- That surgical saw blade, drill, stapler, scissors and
forceps were all sold in packages clearly labeled as single-use devices.
That means the manufacturer designed the device as a throwaway. Use on
one patient, and then discard.
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- So was the surgical gown, elastic bandage, the catheter
used for balloon angioplasty, the mask used for anesthesia, and plenty
of other common medical equipment used in hospitals and doctors' offices.
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- How many times has that "nonreusable" medical
device actually been reused? Is a balloon angioplasty catheter, used to
treat blockages in coronary arteries, just as flexible, safe and effective
the second time around? Or the third?
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- Does your kid care if those metal braces had a previous
home in a mouth or two before they were glued to her teeth? After all,
everything has been carefully sterilized. But will the metal in those used
braces be more likely to break in the middle of a vacation or another inconvenient
time?
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- Patients should be asking those questions because disposable
medical devices are reused all the time. In addition, nobody knows how
well devices made for one use stand up to repeated use.
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- The practice of reprocessing and reusing "single-use
devices" has become common during the last few years. A 2000 congressional
study concluded that at least one-third of American hospitals reuse some
disposable medical devices. Experts believe the trend is growing.
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- Cost-cutting efforts are one factor. A hospital or clinic
can save money by reusing disposable medical devices. Sales of these devices
totaled $56 billion in 1999. Use a disposable umbilical scissors to cut
the cord on one newborn baby, for instance, and pay full price. Use it
on two newborns, and the hospital's costs drop by 50 percent.
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- Advances in plastics and other materials used to make
the 80,000 to 100,000 different kinds and brands of medical devices are
another factor. Single-use devices are made from sturdier materials, and
it seems reasonable that such material can be reprocessed and safely reused.
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- However, few studies have been done to verify that belief.
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- In order to get U.S. Food and Drug Administration (FDA)
approval to sell a single-use device, manufacturers must prove only that
it is safe and effective for one use. Manufacturers need not do studies
proving that the device can be reprocessed and used multiple times just
as safely and effectively as the first.
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- Reprocessing usually means that the device is carefully
cleaned, inspected, refurbished and sterilized before use on the next patient.
Some hospitals reprocess single-use devices themselves. Others send used
devices to companies that reprocess them.
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- Cleaning and sterilizing medical devices made for one-time
use may be more difficult than sterilizing devices manufactured for multiple
use, according to the FDA.
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- FDA studies identified several theoretical problems with
reused medical devices. These include possible increased risk of infection
if devices are not properly sterilized before reuse, possible increased
risk of failure in orthodontic products, possible loss of elasticity and
durability in balloon catheter devices and possible loss of original lubricants.
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- Studies, however, find little evidence of widespread
health problems from recycling single-use devices.
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- Only 245 "adverse events" were linked to reuse
of such devices during the last three years of the 1990s, according to
the FDA. Manufacturers reported seven patient deaths, 72 injuries and 147
device malfunctions.
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- The FDA in August, however, decided on stricter regulation
and monitoring of single-use-device reprocessing by third-party companies
and hospitals. It hinted that more regulation may be on the horizon.
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- Patients may want to talk with their doctors about recycled
medical devices before undergoing procedures and ask, too, whether such
devices could have been a factor if a procedure goes bad.
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