The document summarizes a study on electromagnetic interference between RFID systems and critical care medical devices. The study tested two RFID signals - an 868 MHz passive signal and 125 kHz active signal - against 41 medical devices and found 34 interference incidents, with the 868 MHz signal causing 26 incidents including 22 hazardous incidents. The study concludes RFID safety must be carefully managed and standards updated to safely introduce wireless technologies like RFID in critical care environments.

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

21. www.RFIDzorg.nl

22. Is RFID electromagnetic compatible with critical care equipment?

24. Electronic Patient Record in the ICU

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 Draft Guidance for Industry and FDA Staff Radio-Frequency Wireless Technology in Medical Devices Chapter 5: Risk Management for RF Wireless Medical Devices: General Concepts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.

29. June 25, 2008

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

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

41. Donald Berwick

43. Safety rule in aviation: all near accidents finally leads to a real one

45. 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."

46. Nov, 2007

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

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

52. European Telecommunications Standards Institute & ……

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)

58. [email_address]

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

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]