Analysis

FDA regulations update medical devices for safety and security

3rd September 2018
Anna Flockett

Protecting patients and promoting public health is a key directive for the US Food & Drug Administration (FDA). This directive includes oversight on the safe and secure use of medical devices for patient care.

Guest blog written by Jeff Kataoka, Wind River.

That means that if you are a medical device manufacturer, your company needs to ensure that its medical device is meeting FDA regulations and guidelines for safety, security and healthcare use.

Earlier this year, the FDA released an article: “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, that describes the new FDA actions to improve medical device safety. A major element of this plan was the call for mandatory built-in capabilities providing safety and security updates to medical devices.

Many medical devices are closed devices that do not allow easy update capabilities at the hospital, medical centre or in the home. Many of these devices are not connected to a network or have limited communication connection capabilities that require a manual update by service people from the manufacturer. Now, the challenge for medical device manufacturers is how to securely, reliably and cost-effectively create safety and security update capabilities into their medical device products.

With the hospital and patient use of medical devices expanding each day, new safety concerns emerge that need to be dealt with to maintain patient health. Plus each day, as new cyber security vulnerabilities are revealed and announced, they need to be quickly mitigated to ensure patient health and safety.

Medical device manufacturers need a technology solution that they can build their device upon that will allow an easy, convenient and secure method to quickly update their devices to maintain patient safety and security. Virtualisation and workload consolidation technology are offering a solution to upgrade the safety and security software within a medical device that can help enable upgrade capabilities to meet FDA requirements.

Using virtualisation technology as part of the system platform running a medical device, a medical device company can set-up a workload consolidation solution within the device that utilises a hypervisor and virtual machines to run the medical, safety and security applications.

When connected to a network, this would allow for easy and fast updating of the safety and security applications to fix any issues or to provide application updates.  With the use of virtualisation and workload consolidation, it is possible to utilise a different operating system for the various installed virtual machines, even a real-time operating system in one virtual machine and open-source operating systems, like Linux, in another. To learn how a medical device company can update their products with a virtualisation technology and workload consolidation solution, read the use case: “Update Capabilities for Medical Devices Building in Safety and Security to Meet Regulatory Requirements.”

To view further information about how Wind River is providing solutions for the medical market segment, visit the Wind River medical market page here.

Courtesy of Wind River.

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