If the goal of the MITA standard was truly patient safety, why was there no attempt in either the MITA standard or in the creation of any corollary consensus document to deal with the elephant in the room? Could the reason for this sidestepping possibly have its real genesis in competitive origins to exclude independent diagnostic imaging servicers from undertaking certain servicing contracts? We welcome being disabused of this concern.

A standard potentially unattainable for ISOs
We also hope that the American National Standards Institute (ANSI) and other interested parties take notice that there are substantial issues of dominance, openness and balance contrary to the Essential Requirements of ANSI. See ANSI Essential Requirements: Due Process requirements for American National Standards.



IAMERS elected to be an observer in this process. While ANSI requirements require consensus, it is challenging to build a consensus when open and obvious standards requirements are dismissed in favor of watered-down language. An example of this is "training" on the equipment. Since a comprehensive ‘training’ provision would plainly require access to equipment information and such was unpalatable, putting in a substitute provision that training must be "as determined by the owner of said device" was a half measure.

In this era of reduced regulatory activity, standards, when approved or incorporated into health care procurement programs may well have, for practical purposes, the force of law. One only needs to note ISO quality standards such as ISO 9001 and 13485 to observe they often serve as a framework for many medical device businesses. In the case of the MITA imaging standard for servicers, the proposed standard would require servicers to assume many of the responsibilities currently imposed on manufacturers by the FDA quality management regulation, 21 C.F.R. 820 et. seq. without any defined path toward access to the information necessary to achieve the standard. Indeed, the manner in which MITA sidestepped this area during months of drafts by the insertion of ambiguous terms such as "specified requirements", "established procedures" and adherence to "intended purposes" or "applicable authorities", removes doubt that MITA purposely did not address how independent servicers would achieve the many benchmarks established without manufacturer cooperation.

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