Issues Concerning Reprocessed Medical Equipment

A new U.S. federal law requiring medical device reprocessors to put their company name on the reprocessed devices as well as on the packaging could help determine who is to blame when problems occur.

The reprocessing of medical devices labeled for single use emerged over two decades ago, when original equipment manufacturers (OEMs) began to change the labels on certain devices from reusable to single use, without making significant structural changes in the devices. Hospitals began reprocessing devices up to six times, cutting costs by about half, and claiming that the single use label was often motivated by economic objectives, rather than patient-safety concerns.

While the majority of reprocessing has historically been conducted at in-hospital reprocessing centers, during the last decade a third-party reprocessing industry has emerged, at the request of hospitals that were seeking a way to outsource their reprocessing needs. Third-party reprocessing is a small but expanding industry, with two companies controlling 95% of the market.

However, while the Association of Medical Device Reprocessors (AMDR, Washington D.C., USA) states that reprocessors must meet stringent FDA standards after first proving they can safely clean and sterilize each type of device, the manufacturers' main trade group, the Advanced Medical Technology Association (Washington, D.C., USA), noted that about half of the reprocessors' applications for the reprocessing of individual devices were rejected by the U.S. Food and Drug Administration (FDA), a sign of the difficulty of properly cleaning complex devices.

"There's far more risk of medication errors in a hospital than of a problem arising with a reprocessed device, said Mr. Ken Hanover, CEO of the seven-hospital Health Alliance of Greater Cincinnati (OH, USA), who claims the hospitals have used reprocessed devices for about eight years without a problem. He added that his hospitals probably would honor patient requests to have only new devices used on them.

Since early 2004, when reports of problems with medical devices were first required to note if devices had been reprocessed, the FDA has received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm, although some may be duplicate reports.



Related Links:
Association of Medical Device Reprocessors
Advanced Medical Technology Association