FDA workshop: is it servicing or remanufacturing?

FDA workshop: is it servicing or remanufacturing?

por John R. Fischer, Senior Reporter | December 12, 2018
Parts And Service

For one table, a scenario outlined was the patching of a small hole in the liquid helium reservoir of an MR system. The hole was patched with materials that are different than an OEM reservoir. The table determined that classifying such a repair depends on whether or not the party providing the service has access to and can meet the original specifications laid out by the OEM without changing them.

“One of my arguments would be you can put a material on there that can seal it but would it seal it for as long as the original material would? Would it seal it longer,” said Jim Nestel P.E., director of operations for Hitachi Healthcare Americas.

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The next session addressed the subject of labeling, challenging attendees to question what specifications and considerations should be included in device labels to ensure high quality, safe and effective servicing.

“For our table, there was no consensus as to what falls into labeling and what falls within intellectual property," said Rob Kerwin, legal counsel for the International Association of Medical Equipment Resellers and Servicers (IAMERS). "There was also no consensus on whether there should be a warning on non-OEM, FDA-registered devices manufactured by ISO-certified companies with respect to things such as warnings, which may be omitted when non-OEM equipment is installed. But there was recognition of a need to address counterfeit or safety issues, though such should not lock access to the device.”

Following the end of the second session, a panel discussion was held on a set of proposed guiding principles. Topics discussed included documentation, risk management, cybersecurity, certification and educational opportunities, as well as AI and big data.

The subjects were addressed again the following day during a larger panel discussion in which stakeholders from all viewpoints discussed the nuts and bolts of what should make up a collaborative community, including how it should work alongside OEMs, ISOs, in-house personnel and other parties; how it should be structured; and what areas of interest must be agreed on in establishing one.

Reflecting on the meeting, panelist Diana Upton, president of IAMERS, told HCB News that reaching a consensus on what a collaborative community should look like will take a while but that she hopes to see more frequent gatherings such as this to help all medical equipment personnel come to an understanding on what such a community should encompass and how all types of parties can play a role in its development and success.

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