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A bill in Massachusetts could make it the first state to require caregivers to get patient consent before using a reprocessed SUD that would pierce the skin or enter the body or bloodstream. Hearings on the bill were held in November.

As expected, MassMEDIC, the trade association for Massachusetts's device industry, spoke in favor of the bill (SB 1321). The Association of Medical Device Reprocessors (AMDR; Washington, DC) spoke against it.

MassMEDIC argued that the Medical Device User Fee and Modernization Act does not go far enough to ensure patient safety. Specifically, said Tom Sommer, MassMEDIC's president, the act does not require validation data for all classes of critical SUDs. It does not mandate that hospitals create a tracking program for reprocessed SUDs or disclose their use to patients.

Also, he said, SUDs are not designed to withstand repeated cleaning and sterilization. And many, by virtue of their design, are difficult to clean. In some cases, reprocessing can destroy structural integrity. However, patients and clinicians are often not aware of these risks, he said.

Sommer added that the state should also require hospitals to develop tracking systems for SUDs. They should also force reprocessors to assume sole and complete liability for an SUD's safety and effectiveness, he said.

Pamela J. Furman, AMDR's executive director, said the bill is not about patient safety. Rather, she said, it is about the device industry's attempt to get rid of economic competition from the reprocessing industry.

She argued that many of the nation's top hospitals decided to use reprocessed SUDs after studying the issue. She noted that the American Hospital Association is not aware of any evidence deeming them unsafe. She also said that industry has not given legislators examples of patient harm resulting from reprocessed SUDs. Instead, industry has given them pictures whose authenticity has not been verified.

Furman said that because reprocessing is safe, cost-effective, and environmentally sound, the bill should be defeated.

No decision on the bill's fate had been made at press time, and none was expected until later this year.

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