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FDA Has Always Required
Hospitals To Report and Identify Adverse Events Attributable to Reprocessed
Devices
FDA has always required that
hospitals notify the agency when a reprocessed device was involved in adverse
events associated with death or serious injury.
FDA Regulation of Reprocessing
Prior to 2000 Was Similar to FDA Regulation of Original Equipment
The Post is wrong to say that
reprocessing "had little federal oversight" prior to 2000. Except for premarket
submissions, FDA has always required reprocessors to meet the same regulatory
requirements as the original equipment manufacturers, including registration and
medical device listing for the single-use devices that were to be reprocessed;
adverse event reporting; reports to FDA of voluntary corrections and removals;
compliance with Quality System Regulation; and labeling controls.
Original Equipment
Manufacturers Reverse Engineer Devices, Too
When an original equipment
manufacturer wishes to introduce to the market an original device, the
regulatory process requires, at a minimum, that the device be substantially
equivalent to another device that is already legally marketed.
FDA requires that reprocessed
devices be as safe and effective as legally marketed devices. Third-party
reprocessors hire the same types of engineers to determine how to make their
devices equivalent to the original equipment. If these biomedical, mechanical,
electrical, and chemical engineers and microbiologists determine that, after
reprocessing, a device may not be clean, sterile, and functional, AMDR's members
do not reprocess it. In fact, a very small percentage of the various types of
"single use" devices on the market are actually reprocessed.
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.
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