A new whitepaper released by the Medical Imaging & Technology Alliance (MITA) put forth a framework for establishing the difference between servicing and manufacturing activities for medical imaging devices.
The document, “Considerations for Remanufacturing of Medical Imaging Devices,” urges the FDA to establish a clearer distinction between servicing and remanufacturing, and provides descriptions to clarify each.
According to the MITA whitepaper, medical device servicing should be defined as follows:
“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 OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).”
As of now, third-party medical device servicers aren’t required to have controls in place to determine if their servicing activities fall in line with FDA-defined remanufacturing. The FDA does regulate medical device remanufacturing, but not servicing.
The overall lack of safeguards in place to differentiate service from remanufacturing poses an increased risk to public health and the safety of patients and those who use medical devices, according to the release.
“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,” said Dennis Durmis, Chair of MITA’s Board of Directors, in a prepared statement. “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.”