por John R. Fischer
, Senior Reporter | March 13, 2019
“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.”Back to HCB News