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.

Parts And Service Homepage