From the May 2017 issue of HealthCare Business News magazine


Just like the in-house biomedical engineering department, ISOs have to work hand in hand with the IT department at a client hospital. If the problem concerns the medical device or system, then the biomedical engineer takes care of it, but if there’s a communication breakdown between the device and EMR, they work together with IT.

“We don’t just turn it over to the IT department and tell them this is where their responsibility stops and where theirs starts,” says Morford. “It’s a joint responsibility, so together, as a team, we attack that problem.”


Greater access to training needed
Riehm hopes the outcome of the FDA docket on third-party servicing and refurbishment of medical devices will be greater access to OEM training for both in-house biomedical engineers and ISOs.

“It’s still very difficult in some instances to get the training or to get access to resources that you need to service systems as an in-house biomedical engineer, even down to service manuals and things like that,” he says.

In a formal response to the docket, Renovo stated that, “all third-party servicers would appreciate a level playing field in which the device manufacturers would make available at a reasonable cost all necessary repair parts, thorough repair documentation and ‘factory’ training.”

Riehm explains that it’s generally easy to get access to OEM training for general medical devices, but that they are still very restrictive when it comes to imaging and specialty equipment.

“It is a challenge and it’s one where I would say even OEM to OEM they are doing themselves no favor,” he says. “If it opens up access to training and support and makes every biomedical engineer a better one, which obviously makes the equipment much safer, I think that would be a wonderful outcome.”

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