The Food and Drug Administration (FDA) has released draft guidance for medical device manufacturers intended to clarify guidelines for medical device interoperability, AAMI has reported. The new document includes direction on the design and testing of interoperable devices, as well as recommendations for labeling that warns users that improper use could result in harm to patients.
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices is the latest result of ongoing efforts by federal organizations to improve reliable and safe interoperable medical devices. The document advises manufacturers to consider data attributes, the role the device plays within a system, and how the device connects to the system during the design and development process for medical equipment. In addition, manufacturers should consider the types of data exchanges taking place; the range of anticipated users, including clinicians, biomedical engineers, IT professionals, and systems designers; and related security concerns, such as unauthorized persons accessing a device.
“Failure to establish and implement appropriate functional, performance, and interface requirements during product development may lead to the exchange of inaccurate, untimely, or misleading information. It may also lead to device malfunction, including the failure to operate, and can lead to patient injury and even death,” the document states.
The document is open for comments through March 28, 2016. Readers can submit feedback at www.regulations.gov.