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AdvaMed and MITA exit collaboration with non-OEM service stakeholders

by Gus Iversen, Editor in Chief | May 20, 2020
Business Affairs HTM Parts And Service

In-house and independent service groups, on the other hand, generally argue that the biggest threat to safety is the lack of cooperation they get from OEMs regarding access to manuals, passcodes and other necessary information. In a response to Hope's article, Arif Subhan, then president of the American College of Clinical Engineering (ACCE), observed that reporting of adverse events is the job of facilities (not servicers) and asserted, "it is grossly misleading to suggest servicers are held to a lower standard when clearly it makes no sense to hold servicers to manufacturing-specific regulations."

The clashing viewpoints are comparable to high-profile right-to-repair controversies concerning consumer products like smartphones and tractor-trailers, where manufacturers like Apple and John Deere have argued that a robust service market for their products would open the door to safety and security concerns.

"In reality, AdvaMed and MITA have been stalemating progress in the collaborative communities for over a year," said Francoeur. "They couldn't agree on antitrust-focused language, and they couldn't agree on voting rights."

Although COVID-19 has put the MDSCC on hold, Francoeur said that "mini groups" have been formed within the alliance to concentrate on specific topics (training materials, definitions, QMS solutions, and key performance indicators) and he expects those groups to continue their work despite the departure of MITA and AdvaMed.

The International Association of Medical Equipment Remarketers and Servicers (IAMERS), another MDSCC member representing non-OEM viewpoints, echoed that sentiment. "IAMERS is disappointed that AdvaMed and MITA will not be continuing with the Medical Device Servicing Collaborative Communities initiative," Robert Kerwin, general counsel for the organization, told HCB News. "Like other stakeholders, we have devoted many hours to the MDSCC initiative and will continue to pursue this and other collaborative initiatives."

The need for better partnerships between medical equipment OEMs and service teams has been highlighted by the COVID-19 pandemic. In April, five state treasurers called upon device manufacturers to increase the availability of ventilator service manuals for service technicians on the front lines.

“In a public health crisis, every second counts. There shouldn’t be a single ventilator sitting in a closet because a hospital, already under extreme pressure, isn’t able to make necessary repairs to it," wrote Pennsylvania State Treasurer, Joe Torsella. "I call on manufacturers of this lifesaving equipment to release this information and remove this barrier that hospitals are facing.”

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(1)

Wayne Webster

It's my way or the highway

May 22, 2020 10:55

AdvaMed and MITA representing their masters, the OEM's, had one goal from the start and that was to remove third parties service organizations from the market mix leaving the OEM's with a monopoly. With this monopoly in place the OEM's knew they could control pricing and the life-time of equipment. With the independents serving the market the OEM's knew they would have complete freedom to raise prices and declare end of life forcing replacement equipment purchases. The Federal Trade Commission should be looking at these deceptive practices as a result of this refusal by the OEM's to participate in the community and act accordingly.

Our health care systems are stressed enough without further needless expense being added by the OEM's. Their actions and the tantrum thrown, withdrawing from the collaborative community effort, is evidence they, the OEM's, had no interest in participating from the outset.

FDA should move immediately to require OEM's to provide the information needed to maintain and repair the equipment they sell or forfeit the right to participate in the marketplace.

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Gerald McNeil

AdvaMed and MITA exit collaboration

May 22, 2020 10:55

It's my simple opinion that OEM's are merely attempting to protect their precious service income trying to block out independent service provides and in-house groups. I've been working in the Biomed field for 14 years in an in-house group and we've very successfully taken over many OEM service contracts with qualified BMETs and not once have we caused any harm to a patient because of lack of knowledge. One of the biggest obstacles is the lack of cooperation from OEMs under the guise of safety and protecting the patient, more like protecting their bottom dollar!

Thanks,

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