由 Gus Iversen
, Editor in Chief | May 20, 2020
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.
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"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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