Janet Moore, staff writer for the Minneapolis-St. Paul Star Tribune takes a look at the medical device reprocessing debate. If you’ve been following our coverage on the issue, there’s nothing really new here. Nonetheless, we’ve got excerpts…
Privately held SterilMed is one of the two biggest companies in a burgeoning $100 million industry that reprocesses medical devices originally labeled for single use – a practice it says is completely safe and strictly regulated by the Food and Drug Administration. Since 2000, more than 40 million medical devices have been reprocessed.
The FDA says reprocessed devices are as safe and effective as new ones – provided they meet the agency’s regulatory requirements.
But the practice infuriates medical device manufacturers, who have labeled and designed their devices for one-time use only. Many of these products, they say, are too intricate to withstand the rigors of reprocessing, and their delicate coils, joints and angles can collect organic matter, such as blood, feces and respiratory secretions. This, the industry contends, threatens patient safety.
The side players in this unfolding drama are hospitals, which are looking for ways to cut costs. Several hospitals in Minnesota, including the Mayo Clinic, use devices reprocessed by companies like SterilMed. Industry figures indicate, on average, reprocessed medical devices cost 50 percent less than new products. Proponents note that reprocessing reduces the amount of medical waste that goes into landfills.
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