Toward Safe and Effective Wireless Medical Devices and Systems

1. Toward Safe and Effective Wireless Medical Devices and Systems Donald Witters Office of Science and Engineering Laboratories Center for Devices and Radiological Health Food and Drug Administration

2. Safe, effective, reliable, and secure wireless medical devices integrate risk management into the design, testing, deployment and maintenance.

3. Overview • Risks for RF wireless medical devices • Considerations to manage risks • Challenges and opportunities • Summary

4. Wireless Medical Device Issues • Wireless technology is dynamic & changing • EMC: RF wireless is both a source and victim for EMI • Competition/coexistence among users • Convergence, interoperability • Security • Standards

5. Key Terminology • Radio frequency (RF) wireless medical device - a medical device that includes at least one function via RF wireless communications • include data transfer, device control, programming, power transmission, remote sensing and monitoring, and identification

6. WMTS MedRadio (MICS) DTV Wireless Technology Mobile Phones Cognitive Radio Mobile Radio Wi-Fi Bluetooth NFC Zigbee WiMax RFID GPS

7. Wireless Medical Devices* *Based on sample of 303 wireless medical devices.

8. EMC and Wireless Technology Standards and Documents • IEC 60601-1-2 Medical Elect. equip. • ISO 14708-1 Active implantable • ISO 14117 (PC 69) pacemakers, ICDs • IEEE 802.11, Bluetooth, Zigbee • Cellular Telephone • RFID • MedRadio (MICS), WMTS

9. EMC Terminology Electromagnetic Interference (EMI) Disruption of the device function by Electromagnetic energy (EM) Radiated EM (e.g. radio waves) Conducted (e.g. AC power surges) Electrostatic discharge (ESD) Electromagnetic Compatibility (EMC) Device functions properly in its EM environment (immunity); Device EM emissions do not cause EMI in other devices 9

10. RFID Testing with Implantable Cardiac Pacemakers Implantable cardiac pacemaker and lead Inhibited ventricular stimulation From S. Seidman et. al.In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators, JAMA 2010.

11. Medical Device EMC Considerations • Reference standards • IEC 60601-1-2 std. covers most medical electrical equipment • Active implants ISO 14117 (PC69), EN 45502, ISO14708-1 • Emissions and immunity testing • important to include active wireless links • test findings • pass/fail criteria • deviations from standard • Device modifications • User information • IEC 60601-1-2 requirements

12. Additional EMC Considerations Special Concerns Cell phones, Security systems, RFID MRI exposure Special environments? Present standards can be inadequate for wireless medical device concerns IEC 60601-1-2 3rd Ed. and IEC 61326-1 allow an exclusion from testing in the RF wireless frequency band IEC 60601-1-2 4th Ed. is different with immunity testing in common RF emitter bands 12

13. Comparison of Sample Wired vs. Wireless Active Medical Devices (Since 1996)

14. Wireless Medical Device Considerations • Overall risk management • Choice of wireless technology • Wireless functions & performance • Wireless data integrity • Quality of Service • Wireless Coexistence • Wireless security • EMC • Information for user

15. Final RF Wireless Medical Device Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm Wireless technology not covered in this guidance: MRI, X-ray, CT, RF/microwave diathermy

16. Medical Wireless Risks & Priorities Shared risk environment Risk related to device/system intended use, and wirelessly enabled functions and needed performance Consequences of not getting data across wireless link correctly, timely, and securely Life critical functions, high priority alarms, therapy, remote control Risk Low priority data, No therapy or alarms

17. RF Frequencies Used by Wireless Medical Devices* *Based on sample of 324 wireless medical devices

18. Ex. Wireless User Information (1) The X system was designed and tested for RF wireless connections to an appropriately configured and secured WLAN within the {Healthcare} facility. The following equipment and configurations were tested for wireless connection and transmission of X system data and information at the specified Quality of Service.

19. Ex. Wireless User Information (2) Wireless Equipment needed for the X system wireless functions: Model A1 Portable Data Terminal (PDT) X System was used for development and testing with the following features: • Integrated wireless technology IEEE 802.11b/g operating in the 2.4 GHz Industrial, Scientific, Medical (ISM) frequency band • 64 MB RAM • Integrated laser bar code reader RF wireless equipment needed to support a WLAN at the {Healthcare} facility: - model B1 Dual Band Wireless Access Point certified for IEEE 802.11b/g technology - Integrated PC Network Cards certified for IEEE 802.11b/g technology

20. Wireless Protocol Used by Medical Devices* *Based on sample of 326 wireless medical devices

21. Example QoS Information (1) Understanding Wireless LAN Quality of Service To achieve the same level of wireless quality of service demonstrated during testing wireless X device system needs the following service: • Maintain the network according to IEEE 802.11a/b/g standards with encryption. • Traffic on the 802.11 wireless network does not peak at more than sixty percent (60%) for a sustained interval of thirty (30) seconds or more when measured over any continuous six (6) hour period.

22. Example QoS Information (2) Understanding Wireless LAN Quality of Service (cont.) • Handheld devices for the wireless X device system must be configured to 802.11b or 802.11g, channel 6. • Minimum available data rate at the desired location of service must be 2 Mbs. • Recommended wireless network security protocol of WPA2 encryption. • The wireless LAN must have a minimum of two (2) wireless access points with a physical separation of no more than 50 m. • Handheld devices for the wireless X device system must be at least one (1) meter and no more than twenty-five (25) meters from a wireless access point to maintain connectivity. • The error rate of data transfer must be less than 2% dropped packets.

23. Coexistence Testing Sample wireless interferer Device wireless link Sample wireless interferer Distance & orientation Sample wireless interferer Sample wireless interferer

24. Wireless Security Considerations • Wireless security issues • Open architecture • Multiple combinations of technology • Rogue wireless users • Health Insurance Portability and Accountability Act (HIPAA) issues • Wireless security considerations • Authentication – to ensure authorized users • Encryption – to secure sensitive data and wireless links

25. Security of Wireless Signals and Data • Approaches • Part of comprehensive security plan and procedures • see FDA’s draft guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm356186.htm) • Use the most up-to-date wireless security encryptions

26. Ex. Wireless Security Information (1) Wireless Security and SSID The WPA2 wireless security encryption protocol is strongly recommended for all users of the X medical device system in addition to all other security protocols and procedures that are used by the healthcare facility systems.

27. Ex. Wireless Security Information (2) Wireless Security and SSID The X wireless medical device system was designed and tested to work with wirelessly enabled platforms using the IEEE 802.11b/g protocols, which runs under a network ID (SSID) that is broadcast by default to 802.11 capable hardware. To securely operate X wireless medical device system it is recommended that the wireless broadcasting of the SSID be disabled so that only devices communicating over the {Healthcare} facility defined SSID can transmit and receive on the same network.

28. Information for Set-up and Use • Information to properly configure, deploy, use and maintain the wireless device system • Wireless functions and performance • Limitations, environments, proximity of other wireless, international regulations if appropriate • Specific wireless technology (e.g., IEEE 802.11b/g/a), frequencies, wireless modulations, effective radiated RF power • QoS, recommended security information (e.g. WPA2) • EMI recognition & mitigation information • FCC labeling as appropriate

29. Maintaining the Wireless Device • Device Life Cycle • EMI/EMC issues • Accessories, additional equipment (e.g. modems) • Repeated failures at same location or other locations • Servicing • Maintaining wireless integrity and performance

30. Challenges and Opportunities Rapidly changing wireless technology, limited spectrum Wider integration and greater need for shared risk management Increase in home health care with more functions and less on-site management Need for information and standards for safe, secure, and reliable medical systems Opportunity to create products and pathways for wireless in healthcare

31. Summary Medical wireless technology is rapidly evolving and helping to drive innovation in health care. Safe, secure, and reliable wireless medical systems require risk management. 31

32. Summary • Considerations for wireless medical systems include: • Wireless technology, functions and characteristics • QoS, data integrity, coexistence, security, EMC, user information & maintenance • Many challenges and opportunities for research, products, standards, and guidance to meet present and future needs.

33. Safe, secure, and reliable wireless medical device systems require risk awareness and management focused on key considerations including wireless performance, security, and EMC.

34. Donald Witters Center for Devices and Radiological Health, Food and Drug Administration 10903 New Hampshire Ave. Building 62, Room 1130 Silver Spring, MD 20993-0002 USA Phone: 301/796-2483 donald.witters@fda.hhs.gov

35. FDA Semi-Anechoic Chamber