Kathy F. Mahdoubi
This report originally appeared in the March 2010 issue of DOTmed Business News
A movement is gathering speed in Europe toward the wholesale regulation of used and refurbished medical equipment. COCIR, the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry, is now going on its third edition of a green paper titled "Good Refurbishment Practice For Medical Equipment." The document represents an official push for universal standards, additional reporting, post-market surveillance and greater control over the lifecycle of equipment, which, if implemented, could have a dramatic impact on the financial livelihood of independent sales and service companies.
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DOTmed has spoken with members of both the European and Japanese radiological communities and the consensus is that the used market is still relatively a fledgling segment of the industry in Europe, but one that may be growing of necessity. Economic pressures could increase competition and provide an opportunity for independent brokers, dealers, and refurbishing and service organizations to overtake some market share.
In the 2007 first edition of the COCIR green paper, COCIR president Heinrich Von Wulfen wrote in his foreword that, "in recent years, some regional health care markets have been flooded with used medical equipment of questionable and inconsistent quality," and this was the principle reason for advocating more rigorous regulation. The statement aroused dismay and a number of people have expressed that they felt the language showed the industry in a bad light, as if it were filled with predatory short-term profit traders.
IAMERS, the International Association of Medical Equipment Remarketers and Services, first acted by writing to the U.S. Food and Drug Administration to verify whether any such regional dumping of sub-standard equipment had occurred. The FDA responded stating that a diligent search was conducted of official records for fiscal years 2007 and 2008, which revealed no pattern of adverse event reports or incidents indicating that refurbished and remarketed devices had been associated with or had contributed to a death, serious injury, or malfunction. Accordingly, IAMERS requested that COCIR remove the troubling language from its report and COCIR granted their request. "We felt that it was not the best way to portray the industry," remarked IAMERS President Diana Upton.