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Regulatory News | 25 January 2016 | By Zachary Brennan
With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling.
The advance of interconnected devices could be a boon for patient care, particularly in cases where device-specific information, such as unique device identifiers (UDIs), and patient-specific data, such as electrocardiogram (ECG) waveforms, contained within a medical device can be relayed to other devices or used to fill electronic health records to improve health care decisions.
“FDA has recognized various consensus standards that support medical device interoperability while at the same time exercising enforcement discretion for medical device data systems (MDDS) to make it easier to share and display data from medical devices,” the agency explains.
And this draft guidance is intended to highlight what device manufacturers should consider to ensure the safety and effectiveness of their interoperable devices, particularly for designing systems with interoperability as an objective; conducting performance testing and risk management activities; and specifying the functional, performance and interface characteristics via labeling.
FDA maintains that for devices connected to an interoperable system in which data is passed back and forth between multiple devices, safety is the most important consideration, particularly as errors from inadequate interoperability can occur, such as the transmission of weight in kilograms when the receiving medical device assumes the measurement is in pounds, which can lead to patient harm and even death.
“Medical device interoperability is not limited to unidirectional patient data but includes more complex interactions, such as exerting command and control over a medical device(s),” FDA says. “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.”
FDA says elements to consider in the design of the device’s electronic data interface include (but are not limited to):
And as far as what an interoperable device’s label should contain, FDA notes that the electronic data interface on the device should be properly described.
“If the device is meant to interact with only a few specific devices, the labeling should explicitly state that the medical device is meant to connect with the specific devices listed (including the version) and that it should not be used with other medical devices or non-medical device technologies,” FDA says.
But if the interface is only meant to be used by the manufacturer’s technicians for software updates or diagnostics, manufacturers should include that detail in the labeling, too.
Other considerations include:
The draft document also includes a section on which interoperable devices require a premarket submission and how device manufacturers should identify an anticipated user for the device and how it will be used in an interoperable system.
Draft Guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Tags: interoperable devices, medical devices online, device interoperability, FDA draft guidance