Hospitals reusing single-use devices without validated cleaning:

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TORONTO - A significant number of Canadian hospitals are still reusing single-use medical devices and the vast majority of those that do sterilize or "reprocess" the devices in-house - a practice fraught with risk, infection control experts say.

But while there appears to be consensus that a national policy is needed and that the practice of in-house reprocessing ought to be banned, a regulatory void means that in many parts of the country hospitals can do as they wish when it comes to reuse of single-use medical devices.

Among the devices being reused are biopsy forceps used in stomach and bowel surgery, membrane scrapers used in eye surgery, breast pump kits and blades, burrs and drill bits used to bore through bone.

"I'm absolutely appalled," says Dr. Mark Miller, head of infection prevention and control with Montreal's Jewish General Hospital, and the author of a 2001 report on reuse of single-use devices that for a time put the issue on the political front burner.

Miller was commenting on the findings of the latest survey into single-use device reuse by Canadian hospitals, the results of which are published in the May issue of the journal Infection Control and Hospital Epidemiology.

Of 398 hospitals that responded, 28 per cent admitted to reusing single-use devices. While some of the reprocessing is farmed out to U.S. companies certified by the U.S. Food and Drug Administration, 85 per cent of the hospitals that admitted to reprocessing said they did the work in-house.

The senior author of the study, Dr. Michael Gardam, says the numbers are probably even higher. "I doubt that we're underestimating the problem."

Forty per cent of the hospitals that reprocess single-use devices reported that they had no written policy on the practice. "They just do it," Miller says, sounding incredulous.

In fact, the percentage of hospitals that currently reuse single-use medical devices is only slightly lower than the 31 per cent that reported reuse of single-use devices in a survey taken in 1986.

In the 20-plus years since that earlier survey, tragedies like the tainted blood scandal and cases of variant Creutzfeldt-Jacob disease - the human form of mad cow disease - linked to reuse of tools used in brain surgery have deepened the understanding of infection risks and raised the bar for infection control in hospitals.

And in recent years, a number of hospitals have had to ask former patients to be tested for HIV and hepatitis after discovering they had not been properly cleaning devices they reused. In 2004, nearly 1,500 Quebecer who had undergone hip surgery had to be tested after it was learned hospitals weren't completely cleaning a reamer, a type of surgical drill part.

Most in the field believe some single-use devices can be reused safely, if they are put through a thorough reprocessing procedure. They say medical device manufacturers almost routinely designate devices "single-use," for economic not safety reasons.

"If they can make it disposable, they can sell a hell of a lot more devices and it's actually a lot easier to bring it to market," explains Gardam, head of infection control for Toronto's University Health Network.

"Because if you want to make it reusable, you have to ... prove you can reprocess them. So obviously the manufacturer would far rather churn out single-use devices, because they only have to prove that it's sterile in the package when you get it."

The multitude of single-use devices drives up health-care costs and generates extraordinary amounts of waste.

In the United States, the FDA regulates an industry that has cropped up to reprocess single-use devices. Companies in the business must provide proof that the devices they reprocess can be thoroughly sterilized without compromising the integrity of the material from which the device is made.

A number of Canadian hospitals - Gardam's and Miller's among them - take advantage of that industry, trucking things like $3,000 single-use cardiac catheters to Minnesota to be reprocessed for about $1,000 a trip.

Accredited companies log each device, using bar codes and similar technology to ensure each one goes back to the sending hospital and that devices are only reprocessed the number of times that testing suggests is safe. That means if it's been determined the cardiac catheter can be safely reprocessed 10 times, it will be discarded if it makes an 11th trip to Minnesota.

Health Canada does not regulate this field. And while infection control experts have called for the department to take on this task, it says it does not have the legal authority to do so.

"The Food and Drugs Act, from which the Medical Devices Regulations derive their authority, is not intended to apply to the use of a device after its sale," the department explains in an e-mail from spokesman Paul Duchesne.

"Reprocessing of a device by a hospital for reuse in that hospital does not constitute sale. Therefore, Health Canada does not have the authority to regulate reuse or reprocessing."

Furthermore, it doesn't plan to seek those powers.

"The practice of reprocessing by hospitals of medical devices relates to health-care system management in provincial and territorial jurisdiction and therefore is not within the federal role. Therefore, creating new authorities is not being considered."

Instead, it says it is exploring with provincial and territorial partners the possibility of creating a "pan-Canadian framework."

Currently some jurisdictions have rules, while others are silent on the issue.

Manitoba bans reuse of devices that come in contact with blood or are used inside the body. Since the start of this year, British Columbia has ordered that these so-called critical contact devices can only be reused if they are reprocessed by regulated companies.

In Ontario, guidelines Gardam helped to write for the Ontario Hospital Association say reuse of single-use devices is only permissible if hospitals prove it is safe to reuse them.

The only way to do that, he says, is to use licensed third-party reprocessors. "They take them through far more hoops than a hospital would to reprocess a multi-use device. So they're very, very stringent in terms of what they do."

But Gardam believes a large percentage of hospitals that are reusing single-use devices haven't taken the steps to prove what they are doing is safe. And Miller says hospitals that reprocess in-house simply don't have the wherewithal to do the work the way it needs to be done.

"We don't have the resources, the people and the money to be able to do it properly. And I know that the hospitals that are reprocessing - unless they're different than every other hospital that's been reprocessing across North America - that they're not doing it according to all the norms," he says.

"And therefore if they're not doing it according to all the norms, then they're exposing patients and the workers who are working with these instruments to potential dangers. And that's just the way it is."

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