Lawmakers tackle product liability

The other side came from Pamela J. Furman, executive director of the Association of Medical Device Reprocessors and an attorney specializing in FDA medical device law. She noted the single-use designation is one "chosen by manufacturers, sometimes to sell more, not for patient safety," and not an FDA requirement.

There are clearly many items labeled single use that can be cleaned up and used again, she said, the "reason reprocessing has been standard practice for over two decades." She says doing so saves money and needless waste.

Furman distributed copies of a 2000 General Accounting Office investigation of reprocessing that noted a "lack of meaning of the single-use label."

She also presented material showing the FDA itself has cited "a lack of evidence of adverse effects" from medical-device reprocessing.

Reprocessors should be liable if something in the reprocessing leads to a product failure that harms a patient, she said. But just removing all liability from a product if it's reused doesn't serve the patient well, since some problems can stem from design flaws.

She cited the example of an electrophysiologic catheter. Occasionally, she said, the tip breaks off, but there's no evidence it breaks off more because of reprocessing.

If a problem is the "result of manufacturing, it should be theirs, if reprocessing, ours."

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E-mail: lois@desnews.com