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(Washington, D.C.) December 12,
2005 -- A year-long Washington Post investigation into the widely-used practice
of reprocessing medical devices found no evidence that patients are put at an
increased risk from the practice. The article was irresponsible in avoiding a
basic fact: that no surgery is without risk, and that hundreds of surgical
incident reports are filed every year as a result of unreprocessed or "original"
devices. Any article that discusses failures of reprocessed devices and neglects
to put that information in the context of the failure rate of their alternative
-- original devices-- is deliberately misleading and unfairly disparages an
industry that is doing good for patients, hospitals, and the environment.
A simple review of FDA's adverse
event reporting database will uncover many times more examples of failures or
problems involving original devices than failures or problems involving
reprocessed devices. Over 30 million devices have been reprocessed, and the
practice of reprocessing has been found to be every bit as safe, if not more
safe than original devices.
The Post Does a Disservice to
Patients By Instilling Panic Through Outdated or Irrelevant Examples
The problem with The Post article
is that it seeks to alarm readers by exaggerating the risks associated with
reprocessed devices. The fact is that there are far more problems reported for
original devices than there are for reprocessed devices.
The Nation's Third-Party
Reprocessors Have a Stellar Safety Record
There is no evidence that
third-party, FDA-regulated reprocessing increases the risk faced by patients. In
fact, it may be that reprocessing makes medical procedures safer, because if an
original device fails when it is first used, it is not reprocessed. And because
every reprocessed device is inspected or tested prior to use, the strong
likelihood is that the device will again work properly. The same cannot be said
for original devices, which are subject only to sample-testing.
Single-Use Label, Not Required
by FDA, But Serves to Sell More Original Devices
The Government Accountability
Office report to which the article referred found that the "single-use" label is
often little more than a marketing tool of the original equipment manufacturer,
who has every incentive to use it in order to sell more devices and avoid the
costly validation analysis our members must perform prior to reprocessing.
Patients should understand that it is the manufacturer's choice to put the
single-use label on a product, it is not an FDA requirement.
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