Perhaps a rule of thumb could be to also provide the device instructions, which are supplied by the OEM when submitting to the FDA a device for premarket approval. 21 C.F.R. 807.87 requires, in connection with a premarket notification submission, the FDA receive “proposed labels, labeling and advertisements sufficient to describe the device, its intended use and the directions for its use. Where applicable, photographs or engineering drawings should be supplied.” Is it really appropriate, as some suggest, these likely more detailed "instructions for use" be withheld under a "trade secret" designation? The trade secret designation is of small solace when a problem arises that requires immediate servicing activities.
The draft guidance also notes an additional concern for servicers who may not possess adequate instructions for use: “[u]nintentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications.”
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Could a scenario arise where adequate instructions are withheld from distribution and thereafter a claim of remanufacturing is advanced? This situation might be alleviated if the final guidance confirms that distribution of the instructions for use is "mandatory" under existing law.
The recent
executive order from the Biden Administration requires the heads of all federal agencies to consider using their authority to further the policies of promoting competition. Accordingly, a hospital’s right to have choices in the servicing of equipment could well be another reason for clarification in the guidance. Shouldn’t the paramount interests of patient safety confirm that hospital medical device owners and their designated servicers receive adequate instructions? Shouldn’t there be meaningful consequences outlined if these instructions are withheld from the hospital owners and their designated servicers?
About the author: Robert J. Kerwin is the general counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS).Back to HCB News
Robert Hibdon
Great effort keeping the ISO community up to date
August 09, 2021 11:00
Thanks for keeping the community up to date on the "Right to Repair" developments in the medical equipment service arena. While the threat to independent service impacts our community, it also has the potential to threaten rural and community hospitals throughout the country, and in doing so, impact the quality of healthcare in general.
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