Special report: Reprocessing in an era of health care reform

by Carol Ko, Staff Writer | January 22, 2014
From the January 2014 issue of HealthCare Business News magazine

Over the last ten years, the practice of reprocessing has faced more scrutiny at both the state and federal levels, but two Government Accountability Office reports showed that it has resulted in very little harm. In particular, a 2008 report concluded that based on then-current data, there was no evidence showing that reprocessed devices were less safe than original devices.

“Much of the controversy started going away after the FDA began regulating the practice,” says Chris Lavanchy, engineering director at not-for-profit medical technology think tank ECRI Institute.

But questions still continue to linger within the medical community. For example, in October 2012, the American College of Obstetricians and Gynecologists released a committee opinion calling for studies that assess the safety, cost-effectiveness and quality of reprocessed devices used in gynecologic procedures.

“Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices,” the statement said. The release also raised the question of whether patients should be informed that reprocessed devices will be used on them during surgery.

In many ways the debate is similar to the high-publicized controversy surrounding the ethics of labelling genetically modified foods: GMO lobbyists argue that the label might lead consumers to reject genetically modified products that many scientists and regulators argue pose no danger. Similarly, reprocessing proponents argue that patients unfamiliar with reprocessing may reject the idea without understanding its economic and environmental benefits.

What complicates matters is the ongoing lack of data around reprocessed devices: since hospitals still don’t track whether a reprocessed device was used in a procedure, it is difficult to ascertain whether those devices lead to more complications or other adverse events in patients.

The left hand doesn’t know…
An inherent conflict of interest may contribute to the suspicion among clinicians about the safety and efficacy of reprocessing: Johnson & Johnson and Stryker were vocal, long-time critics of reprocessing before later purchasing and acquiring third-party reprocessing companies.

Stryker paid a hefty $525 million in 2010 to acquire Phoenix-based Ascent Healthcare Solutions and renamed it Stryker Sustainability Solutions, and in 2011, Ethicon Endo-Surgery (a subsidiary of Johnson & Johnson) acquired SterilMed, the second largest reprocessing company in the U.S.

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