Radio Frequency Wireless Technology in Medical Devices
This guidance addresses considerations for medical devices incorporating RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and EMC. It applies to implanted, worn, and external wireless medical devices used in hospitals, homes, clinics, laboratories and blood establishments. Both induction-based and radiated RF technology devices are covered.
What You Need to Know? 👇
What are the key considerations when selecting RF wireless technology for medical devices?
When selecting RF wireless technology, consider the medical device functions to be wirelessly enabled, intended use environment, data integrity requirements, international frequency band allocation, interference mitigation techniques, and tissue propagation characteristics for implantable devices.
How should manufacturers address wireless coexistence in medical device design?
Manufacturers should test devices in the presence of expected in-band RF sources, consider co-channel and adjacent channel interference, assess environmental EMD sources, and implement appropriate risk mitigation measures based on the intended use environment.
What wireless security measures does FDA recommend for medical devices?
FDA recommends implementing wireless encryption appropriate to device risks, protecting against unauthorized access, using up-to-date security protocols like WPA2, avoiding known vulnerabilities like WEP, and carefully managing discovery modes in wireless technologies.
How does EMC testing differ for wireless medical devices compared to standard requirements?
Wireless medical devices require additional EMC testing beyond IEC 60601-1-2 standards, including testing with wireless communications actively transmitting during immunity testing, since standard EMC exemptions don’t adequately address in-band electromagnetic disturbances.
What information must be included in premarket submissions for wireless medical devices?
Submissions must include device descriptions with wireless specifications, risk-based verification and validation data, wireless QoS requirements, coexistence testing results, security measures, EMC testing summaries, and comprehensive labeling addressing wireless-specific considerations.
What are the main risks associated with RF wireless technology in medical devices?
Key risks include lost or corrupted transmissions, electromagnetic interference, compromised wireless security, inadequate quality of service, coexistence issues with other wireless devices, and potential misuse due to insufficient user instructions.
What You Need to Do 👇
Recommended Actions
- Perform comprehensive risk analysis of wireless functions and technology selection
- Implement appropriate wireless security measures including encryption and access controls
- Conduct thorough verification and validation testing of wireless performance, coexistence, and EMC
- Develop clear user instructions for wireless setup, operation and maintenance
- Include required wireless-related information in device labeling
- Establish ongoing monitoring of wireless-related issues through the product lifecycle
- Maintain documentation of wireless design considerations and testing
- Consider international aspects of wireless frequency usage
- Implement appropriate quality system controls for wireless components
- Establish procedures for investigating wireless-related failures or complaints
Key Considerations
Non-clinical testing
- Test for wireless coexistence with other RF devices expected in the use environment
- Test EMC with wireless functions actively transmitting during all EMC immunity testing
- Validate wireless performance including data throughput, latency, and data integrity
- Test security measures and protection against unauthorized access
Human Factors
- Consider user interface aspects related to wireless setup, configuration and troubleshooting
- Provide clear instructions for proper wireless setup and operation
- Include information about wireless limitations and potential interference sources
Software
- Implement appropriate error control processes for wireless data transmission
- Include software protections for wireless data security and access control
- Validate software aspects of wireless functions
Cybersecurity
- Implement appropriate wireless encryption and authentication
- Protect against unauthorized wireless access to device control and data
- Consider security implications of wireless discovery modes
- Maintain secrecy of encryption keys
Labeling
- Include wireless technology specifications and operating characteristics
- Provide wireless security setup and maintenance information
- Include warnings about potential RF interference sources
- Specify wireless coexistence considerations and separation distances
- Include FCC-required wireless labeling
Safety
- Ensure reliable wireless transmission of safety-critical functions and alarms
- Consider backup modes for loss of wireless connectivity
- Address priorities for wireless system access
- Validate safety aspects of wireless functions
Other considerations
- Consider international frequency band availability
- Address wireless quality of service requirements
- Consider tissue propagation for implanted/worn devices
- Maintain wireless function integrity during servicing
Relevant Guidances 🔗
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations and Recommendations for Interoperable Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms 📂
- IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
- ISO 14708-1: Implants for surgery - Active implantable medical devices - General requirements
- IEEE 11073-00101: Guidelines for RF Wireless Technology in Medical Devices
- IEC TR 80001-2-3: Risk Management for IT-Networks with Medical Devices - Wireless Networks
- ANSI/AAMI PC69: EMC Test Protocols for Implantable Cardiac Devices