Divisive Medical Imaging Service Standard to Undergo Revision

Posted December 27, 2017

A Medical Imaging & Technology Alliance (MITA) Canvass Group failed to reach consensus earlier this month on a draft American national standard for the servicing of medical imaging equipment. The first ballot did not cross the 67% threshold needed for approval under American National Standards Institute procedures.

The final 14-to-13 vote was clearly divided between stakeholder groups, with original equipment manufacturers (OEMs) voting overwhelmingly for passage and healthcare technology management (HTM) professionals and independent service organizations voting against. The Food and Drug Administration and AAMI abstained.

The proposed standard outlines the minimum quality management system (QMS) requirements for any entity that services medical imaging equipment, such as computed tomography and magnetic resonance imaging equipment, as well as the software, hardware, and systems that make up imaging devices. In addition, the standard summarizes necessary purchasing controls, training, acceptance activities, and inspections, as well as requirements for service reports, managing customer feedback, corrective and preventive action, and cybersecurity considerations.

There were three main areas of disagreement among those who voted to “disapprove” the standard:

  1. The current draft only deals with the service of medical imaging equipment. “We believe any QMS standard should apply to servicers of any type [of] medical equipment,” according to one commenter. “A service organization should only have to follow one quality standard,” wrote another.
  2. The standard is largely based on a QMS regulation for manufacturers―21 CFR 820. “We believe a QMS standard for medical equipment should be derived from a broader and more current standard (e.g. ISO 9001:2015) and should be refined and adapted to servicers,” according to a voting HTM member.
  3. The proposed standard does not require OEMs to provide service providers with “reasonable access” to quality service manuals, diagnostic software, service training, and specialty tools. “Since the standard is intended to improve patient safety, ready access to this information would allow all servicers to perform PM [preventive maintenance] according to the manufacturer specifications,” wrote one commenter.

MITA has scheduled a teleconference for Canvass Group members to resolve these comments on Jan. 12 before the standard is recirculated for a second vote.