Wireless Medical Devices
- Coordination with Federal Communications Commission (FCC)
- Benefits and Risks
- Information for Patients
- Information for Health Care Facilities: Risk Management
- Information for Industry: RF Wireless Developers and Manufacturers
- RF Wireless Coexistence Challenges
- FDA Recognized Standards
- Other Relevant Standards for Wireless Medical Devices
- Industry Guidance and Guides
- Reporting Problems to FDA
Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication to support health care delivery. Examples of functions that can utilize wireless include transferring patient data from the device to another source, device control and programming, and monitoring patients remotely. As this technology continues to evolve, it is increasingly incorporated in the design of medical devices.
Examples of the technologies that utilize RF wireless technology include:
The Federal Communications Commission (FCC) oversees the use of the public radio (RF) spectrum within which RF wireless technologies operate. The FDA coordinates our policies on wireless medical device with the FCC to improve government efficiency in the oversight of broadband and wireless enabled medical devices. Our continued work with the FCC will provide medical devices manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize this technology.
- Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the FDA/FCC Public Workshop: Enabling the Convergence of Communications and Medical Systems (2010)
- Joint Statement on Wireless Medical Devices - U.S. Food and Drug Administration, Federal Communications Commission
For information on applicable FCC requirements for wireless medical devices, please refer to the following links:
A good summary of the specifications, output power, frequency bands, and international use of several applicable RF wireless technologies can be found in the ISO technical report TR 21730, Health Informatics – Use of mobile wireless communications and computing technology in healthcare facilities – Recommendations for the management of unintentional electromagnetic interference with medical devices (ISO/TR 21730: 2007(E)).
Incorporation of wireless technology in medical devices can have many benefits including increasing patient mobility by eliminating wires that tether a patient to a medical bed, providing health care professionals the ability to remotely program devices, and providing the ability of physicians to remotely access and monitor patient data regardless of the location of the patient or physician (hospital, home, office, etc…). These benefits can greatly impact patient outcomes by allowing physicians access to real-time data on patients without the physician physically being in the hospital and allowing real-time adjustment of patient treatment. Remote monitoring can also help special populations such as our seniors, through home monitoring of chronic diseases so that changes can be detect earlier before more serious consequences occur.
As wireless developers and device manufacturers increasingly utilize RF wireless technology, they should consider the following:
- Selection of wireless technology
- Quality of service
- Electromagnetic Compatibility (EMC)
The use of RF wireless technology can translate to advances in health care, but patients should be informed about the safe and effective use of these devices in the course of daily life.
If you are sent home with a RF wireless medical device, talk with your physician or health care provider about any restrictions when it comes to the use of personal computers, cellular phones, or any other personal electronic devices that are commonly used in home environments, as they can interfere with signals coming from medical devices that also use wireless technology. In addition, the home electronic devices can add additional burdens on available wireless capabilities (e.g., bandwidth).
Most well-designed and maintained RF wireless medical devices perform adequately. But, an increasingly crowded RF environment could impact the performance of RF wireless medical devices, which makes risk management an important part of integrating RF wireless technology into medical systems.
For additional information, please review FDA’s Recommendations for EMC/EMI in Healthcare Facilities.
Medical devices that incorporate wireless technology introduce some unique risks that should be addressed. The Radio Frequency Wireless Technology in Medical Devices focuses on considerations that should be taken into account to support safe and effective wireless medical devices. Medical device manufacturers are encouraged to read this document to help in the development, testing, regulatory submission and use of wirelessly enabled medical devices.
All types of wireless technology face challenges coexisting in the same space. For example, devices operating under FCC Part 15 rules must accept any interference from primary users of the frequency band. (Note: FCC Part 15 is applicable to certain types of low-power, non-licensed radio transmitters and certain types of electronic equipment that emit RF energy unintentionally.)
The FDA recommends that you periodically consult the FCC website for new specifications and updated information. Mobile wireless equipment can also transmit on an unlicensed basis in frequency bands such as the Industrial, Scientific, Medical (ISM) bands. ISM bands include 900 MHz, 2.4 GHz, 5.2 GHz, and 5.8 GHz and are commonly used for cordless phones and wireless data network equipment.
Through federal law, the FDA has formally recognized several standards related to RF wireless medical devices. When manufacturers submit pre-market notification to the FDA for device clearance or approval, declarations of conformity to these standards may eliminate the need for certain safety and effectiveness data. For more information see:
- ISO 14117 (2012): Active implantable medical devices— Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- AAMI TIR18: Association for the Advancement of Medical Instrumentation – Guidance on electromagnetic compatibility of medical devices in healthcare facilities (2010)
- ANSI/RESNA WC-2: American National Standards Institute/Rehabilitation Engineering and Assistive Technology Society of North America - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs (2008)
- IEC 60601-1-2: International Electrotechnical Commission – Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (2007)
- ANSI C63.18: American National Standards Institute - Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio frequency transmitters (1997)
The IEEE 802.11 family of standards refers to RF, over-the-air interface between a wireless client (such as a medical device) and a base station (or access point) or between two wireless clients. There are several specifications in the 802.11 family, including:
- IEEE 802.11: IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications . This standard applies to wireless LANs and provides 1 or 2 million bits per second (Mbps) transmission in the 2.4 GHz band using either frequency-hopping spread spectrum (FHSS) or direct sequence spread spectrum (DSSS).
- IEEE 802.11a: IEEE Standard for Telecommunications and Information Exchange Between Systems - LAN/MAN Specific Requirements - Part 11: Wireless Medium Access Control (MAC) and physical layer (PHY) specifications: High Speed Physical Layer in the 5 GHz band. This standard is an extension of 802.11 that applies to wireless LANs and provides up to 54 Mbps in the 5 GHz band . The 802.11a standard specifies an orthogonal frequency division multiplexing encoding scheme rather than FHSS or DSSS.
- IEEE 802.11b: IEEE Standard for Information Technology - Telecommunications and information exchange between systems - Local and Metropolitan networks - Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) specifications: Higher Speed Physical Layer (PHY) Extension in the 2.4 GHz band . This standard is an extension to 802.11 that applies to wireless LANS and provides 11 Mbps transmission (with a fallback to 5.5, 2 and 1 Mbps) in the 2.4 GHz band. The 802.11b standard specifies only DSSS and allows wireless functionality comparable to Ethernet.
- IEEE 802.11g: IEEE Standard for Information technology-- Local and metropolitan area networks-- Specific requirements-- Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications: Further Higher Data Rate Extension in the 2.4 GHz Band . This standard applies to wireless LANs and provides 20+ Mbps in the 2.4 GHz band.
- IEEE 802.11n: IEEE Standard for Information technology-- Local and metropolitan area networks-- Specific requirements-- Part 11: Wireless LAN Medium Access Control (MAC)and Physical Layer (PHY) Specifications Amendment 5: Enhancements for Higher Throughput. This standard is an amendment to WLAN MAC and PHY specifications, intended to serve as an upgrade to all existing IEEE WLANs. An actual data transfer rate of 100 Mb/s is planned, with compatibility for devices conforming to IEEE 802.11a/b/g.
- Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff (2013)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (2013)
- Wireless Medical Telemetry Risks and Recommendations (2000)
- Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry (2000)
- Electromagnetic Compatibility Aspects of Medical Device Quality Systems
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with RF wireless medical devices. We encourage health care providers and patients who suspect a problem or hazardous event to file a voluntary report through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Health care personnel employed by facilities that are subject to Reporting Adverse Events (Medical Devices) requirements should follow the reporting procedures established by their facilities.
Manufacturers, distributors, importers, and device user facilities (which include many health care facilities) must notify the FDA immediately upon discovery of any accidental radiation occurrence or radiation safety defect by Reporting Adverse Events (Medical Devices).
- FDA Safety Communication: Cybersecurity for Medical Devices and Hospitals Networks
- FDA: Electromagnetic Compatibility (EMC)
Association for the Advancement of Medical Instrumentation: Healthcare Technology in a Wireless World Association for the Advancement of Medical Instrumentation: Wireless Technology