Interoperable Medical Devices: FDA Offers Design, Labeling Considerations

Regulatory News

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products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling.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And this draft guidance is intended to highlight what device manufacturers should consider to ensure the safety and effectiveness of their interoperable devices, particularly for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.

Design Specifics

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):

• Types of devices that it is meant to connect to;
• Whether a device is sending, receiving, issuing a command and/or controlling data;
• The use of standards (data format, transmission, interface standards, etc.);
• The need for time synchronization;
• Method of data transmission;
• The necessary timeliness and the reliability of information (e.g. sample rate, transmission rate, etc.);
• What the user should or should not do with the electronic data interface, including contraindications, warnings and precautions on the use of the exchanged information;
• Clinical context for the use of the information exchanged, such as an infusion pump used to deliver anesthesia to a sedated patient in the intensive care unit;
• How the manufacturer anticipates the interface being used. “For example an interface on a pulse oximeter is used to send data to a computer system in an eight hour study on neonates to assess sleep. The computer system is also gathering information from ECG. Therefore the information from the pulse oximeter and ECG need to have their times synchronized and data collected at a specific rate.”
• The functional and performance requirements of the device as a result of the exchanged information;
• Expected flow of information or exchange of information through an application programming interface (API) which may include considerations of acceptable and unacceptable commands on the interface.

Labeling

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 purpose of the interface, including any devices, device types, or software (including the version of the software) with which the device is meant to connect.
• Whether the data is meant for a specific purpose or user, or simply for anyone to access.
• Whether the connection is meant to control the operations of another device.
• Specifications for each interface, as well as the necessary performance and functional requirements from the device related to the sending or receiving of data/control.
• Summary of the testing performed on the interfaces to verify interoperability claims and any activities required by the user to verify safe operation. “In the case where testing was performed to an interface specification and verified with a representative device, please specify the representative device used,” FDA says.
• Reference relevant standards used.
• A description of any fault tolerance behavior, boundary condition testing, or fail safe for critical functions (e.g., delivering energy) that will allow the user to understand how to use the interface correctly.
• Specify any known limitations (what the user should not do), contraindications, precautions and warnings.
• Recommended connections or architectures.
• Recommended settings, or configurations for the electronic data interface.
• Instructions for IT personnel on how to connect or install and disconnect or uninstall the device.

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