MITA White Paper Clarifying Distinction Between Medical Imaging Device Servicing and Remanufacturing

02.07.19

WASHINGTON – The Medical Imaging & Technology Alliance (MITA) today announced the release of a white paper outlining a framework for establishing the distinction between servicing and remanufacturing activities for medical imaging devices.

The paper, titled “Considerations for Remanufacturing of Medical Imaging Devices”, calls on the U.S. Food and Drug Administration (FDA) to clarify the distinction between servicing and remanufacturing and offers detailed descriptions of the types of activities that would constitute either. Further, the white paper recommends that organizations adopt appropriate quality management systems to define the nature and scope of the activities they are undertaking.  This is to ensure servicing and remanufacturing activities are properly performed, documented, and regulated.

In a May 2018 report to Congress, the FDA expressed its intent to develop draft guidance on remanufacturing of medical devices.

“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. “It is important that a sound process and clear definitions are in place to ensure that servicing activities are clearly distinguishedfrom remanufacturing and all stakeholders understand the differences.”

According to the MITA white paper, medicaldevice “servicing” should be defined explicitly 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 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-partymedical device servicersare not required to have controls in place to determine if their servicing activities constitute remanufacturing as defined by the FDA. While the FDA does regulate the remanufacturing of medical devices, it does not regulate servicing activities and has few safeguards in place to ensure that servicingactivities do not cross over 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.

In December 2018, the FDA held a public workshop to discuss the distinction between servicing and remanufacturing to better inform the development of future guidance on this issue. The workshop was accompaniedby the release of the agency’s white paper, which acknowledged the need for clarification between the two activities.

“We look forward to working with the FDA and industry stakeholders in the coming months toensure the third-party servicing of devices is donein a manner that maximizes patient health and safety,” Durmis concluded.

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