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Discussing the FDA's examination of third-party providers at AAMI

por Lauren Dubinsky, Senior Reporter | June 14, 2017
HTM Medical Devices Parts And Service
Pat Baird, Arif Subhan, Alan Lipschultz,
Malcolm Ridgway and Barbara Maguire
(right to left)
Tension was high during a panel discussion of the FDA's investigation into third-party service at the AAMI annual meeting on Monday.

"I was debating what headwear I should bring to this panel discussion," joked Pat Baird, global head of software standards at Philips Healthcare. "At first I was thinking just a black hat so it would be really easy to identify the 'bad guy' in the room, but then since I'm concerned about safety I thought about bringing in a helmet."

He proposed that OEMs, ISOs and in-house departments agree on 90 to 95 percent of the things pertaining to service, but that a different language is what has them at odds.

"I may accidentally use a key word that means something totally different to you," Baird explained.

Barbara Maguire, vice president of Geisinger Clinical Engineering and Quality at ISS Solutions, stated that an analysis from 1998 that investigated equipment incidents related to service found the incidence rate was very low. ECRI recently repeated the study and demonstrated that the rate was even lower.

Baird argued that the ECRI analysis was based on certain key words, but that there are no common key words that the industry has agreed on for reporting incidents to the FDA.

"I believe that ECRI was trying to do due diligence, but you should know that there was stuff that was missed, and there are things that are being underreported," he added.

He noted that the FDA audited 15 out of 17 hospitals in December for not reporting incidents.

But the American College of Clinical Engineering is concerned that adding regulations to third-parties would increase the cost burden on providers without improving patient safety.

"Because of the lack of credible evidence of problems associated with device maintenance service provided by third-party entities, we believe there is simply no rational justification for any action that would increase by any amount the overall cost to maintaining the nation's medical equipment," said Malcolm Ridgway of ACCE.

Alan Lipschultz, president of HealthCare Technology Consulting LLC, made the case that all parties need to look for common ground. He said there's a strong need for standardization within the health care technology management community, particularly around processes and data standards.

“My ultimate goal is electronic data exchange between manufacturers and organizations because [then we’d be] speaking the same language,” he said. "One of the manufacturers’ biggest issues is that they don’t know what’s going on with the equipment they’re responsible for in hospitals, and we in hospitals want to know what the manufacturer has done when they come in to service the equipment.”

“Wouldn’t it be nice if we could just be on the same page?,” he concluded.

Richard Geertson

Head gear

June 16, 2017 10:24

I am thinking the helmet would have been more appropriate. These OEMs keep talking as though the sky is falling, but cannot produce anything beyond old, worn out, anecdotal evidence to speak to their claims. ISOs can also produce examples of sub par OEM service. Ultimately, impacts on patient safety should set the bar, and to date, the evidence to that affect is less than scant. HR 2118 is a solution to a problem that does not exist, which renders it nothing more than cumbersome and costly bureaucratic red tape!

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Gary Provenzano


June 21, 2017 10:12

Ha, wouldn't work on this Philips crap for any amount!
Even Toshiba is better. 6 pt font in a 2 inch square on a 21 inch screen, to run their "protocols". Still won't accept United States customary units, yep, kilograms , or nothing at all. And the rollouts of next gen hardware on existing legacy platforms, ad infinitum...

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