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Third-parties and OEMs seek common ground in service discussion

by John R. Fischer , Staff Reporter

Improving cybersecurity as it relates to servicing medical devices was an area where everyone agreed there is much work to be done, and standardization is key. Currently, there are no standards or required actions in place for how to systematically address cyberattacks.

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Speakers emphasized particular areas where standards were needed, such as sharing information related to identified security vulnerabilities; the securing of legacy devices; enhanced training and avoidance of careless actions; and the need to better understand and simplify approval processes.

“From an equipment perspective, we just don’t have the ability with our equipment that’s on the network at this time to do any automatic port control, as well as encryption,” said Mike Busdicker, system director of clinical engineering at Intermountain Healthcare, indicating the challenges faced by many front line healthcare providers.

Busdicker also stressed the need for equipment suppliers to assist providers with changing passcodes internally in order to mitigate the threat of security breaches.

Quality management principles
Establishing quality management principles, and ensuring their effectiveness, is a core objective of the FDA and equipment stakeholders in the wake of the service report. Such wide-reaching protocols would impact the training of technicians; sharing of information; reporting of issues; and following of certification practices, to name a few.

Katrina Jacobs, a biomedical engineer for the U.S. Department of Veteran Affairs, said that she would like to see an agreed-upon source of guidance to help organizations determine the best partners to collaborate with for safe and effective servicing of their devices.

“A lot of our folks in the contracting business will say ‘Why are you going to the OEM when this independent is offering a cheaper price? What about this independent versus this independent? What’s wrong with going with the cheaper option?',” she said. “There should be some sort of agreed-upon best practice or guidance widely available to help those people to make that decision and understand the important principles.”

Fostering evidence development
Establishing a standard set of quality management principles is confounded by the lack of baselines to quantify safety, effectiveness or quality and demonstrate positive impacts made on servicing.

Identifying data sets on these matters and understanding how to use them, along with the environment and performance of the devices and services, and the potential outcomes of any particular failure, is an area of interest that also leaves more questions than answers.
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