There’s an interesting article in Boston Business Journal about the battle shaping up over ‘reprocessed’ medical device parts. A new bill in the state legislature may require docs to discose whether their medgadgets have previously-used parts. If there’s a problem with the equipment, the docs would be liable:
“People have a right to know they have used-car parts from a third-party manufacturer instead of an original supplier. Why shouldn’t the same be applied to medical instruments?” said Nigel Wilkinson, Smith & Nephew Endoscopy’s vice president for regulatory affairs and quality.
Are greedy doctors and hospital administrators hiding crucial safety info from patients, or are greedy medical device makers insisting durable, reusable products only be used once?
For years, hospitals have legally taken some “single-use” devices after their initial use, then had them sterilized, repackaged and reused for about half the cost of the original equipment…
…Their reprocessing is closely regulated, and the U.S. Food and Drug Administration a few years ago revised its guidelines toward establishing detailed standards and practices. Those changes reinforce the safety of reprocessed devices by making them meet standards “above and beyond” original manufactured devices, said Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors in Washington, D.C.
“It is a decades-old practice with a stellar safety record,” Vukelich said, adding that some medical devices are now labeled as single-use when they used to be labeled for multiple uses, even though nothing has changed about them.
We’re all for disclosing risks to patients, but if a reprocessed device has passed certification, it seems unnecessarily burdensome to warn patients about it. Though, to extend the example above, we think it’d be pretty funny if medical devices had VIN numbers, like cars. You could check and see who had your endoscope down their throat, or where your pacemaker’s been, before it found a home in your chest.
