In spite of its widespread use and growing application in a variety of markets, the reprocessing of medical products designated as single-use devices (SUDs) continues to be a controversial subject. The objectivity of reports regarding the safety, efficacy, and cost savings of the practice is frequently compromised by the agenda of the organization behind the particular study. In general, medical device manufacturers have tended to resist third-party SUD reprocessing since it is seen as having an adverse impact on their sales. Hospitals tend to be supporters, since purchasing such devices lowers their operational costs.

Tucker: Legislating reprocessed devices.

And now a new wrinkle may be emerging. Massachusetts State Senator Susan Tucker (D–Andover) has introduced a bill that would require doctors, hospitals, and other healthcare providers to notify patients if any reprocessed devices will be used in the course of their treatment. Countering, hospitals and reprocessors say that such a requirement would drive up medical costs.

“I look at it as a consumer rights bill—it's a patient-protection bill,” says Tucker.

MassMedic's Sommer: Safety concerns.

The bill has the support of the Massachusetts Medical Device Industry Council (MassMedic; Boston) a 300-member industry trade group. MassMedic president Thomas Sommer says that the organization's members are “concerned about the safety and integrity of reprocessed SUDs, which are not designed for multiple use.”

Paul Wingle of the Massachusetts Hospital Association (Boston) takes an opposing view. “Medical device manufacturers are trying to use legislation to fend off competitive pressures from reprocessors, despite evidence that reprocessed devices are safe—and save precious health dollars,” he says.