An editorial by Robert Kerwin

On January 12, 2018, the Medical Imaging Technology Association (MITA), a division of the National Electrical Manufacturers Association, held a conference call of the canvass group (including independent servicers) and observers.

The purpose of the meeting was to review the results of the first ballot on the proposed MITA American National Standard for Servicing of Medical Imaging Devices. After eight months of standards committee meetings, the MITA canvass group members had failed to approve the standard. All the OEMS had voted to accept the standard. Virtually all the ISOs and the HTM professionals had voted in the negative. The required percentage of canvass group members necessary to approve the proposed standard (67 percent) was not achieved.



Some sought a more comprehensive quality management system that covered all medical equipment, not just imaging equipment. Some thought that the source document should not be the manufacturer regulation, 21 CFR 820, but rather ISO 9001:2015 or ISO 13485:2016.

IAMERS submitted a comment to the effect that it believed the draft failed to address patient safety responsibilities of the manufacturer to cooperate in providing access to service keys, passwords and training. With the current MITA draft largely based on the quality management system regulation of manufacturers, 21 CFR 820, IAMERS was concerned that it would have the practical effect of excluding some servicers from complying, as the sections pertaining to, among other things, training, testing and equipment maintenance could not be met without addressing manufacturer responsibilities for cooperation.

During the January 2018 call, further input was solicited by MITA as to the reasons for the negative vote and where to go from here. ACCE noted that the current draft limits itself to medical imaging equipment. ACCE advised the call participants that in their view any QMS standard should be applied to servicers of all types of medical equipment. ACCE also restated its concern that the current draft was largely based on a QMS regulation tailored for manufacturers.

One canvass member suggested that MITA might not be the best facilitator for a standard as that member felt there was too much distrust, and suspicion that this could be an effort to protect a revenue stream and not really an initiative to improve safety.

Citing the example of NEMA/MITA XR-29 standard, which was incorporated into P.L. 113-93, I expressed concern that there might be an effort to incorporate the servicing standard into upcoming legislation. MITA advised that this was not their current intent but acknowledged that the MITA draft standard had been provided to certain Congressional staff who had expressed an interest in receiving it.

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