Yrys
Army.ca Veteran
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I thought it was the best board for it. move, if not ...
Hospitals reusing single-use devices: survey
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."
I sure hope the army isn't doing it when it can be avoid (reusing without proper cleaning) ...
Hospitals reusing single-use devices: survey
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."
I sure hope the army isn't doing it when it can be avoid (reusing without proper cleaning) ...
