Last week DOTmed reported that the U.S. Department of Commerce (DOC) was poised to submit a concept paper to the World Trade Organization and that IAMERS alerted members that the document likely recommends that used medical equipment be OEM certified for sale worldwide.

This week, the DOC told DOTmed that the paper was not submitted at the recent WTO conference in Geneva and that the document was still in draft form. The DOC's policy is not to comment on the content of "concept papers" when they are in draft form. (Steps toward global standards stem from a larger "Global Harmonization" initiative begun in 1992 to regulate medical devices (http://www.ghtf.org/).

IAMERS voiced its opposition to OEM certification in an October 11 letter to the Secretary of Commerce stressing the professional effort by our industry to ensure ethical business practices among independent firms that test and inspect equipment.
Sweeping regulation of used medical equipment may require full disclosure of proprietary equipment maintenance information, according to Thomas J. Quinn who has followed regulatory matters affecting the industry for many years. "Once we get the idea of what manufacturers' responsibilities are to certify, then I think we will see everybody back away from this in a big hurry," he suggested. "If the manufacturer is going to certify somebody [to be a refurbisher], they are going to have to give them the proper ability to do the certification process." Quinn is president of Medical Resources Alliance, Pittsburgh, Pa.

The content and status of the concept paper remain to be seen. Watch DOTmed News for further updates on this story and other important regulatory issues.

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