Electromagnetic Interference Wireless Medical Telemetry

Description

• Electromagnetic Compatibility Program
• What is Electromagnetic Compatibility (EMC)? September 5, 2002
• CDRH's Role September 5, 2002
• CDRH EMC Working Group September 9, 1996
• Medical Devices and EMI: the FDA Perspective September 9, 1996
• About Wireless Medical Telemetry Service (WMTS) September 1, 2002
  • What is it?
  • FCC order establishing WMTS
  • Authorized users
  • Service rules for equipment and use
  • Use of WMTS

Procedures

Risks/Benefits

• Wireless Medical Telemetry - Electromagnetic Interference (EMI) September 1, 2002
• FDA Public Health Advisory: Risk of Electromagnetic Interference with Medical Telemetry Systems July 11, 2000

Laws, Regulations & Standards

Advice to Professionals

• FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities October 7, 2002
• FDA Public Health Advisory:Interference Between Digital TV Transmissions and Medical Telemetry Systems March 20, 1998

Industry Guidance

• Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device July 10, 2000
• Guidance for EMC in Medical Device Quality Systems October 25, 2000
• Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations September 27, 2000
• Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
• Letter to all Manufacturers of Electrically-Powered Products, Trade Associations and Professional Associations September 4, 1997

Other Resources

• Documents Available to help resolve medical device EMC problems March 25, 1998
• Medical Device EMI Problems and Solutions: What Can/Should We Learn from Reports of Medical Device Electromagnetic Interference? September 9, 1996
• CDRH References on Medical Device EMC September 10, 1997
• Wireless Medical Telemetry - CDRH Initiatives: Timeline of Activities September 1, 2002
• Joint FDA/FCC statement on Wireless Medical Telemetry and Digital TV March 25, 1998
• Center for the Study of Wireless Electromagnetic Compatibility, University of Oklahoma
• IEEE EMC Society October 13, 2005
• Association for the Advancement of Medical Instrumentation (AAMI)
• International Electrotechnical Commission (IEC) (EMC area)
• Emergency Care Research Institute (ECRI)
• UK Medicines and Healthcare Procucts Regulatory Agency