Anda di halaman 1dari 4

Journal of Critical Care (2006) 21, 267 270

Electromagnetic interference in critical care


Stephen E. Lapinsky MB, BCh, MSc, FRCPC*, Anthony C. Easty BSc (Hons), PhD
Intensive Care Unit, Mount Sinai Hospital, Toronto, Canada M5G1X5 Department of Biomedical Engineering, Mount Sinai Hospital, Toronto, Canada M5G1X5 Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada M5B 1W8 Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada M5S 3G9 Keywords:
Critical care; Electromagnetic interference; Mobile communication

Abstract Mobile communication and wireless data transmission are playing an increasing role in health care. Reports describing medical device malfunction related to cellular phones have raised awareness about the problem of electromagnetic interference. Although initial institutional responses were to ban cellular devices in hospitals, these restrictions are relaxing as the knowledge base in this area expands. Medical device malfunction is extremely rare if the distance from the transmitting device is greater than 1 m. This article reviews the current understanding of electromagnetic interference as it applies to the technology-rich critical care environment. D 2006 Elsevier Inc. All rights reserved.

1. Introduction
There are many causes of radiofrequency electromagnetic radiation in the hospital environment, with a dramatic increase in emission sources in the past decade. Several reports since the early 1990s [1-4] have raised awareness about electromagnetic interference (EMI) with critical medical devices, but many misconceptions persist. All electric devices have the potential to produce electromagnetic radiation, but attention has been largely placed on the use of cellular phones. Other common devices to bear in mind include walkie-talkie radios, wireless networks, personal digital assistants, and Bluetooth devices. The frequency spectra, power output, and potential risk of these sources vary significantly (Table 1). Wireless technology has potential benefits for patient care, improving communication and information access [5]. As their penetration into the health
* Corresponding author. Mount Sinai Hospital, Toronto, Canada M5G1X5. Tel.: +1 416 586 4800x3211; fax: +1 416 586 8480. E-mail address: stephen.lapinsky@utoronto.ca (S.E. Lapinsky). 0883-9441/$ see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.jcrc.2006.03.010

care environment increases, blanket bans on wireless devices are gradually being replaced by less-restrictive evidencebased policies. This article reviews current knowledge regarding EMI in health care, with particular reference to the technology-rich critical care environment.

2. What is EMI?
Electromagnetic radiation is emitted intentionally (eg, cellular phones) or unintentionally (eg, computers) by devices that generate electromagnetic fields (Table 2). Unwanted reception of this electromagnetic radiation may affect the functioning of medical devices if they are susceptible. Analog signals or digital data that have been altered by the currents produced by undesired electromagnetic fields are said to be corrupted. Data corruption of digital devices by radiated electromagnetic fields can alter data values, which may produce inaccurate results or even cause a device to freeze as a result of invalid operations. Analog devices may also suffer effects caused by changes in

268
Table 1 Comparison of frequency and power output of common transmitting devices Device Two-way radio Cellphone/Blackberry Wireless local area network (802.11) Bluetooth Frequency 60 to 400 MHz 860 to 1900 MHz 2.4 and 5 GHz 2.4 GHz Power 2 to 5 W 60 mW to 2 W 10 to 100 mW 1 to 10 mW Table 3

S.E. Lapinsky, A.C. Easty


Evolution of cellular technology Analog GSM CDMA TDMA GPRS (GSM based) 1RTT (CMDA based) EDGE (GSM based) UMTS (W-CDMA) EVDO (CMDA 2000)

Generation 1 Generation 2 (9.6-14.4 kbps)

Generation 2.5 (~30-140 kbps) Generation 3 (~140-700 kbps)

currents, producing temporary or permanent malfunctions. Multiple devices in close proximity may interact in unpredictable ways.

Generation 4 (N2 Mbps)


GSM indicates global system for mobile communications; CDMA, code division multiple access; TDMA, time division multiple access; GPRS, general packet radio services; 1RTT, (single carrier) radio transmission technology; EDGE, enhanced data rate for GSM evolution; UMTS, universal mobile telephone standard; EVDO, evolution data only.

3. Factors affecting EMI


The factors affecting EMI can be broadly classified into properties of the emitting device (ie, frequency, which is inversely proportional to wavelength, and power of emissions); the physical relationship between the devices (ie, distance); and susceptibility of the affected device (ie, electromagnetic shielding).

ogies (Table 3) introduce new variables that may affect EMI. Wireless local area networks (802.11) and Bluetooth function at a higher frequency and lower power as compared with cellular devices and are far less likely to produce EMI.

3.2. Distance and environment


For electromagnetic fields, the energy level falls rapidly as the distance from the source increases (proportional to the square of the distance). Clinically relevant EMI is very uncommon at distances greater than 1 m [6-8]. Building structures and many other environmental factors may influence the degree of EMI [9]. Electromagnetic radiation from multiple sources in a dense intensive care unit (ICU) environment may aggregate and produce more pronounced effects than anticipated. Although many factors affecting EMI are difficult to predict, the reduction in field strength with distance is generally predictable.

3.1. Emitting device


The frequency of electromagnetic radiation plays a role in relation to the length of various electric components in the susceptible device. These act as antennae to receive interfering signals. Long wavelengths (low frequencies) transfer minimal energy to small electronic components, and very short wavelengths (extremely high frequencies) are easily shielded. Frequencies between 10 kHz and 1 GHz are generally the most problematic. The amplitude (or power) influences the effect that the EMI has on the susceptible device. Handheld radios transmit at a constant power output of 2 to 5 W. Early analog cellular phones functioned at high power output levels, but more recent digital cellular phones can vary in their power output levels during use and function at less-problematic higher frequencies. The lowest power output occurs during standby operation, with variable power when the cellular phone is in use and maximal power when it is ringing [6]. Power output may be as low as 60 mW, with peaks to 2 W, averaging 600 mW. Within hospitals, shielding from the base station may force cellular devices to operate at higher power. New cellular technolTable 2 Sources of radiofrequency emissions in a hospital environment Wireless transmitting devices Walkie-talkies Cellular phones Bluetooth devices Wireless local area network Medical telemetry Other devices Radiology equipment Electrocautery equipment Fluorescent lights Fire alarms Computers

3.3. Affected device


Electromagnetic compatibility (EMC) refers to the ability of electronic devices of different types to operate in an electromagnetic environment without loss of intended function. The EMC of the affected device affects the degree of malfunction that may occur. Newer devices are designed according to more stringent standards, with attention to shielding and electromagnetic immunity, and are less susceptible to EMI. Equipment manufactured before 1993 are significantly more susceptible to EMI as compared with more modern equipment, which are now subject to International Electrotechnical Commission Standard 60601-1-2 [10]. Even higher standards are required for critical and life-support devices [10].

4. Electromagnetic interference in the ICU


Electromagnetic interference is usually associated with wireless transmitter devices, but it is important to consider

Electromagnetic interference in critical care the radiofrequency emissions produced by other electronic devices (Table 2). Clinically significant effects of EMI from devices that are not specifically designed to transmit signals are uncommon but add to the complexity of the ICU environment. The first reports of cellular phone interactions with medical equipment occurred in the early 1990s, involving devices such as infusion pumps, infant incubator heaters, electric wheelchairs, and ventilators, usually at a close range of less than 2 m [1-3]. Of concern is that silent equipment malfunctions, occurring when normal alarm mechanisms also malfunction, were documented [3]. Pacemakers were subsequently identified as devices at considerable risk for interference by cellular phones [11]. Clinical reports of adverse effects caused by EMI in the ICU environment include rare descriptions of ventilator malfunctions and effects on pulse oximeters, all with a close range exposure [4,6]. A potentially dangerous early report affecting neonatal ICUs identified the heater element of an infant incubator being turned on to maximum heat [12]. Over the past decade, the use of cellular phones has increased dramatically, as have the number and complexity of electronic devices used in the ICU. However, the incidence of EMI has not increased owing to reduced power output from cellular phones and improved electromagnetic immunity of medical devices. Recent reports relevant to the ICU have evaluated the risk of EMI in simulated clinical situations. An early study evaluating the effects of GSM (global system for mobile communications) cellular phones and ultrahigh frequency radios on mechanical ventilators demonstrated varying degrees of temporary effects, with 3 of 22 ventilators failing altogether under some circumstances [13]. A laboratory study on 14 ICU ventilators exposed to an analog cellular phone demonstrated that interference caused the failure of 1 ventilator and affected ventilatory rate, displayed tidal volume, and alarm function in 4 others [6]. These effects only occurred in close proximity (30 cm), with no interference at 1 m. A recent study identified that at distances of less than 1 m, high-power 2-way radios caused significant operating problems for ICU ventilators, including the shutting down of 1 ventilator. Medium-power cellular phones caused some ventilator displays to give erroneous readings, whereas Bluetooth devices were innocuous [14]. The problem of EMI is a moving target as new radiofrequency communication technology is developed and proliferates. Newer cellular technologies that allow faster data transfer are being developed (Table 3), few of which have been tested in a health care environment. A study comparing a third-generation UMTS (Universal Mobile Telephone Standard) system with an earlier GPRS (general packet radio services) digital system found less interference with the newer technology [15]. Wireless area networks (802.11b initially and now 802.11a and 802.11g) are common in the non-medical environment and are now entering the health care field. These higher-frequency and relatively lower-power systems have been evaluated in

269 clinical situations and are unlikely to interfere with medical devices [15,16]. A study evaluating the short-range Bluetooth technology in the ICU, assessing 44 pieces of medical equipment, demonstrated no evidence of EMI [17]. Indeed, medical devices such as patient monitors are now being sold with Bluetooth and 802.11 wireless local area network capability included (eg, Schiller, Maglife C monitor). Most health care institutions initially responded to the problem of cellular phonerelated EMI with an institutionwide ban on cellular phone use, although walkie-talkie use was often permitted despite their higher power output. However, as the knowledge base in this area has grown and with the changing technology and standards for susceptibility to EMI, these rules are relaxing. Our institutions (University Health Network and Mount Sinai Hospital, Toronto, Canada) implemented a ban on the use of cellular phones in 1994 but have allowed such use outside patient care areas since 2000. The only reported incident, at the University Health Network in the mid 1990s, involved the sudden loss of a patients electrocardiogram waveform on an analog telemetry-based central station monitor in a cardiac unit. Prompt investigation by the nurse caring for the patient revealed that several visitors were operating cellular phones in very close proximity to the patient. Once the cellular phones were turned off, the electrocardiogram waveform was restored.

5. Testing for EMC


Medical devices are tested as to the extent that they are susceptible to or are sources of EMI. The International Electrotechnical Commission Standard 60601-1-2 provides standards for EMC testing and documentation for medical devices. Standard test methodologies defined by the American National Standards Institute control emission levels from computing devices. The US Food and Drug Administration requires EMC test data to accompany applications for device approval. The European Community consolidated its EMC regulations with standards for electromagnetic emissions and for immunity to EMI. Device testing by manufacturers cannot fully account for the complexity of an ICU environment. A variety of factors may affect susceptibility, such as the orientation of leads and power cords or whether the device is located on a plastic or metal cart. Devices in the clinical environment may be exposed to radiation from many sources, ranging from cellular phones to computing devices and the much higher power radio transmitters from ambulances. An environmental assessment can be performed to evaluate level of electromagnetic radiation and potential risk for EMI. The susceptibility of devices to the most commonly encountered and highly used wavelengths and power levels of electromagnetic radiation must be assessed. Ad hoc onsite testing procedures have been developed by the Institute of Electrical and Electronic Engineers (C63.18) [18].

270

S.E. Lapinsky, A.C. Easty


[2] Clifford KJ, Joyner KH, Stroud DB, et al. Mobile telephones interfere with medical electrical equipment. Australas Phys Eng Sci Med 1994; 17:23 - 7. [3] Segal B, Retfalvi S, Pavlasek T. bSilentQ malfunction of a critical-care device caused by electromagnetic interference. Biomed Instrum Technol 1995;29:350 - 4. [4] Berek B. Trouble in the air. Electromagnetic interference can wreak havoc with medical devices. Health Facil Manage 1994;7(48):50 - 1. [5] Morrissey JJ. Mobile phones in the hospital: improved mobile communication and mitigation of EMI concerns can lead to an overall benefit to healthcare. Health Phys 2004;87:82 - 8. [6] Shaw CI, Kacmarek RM, Hampton RL, et al. Cellular phone interference with the operation of mechanical ventilators. Crit Care Med 2004;32:928 - 31. [7] Lawrentschuk N, Bolton DM. Mobile phone interference with medical equipment and its clinical relevance: a systematic review. Med J Aust 2004;181:145 - 9. [8] Tri JL, Severson RP, Firl AR, et al. Cellular telephone interference with medical equipment. Mayo Clin Proc 2005;80:1286 - 90. [9] Davis D, Segal B, Pavlasek T. Can minimum separation criteria ensure electromagnetic compatibility in hospitals? An experimental study. Biomed Instrum Technol 1999;33(5):411 - 6. [10] International Electrotechnical Commission (IEC) Standard 60601-1-2. 2nd edition, Part 1-2: General requirements for safetycollateral standard: Electromagnetic compatibilityrequirements and tests, 2002. [11] Barbaro V, Bartolini P, Donato A, et al. Do European GSM mobile cellular phones pose a potential risk to pacemaker patients? Pacing Clin Electrophysiol 1995;18:1218 - 24. [12] Emergency Care Research Institute. Cellular telephones and radio transmittersinterference with clinical equipment. Guidance articleHealth Devices 1993;22:416 - 8. [13] Barbaro V, Bartolini P, Benassi M, et al. Electromagnetic interference by GSM cellular phones and UHF radios with intensive-care and operating-room ventilators. Biomed Instrum Technol 2000;34:361 - 9. [14] Jones RP, Conway DH. The effect of electromagnetic interference from mobile communication on the performance of intensive care ventilators. Eur J Anaesthesiol 2005;22:578 - 83. [15] Wallin MKEB, Marve T, Hakansson PK. Modern wireless telecommunication technologies and their electromagnetic compatibility with life-support equipment. Anesth Analg 2005;101:1393 - 400. [16] Tan KS, Hinberg I. Effects of a wireless local area network (LAN) system, a telemetry system, and electrosurgical devices on medical devices in a hospital environment. Biomed Instrum Technol 2000; 34:115 - 8. [17] Wallin MK, Wajntraub S. Evaluation of Bluetooth as a replacement for cables in intensive care and surgery. Anesth Analg 2004;98: 763 - 7. [18] Institute of Electrical and Electronics Engineers, Inc. American National Standards Institute recommended practice for on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio-frequency transmitters (standard C63.18). Piscataway (NJ)7 IEEE; 1997.

6. Developing an EMC program


We recommend that institutions develop policies that balance the potential for cellular phones, walkie-talkies, and other emitting devices to interfere at close range with medical devices with the need to provide timely mobile communications. Health care providers are becoming increasingly dependent on the use of mobile communication technology to communicate as well as diagnose and treat patients, and this need should be balanced against the concerns about medical device malfunction. As the devices used by professionals can be controlled and tested to some extent, different criteria may be applied to the professional and public use of cellular devices. Many institutions have lifted complete bans on the use of mobile communication technologies and now permit their use in areas where limited or no medical equipment is in use. Some institutions have followed the evidence presented earlier that all significant interference problems occur at distances of 1 m or less. A 1-m rule can be established, in which the use of mobile technologies is permitted even in highly instrumented areas, such as the ICU, provided that they are deactivated within 1 m of any functioning device (for practical purposes, this typically means within a patients room). Health care workers and biomedical engineering staff need to be aware of the problem of EMI, and this should be considered in any device failure or otherwise unexplained adverse event. Protocols to limit transmitting devices and test for EMI should be instituted until the situation is resolved. Wireless networks from the 802.11 family have now been widely deployed in hospital environments, and there is no published report on these systems causing any disruption to medical devices at all at this time. We have experience with the deployment of such a network in an ICU and an operating room environment where extremely low-level signals are being monitored during neurosurgical procedures. No disruption has been observed even in this very sensitive environment. Finally, we recommend that institutions discuss these issues in the context of their specific use of technologies and frame a policy that is clear and straightforward to guide staff, patients, and visitors. We predict that mobile communication will play an increasingly important role in providing effective patient care, and we look forward to the release of mobile devices that will switch between established cellular phone standards such as GPRS and local lower-power wireless networks when these are available. In this way, institutions that are equipped with wireless networks will be able to offer complete communication coverage in all situations without any risk of disrupting medical devices.

Resources
US FDA Electromagnetic Compatibility Program http://www.fda.gov/cdrh/ emc FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities http://www.fda.gov/cdrh/emc/emc-in-hcf.html Mobile Healthcare Alliance www.mohca.org Institute for Electrical and Electronic Engineers http://www.ieee.org/portal/ site Center for the Study of Wireless Electromagnetic Compatibility, University of Oklahoma School of Industrial Engineering http://www.ou.edu/ engineering/emc

References
[1] Silberberg JL. Performance degradation of electronic medical devices due to electromagnetic interference. Compliance Eng 1993;10:1 - 8.

Anda mungkin juga menyukai