Courtney S. Young, Esq. |Senior Attorney, Medmarc Risk Management
Last week, the FDA released its final guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The draft of this document was issued on January 26, 2016.
The document begins with FDA’s acknowledgment of the increasing prevalence of interconnected medical devices and a statement that “FDA intends to promote the development and availability of safe and effective interoperable medical devices.” It then defines interoperability in this context as “the ability of two or more products, technologies, or systems to exchange information and to use the information that has been exchanged. It relies on § 201(h) of the FD&C Act for the definition of interoperable medical device.
Regarding potential harms associated with errors in interoperability, the guidance provides the example of “transmission of weight in kilograms [by one device] when the receiving medical device assumes the measurement is in pounds” and states that such an error “could lead to patient harm and even death.”
Design Considerations for Interoperable Devices
The guidance highlights the following considerations as appropriately tailored “to the selected interface technology, and the intended use and use environments for the medical device.” I will provide some of the elements the guidance lists under each consideration.
- Purpose of electronic interface
- Types of devices that it is meant to connect to
- Need for time synchronization
- What the user should or should not do with the electronic interface including contraindications, warnings, and precautions on the use of the exchanged information
- Functional and performance requirements of the device as a result of the exchanged information
- The transmission of metadata (UDI, software version, configuration, settings).
- The anticipated user (and what information each user group needs to know)
- Users, operators, and clinicians need to know the clinical uses and potential risks relevant to the use environment and the clinical task at hand;
- Equipment maintenance personnel and hospital clinical engineers need to know what actions to take to verify correct configuration
- Patients may need specific instruction son how to use their device in a home environment
- Risk management considerations
- Whether implementation and use of the interface degrades the basic safety or risk controls of the device
- Whether appropriate security features are included in the design
- Verification and validation
A manufacturer should:
- Verify and validate that when data is corrupted is can be detected and appropriately managed;
- Perform testing to assure that the device continues to operate safely when data is received in a manner outside of the bounds of the parameters specified.
- Verify only authorized users (individuals, devices, systems) are allowed to exchange information with the interoperable device
- Assure that reasonably foreseeable interactions do not cause incorrect operation of other networked systems
- Labeling considerations
- The manufacturer should determine the appropriate way to provide the information based upon the anticipated users and the risk analysis.
- Use of consensus standards
- FDA recognizes the benefits of relying on published consensus standards in the design of medical devices, in general, and in the development of interoperable medical devices, in particular.
Recommendations for Contents of Pre-Market Submissions
The last part of the guidance focuses on what manufacturers of interoperable devices should include in their pre-market solutions. The guidance elaborates on each of these elements: device description, risk analysis, verification and validation, and labeling.