The Medical Imaging & Technology Alliance (MITA) released a new whitepaper to bring forth a new framework. With this research, they want to establish the difference between manufacturing and servicing for all medical imaging devices.
The latest document called, ‘Considerations for Remanufacturing of Medical Imaging Devices’, insists on establishing a clearer differentiation between manufacturing and servicing, to the FDA. The document also provides necessary descriptions clarifying each section.
The MITA whitepaper defines medical device servicing in the following lines as, “Preventative maintenance, calibration, or repair of a finished medical device after distribution for purposes of maintaining it within or returning it to the safety and performance specifications established by the OEN and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
At present, it is not necessary for the third-party medical devices services to have controls in order to determine whether service activities are in line with FDA regulations of remanufacturing. In addition, the FDA regulates the process of medical device remanufacturing, but it does not play any role in service.
However, the overall lack of adequate safeguards to difference remanufacturing from service is a concern. It increases public health and safety risks, especially for those using medical devices.
Dennis Durmis, Chairperson, MITA Board of Directors said, “We hope this white paper will serve as a resource for the FDA and the broader stakeholder community as it moves forward with future guidance on this issue. It is important that a sound process and clear definitions are in place to ensure that servicing activities are clearly distinguished from remanufacturing and all stakeholders understand the differences.”
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