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Five things you missed at the FDA refurb workshop

by Gus Iversen, Editor in Chief | November 02, 2016
Business Affairs HTM Parts And Service

An OEM won't share necessary maintenance documents? There's a solution to that.

Repeatedly, ISOs and HTMs made the case that OEMs are uncooperative when it comes to sharing certain manuals and maintenance documents that may be essential for servicing their equipment. On the OEM side, this practice of withholding was sometimes justified as a necessity for keeping trade secrets out of the hands of their competitors.

Whatever the reason may be for withholding service instructions, Salvatore Tatta, director of clinical engineering services at James J. Peters VA Medical Center, offered a practical and straightforward solution. He said that at his facility they include the supply of these documents in the initial contract they sign with the OEM.

If an OEM refuses to share such information, they are in violation of the agreement. If they refuse to comply with the initial agreement, they lose a customer.

Where is that system now? I don't recall

Repeatedly, OEMs argued that they face a disproportionate degree of responsibility for the equipment they've designed, even after it has traded hands on the aftermarket. One of the clearest examples of this was offered by Hitachi's Nestel, who said that when a recall occurs, the OEM is responsible for notifying the entire install base.

When a third-party has bought or sold the system it becomes difficult — and in some cases impossible — to track down the current end user.

One area where HTMs, ISOs and OEMs all seemed to be on the same page was with establishing a better record of activity. Nobody wants to try to service or repair a piece of equipment without a complete record of all the previous work that has been done on it.

Nestel said that since third-parties are not required to label systems after servicing them, sometimes an OEM will be called on to fix something, but have to do a lot of detective work before discovering how previous maintenance has contributed to the system's failure.

Are further regulations on third-parties... un-American?

The FTC was represented at the workshop by Katie Ambrogi, attorney advisor in the commission's Office of Policy Planning. Although she didn't spend a lot of time addressing the crowd, the FTC's presence was felt throughout the event.

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