A new and rapidly growing technology, cloud computing is changing how medical device developers think about data and computational costs. However, for medical devices and quality systems, the significant benefits of cloud computing also come bundled with a new set of risks. That’s why experts from industry, medical device software development, and regulatory consulting recently pooled their knowledge to develop a new consensus report (CR) with the Association for the Advancement of Medical Instrumentation (AAMI).
Titled CR510, Appropriate use of public cloud computing for quality systems and medical devices, the new document provides guidance regarding the appropriate use of public cloud computing both as a component of medical devices and in support of quality systems.
“Cloud technology providers, medical device manufacturers, regulatory professionals and regulators alike should be able to refer to this document to identify known best practices for ensuring that the public cloud computing component of any medical device (or quality system component) works both within the spirit and the letter of regulations designed to ensure that medical devices improve patient outcomes and/or help manage healthcare costs, while also being safe and effective,” wrote the document’s authors, who are members of a task group developed under the auspices of the AAMI Application of Quality Systems to Medical Devices Working Group.
Quest Imaging Solutions provides all major brands of surgical c-arms (new and refurbished) and carries a large inventory for purchase or rent. With over 20 years in the medical equipment business we can help you fulfill your equipment needs
Challenges with Change
One important consideration with public cloud computing is that service providers regularly make changes to their platforms that can affect computing or functions.
“Those changes can occur without your prior consent, sometimes without prior notice, and perhaps even without notifying you after the changes have been made,” said Randy Horton, vice president of Solutions and Partnerships at Orthogonal, who co-chaired CR510’s task group.
“When medical devices are approved, they are under strict ‘change control.’ That is, any change they undergo must be assessed to determine if it requires resubmission for approval by regulators like the U.S. FDA,” explained Joe Lewelling, senior advisor on content & strategy at AAMI. “That’s fine when you control everything, but when you are using cloud computing, you’re working with a service provider. CR510 is the first document that really addresses how to use third-party computing platforms to operate a medical device safely and effectively.”
The pioneering guidance document specifically details how to explore six recommendations that stakeholders should consider before implementing cloud-based technologies in a medical device or quality system: