The Medical Imaging & Technology Alliance (MITA) has released a new white paper outlining the differences between servicing and remanufacturing activities for medical imaging devices, urging the FDA to clarify its own definitions of the two terms.
Titled Considerations for Remanufacturing of Medical Imaging Devices, the white paper also recommends that organizations use appropriate quality management systems to define exactly what activities they are undertaking to ensure proper performance, documentation and regulation.
According to the document, medical device servicing should be defined as the following:
“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).”
Currently, third-party medical device servicers are not required to have controls in place to determine if servicing activities constitute remanufacturing as defined by the FDA, according to MITA. The FDA does regulate the remanufacturing of medical devices, but does not regulate servicing activities.
Additionally, MITA noted that the FDA has few safeguards in place to ensure servicing activities don't infiltrate into uncontrolled and unregulated remanufacturing.
“This lack of oversight poses an increased risk to public health and thus the safety of patients and device users,” MITA wrote in a news release.
In May 2018, the FDA sent Congress a report expressing its intent to develop draft guidance on remanufacturing of medical devices. Seven months later, the agency held a public workshop to discuss the distinction between servicing and manufacturing accompanied by the release of the agency's white paper acknowledging the need for clarification between the two activities.
“We hope this [MITA] 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,” Dennis Durmis, chair of MITA’s Board of Directors, said in the MITA news release. “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.”