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FDA Releases Draft Guidance for Medical Device Interoperability

January 27, 2016
by Heather Landi
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The U.S. Food and Drug Administration released on Tuesday draft guidance as recommendations for medical device manufacturers on how to include interoperability in the design and development of devices.

Safety is the most important consideration for medical device interoperability, the FDA stated in the draft guidance.

“Increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost. However, appropriate safety considerations including system level safety considerations that are not taken into account in the device design can result unforeseen safety and effectiveness issues for the device or for the system,” the FDA wrote.

And, the FDA stated, “Device design elements that factor in interoperability considerations 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.

“The 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The draft guidance calls on device manufacturers to design systems with interoperability in mind and perform a risk analysis and appropriate performance testing that considers the risks associated with interoperability.

“In designing a medical device’s electronic data interface, manufacturers should consider the level of interoperability needed to achieve the purpose of the interface, as well as the information necessary to describe the interface. The labeling should be in sufficient detail to allow any user to connect and use the medical device and interface as it is intended,” the FDA wrote.

Regarding the design of the device’s electronic data interface, device developers should consider the type of devices that it is meant to connect to, the type of data exchange taking place (i.e. sending, receiving, issue command and control), the use of standards (data format, transmission, interface standards), the need for time synchronization and the method of data transmission. Device developers also should consider the clinical context for the use of the information exchanged in the interface, such as an infusion pump used to deliver anesthesia to a sedated patient in the intensive care unit, and the functional and performance requirements of the device as a result of the exchanged information.

Device manufacturers must also consider the anticipated users of the electronic data interface as that will help in appropriately applying risk management strategies for activities such as developing appropriate instructions for use and setting limitations for use of the device, including contraindications, warnings and precautions, the FDA stated.

With security and risk management in mind, the FDA recommends that manufacturers include in their risk management approach a particular focus on the potential hazards, safety concerns and security issues introduced when including an electronic data interface. Device developers should consider whether the device has the ability to handle data that is “corrupted or outside the appropriate parameters” as well as whether implementation and use of the interface degrades the basic safety or risk controls of the device.

And, the FDA recommends that manufacturers include the functional and performance requirements of the electronic data interface in labeling “Manufacturers should also include in labeling any limitations of the connection to discourage any misuse of the device. Precautions, warnings and contraindications should be included in device labeling as well. Validation of labeling should include human factors studies that include all identified potential users of the data interface,” the FDA stated.

"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. "If the interface is only meant to be used by the manufacturer’s technicians for software updates or diagnostics, this should be stated in the labeling in an appropriate way that prevents access by other users."

 

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