"To date, the published economic data do not allow drawing any conclusion on the cost-effectiveness of the reprocessing practice for single-use medical devices when performed with a sufficient level of quality and safety," the report said. "This cost-effectiveness needs to be demonstrated by long-term studies including a large number of patients and clear calculation of the direct and indirect costs."

Because the United States has strict guidelines for reprocessed equipment and devices, the Association of Medical Device Reprocessors calls the European report irrelevant.


"It's comparing apples and oranges," said Dan Vukelich, the president of AMDR, with regard to reprocessing in the United States and in Europe.

Vukelich pointed out that in the United States, total economic benefits from reprocessing have been proven time and time again. In fact, reprocessing saves hospitals nationwide $250 million a year, he said.

Here, reprocessing companies are viewed as the manufacturers and assume all of their responsibilities, Vukelich said.

The report itself said, "In the United States, before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers."

The takeaway message for the U.S. market, said Vukelich, is that hospitals use safe, FDA-regulated devices.

"In Europe, that's not necessarily the case," he said. "Any conclusion on reprocessing in Europe is not relevant here."

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