Hospitals properly cleaning single-use
TORONTO – A study of nearly 400
Canadian hospitals found that 28% are re-using single-use medical
devices, according to a report in the Canadian Press. And the majority
of the hospitals that re-use instruments in this way sterilize or
“reprocess” the devices in-house – which is thought to be extremely
risky, according to infection control experts.
There appears to be agreement that a national policy is needed to ban
the practice of in-house reprocessing. However, the current regulatory
void means that in many parts of the country, hospitals can do as they
wish when it comes to the 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.
Dr. 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
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 percent
of the hospitals that admitted to reprocessing said they did the work
The senior author of the study, Dr. Michael Gardam, says the numbers are
probably even higher. “I doubt that we’re under-estimating the problem.”
Forty percent of the hospitals that reprocess single-use devices
reported that they had no written policy on the practice. “They just do
it,” Miller says.
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 22 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
Dr. Gardam, head of infection control for Toronto’s University Health
“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
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
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
“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
re-processors. “They take them through far more hoops than a hospital
would to re-process a multi-use device. So they’re very, very stringent
in terms of what they do.” But Dr. 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.”