As the FDA continues to examine the distinction between servicing and remanufacturing of medical devices, the Medical Imaging & Technology Alliance (MITA) has released a white paper with a proposed framework on the matter.

Titled, “Considerations for Remanufacturing of Medical Imaging Devices”, the paper provides detailed descriptions of the types of activities and conditions that separately fall under servicing and remanufacturing, and recommends the adoption of quality management systems (QMS) by organizations to ensure their practices around servicing and remanufacturing are properly performed, documented and regulated.

"If you look at the report that the FDA put out in May 2018, they highlighted that many of the case studies and examples that were brought to them and were called inadequate or inappropriate servicing actually constituted remanufacturing," Peter Weems, senior director of policy and strategic operations at MITA, told HCB News. "It's important that folks who engage in any kind of aftermarket technical support for a medical imaging solution or any other device have appropriate controls in place to make sure the device is returned to safe and effective condition for its intended use. Among those controls would be a way of determining whether or not their activities cross into remanufacturing."

The paper defines “servicing” as preventive 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).

While current FDA standards regulate the remanufacturing of medical devices, regulation of servicing is not a requirement. In addition, few safeguards exist to prevent the crossover of servicing activity with that of remanufacturing, creating increased risks to public health, the safety of patients and providers who use the technology.

These risks are elaborated on in the white paper and include electrical shock, overexposure to ionizing radiation, improper dosing and cybersecurity vulnerabilities, among others.

It also describes in detail examples of activities considered to be remanufacturing, specifying changes to components such as the energy used for a device; the mode of operation or mechanism of an action for which a device fulfills its intended purpose; or a control mechanism that dictates the directions of actions for a device.

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