Implications for competition, cost and rural hospitals must be considered
All of this has cost and competition implications for hospital servicing, if adopted. Under the 21st Century Cures Act, it would seem possible that MITA could well propose the standard for FDA adoption, and the FDA would have 60 days to determine whether to accept or decline the standard.

Could it be that there is a strategy to pass the “Medical Device Servicing Safety and Accountability Act” and then submit the MITA Servicing Standard for FDA adoption? None of this seems consonant with the standards requirement that a standard should not be implemented, where possible, to adversely affect trade or commerce.
If there continue to be reports by independent servicers of withholding of AIAT, manuals and service key information, how will these vital stakeholders meet the MITA standard? What happens to the hospitals that welcome choices and competition in the marketplace? What are the possible implications for job loss and for the future of rural and regional hospitals, which so depend on having choices, with the presence of independent servicers in the marketplace? Is any of this going to be examined in the rush for consideration of the Servicing Legislation and Standard Implementation?

IAMERS hopes that MITA might make good on its professed desire to work together (recently expressed again) and also on assessing the potential rising hospital costs and loss of competition if MITA succeeds.

In the meanwhile, IAMERS encourages servicers and indeed all stakeholders to oppose the rush to approve servicing legislation. We hope we are misplaced in our concern that some seek — in this time of rising health care costs — to regulate independent competitors potentially out of existence.

ABOUT THE AUTHOR: Robert J. Kerwin has served as general counsel to the International Association of Medical Equipment Remarketers and Servicers, Inc. for over twenty years.

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