Toronto neurologist whose patients developed hepatitis B after undergoing electroencephalography. The tests were conducted by a clinician infected with the virus, and some electrodes used in the tests were reused.
The reuse of SUDs — these include surgical drills, biopsy forceps, catheters and laparoscopy scissors — is common in many hospitals, yet the cleaning and sterilizing protocols differ greatly. “This issue needs to be brought out into the open and discussed rationally — we need some national directive on this,” Dr. Michelle Alfa, associate professor of microbiology at Wayne State University in Detroit, told the conference. “It's going on and there's nothing to regulate it. A lot of people don't realize the extent and types of reuse.”
Alfa, an expert on the safe reprocessing of these devices, says it is impossible to sterilize many types of SUDs adequately. For instance, balloon cardiac catheters cannot be sterilized in an autoclave because of heat sensitivity, and may be left with residual cellular material after undergoing gamma irradiation.
But any hope of quick action from the federal government may be wishful thinking. Dr. Philip Neufeld, manager of Health Canada's Medical Devices Bureau, pointed out that Canadian hospitals have been reusing instruments for more than 3 decades. Several drafts of legislation and information letters proposing standards for the proper cleaning of these devices have been written, but there is no federal legislation enforcing the rules.
The US Food and Drug Administration began phasing in new rules last year in order to control hospital reuse (www.fda.gov/cdrh/reuse) and third-party reprocessors. Although Neufeld urged health professionals to use caution, he stopped short of promising immediate action. He said Health Canada is “examining its authority to regulate reuse, and exploring its options. We're thinking about it.”
A 2001 Health Canada survey of 741 hospitals revealed that 38% of institutions with more than 250 beds had a committee on reuse, while only 3% of hospitals with fewer than 250 beds had one. Manitoba banned the reuse of all critical care devices after Alfa's 1999 report on reuse in Manitoba was leaked (Fallding F. Surgical reusables' sterilization faulted. Winnipeg Free Press 1999 Dec 5;Sect A:4) That decision has cost the province an estimated $5.5 million.
The combination of alarm over proper reuse and the lack of federal directives left some at the Toronto conference feeling anxious. Susan Hadfield of Winnipeg's Health Sciences Centre admits to being caught between budget worries and concerns about patient safety. “I wish Ottawa would just say no to reuse. But the way the federal budget is going, we'll just have to deal with it in our own way.” — Brad Mackay, Toronto