In an effort to improve the interoperability of medical devices, the FDA has released draft guidance that is intended to clarify how it evaluates devices that electronically connect to and interact with other devices and/or systems. In this guidance, the agency provides direction on the design and testing of interoperable devices, as well as recommendations for labeling, warning that a failure to take appropriate steps could result in harm to patients, even death.
“Interoperability in health care has the potential to encourage innovation and facilitate new models of health care delivery by promoting the availability and sharing of information across systems even when products from different manufacturers are used,” the FDA said in the guidance.
Seamless connection between medical devices and other technology has the potential to improve the efficiency of health care by automatically populating electronic health records with patient data or allowing doctors to monitor patients remotely, among other tasks. However, achieving widespread interoperability between medical devices and health IT systems has been a challenge.
The FDA’s Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices is the latest effort by federal organizations, including the Office of the National Coordinator for Health Information Technology, to improve the interoperability of healthcare technology and create interoperable systems that are reliable and safe.
The FDA says that patient safety is the most important consideration when designing interoperable devices. It 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. The agency recommends that manufacturers pay particular attention to:
The purpose of the electronic data interface, including the types of data exchanges taking place, such as sending, receiving, or issue command and control.
The anticipated users, which may include clinicians, biomedical engineers, IT professionals, and systems designers.
Mitigating all identified risks, including “inappropriate access to the 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,” according to the draft guidance. The FDA gave the example of a device transmitting the weight of a patient in kilograms when the receiving medical device assumes the measurement is in pounds.
According to the guidance, premarket submissions should include a description of key interoperability characteristics, such as whether the device is meant to transmit, receive, or exchange date — information that should also be included in the labeling. In addition, the agency emphasized that if a device is only meant to interact with specific devices, these devices should be listed in the labeling, and the manufacturer should explicitly state that it should not be used with other devices or technologies.
The public is encouraged to provide comments and suggestions on the draft guidance, and these can be submitted through www.regulations.gov until March 28, 2016.
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