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.

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