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FDA tightens rules for reused devices

Reuters Health
August 20, 2000


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Washington. The Food and Drug Administration announced Aug. 2 tighter controls over the common practice of reusing disposable medical devices because of concerns for patient safety.

The new policy comes in response to criticism from Congress and others that the growing reprocessing industry may be putting patients’ health at risk.

Hospitals use recycled devices, usually without telling patients, to cut costs and reduce medical waste. Critics worry that reusing such devices could spread infectious bacteria or cause delicate devices to fail.

Companies and hospitals that recycle devices considered to pose the highest risk for harming patients will need FDA approval before they can clean, repackage and reuse or resell the products.

"There are more complex devices now being reprocessed and ... there has been some growth in the third-party reprocessing industry," FDA spokeswoman Sharon Snider said.

The new rules take effect in six months for high-risk devices, in one year for moderate-risk devices and in 18 months for the lowest-risk devices.

An industry group said third-party reprocessors would comply with FDA rules even though companies felt the tighter scrutiny was unnecessary.

"We don’t believe there’s a public safety rationale to impose this new level of regulation, [but] we feel very prepared to comply," said Pamela Furman, executive director of the Association of Medical Device Reprocessors.