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.
“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.
“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.
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.”