Joint Commission’s Mills Addresses Fight over Service Manuals


Posted June 10, 2017

Stepping into the hot debate over the service and support of medical devices, George Mills, director of engineering at The Joint Commission (TJC), announced Friday that the accrediting organization will add a new element of performance (EP) in January that is intended to “assist HTM professionals when requesting information from suppliers and vendors.”

The new EC.01.01.01, EP 3 states: “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins, and other information.”

“I wrote this EP just for you,” Mills told the room of healthcare technology management (HTM) professionals, earning him a round of applause. “My intent was to provide something that HTM can point to when requesting information that historically was not readily available.”

Mills made his comments during the 33rd Annual Conference on Clinical Engineering Productivity and Cost Effectiveness (more commonly known as the Manny Meeting). The conference was held in conjunction with the AAMI 2017 Conference & Expo in Austin, TX.

Mills is expected to discuss the EP and other TJC plans during his keynote session on Monday at 8:30 a.m. in Ballroom A of the Austin Convention Center.

Before Mills spoke at Friday’s Manny Meeting, HTM professionals gave voice to their frustration over the question of how to best service medical devices.

Stories were told of endoscopes being sent out to original equipment manufacturers (OEMs) for inspection only to return in “body bags,” and parts being withheld for simple, noncritical devices.

“You’ve got OEMs hiding behind the word ‘safety,’” said Dave Dickey, corporate director of McLaren Clinical Engineering Services with McLaren Health Care in Flint, MI. “In the eyes of OEMs, in-house biomeds are not ‘trained professionals’ who can work on these devices.”

The debate over who can—and should—repair medical devices has been roiling the industry for years.

On one side, OEMs say that third-party servicers, such as independent service organizations, need greater federal oversight in order to ensure patient safety. They contend that some third parties have at times used unqualified personnel to service devices, installed parts that have not been validated, and inadequately documented their work.

On the other, HTM professionals cite statistics showing there is no evidence of a patient safety issue.

During the meeting, Mark Bruley, vice president for accident and forensic investigation at ECRI Institute, said that data from the Pennsylvania Patient Safety Authority show that approximately 2% of reported patient safety incidents are related to medical devices. Of those, 70% are related to “technique of use” or “use error,” making very few incidents the result of service or repair—maybe “a couple of hundred” a year, he estimated.

Manufacturers have said not enough data have been collected to draw any firm conclusions.

For HTM professionals, the real concern, though, is the struggle to get service manuals, affordable training, replacement parts, and passwords from many OEMs, which makes it difficult—if not impossible—to maintain and service devices in hospitals and other healthcare delivery organizations.

Although this type of documentation is required to be provided according to the NFPA 99 Health Care Facilities Code, ensuring access to needed resources is something that should be contractually obligated, according to Alan Gresch, vice president of client success at Accruent.

“Once the capital is in [manufacturers’] hands, you’ve lost all leverage on the subject,” Gresch told attendees.

Another participant agreed that healthcare delivery organizations shouldn’t do business with vendors that won’t provide the information and parts necessary to service and maintain the device. “Hit them back where it hurts—in the pocketbook,” he said.

Although this was seen as sound advice, it doesn’t cover the sizeable number of legacy devices HTM professionals repair and maintain. To that end, Mills said the new EP could help HTM professionals when they seek out this information.