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Medical Device
Reprocessing
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We reproduce abstracts of a
recent debate regarding use of reconditioned medical devices highlighted by
"Washignton Post " under the heading , "Hospitals Save Money, But Safety Is
Questioned " .
The Association of Medical Device Reprocessors counters it by giving various
facts listed below and concludes by saying that …….
"We are deeply disappointed that the investigation failed to compare the
safety profile of reprocessed devices to that of the original equipment
manufacturers. The Post missed its opportunity to provide a valuable public
service, which we believe would have found that reprocessed devices are
every bit as safe, if not safer than original devices.
Reprocessing saves valuable health care dollars, which hospitals can use to
provide better access to care, more staff, and better technology.
Reprocessing eliminates over 900 tons of medical waste per year. The
nation's third-party reprocessors are committed to providing safe products
at a fraction of the cost." |
The Washington Post - Abstracts (
DEC. 11, 2005 )
Unlike consumer products, medical
devices are often used internally and require a much higher degree of
reliability. There are a number of issues that make the practice potentially
problematic even though hospitals vouch for their safety and dependability.
Some possible areas where
difficulties may arise are as follow:
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Hospitals are not required to
inform patients that a recondition medical device will be used in a procedure or
surgery.
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The reconditioned devices are not
guaranteed by the original manufacturer.
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Manufacturers warn against
reusing of one-time medical devices and will not vouch for their safety after
being reconditioned.
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While hospitals maintain
sterilization of reconditioned devices is thorough and even meticulous, the fact
that they have been used before makes it impossible to guarantee the same degree
of safety as an unused, sterilized, and sealed devices.
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There are numerous reported cases
of reconditioned medical devices breaking or malfunctioning during reuse with
anywhere from minor to catastrophic consequences.
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One-time -use products are
approved under a different standard than multiple-use devices. The one-time-use
devices are often opted for by manufacturers because they do not have to be as
sturdy and the manufacturer's exposure to liability will be greatly diminished.
One-time-use devices also ensure "a steady stream of replacement orders.
Hospitals see reconditioned
medical devices as a significant cost-cutting measure since they regard the
one-time-only "designation as a manufacturer's ploy to force them to buy more
devices then they need." Thus, it is becoming more common for hospitals to
ignore warnings against reuse.
Statement From the Association of
Medical Device Reprocessors
( Abstracted from a report on www.complianceonline.com )
Editor's Note: The following is
an updated version of a statement that previously ran on washingtonpost.com
Sunday, Dec. 11 and Monday, Dec. 12.
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