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Electromagnetic Interference:  What You’re Not Hearing About RFID Erik van Lieshout, MD critical care physician (internist-intensivist)  head of Mobile Intensive Care Unit Academic Medical Center, University of Amsterdam,  the Netherlands
 
 
 
 
 
 
 
 
 
 
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www.RFIDzorg.nl
Is RFID electromagnetic compatible with critical care equipment?
 
Electronic Patient Record in the ICU
 
 
 
Draft Guidance for Industry and FDA Staff Radio-Frequency Wireless Technology in Medical Devices Chapter 5: Risk Management for RF Wireless Medical Devices: General Concepts FDA recommends you manage the risks systematically using risk analysis, risk evaluation, and risk controls.
June 25, 2008
 
 
[object Object],[object Object],[object Object],[object Object],[object Object]
 
hazardous incident  (direct physical influence   on a patient by unintended change in equipment function) eg,   total stop of syringe pump or incorrect pacing by an external   pacemaker significant incident  (influence on monitoring with   significant level of attention needed causing substantial distraction   from patient care) eg, incorrect alarm or inaccurate monitoring   of blood pressure light incident  (influence on monitoring   without significant level of attention needed) eg, disturbed   display
[object Object],[object Object],[object Object],[object Object]
type of incidents and distances per signal distance (cm) type of incidents per RFID signal median [range] 868 MHz 125 kHz hazardous incidents 25 cm [5-400] 17 H 5 H significant incidents 310 cm [20-600] 1 S 1 S light incidents 45 cm [0,1-600] 8 L 2 L         30 [0,1-600] 26 8
www.jama.com  ( search: RFID) www.amc.nl/rfid
 
 
 
Donald Berwick
34 incidents (22 hazardous) ,[object Object],[object Object]
Safety rule in aviation: all near accidents  finally leads to a real one
 
There needs to be a growing awareness among hospitals that problems can occur," Collins says. "And it is difficult to say if something, such as an RFID system, will interfere with critical care equipment unless you do a study. Hospitals need to do a risk assessment of every wireless device that comes into the hospital, because [the wireless devices] all create a greater noise level in terms of radio frequency waves.  You really don't know what to expect until they are tested."
Nov, 2007
 
Biomed Instrum Technol. 2008 Nov-Dec;42(6):479-84 Christe e.a. Testing potential interference with RFID usage in the patient care environment No events
[object Object],[object Object],[object Object],[object Object]
60601-1-2 edition 3.0, 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ISO/IEC 18000-1:2004 Information technology – RFID for item management ?? Part 15 regulations Jul 2008: Radio Frequency Devices ?? European Telecommunications Standards Institute ETSI EN 301 489-1 ElectroMagnetic Compatibility ??
60601-1-2 edition 3.0, 2007 Medical electrical equipment - Electromagnetic compatibility
European Telecommunications Standards Institute & ……
[object Object],[object Object],[object Object],[object Object],[object Object]
Testing  all your critical care equipment involved according to the  test protocol Practice for On-site Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity   of Medical Devices to Specific Radio-frequency Transmitters (Standard C63.18, 1997)
 
 
 
[email_address]
Low Frequency (LF) 125-135 KHz  High Frequency (HF) 13.56 MHz  Ultra High Frequency (UHF)  868-930 MHz  Microwave  2.45 GHz  Microwave  5.8 GHz
Part 15 regulations Jul 2008: Radio Frequency Devices field strength  < 11,000 microvolts / meter @ 3 m peak level  < 55,000 microvolts / meter @ 3 m
 
Table 1 Categories of medical devices, interference distances and type of incidents per signal. number of devices distance (cm) type of incidents per RFID signal tested influenced median [range] 868 MHz 125 kHz   infusion / syringe pumps 9 8 30 [0,1-100] 5H*, 3L*** 1H external pacemakers 3 3 25 [5-30] 3H 2H mechanical ventilators 4 2 20 [5-400] 2H 1S dialysis devices 2 2 15 [10-20] 2H pacemaker programmers 2 2 150 [25-600] 1H, 1S** 2H balloon pumps 3 1 50 1H blood warmers 1 1 50 1H heart-lung machines 1 1 10 1H cell savers 1 1 5 1H anaesthesia devices 4 1 325 [25-600] 1L 1L defibrillators 3 2 302,5 [5-600] 2L electrocardiogram devices 1 1 137,5 [25-250] 1L 1L monitors 3 1 50 1L IC beds 2 0 operating tables 1 0 cooling machines 1 0 vacuum pumps 1 0 hazardous incidents 25 cm [5-400] 17H 5H significant incidents 310 cm [20-600] 1S 1S light incidents 45 cm [0,1-600] 8L 2L       42 26 30 [0,1-600]
 
 
 
 

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Amc @ Las Vegas Jan20, 2009

  • 1. Electromagnetic Interference: What You’re Not Hearing About RFID Erik van Lieshout, MD critical care physician (internist-intensivist) head of Mobile Intensive Care Unit Academic Medical Center, University of Amsterdam, the Netherlands
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  • 22. Is RFID electromagnetic compatible with critical care equipment?
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  • 28. Draft Guidance for Industry and FDA Staff Radio-Frequency Wireless Technology in Medical Devices Chapter 5: Risk Management for RF Wireless Medical Devices: General Concepts FDA recommends you manage the risks systematically using risk analysis, risk evaluation, and risk controls.
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  • 34. hazardous incident (direct physical influence on a patient by unintended change in equipment function) eg, total stop of syringe pump or incorrect pacing by an external pacemaker significant incident (influence on monitoring with significant level of attention needed causing substantial distraction from patient care) eg, incorrect alarm or inaccurate monitoring of blood pressure light incident (influence on monitoring without significant level of attention needed) eg, disturbed display
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  • 36. type of incidents and distances per signal distance (cm) type of incidents per RFID signal median [range] 868 MHz 125 kHz hazardous incidents 25 cm [5-400] 17 H 5 H significant incidents 310 cm [20-600] 1 S 1 S light incidents 45 cm [0,1-600] 8 L 2 L         30 [0,1-600] 26 8
  • 37. www.jama.com ( search: RFID) www.amc.nl/rfid
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  • 43. Safety rule in aviation: all near accidents finally leads to a real one
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  • 45. There needs to be a growing awareness among hospitals that problems can occur,&quot; Collins says. &quot;And it is difficult to say if something, such as an RFID system, will interfere with critical care equipment unless you do a study. Hospitals need to do a risk assessment of every wireless device that comes into the hospital, because [the wireless devices] all create a greater noise level in terms of radio frequency waves. You really don't know what to expect until they are tested.&quot;
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  • 48. Biomed Instrum Technol. 2008 Nov-Dec;42(6):479-84 Christe e.a. Testing potential interference with RFID usage in the patient care environment No events
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  • 50. 60601-1-2 edition 3.0, 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ISO/IEC 18000-1:2004 Information technology – RFID for item management ?? Part 15 regulations Jul 2008: Radio Frequency Devices ?? European Telecommunications Standards Institute ETSI EN 301 489-1 ElectroMagnetic Compatibility ??
  • 51. 60601-1-2 edition 3.0, 2007 Medical electrical equipment - Electromagnetic compatibility
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  • 54. Testing all your critical care equipment involved according to the test protocol Practice for On-site Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-frequency Transmitters (Standard C63.18, 1997)
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  • 59. Low Frequency (LF) 125-135 KHz High Frequency (HF) 13.56 MHz Ultra High Frequency (UHF) 868-930 MHz Microwave 2.45 GHz Microwave 5.8 GHz
  • 60. Part 15 regulations Jul 2008: Radio Frequency Devices field strength < 11,000 microvolts / meter @ 3 m peak level < 55,000 microvolts / meter @ 3 m
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  • 62. Table 1 Categories of medical devices, interference distances and type of incidents per signal. number of devices distance (cm) type of incidents per RFID signal tested influenced median [range] 868 MHz 125 kHz   infusion / syringe pumps 9 8 30 [0,1-100] 5H*, 3L*** 1H external pacemakers 3 3 25 [5-30] 3H 2H mechanical ventilators 4 2 20 [5-400] 2H 1S dialysis devices 2 2 15 [10-20] 2H pacemaker programmers 2 2 150 [25-600] 1H, 1S** 2H balloon pumps 3 1 50 1H blood warmers 1 1 50 1H heart-lung machines 1 1 10 1H cell savers 1 1 5 1H anaesthesia devices 4 1 325 [25-600] 1L 1L defibrillators 3 2 302,5 [5-600] 2L electrocardiogram devices 1 1 137,5 [25-250] 1L 1L monitors 3 1 50 1L IC beds 2 0 operating tables 1 0 cooling machines 1 0 vacuum pumps 1 0 hazardous incidents 25 cm [5-400] 17H 5H significant incidents 310 cm [20-600] 1S 1S light incidents 45 cm [0,1-600] 8L 2L       42 26 30 [0,1-600]
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