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MITA publishes QMS standard for servicing of imaging devices

John R. Fischer , Staff Reporter
The Medical Imaging and Technology Alliance (MITA) and its parent organization, the National Electrical Manufacturers Association (NEMA) have published a voluntary standard outlining minimum quality management system (QMS) requirements for servicing medical imaging devices.

Called NEMA/MITA 2 – Requirements for Servicing of Medical Imaging Equipment, the free-to-download guideline is the first dedicated solely to the servicing of medical imaging equipment.

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“Until now, there have not been any QMS Standards developed specifically for servicing of medical imaging devices,” MITA's executive director Patrick Hope and director of policy Peter Weems told HCB News. “MITA saw this as a critical gap that needed to be filled in order to protect patient safety and device integrity.”

The publication of this standard comes as the medical equipment industry awaits FDA guidance for what differentiates servicing from remanufacturing of medical devices.

The decision by the agency to develop the guidance stems from the completion of a two-year investigation last May, which found insufficient evidence that third-party equipment servicers are a public health concern. In that report, the FDA stated that it 'found no evidence that additional formal regulatory action is warranted, based on available information and findings'.

Adoption of the new QMS standard, according to MITA, will enable stakeholders to ensure that their servicing activities do not cross into remanufacturing. The imaging OEM group observed that while remanufacturing is regulated by the FDA, the agency does not currently require third-party medical device servicers to have controls in place to determine if their servicing activities constitute remanufacturing. This lack of oversight poses an increased risk to public health and patient safety, MITA wrote in a statement.

In Februrary, MITA released a white paper outlining a framework for establishing the distinction between the two activities to serve as a resource for the FDA and the broader stakeholder community.

Some industry stakeholders argue that the new standard, as well as the white paper, fail to consider the interests of non-OEM stakeholders, and the value those stakeholders bring to the healthcare ecosystem.
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Wayne Moore

MITA Service Standard

March 15, 2019 08:08

Your DOTMED article says that ISO 13485 is only for manufacturers of medical devices; this is simply NOT true. ISO 13485 is designed to be used by all organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. In short it is designed by ANYONE involved in the above including servicing. Get the facts right before you publish your news releases.

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John R. Fischer

re: MITA Service Standard

March 18, 2019 10:31

Hi Wayne,

Thanks for the comment. My article states ISO 13485 is for manufacturers. It does not state it is only for manufacturers. My apologies to anyone who may have been confused - I have revised the article to state "ISO 13485 is a quality system standard for the medical device industry."

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Wayne Moore

re: re: MITA Service Standard

March 19, 2019 10:26


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Stephen Grimes

re: MITA Service Standard

March 28, 2019 09:30

Examine the current 13485 standard and you will it see input was only from OEMs and not from third party servicers. Irrespective of what the what the standard says, it's a dubious claim to make that the standard is appropriate for third party servicers when no 3rd party servicers were involved in its development.

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