MITA publishes QMS standard for servicing of imaging devices

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MITA publishes QMS standard for servicing of imaging devices

by John R. Fischer, Senior Reporter | March 13, 2019
Parts And Service

“The MITA Service standard did not get approval by the HTMs and ISOs," Robert Kerwin, legal counsel for IAMERS, an industry group representing equipment remarketers and servicers, told HCB News. "Stakeholders should recognize that it was not endorsed, as it was based on the FDA QSR regulation pertaining to manufacturers and did not adequately address training and calibration of equipment.”

The NEMA/MITA 2 standard is based on ISO 9001, a general quality system standard which can be adopted by any type of organization; ISO 13485, a quality system standard for the medical device industry; and the FDA Quality System Regulation. According to Hope, it also incorporates input from a wide variety of stakeholders, including medical imaging device manufacturers, independent servicing organizations, clinical engineers, hospital system regulators, and accreditors.

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Though designed primarily for medical imaging device users, the principles and guidelines of the standard can be applied to the servicing of other types of equipment. MITA expects it to serve as a foundation for the development of other standards and to help in its aim to work with stakeholders in the development of an American National Standard for quality management of servicing medical devices.

“MITA has elected to publish this document as a NEMA Standard, given the ongoing need to protect patient safety and device integrity through the adoption of quality management principles in the medical imaging device servicing industry," said Hope and Weems. "All entities that engage in servicing of medical devices should be held to consistent quality, safety, and regulatory requirements, including adoption of appropriate quality management systems such as NEMA/MITA 2, registration with the FDA, and filing of adverse event reports.”

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(12)

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

10-4

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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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