The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively.
For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices. It demonstrates the FDA’s focus on the safety and effectiveness of devices as implemented in an interconnected environment and the expectations of FDA on manufactures to anticipate and design for anticipated uses and reasonably foreseeable misuses. Manufactures should consider this guidance in the design, development, and on-going monitoring of connected medical devices.
This guidance may be helpful for other audiences as well:
- Care providers that frequently interact with medical devices in the course of patient care
- Hospital IT teams who make device purchasing decisions
- Vendors of health technologies that frequently exchange data with medical devices
FDA emphasizes two goals:
- Protecting patient safety: FDA recognizes that when medical devices fail to seamlessly talk to each other, patient safety is at risk. A repeated example included in the guidance is a medical device that interacts with other technologies to control dosage of a medication.
- Promoting transparency: FDA encourages manufacturers to be open about the operating requirements of their products, allowing providers and their IT teams to make informed choices about what will work in their care setting.
The guidance includes many specific examples of risks, testing approaches, and strategies for design for devices and premarket approval submission. Some of the key takeaways include:
Keep in Mind the Intended Use and Anticipated Users: To help providers understand how to use their connected device seamlessly with other technology, FDA recommends that manufacturers clearly state their device’s intended use in device labeling and include specific instructions on what levels of interoperability are needed to connect with other devices. The agency also suggests that continuously referring to the device’s intended purpose, use, and users throughout the design process can help mitigate common flaws that block the flow of data between devices.
Appropriately Manage Risk: FDA encourages manufacturers to think ahead about what can go wrong when it comes to the interoperability of their product with the myriad of other technologies that can proliferate in clinical care settings, and mitigate risks accordingly. This includes intended and unintended access of medical devices through the interface. The agency recommends creating a risk analysis for each connected device and conducting testing to account for different scenarios that may result in harm to a patient. The guidance specifically mentions safety hazards and security risks as examples of problems that manufacturers should consider and address.
Set Clear Expectations: FDA emphasizes including performance and technical requirements in device labeling – information that will help providers to make more informed decisions when selecting connected devices for their patients. FDA wants purchasers and end users of these devices to know what they are buying and avoid surprises when one device doesn’t work as expected with others in the hospital setting.
Put the Users First: A user-centered approach is an important theme of this guidance, and FDA encourages manufacturers to think about all the different people who may be utilizing their products, and design with them in mind. This includes not only physicians and other care providers in a clinical setting, but also individual patients using devices in their home, IT professionals, and engineers and designers of other medical devices who may need to integrate with other manufacturers’ products.
Test, Test, Test: FDA recommends that manufacturers systemically validate and verify that their products function in the way that they were intended, taking into account continued use over time, upgrades and bug fixes, and connection with other devices.
Build off Consensus: FDA recognizes that several interoperability standards have been developed by industry and encourages their use to reasonably ensure that medical devices interact seamlessly with each other and other technologies in the clinical setting or patient’s home. However, the guidance also allows that manufacturers may choose “their own design preferences” instead of a standard. Whether or not a manufacturer leverages standards, FDA reiterates that transparency about device requirements are key to ultimately achieving interoperability with other technologies. Thus, manufacturers seeking a more unique or tailored design retain some flexibility.
How to Interpret This Guidance
The guidance represents the FDA’s most recent thinking and perspective on what manufacturers should keep in mind as they design their products. It does not create any new requirements for the design or premarket submission process, but it does suggest criteria that FDA will focus on in their review and considerations in applying existing authority. Therefore, manufacturers should always pay close attention to agency recommendations and suggestions when putting together their premarket submissions. For example, if a company chooses to eschew a consensus-based standard in favor of their own unique approach, it is a good idea to detail why its approach is best suited for its users and the relevant care setting, including how their approach focuses on patient safety and enhances user experience. Manufacturers should also consider previous relevant guidance from FDA, including “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” and “Postmarket Management of Cybersecurity in Medical Devices.”