Anda di halaman 1dari 11

FOCUS: Mobile Computing

Safe Use of Cellular


Telephones in Hospitals:
Fundamental Principles
and Case Studies
Ted Cohen, MS, CCE; Willard S. Ellis, PhD, MD; Joseph J. Morrissey, PhD;
Craig Bakuzonis, MEng, CCE; Yadin David, PE, EdD, CCE; and W. David Paperman, CE

A B S T R A C T
Many industries and individuals have embraced cellular telephones. They provide mobile,
synchronous communication, which could hypothetically increase the efficiency and safety of
inpatient healthcare. However, reports of early analog cellular telephones interfering with critical lifesupport machines had led many hospitals to strictly prohibit cellular telephones.A literature search
revealed that individual hospitals now are allowing cellular telephone use with various policies to
prevent electromagnetic interference with medical devices. The fundamental principles underlying
electromagnetic interference are immunity, frequency, modulation technology, distance, and power.
Electromagnetic interference risk mitigation methods based on these principles have been
successfully implemented. In one case study, a minimum distance between cellular telephones and
medical devices is maintained, with restrictions in critical areas. In another case study, cellular
telephone coverage is augmented to automatically control the power of the cellular telephone.
While no uniform safety standard yet exists, cellular telephones can be safely used in
hospitals when their use is managed carefully.

K E Y W O R D S

Cellular telephones

Hospital
EMI

Medical devices
Distance
Power

Introduction
Inpatient healthcare requires multiple, simultaneous
processes and teamwork involving physicians, nurses, unit
secretaries, and ancillary staff. Frequent communication is
necessary to ensure safe and efficient delivery of healthcare.
The inefficiencies of traditional communications methods
were highlighted by a recent study comparing wireless
voice communications to overhead paging, estimating a

38

Journal of Healthcare Information Management Vol. 19, No. 4

Safety

Interference

potential savings of more than 3,400 hours per year on two


32-patient hospital wards.1 Furthermore, it is estimated that
from 44,000 to 98,000 fatal medical errors occur annually in
U.S. hospitals2 and that many could have been avoided
through better communication. Efficient and improved
communications should contribute to both cost savings and
safety improvements in healthcare delivery.
Other industries and many private individuals have

FOCUS: Mobile Computing

embraced cellular telephones to increase productivity and


facilitate mobile communication. To date, there is little
published data describing the benefits of cellular telephone
use by healthcare providers. Even so, many clinicians
reportedly prefer to be contacted by mobile phone,3 and
some large hospitals already have incorporated wireless
communications devices, including cellular phone systems,
for their staff as a principle means of in-house and offcampus communication.
Many hypothesize that another benefit from cellular
telephone use is the reduction in ambient noise, such as
overhead pages.4 Cellular phone systems also offer mobility
to both caller and receiver, increasing efficiency by helping
them make use of time moving between tasks inside the
hospital. In addition, patients and visitors have frequently
indicated that they would like the convenience of using
their cellular phones in the hospital.5

Other industries and many private


individuals have embraced cellular telephones
to increase productivity and facilitate
mobile communication.
Despite these possible benefits, the healthcare industry
has been reluctant to embrace cell phones. Much of this
reluctance stems from anecdotal reports of early analog
cellular telephones and handheld radios interfering with
critical life-support machines and later reports that even
modern, digital cellular telephones can cause malfunctions,
including irrecoverable cessation of ventilation under test
conditions.6 Hospitals in England, France, Germany, and
some in the United States (see Table 1), have strictly
prohibited cellular telephones, with some employing
electronic mobile phone detectors to enforce the ban.7
However, many hospitals are in the process of changing
their policies. Specifically, in July 2004, the Medicines and
Healthcare Products Regulatory Agency (MHRA) of the UK
released new guidance specifying that a total ban on
mobile phones in hospitals was not necessary, although
appropriate management procedures were needed.
For this review, researchers attempted to identify appro-

priate management procedures with a review of the literature. A search of the PubMed database using the terms
cellular telephone identified 443 articles published as of
March 2005. Of these, 38 articles were identified as relevant
to cell phone use in hospitals. Articles were excluded that
addressed interference with implanted devices and biological effects of electromagnetic fields because those topics
are not specific to a hospital environment. Although many
articles exist, they report testing of specific devices; no
universal guidelines or management procedures have
been published.
The Science of Interference
The ability of electromagnetic emissions from cell phones
to interfere with medical devices is based on properties of
propagation of electromagnetic energy: the output power of
the cell phone (source), the frequency and modulation
technology, the separation distance between the source and
medical device, and the immunity of the medical device.
Irnich and Tobish tested more than 220 electronic
devices in a hospital environment and were able to demonstrate greater than 98 percent safety when cellular
telephones were kept more than one meter away.8
However, using different cell phones and medical devices,
various hospitals have recommended safe distances varying
from arms length to three feet, one meter, two meters, to
even five meters.6,7,8,9,10 One practical version of distancing
cell phones from critical medical devices is to allow them in
specific locations, such as non-patient care areas of the
hospital, but exclude them from more sensitive areas, such
as intensive care units and emergency departments.7
More recent policies among several hospitals have taken
advantage of the dynamic power control feature in modern
digital cell phones designed initially to conserve their
batteries by transmitting at low power in areas of good
cellular coverage. Switching to low power decreases the
electromagnetic field generated by a cell phone and its
potential to interfere with medical devices.
Thus, some hospitals have chosen to embrace and
control the technology.11 These hospitals have arranged for
installation of either microcells (small-scale base station
sites) or repeater antennas (in-building antennas linked to
an external antenna to augment interior coverage) to
increase signal coverage, thereby causing staff telephones to

Journal of Healthcare Information Management Vol. 19, No. 4

39

FOCUS: Mobile Computing

transmit at lower power levels. Some hospitals have chosen


a single service provider to outfit their building, although
only cell phones operating on that network can be assured
of appropriate dynamic power control. However, this
concept can be extended to any modern digital cellular
telephone technology. For example, Beth Israel in Boston
has chosen a vendor-neutral solution by installing a microcell, and when you walk into the building, your cell phone
switches to B[eth] I[srael] as your service provider.11
Recognizing the current flux in hospital policies, this
article further reviews and explores the fundamentals of
medical device interference from cellular telephones and
includes two case studies demonstrating successful
mitigation methods.
Interference
As shown in Table 2, and described in several other
studies,12,13,14,15,16 cell-phone-induced electromagnetic interference, or EMI, events can be repeatedly generated under test

40

Journal of Healthcare Information Management Vol. 19, No. 4

conditions in susceptible medical devices. To test worst-case


scenarios and create repeatable test methodologies, many of
these reported laboratory tests were performed with the
mobile phones transmitting at maximum handset power.
Problems encountered are shown in Table 2 and range
from small changes in ventilator parameters at close range
(test samples number 1,4,5,7) to total shutdown of an
infusion pump at close range (test sample number 12) to
chronic interference on a defibrillator monitors ECG display
(test sample number 9C). Figure 1 shows more detail on the
defibrillator monitor test sample. Additional testing was
done on some very sensitive equipment used in the
operating roomthe Cadwell model Cascade 16 neuromonitoring device17 showed interference at low power levels
from most cell phones. These EEG devices are intended to
amplify very low signal levels, and because of that, their
high-gain amplifiers are prone to interference, even from
relatively low-power interference sources.
Recognizing that interference occurs with specific

FOCUS: Mobile Computing

medical devices and cellular telephones is the first step in


risk mitigation. The criticality of the EMI event must be
objectively determined by the hospital. Interference is a
function of several differing and interacting factors that
include medical device immunity, frequency, modulation
technology, distance, and power.
Immunity. EMI is not limited to cellular telephones; it
can theoretically occur between any two devices that either
intentionally or unintentionally emit electromagnetic energy.
Medical equipment manufacturers generally comply with a
10 volts per meter immunity level against interference from
radio frequency emissions in the design of new life-critical
medical devices.18 However, not all new medical devices
comply with the IEC immunity standard, and there are
many older medical devices in use that do not meet this
standard. Even on relatively new devices, some manufacturers continue to recommend cell phone/medical device
separations of as much as 10 meters presumably because
their devices do not meet the IEC immunity standard.19 A
careful inventory of medical devices and their immunity
characteristics is very useful in designing a risk mitigation
policy. However, even a hospital with new equipment,
uniformly meeting the IEC immunity standard, still would
be vulnerable to interference because cellular telephones
may exceed 10 volts per meter when operating in close
proximity.16
Frequency and modulation technology. Cell phones
utilize transmission frequencies that are licensed by the FCC

and other government organizations outside the US and are


dedicated to cell phone use.
Over time, and in different
countries throughout the world,
various cell phone modulation
technologies and frequencies
have been used. Older, so-called
first-generation analog (1G) and
early digital technologies, such as
certain types of TDMA, are being
phased out and replaced by
second-generation (2G) GSM and
CDMA technologies.15 Newer
global CDMA standards (3G)
have been defined, and this new
technology is under development. No one has yet developed
a way to empirically determine
the interference impact of a
specific frequency or modulation
technology on a given medical
device. However, even limited
testing (see Table 2) demonstrates that cellular telephones
with different frequency or
modulation technologies produce different patterns of interference. Also, some handsets are multi-mode and can have
differing potential interference characteristics, depending on
the network available at a particular location. Morrissey15
discusses more detailed information on power control,
frequency, and modulation technology. Because interference risk as a result of frequency and modulation is difficult
to predict, hospitals should choose staff cell phones with
one specific technology or perform worst-case scenario
testing with multiple technologies.

Recognizing that interference occurs with


specific medical devices and cellular telephones
is the first step in risk mitigation.

Distance. A fundamental principle of electromagnetic


fields is that they decrease exponentially as distance from
their source increases. Figure 2 shows the average electromagnetic field strength generated by cell phones as a
function of distance. At close distancesless than one
meterfield strengths can exceed the current IEC medical
device immunity standard for life-critical equipment of 10
volts per meter.18 At distances greater than one meter, field
strengths rapidly decrease and become increasingly unlikely

Journal of Healthcare Information Management Vol. 19, No. 4

41

FOCUS: Mobile Computing

to cause any interference issues. Therefore, separation


is one key to safe use of cell phones in healthcare
environments.
However, although the fundamental principles apply to
any cell phone technology, actual field strengths at any
particular distance vary depending on the specific environment, cell phone modulation technology, and maximum
handset power. The first case study describes the testing
required and implementation of a safe cellular telephone
policy based on specific devices and separation distances
(see Figure 2).
Power. Modern digital, cellular telephones have a
second characteristic that can be exploited to create a safe
cellular telephone policy. To optimize battery life and
prevent interference with other cellular telephones,
individual handsets attempt to operate at the lowest power
that provides reasonable signal quality. Cell phone systems
automatically adjust for low signal strength by increasing
power up to the power maximum of the particular cell
phone handset. Cell phone systems make this power adjustment automatically without respect to the reason for the
poor signal quality, for reasons that can include building
interference, distance, and other factors. Building construction, including the density and thickness of steel and
concrete, the number of walls separating the handset from
the controlling base station, shielding and reflecting objects,
multipath considerations, and location of external base
station sites with respect to the building all can greatly
affect the transmission characteristics of the cell phone

42

Journal of Healthcare Information Management Vol. 19, No. 4

signal. Hospitals are typically built


with large amounts of steel and
concrete, and are often comprised
of interconnecting buildings built
at different times with differing
construction and materials. Figure
3 shows typical average cell
phone power levels of 0.1 watts
for facility A, which has fair to
poor coverage, but typical power
levels are 10 times lower (0.01
watts and less) at facility B, which
has good coverage.
Following electrical engineering
convention, powerthe Y axis in
Figure 3has been plotted on a
logarithmic scale. The values listed
are average power output from a
GSM handset operating on a US
1900 MHz network and may be
different for GSM handsets
operating on other frequency
bands (850 MHz in the US, 900 or
1800 MHz in Europe) or for
handsets operating on other
technologies, such as CDMA. Because the digital GSM
signal is repeatedly pulsed over a series of timeframes,
the peak power values will be higher than the listed
average power values (for GSM, by a factor of eight times,
since there are eight available time slots in a repeating
time frame).

Many hospitals are choosing to implement a


controlled mobile phone system for use by
hospital staff.
Finally, while the figure accurately illustrates dynamic
power control over a short time period, even in the
presence of good network coverage, handsets may transmit
several short bursts at full power immediately following
power-on and registration or when receiving signal and
exchanging information with a priority network site. Also,
because of very high traffic volume, a handset might be
reallocated to a more distant network site. However, these
scenarios would be uncommon in a fixed location, such as
a hospital room, and any transmission bursts would be very
short, such as fractions of a second; the vast majority of the
time, handsets localized to a confined hospital area would
remain under the constant control of a single network base
station with dynamic power control.
Recognizing that digital cellular telephone power output
varies automatically, it is possible to design an environment

FOCUS: Mobile Computing

in which handsets operating on that network transmit


at managed power levels. The second case study
describes the testing, design and implementation of a safe
cellular telephone system based on creating adequate
cellular coverage.
Risk Mitigation Methods
Most hospitals have policies on mobile phone use,
however these policies can run the gamut from total ban to
controlled use of only certain tested and labeled cell
phones to no controls at all. There are currently no regula-

As communications technology evolves,


medical devices become less EMI-prone and
more is learned about medical device
interference, additional less complex options
will become available.
tions or requirements in the US that mandate mobile phone
controls in hospitals. Although testing at maximum power
shows potential for cell phone-caused interference to
susceptible medical devices, cell phones are increasingly
common in hospitals, and reports of adverse interferencerelated events from the government and other patient
safety-related databases suggest that the overall risk to
patients remains very small.14 It is unknown if such
events are not occurring or if underreporting of such
events is substantial.
Many hospitals are choosing to implement a controlled
mobile phone system for use by hospital staff. Such a
controlled system can take many forms, including adding

additional infrastructure,
such as microcells or
repeaters, using only
certain tested and labeled
phones, designated areas
for cell phone bans (ICUs,
operating rooms, and
EEG laboratories), designated areas for public
cell phone use, and any
and all combinations of
these and other management strategies.
The appendix to this
article documents two case
studies of controlled
implementation of cell
phones. In both cases,
considerable testing was
completed by hospital
clinical engineering staff using simplified versions of the
ANSI/IEEE ad hoc testing recommendations.20 Also in
both cases, administrative controls were developed to
regulate policies, separation requirements, signs, and
continued testing.
Texas Childrens Hospital recently conducted a cell
phone testing program in two of its inpatient areas. The
facility previously had a total ban on cell phones. Based on
the study, the facility implemented administrative controls to
allow cell phone use (from several different carriers but not
all) with a three-foot separation recommendation
throughout the institution. However, the ban will continue
in critical care areas until further testing is completed.
Shands Hospital at the University of Florida used added
infrastructure in key areas to provide coverage at reduced
transmission power (targeted 60 milliwatts maximum) in all
patient care areas. In its case, the infrastructure was funded
by the cell phone carrier, with the hospital guaranteeing an
increase in the number of subscribers to that carrier. Also,
public use of that specific carriers cell phones is allowed
within the hospital.
Conclusions and Future Directions
Safe cell phone use in hospitals requires management
controls. Patient safety should not be compromised for staff
and visitor convenience. However, cell phones offer significant communication improvements for staff, which may, in
itself, improve patient safety. Various safe methods can be
used to manage cell phones, with the primary tradeoff
being cost (for example, adding in-building cellular infrastructure) vs. coverage. Options include adding widespread
infrastructure, adding limited infrastructure in areas where it
is believed to be most essential to tightly manage cell
phone emissions, mandating specific tested cell phone

Journal of Healthcare Information Management Vol. 19, No. 4

43

FOCUS: Mobile Computing


models only, banning cell phones in certain critical areas,
mandating separation between cell phones, patients, and
their medical devices, and many other controls.
Although no laws in the US exist to control cell phones
in hospitals, the management options outlined above are
consistent with the recommendations of ECRI14 and the
International Standards Organization (ISO) TC215 technical
report No. 21730 on electromagnetic compatibility with
medical devices.21
Results of interference testing is just one of several
factors to consider when deciding on a specific cellular or
other wireless communication technology. Other important
factors include the local wireless environment, local
telecommunications conditions, cost issues, clinical culture
and structure, and timing, because the technology is
evolving rapidly. Potential mitigation techniques should be
based on the issues found during testing and local conditions. Often, both management and engineering controls are
used together to provide a reasonable safety margin. For
example, at Texas Childrens Hospital, management
controls, in the form of policies and education, are used to
restrict cell phone use to only certain types of phones and
only in certain hospital areas. Alternatively, at Shands
Hospital, an engineering solution in the form of installation
of an internal antenna infrastructure facilitating handset
power management is used to provide a safe cellular
phone solution.
Some hospitals have successfully implemented safe cell
phone systems, which are subjectively improving staff
communication and increasing convenience for patients and
visitors. Communication technology should not be chosen
solely on EMI considerations, because some RF signals can
cause EMI under unmanaged conditions, and all modern
wireless communication technologies can be managed to
operate compatibly if appropriate management and
engineering controls are implemented.
As communications technology evolves, medical devices
become less EMI-prone and more is learned about medical
device interference, additional less complex options will
become available. Decisions must be made that are safe for
the local conditions and planned technology, with the
knowledge that changes are inevitable and regular followup will be required. Subsequent studies on the potential
positive effects of communication improvement, as well as
public sentiment5 will likely increase demand for cell phone
implementation in hospitals.
Existing and new technology can be expected for both
healthcare communications and medical device data transport. Providers are deploying 802.11b/g (2.45 GHz) and
802.11a (5 GHz) systems to carry basic point-of-care

medical device information, and these networks may carry


real-time patient data in the near future. Voice communication on unlicensed bands using Voice over IP (VoIP) protocols on 802.11a/b/g networks offer low-power in-building
alternatives that might be combined with traditional cellular
telephones in the near future. Other low power technologies (e.g., 802.15.1 / Bluetooth, 802.15.4 / Zigbee) as well
as broadband and ultra wideband technologies (e.g.,
802.15.3a, 802.16) might have potential healthcare applications in the future. The merging of these technologies with
cell phone handsets capable of transmission on many
different licensed and unlicensed networks will add more
capability but also increase the complexity of medical
device EMI as well as RF spectrum management. Although
the field continues to evolve and no uniform standard yet
exists, risk mitigation and cell phone use in hospitals will
continue to expand.
Acknowledgments
The authors wish to acknowledge James Hibbets and
Biju Joseph of the Biomedical Engineering Department at
Texas Childrens Hospital for their contributions. The
authors note that Motorola provides equipment to many
cellular phone carriers. Each hospital mentioned in this
article uses a different cellular telephone carrier and equipment from different manufacturers.
About the Authors
Ted Cohen completed his MS in biomedical
engineering. He is a certified clinical engineer and is
currently the manager of clinical engineering for UC
Davis Health System.
Willard S. Ellis completed a PhD in bioengineering at
UC-Berkeley and MD at UC-San Francisco. He is currently a
hospitalist and assistant clinical professor at UC-Davis.
Joseph J. Morrissey is a staff scientist and engineer at
Motorola Labs.
Craig Bakuzonis received a BS and MEng in biomedical
engineering from Rensselaer Polytechnic Institute. He is
currently director of clinical engineering at Shands Hospital.
Yadin David is director of biomedical engineering at
TCH, appointed in Pediatrics, Baylor College of Medicine,
received Special Citation from the FDA Commissioner, and
is president of the Healthcare Technology Foundation.
William D. Paperman studied digital control and
communications systems, served in the U.S.A.F. Armament
Systems Personnel Research Laboratories, and worked as
clinical engineer at TCH. He now consults on communications systems.

References
1. Breslin, S., Greskovich, W., & Turisco, F. (2004). Wireless Technology Improves Nursing Workflow and Communications. Comp Informatics
Nursing, 22, 275-281.

44

Journal of Healthcare Information Management Vol. 19, No. 4

FOCUS: Mobile Computing


2. Kohn, L.T., Corrigan, J.M., & Donaldson, M.S. (1998). To Err Is Human: Building A Safer Health System. National Academy Press, Institute
of medicine, Committee on quality of healthcare in America, 26.
3. Aziz, O., Sheikh, A., Paraskeva, P., & Darzi, A. (2003). Use Of Mobile Phones In Hospital: Time To Lift The Ban. Lancet. 361,788.
4. Baevsky, R.H., Lu, M.Y., & Smithline, H.A. (2004). The Effectiveness Of Wireless Telephone Communication Technology On Ambient Noise Level
Reduction Within the ED. Am Journ Emer Med. 22,317-318.
5. Rubenstein, S. (2005). Hospitals Ease Cellphone Bans. Wall St J. 18 January, D1
6. Shaw, C.I., Kacmarek, R.M., Hampton, R.L., et al. (2004). Cellular Telephone Interference With The Operation Of Mechanical Ventilators. Crit Care
Med. 32, 928-931.
7. Klein, A.A., & Djaiani, G.N. (2003). Mobile Phones In The HospitalPast, Present, And Future. Anesth. 58,353-357.
8. Irnich, W.E., & Tobisch, R. (1999). Mobile Phones in Hospitals. Biomed Instrum Technol. 33, 28-34.
9. Saleh, G.M. (2004). Mobile Phone Interference In The Ophthalmology Department. Eye. 18, 756-757.
10. Small, D.R. (2003). Use Of Mobile Phones In Hospital. Lancet. 361, 1831.
11. Dreyfus, M. (2004). Another Look At Cell Phone Use In The Operating Room. Anesth News. 1&54.
12. Cohen ,T. (2004). Mobile Phones in Hospitals, A UC Davis Health System Multi-disciplinary Technology Assessment Project. Presented at the 20th
Annual AAMI Productivity and Cost Effectiveness Conference, June 4, 2004, Boston MA.
13. Morrissey, J.J., & Joyner, K. (2004). Compatible Deployment, Use and Management of Mobile Phones and Wireless Communication Equipment in
Hospitals, available at http://www.ips.gov.au/IPSHosted/NCRS/wars/wars2004/proceedings/invited/joyner_t02f.pdf
14. Cell Phones and EMI. Health Devices, March 2003. ECRI. Plymouth Meeting PA.
15. Morrissey, J.J. (2004). Mobile Phones in the Hospital: Improved Mobile Communication and Mitigation of EMI Concerns Can Lead to an Overall
Benefit to Healthcare. Health Phys. 87,82-88.
16. Morrissey, J.J., Swicord, M., & Balzano, Q. (2002). Characterization of Electromagnetic Interference of Medical Devices in the Hospital Due to Cell
Phones. Health Phys. 82, 45-51.
17. Cadwell Instruments: http://www.cadwell.com
18. IEC 60601-1-2:2001, Electromagnetic Compatibility Requirements and Tests for Medical Electrical Equipment, International Electrotechnical
Commission, 2nd edition.
19. Drager Medical Caleo Neonatal Incubator Operating Instructions Manual, Drager Medizintechnik GmbH, 2000.
20. ANSI/IEEE C.63.18, Recommended Practice for and On-site, Ad-hoc test Method for Estimating Radiated Electromagnetic Immunity of Medical
Devices to Specific Radiofrequency Transmitters, 1999.
21. Health Informatics- Use Of Mobile Wireless Communication And Computing Technology In Healthcare FacilitiesRecommendations For
Electromagnetic Compatibility With Medical Devices. Document ISO/TC 215 technical report #21730, 7-28-2004.
22. Gullikson, M.L., David, Y., & Blair, C.A. (1996). The Role of Quantifiable Risk Factors in a Medical Technology Management Program. JCAHO
Environment of Care PTSM series. 13, 11-20.
23. Paperman, W.D., & David, Y. (1998). The Clinical Engineer: A Ghost Hunter or Manager of EMI? Biomed Instrum Technol. 32, 177-181.
24. David, Y. (1996-7). Prescription for EMI Problems in Healthcare. Signature newsletter, Electric Power Research Institute. 7,1.
25. David, Y., Bukari, A.R.S., & Paperman, D.W. (2000). Management of Electromagnetic Interference at a Hospital. J Clin Engin. 95-103.
26. Paperman, W.D., David, Y., & McKee, K.A. (1994). Electromagnetic Interference: Causes and Concerns in the Health Care Environment.
AHA/ASHE Healthcare Facilities Management Series No. 055110, August.
27. American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of
Medical Devices to Specific Radio-Frequency Transmitters, ANSI C63.18-1997, American National Standards Institute.

Appendix
Case Study No. 1: Texas Childrens Hospital
Recognizing that the probability of interference decreases
in proportion to the distance between devices, Texas
Childrens Hospital wanted to determine if a safe operating
distance between existing medical and personal telecommunication devices could be identified. A test protocol was

designed to measure electromagnetic field strengths before


introducing a cellular telephone into the hospital environment and then to observe any effects on the operation of
selected medical devices once cell phones were introduced.
Tests were conducted in the real clinical environment of
the hospital after obtaining informed consent from patients

Journal of Healthcare Information Management Vol. 19, No. 4

45

FOCUS: Mobile Computing


and their families and securing nursing staff to assist during
the studys observation phase. The test protocol was
reviewed and approved by the Baylor College of Medicine
Institutional Review Board. Tests were conducted during a
two-month period. There were a total of 14 valid tests
performed in 13 different rooms of two different designs. A
total of 43 medical devices were present during the tests.
Some medical devices, such as physiological monitoring
devices and infusion pumps, were present in all tests.
The testing consisted of two series of investigations
measuring the background levels of relevant electromagnetic radiation and exposing medical devices to the electromagnetic fields generated by various cellular telephones.
The cellular telephones used in the tests were selected as
being representative of the various types in popular service
during the time period in which the tests took place.
Operation of the cellular telephones was under the control
of technicians from the biomedical engineering department,
who performed the tests.
Multi-mode cellular telephones were placed in locations
most likely to be occupied during staff and family visits.
One location was on the patient bed, positioned so it
would be within convenient reach of the patient. Another
location was in the breast pocket of the technician,
simulating a clinician treating the patient carrying an active
cell phone. Finally, three additional sites within a patients
room were selected based on probable locations of
transient non-occupants, such as visitors and medical staff.
Testing was performed in two patient rooms, each of
different design. Tests were conducted sequentially with
cellular telephones operated in each of the following
modes: AMPS-800; CDMA-800; CDMA-1900; IDEN-800;
GSM-900; GSM-1800; and GSM-1900
Prior to conducting the tests, in addition to obtaining
patient consent from the parents of the subject patient,
approval was required from the local nurse manager. As an
additional precaution, the onsite investigatorsbiomedical
engineering personnel having direct familiarity with the
medical devices22also were instructed to immediately
advise the nurse manager of any change in the operation of
any medical devices observed during testing.
All clinical devices in service in the test areas were
recorded, including the manufacturer, model, serial
number, last date of inspection or maintenance, and
mode of operation.
Immediately before the cellular telephone interference
testing, a spectrum analysis footprint1 of the patient rooms
was performed. The spectrum observed was from frequencies of 800 MHz to 950 MHz and from 1.9 GHz. to 2.4 GHz
in steps of 20 MHz. The emphasis in this observation was
placed on signal activity levels (density) within the cellular
telephone frequency spectra.
The cellular telephones were programmed by the vendor
to operate at full transmission power. Measurements of the

46

Journal of Healthcare Information Management Vol. 19, No. 4

electrical (E) and magnetic (H) field strengths present at the


precise locations at which the cellular telephones were to
be activated were taken both passively, before the cellular
telephone was activated, and while the cellular telephones
were active. The measurements were taken at distances of
12 inches and 1 meter from the cellular phone locations.
To allow cellular telephone emission to interact23,24 with
all possible processor cycle states and to observe the
possible effects25,26 on medical devices during multiple
clocking cycles (computer-driven clinical devices, bit, or
byte corruption), the test period for each cellular telephone
and mode lasted approximately five minutes. The cellular
telephone was turned on and off at random intervals no
fewer than three times during each test period.
During the tests, operation of the medical devices
present in the test environments were closely monitored,
and changes in their operation, including the type of
changeloss or interruption of program, recoverable
failure, or catastrophic failurewere recorded.
Analysis of the spectrum records obtained in phase one
of each study indicated an average level of electromagnetic
activity within the portions of the spectrum of interest. The
levels of electromagnetic radiation were consistent with
those encountered in a dense urban environment with no
cellular telephone sites in the immediate vicinity of the test
site. Further analysis of the records indicated that the risk
factor from aggregated electromagnetic fields in the
spectrum of interest during testing was not of sufficient
intensity to present additive risk to clinical devices exposed
under the test program.
Phase two of the series of tests involved the activation of
commonly used cellular telephones operating in commonly
used modes. Of the 43 medical devices present and active
during this series of tests, the cell phones affected three
devicestwo pulse oximeters and one case of disruption of
audio in a nurse call system pillow speaker. There was no
evidence of a deterioration of performance or a permanent
alteration in function because of the interfering electromagnetic radiation. In all cases, the interfering cellular
telephone was a Motorola iDEN and the disruption of
operation occurred when the cellular telephone was within
less than one meter of the device. Interference ceased and
devices fully recovered when the cellular telephone was
removed from the testing site.
Based on the data acquired from the testing and analysis
phases, the following policies regarding the use of cellular
telephones in the Texas Childrens Hospital clinical environment were proposed and implemented:
The use of cellular telephones is permitted (with the
exception of iDEN cellular telephones, primarily
employed in the Nextel Direct Connect system) in general patient rooms with the recommendation that cellular
telephone devices not be activated within 1 meter of any
medical device. Cell phones can be used with no

FOCUS: Mobile Computing

restrictions in all common areas; in hallways, corridors,


offices and administrative areas; in the outpatient care
center; and in the emergency department areas.
The use of cell phones is restricted in all critical care
areas (NICU, PICU, Cath Lab, and Dialysis, among
others). Testing in those areas of high concentrations of
clinical devices was not yet attempted.
The use of cell phones is restricted in operating rooms
within 1 meter of any medical device.
Case Study No. 2: Shands Hospital
at the University of Florida
In 2001, Shands Hospital at the University of Florida
began to explore a single method to communicate with
staff and physicians as they moved throughout the sevenhospital system. It sought a wireless device that could
enable limited data and unlimited voice traffic in a seamless
process. Cellular phone technology appeared to be able to
meet these needs with a data access application added to
the basic phone menu.
The organization did not want to restrict the use of the
handsets under any condition, but it also did not want to
compromise any aspect of patient safety. To meet the goal
of safe handset use in any patient care area, the organization elected to make use of the dynamic power control
feature in all current cell phones that extends battery life by
minimizing required transmission power depending on
received signal strength. By installing a distributed antenna
system that provides coverage throughout all patient care
areas, the transmission power level of cellular phones can
be reduced to levels that do not interfere with surrounding
medical equipment.
The vendor selection process included an evaluation of
the guarantee of hospital coverage, expanded local area
coverage and engineering experience with safe use of
handsets in a medical environment. The method used at
Shands was successfully applied for one cellular phone
vendor, and it can be extended to a vendor-neutral system.
The financial model required that the installation of the
system have no capital or lease investment, but it could
guarantee an increase in user volume for the vendor.
A test tool also was needed to test both existing and
new medical equipment for electromagnetic compatibility
at expected transmission power levels, and a survey
tool to confirm the correct signal strength in all patient
care areas to ensure that the final environment meets the
design specification.
In the final design, in-building coverage is provided by a
managed distributed antenna system, or DAS, that provides
real-time monitoring and status of the DAS elementsthe
hardware links, the amplifiers, and the antennas. The safe
coverage area includes all patient care areas where
monitoring, diagnostic, therapeutic, and treatment activities

are performed. Also included were common patient transport zones between these areas.
Initial testing of critical medical equipment, such as lifesupport and high-risk devices, was performed using a
modified ANSI C63.18 Recommended Practice for an OnSite, Ad Hoc Test procedure.27 The purpose of ANSI
C63.18 is to provide a guideline test method to assess in a
relatively reproducible manner the radiated RF immunity of
specific medical devices to specific RF transmitters. Based
on this testing methodology, when interference is noted, a
minimum safe distance often can be determined.
ANSI C63.18 includes guidelines on the selection of
medical devices to be tested and the selection of RF
transmitters to test and test methodology, including selections of the test area, placement of the medical device,
evaluation of medical device performance, and precautions
on RF transmitter use. In addition, it includes a specific test
procedure indicating antenna orientation, device location,
initial and minimum separation distances as a function of
transmitter power, multiple axis testing, and more.
The Shands modified procedure included all sides of
medical equipment and distances in very close proximity
less than 5 centimetersto the device being tested. The
cellular phone company was required to provide a
handheld unit of which the transmission power level could
be controlled as the distance was varied between the unit
and the medical device. In general, the test required
approaching the medical device at all sides, one at a time,
with the cell phone set to a specific transmission power
level. Records were kept of the interaction or interference
caused, and then a lower transmission power level was
selected and the test was repeated. The purpose of these
initial tests was to determine the transmission power level
at which interference could not be identified. Medical
devices tested included anesthesia machines, perfusion
systems, ventilators, patient monitors, defibrillators, and
telemetry systems.
At maximum transmission power levels, researchers
found instances of interference and, in one case, a
complete medical device shutdown, with no notice or
alarm. Decreased transmission power levels resulted in
decreased levels of interference.
Testing demonstrated that at power levels of -10db (60
milliWatts), the devices under test exhibited normal operation at all tested distances. Based on these tests, researchers
identified that the design environment was to provide a
signal strength that would enable the handsets to transmit at
power levels of 60 mW (average) or below in all patient
care areas. All other areas were required to have the vendor
minimal signal strength for adequate system use.
The final design of the cellular system included locating
a typical cell site on the roof of the building and putting a
distributed antenna system on almost every floor of the

Journal of Healthcare Information Management Vol. 19, No. 4

47

FOCUS: Mobile Computing


hospital. The final design was qualified by the installation
contractor and an independent walkthrough by hospital
personnel using the survey tool. The internal marketing
plan to our employees, physicians, and contractors was a
coordinated effort that emphasized the unique in-building
coverage (that) will ensure a quality signal and compatibility with patient care equipment. For visitors, the facility
posts signs indicating that it allows the use of the vendors
cell phone anywhere in the hospital.
Medical equipment that is new to the hospital undergoes
an electromagnetic compatibility test with the test tool, at
the 60 mW power level for either every device or 20
percent of the devices if there are more than five in a
single shipment. To date, no other medical devices have
failed this test.
Quarterly walkthroughs are performed with the survey
tool to determine adequate signal strength in the covered
patient care areas. These quarterly surveys have twice
identified inadequate signal strength in a section of the

I chose

coverage area. The reduction was traced to vendor activity


outside the hospital related to either new or modified
existing cell tower sites. Vendors constantly tune their
systems for optimal performance, coverage, and expanded
capacity; these adjustments made by the vendor affected
Shands internal building coverage. A network engineer
from the vendor was assigned to the hospitals account
to handle change management that may affect
in-building coverage.
The hospital also experienced system busy call
blocking once, at the end of a Florida State-University of
Florida football game attended by 90,407 fans. The
University of Florida football stadium is less than one mile
away from the hospital, and cellular traffic temporarily
saturated the hospital cell site. The vendor confirmed this
problem and modified the system to reserve adequate
capacity for hospital call volume.

At Lee Memorial Health System, we are proud of our passion for


excellence, for recently having earned one of the nations 100 Most
Wired hospitals and health care systems award, Top 100 Hospitals and
Employer of Choice (second year running) awards. With an eye on the
future, Lee Memorial offers the opportunity to work collaboratively with
both the Information Technology team and the clinical community in
developing and implementing innovative and cutting edge health
information technology solutions.
We are currently seeking Clinical Informatics Project Managers to provide
technological support for several departments within the Health System.

Clinical Informatics - Project Manager, Clinical Ancillary


Clinical Informatics - Project Manager, Post Acute
Clinical Informatics - Project Manager

an award winning
healthcare provider with
astonishing resources.

Lee Memorial offers outstanding benefits and competitive compensation,


including relocation assistance and sign-on bonuses.
To learn more about available positions, top-rated benefits, our ongoing
expansion and to apply online, please visit us at www.LeeMemorial.org,
or you may apply in person at our new Employment Center located at
4380 Cleveland Avenue, Suite B-2, Ft. Myers, FL 33901 (Next to
Circuit City). Phone: 1-800-642-5627. Relocation assistance is available
for select positions.

The Employer of Choice in Southwest Florida


www.LeeMemorial.org
Drug/Smoke-free workplace. EOE

48

Journal of Healthcare Information Management Vol. 19, No. 4