FDA Guide on Device Design Considerations for Interoperability
FDA has posted a new draft guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” that identifies specific considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. The document refers to interoperability as the “ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.”
The guidance says the use of the exchanged information can include various purposes such as displaying, storing, interpreting, analyzing and automatically acting or controlling another product. “When medical devices are involved in an interoperable system (system of connected devices in which information is exchanged and used across the connections and which includes at least one medical device), safety is the most important consideration,” it says. It adds that appropriate safety considerations “including system level safety considerations that are not taken in to account in the device design can result in unforeseen safety and effectiveness issues for the device or for the system.
Medical device interoperability, according to the guidance, is “not limited to unidirectional patient data but includes more complex interactions, such as exerting command and control over a medical device(s). Establishing and implementing appropriate functional, performance, and interface requirements for devices with such interactions is important. One way to achieve this is through use of standardized architectures and communication protocols. Another way is to specify non-standard interface requirements and characteristics in a public manner such as labeling.”
Device design elements that factor in interoperability considerations, FDA says, may improve “data portability and patient safety. However, errors stemming from inadequate interoperability can occur, such as the transmission of weight in kilograms when the receiving medical device assumes the measurement is in pounds, and can lead to patient harm and even death.”