Electromagnetic Compatibility (EMC)
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Summary
Electrically powered (active) medical devices can be susceptible to electromagnetic interference (EMI) from an array of sources and exposures that can create hazards and related risks. With appropriate design, testing, and use active medical devices can be become compatible with the electromagnetic energy in the intended use environment. Electromagnetic compatibility (EMC) of medical devices is essentially the opposite of susceptibility where the device does not emit electromagnetic energy that might affect other medical devices in the vicinity and has a high degree of immunity to the electromagnetic energy in the device use environment. The EMC program has been at the vanguard of performing research and developing test methods for medical device EMC, and presenting this information and expertise in an array of national and international consensus standards and documents with the aim toward providing tools and methods to maintain and enhance medical device safety and effectiveness. The work in this area crosses into the use of various wireless technologies that are increasingly being incorporated medical devices and device systems. One of the fundamental standards for medical device EMC was written with significant input from the FDA: IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests as well as the AAMI/ANSI version and 2nd/3rd editions.
Our program continues to be among the leaders in the world, collaborating in research, testing, and standards development across a host of active medical device areas including both device or components external to the human body as well as implantable devices such as cardiac pacemakers, cardioverter defibrillators, and neurostimulation devices (e.g., Deep Brain Stimulators). The expertise from research work is applied in the development of standards as well as regulatory review of new and improved medical devices submitted to FDA. Research also includes examining the potential for EMI to active devices from common radiofrequency emitters such as RFID, security systems (e.g. anti-theft systems, metal detectors, body scanners). Our program partners with other federal agencies such as the Federal Communications Commission, academic institutions, medical device organizations (e.g., Assn. for the Advance of Medical Instrumentation), and healthcare organizations, and medical device manufacturers to provide expertise, research, testing, and innovative opportunities to advance the safety and effectiveness of active medical devices through electromagnetic compatibility.
The electromagnetic compatibility (EMC) and wireless lab has a long history of working with other federal agencies on issues involving medical device EMC. Presently, the EMC-wireless lab is engaged in an agreement with the Transportation Security Administration (TSA) to evaluate potential safety issues for the passengers screened and security personnel with the next generation of advanced imaging technology (AIT) millimeter waves (mmW) whole body security scanner systems. These AIT systems use small levels of radio waves in the mmW spectrum to help create the security screening image. TSA and FDA share common interest in assessing the potential risks for passengers with Personal Medical Electronic Devices (PMEDs) such as implanted cardiac pacemakers and cardioverter-defibrillators, implanted and body worn neurostimulators, and body worn insulin pumps. Measurements and analysis by the EMC-wireless lab researchers assessed the human exposure risks of passengers passing through an AIT and nearby security personnel finding these exposure levels to be many thousand times below the limits set by International radiation safety standards organizations. The research also included tests of several sample PMEDs for exposure to the AIT system as well as a novel system developed in the lab that simulates the AIT exposure in ways that can be more controlled. None of the PMEDs showed signs of effects during or after the AIT exposures.
FDA engineer performing measurements in the anechoic chamber evaluating interference between radio-frequency identification (RFID) systems and medical devices.
AIT scanner and a PMED being placed in it for testing.
Current funding sources
Personnel
FDA Staff:
Howard Bassen
Brian Beard, Ph.D.
Joshua Guag
Seth Seidman
Jeff Silberberg
Donald Witters
Research Fellow:
Nickolas LaSorte, Ph.D.
External collaborators
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Boston Scientific, Inc.
Cyberonics, Inc.
Medtronic, Inc.
St. Jude Medical, Inc.
Sorin Group USA, Inc.
Transportation Security Administration (TSA)
Resource facilities
- 10m anechoic chamber
- GTEM cell
- Amplifiers covering the entire EMC spectrum (i.e., Hz-GHz)
- DASY5 Robotic measurements system (Zurich, Switzerland)
- EMC test facility for pacemakers and neurostimulators
Relevant Standards & Guidances
IEC 60601-1-2: 2007[3rd Ed.]: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
Association for the Advancement of Medical Instrumentation (AAMI) SM-WG06
AAMI SM-WG06: Addressing radio-frequency wireless coexistence for medical devices and systems
FDA guidance documents:
- Infusion Pumps Total Product Life Cycle
- Design Considerations for Devices Intended for Home Use
- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, July 11, 2016
Selected peer-review publications
- Seidman and Guag, Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification, BioMedical Engineering OnLine 2013.
- Pantchenko et al., Analysis of induced electrical currents from magnetic field coupling inside implantable neurostimulator leads, BioMedical Engineering OnLine 2011, 10:94.
- Kainz et al., Implantable Cardiac Pacemaker Electromagnetic Compatibility Testing in a Novel Security System Simulator, IEEE Transactions On Biomedical Engineering 2005.