MITA proposes framework for defining 'service' versus 'remanufacturing'

February 13, 2019
by John R. Fischer, Senior Reporter
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.

A special focus of the white paper is dedicated to medical imaging, with an entire section on the subject written up and broken down into different activities that elaborate on what constitutes the remanufacturing of specific modalities, including the impact of non-OEM acoustic arrays on the acoustic output values of ultrasound systems, or modifications made to the radiofrequency body transmit coils of an MR scanner.

In addition, it proposes the establishment of quality management systems as a possible solution to make the practices of organizations more transparent in an effort to ensure that finished medical devices continue to meet applicable requirements and specifications.

“Performance of servicing and remanufacturing activities within an appropriate quality management system by properly trained technicians using qualified, properly sourced parts greatly reduces the risk of harm to the patient or operator and greatly improves the performance of the device,” said the paper. “It also provides a framework – including verification and validation processes – for ensuring that servicing activities do not bridge into remanufacturing, and that remanufacturing activities are appropriately controlled and have appropriate oversight.”

The organization of these and other issues specified in the document stem from the findings of a two-year investigation conducted by the FDA into whether or not the servicing activities of third-party providers harm the quality of medical devices and, in effect, patients who use them.

In a May 2018 report, the federal entity concluded that “currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern relating to servicing of medical devices, including by third-party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.”

It did, however, find that many cases deemed to be examples of inadequate servicing actually constituted as forms of remanufacturing that were changing the safety, performance or intended use of devices. This caused the agency to declare its intent to issue future published guidance that clarifies the difference between both terms, and has subsequently led to much debate, as well as a workshop to discuss the matter in December, to address the various activities of manufacturers and third-party providers.

"MITA is planning on submitting comments to that docket," said Weems. "I think that that workshop, as well as the responses to the docket, will inform a guidance that the agency has indicated it will put out in fiscal year 2019, which will draw a brighter line between servicing and remanufacturing activities for medical devices."

A white paper, entitled “Evaluating Whether Activities are Servicing or Remanufacturing”, for guidance on medical device servicing was released in the fall of 2018 and opened up for public commentary. Initially set for January 25, the deadline for submitting written comments was pushed back one month to February 25.

Comments may be submitted until then at in Docket No. FDA-2018-N-3741.