On September 6th, the FDA issued the guidance document Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
According to the document:
“This guidance is intended to highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices: 1) designing systems with interoperability as an objective; 2) conducting appropriate verification, validation and risk management activities; and 3) specifying the relevant functional, performance, and interface characteristics in a user-available manner such as labeling.” (p. 3)
For those new to the topic, they define interoperability “…as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” (p. 2)
With respect to human factors, it highlights a couple areas of importance for our discipline, including:
- “Validate the user(s) interface. Determine that the user(s) are capable of correctly using the interface(s)” (p. 11)
- “Validation of labeling regarding the use of the electronic interface should consider human factors as appropriate.” (p. 17)
It’s good to see that the FDA understands the challenges associated with interoperability and that human factors is an important part of designing, developing, and deploying interoperable technology that allows users to safely and effectively perform their duties.