An editorial by Robert J. Kerwin
IAMERS General Counsel

On October 24, 2017 following 8 months of standards committee meetings, the Medical Imaging Technology Association (“MITA”), a division of the National Electrical Manufacturers Association (“NEMA”) opened balloting on whether to approve a new standard on the “Requirements for Servicing of Medical Imaging Equipment” (“MITA Servicing Standard”).

If approved, MITA had announced its intention to seek approval of the MITA Servicing Standard as a national standard under the American National Standards Institute, and perhaps eventually approval as an ISO standard.



All votes of the MITA Canvass Group were to be submitted to MITA by December 8, 2017 along with comments on how to resolve any remaining objections of any members who voted to disapprove. The required percentage of Canvass Group votes necessary to approve the proposed standard (67% of votes made) was not achieved. IAMERS was not a voting member of the Canvass Group but submitted a comment to the effect that IAMERS believes the draft standard fails to address patient safety responsibilities of the manufacturer to cooperate in providing access to service keys, passwords and training. IAMERS also noted that the current MITA draft was largely based on the quality management system regulation of manufacturers, 21 C.F.R. Part 820.

The manufacturer members of the Canvass Group voted to approve the Servicing Standard. The independent servicers, clinical engineers and health care delivery organizations (with one exception) voted against adoption of the draft standard in its current form. The FDA and AAMI abstained from the vote but did offer comments.

The comments submitted by those MITA Canvass Group members who disapproved, well-illustrated the divide between the manufacturers and the health care provider community. One member noted that the current draft limits itself to medical imaging equipment, and that any quality management system developed should cover all medical equipment and not just imaging equipment. The member also noted “an effective QMS for servicing medical devices must emphasize that manufacturers should provide service organizations with access to quality service manuals, service training, diagnostic software and specialty tools.” Another member of the canvass group noted that a QMS standard of this scope “[n]eeds to be developed by an organization not named MITA – just too much distrust that this is an effort to protect a revenue stream and not an actual initiative to improve safety, especially after MITA support and assistance in drafting XR 29, DR Imaging and CR obsolescence, and other initiatives which seem to drive profit to OEMs and the cost of health care up, without a particular measurable gain in safety or outcomes.”

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