The medical device industry has gone wireless — as a GAO report from August 2012 and an episode of Homeland demonstrated last year — and concerns regarding the safety and effectiveness of wireless medical devices are heightened. As a result, FDA has finally released Guidance that:
- Addresses considerations that may affect the safe and effective use of medical devices that incorporate wireless technology; and
- Provides recommendations for information to be included in FDA premarket submission for medical devices and device systems that incorporate wireless technology.
In a blog post discussing the Guidance, FDA stated its “goal is to help industry develop a range of innovative, safe, and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality, and benefit patients and providers alike.”
Key Guidance Points:
Considerations for Design, Testing and Use of Wireless Medical Devices
Designers and manufacturers of wireless medical devices should consider the ability of their devices to function properly in the intended use environments where other wireless technologies will likely be located. FDA requires a risk analysis of wireless communications and control functions as part of the design validation process. The following considerations are especially important during the device design and development process.
1. Selection and performance of wireless technology. The medical device functions and intended uses should be appropriately matched with the wireless technology’s capabilities and expected performance. FDA recommends that manufacturers consider:
- International availability and band allocation;
- Whether the device needs to have primary or secondary radio service classification;
- Incumbent users of the selected adjacent bands; Applicable interference mitigation techniques; and
- For implantable and body-worn devices, tissue propagation characteristics and specific absorption rate.
2. Wireless quality of service. FDA recommends use of a risk management approach to deployment, security and maintenance of the necessary level of service and performance needed for the wireless functions of the medical device.
3. Wireless coexistence. FDA recommends that manufacturers address their device’s environment specifications and needs by considering associated sources of electromagnetic disturbance expected in specific environments, and channel interference from other users.
4. Security of wireless signals and data. Authentication and wireless encryption play vital roles in an effective wireless security scheme. FDA recommends that wireless medical devices utilize wireless protection at a level appropriate for:
- The risks presented by the medical device;
- Its environment of use;
- The type and probability of the risks to which it is exposed; and
- The probable risks to patients from a security breach.
5. Electromagnetic compatibility of the wireless technology. FDA recommends that risk management activities should include using risk analyses to identify any potential issues associated with electromagnetic compatibility and determining risk acceptability criteria based on information about the device and its intended use, including:
- Foreseeable misuse;
- Sources of environmental electromagnetic disturbance; and
- The potential for the device radio frequency emissions to affect other devices.
6. Information for proper setup and operation. Appropriate information, including a warning that other equipment could interfere with the medical device system, should be provided to users of the device to help assure proper setup, configuration and performance of the wireless medical device.
7. Considerations for maintenance. FDA recommends that the manufacturer continue to manage the risks associated with the use of wireless technology for the entire life cycle of the device. Procedures for implementing corrective and preventative action must include analyses of possible trends in nonconformance information and complaints.
Recommendations for Premarket Submissions for Devices that Incorporate Wireless Technology
1. Description of device. In order to facilitate the review of the premarket submission, the device description must include:
- A description of the wireless technology and functions, and the intended use of the medical device and the intended use environment;
- A description of how the design of the device’s wireless functions assures timely, reliable, accurate and secure data and wireless information transfer;
- A description of the alarm signal, priority, how risks are managed and mitigated (if wireless technology is used for transmission, reception or processes involving alarm signals); and
- Identification of whether other wireless products or devices are able to make a wireless connection to the device.
2. Risk-based approach to verification and validation. The submission should include information on:
- The wireless quality of service;
- Any risks and potential performance issues that might be associated with wireless coexistence;
- Any risks, potential performance issues and, if appropriate, risk mitigation measures that might be associated with wireless security; and
- How electromagnetic compatibility has been addressed for the device and all wireless functions.
3. Test data summaries. FDA recommends submitting test summaries including information on:
- A description of the tests performed and the protocols used;
- Reference to appropriate medical device, wireless technology or electromagnetic compatibility standards for the tests;
- Explanations for any deviations from the selected standards;
- Modes of device operation during the testing;
- Specific pass/fail criteria for the testing; and
- A statement that all modifications will be incorporated into all final production units.
4. Labeling related to wireless medical devices. Proposed labeling should include risk mitigation measures that address wireless issues and any precautions users should take. FDA recommends that the following information be included in the device label:
- A summary of the medical device wireless functions and incorporated technology;
- A summary of the operating characteristics of the wireless technology;
- A brief description of the wireless quality of service needed for safe and effective operation;
- A brief description of the recommended wireless security measures;
- Information addressing wireless issues and what to do if problems occur;
- Information about any wireless coexistence issues and mitigations;
- Appropriate electromagnetic compatibility test results;
- Wireless communication information as required by the FCC rules; and
- Warnings about possible effects from radio frequency sources in the device’s vicinity.