With the assimilation of wireless communication technology into hospital
infrastructures, hospitals are becoming concerned about the impact of radio frequency
(RF) electromagnetic
interfer (EMI) between wireless technologies and medical equipment. Such
interference may cause undesirable changes to medical equipment, possibly
resulting in misdiagnosis, mistreatment, and/or patient injuryThese wireless
communication devices include: wireless Local Area Networks (LAN), Bluetooth,
wireless telecommunications, paging, two-way radios, telemetry devices, cell
phones, wireless Personal Digital Assistants (PDA), and PC tablets/laptops.
While most medical devices are manufactured now with a recommended 3V/m (10V/m
for life support devices) immunity level against interference from RF emissions (IEC
60601-1-2), older equipment may have inadequate shielding and, therefore, be
more susceptible to interference.
Preventing Interference
Wireless devices are becoming mainstream in today’s society. The
pervasiveness of the mentioned wireless devices in the medical field is
unavoidable and here to stay, with more being introduced all the time. So, what
is the most logical solution for hospitals? One option is to do nothing and deal
with the RFI
interference if and as it happens. Another option is to test every
electronic-based medical
device in the hospital to gauge and measure the potential of interference
issues. Unfortunately, it is virtually impossible to test every combination of
transmitting wireless device and electronic-based medical device.
There have been many discussions, meetings, publications, and suggestions
regarding the use of portable communications equipment in the vicinity of
medical equipment over the past 20 or so years. Most of these dealt with the
early problems reported in infusion pumps, electric wheelchairs, pacemakers, and
anesthesia machines; which due to inadequate shielding, temporarily failed while
exposed to EMI.
Also, early on in the life of cellular phones, analog systems operated with
quite extensive RF outputs. There were reports of interference with electric
wheelchair circuits, cardiac pacemakers, and anesthesia equipment. Of course,
telemetry equipment was particularly vulnerable. It was then that the fear of
cellular phones in hospital began. Consequently, many hospitals totally or
partially banned cell phone use in the building.
The Hazards of Electromagnetic Interference
Electromagnetic interference with electronic circuits can be dangerous in
many ways. As a result, for many years, military, aircraft, and automotive
electronics systems have been required to meet strict RFI requirements for
immunity to up to 200 V/m, because these systems could encounter such levels
during normal operations. The technology has already been developed to “harden”
most medical devices against fields that are much more intense than the 3 V/m
level specified in present RFI standards for medical devices. Most hardening
techniques are not costly if they are incorporated into the initial design of
the electronics system. Standard RF immunization techniques include the use of
shielding, grounding and filtering. Shielding includes enclosing the device in
metal boxes or in plastic boxes coated with metallic paint.
Grounding of electronics circuitry and cable shields is an inexpensive but
necessary step toward ensuring RFI immunity. RF
filtering of signal-carrying conductors, especially in sensitive patient
monitoring equipment, should be performed carefully. The potential for the
success of these techniques has been demonstrated in implanted cardiac
pacemakers, which commonly achieve immunity of up to 200 V/m, even though these
devices monitor weak electrophysiological voltages.
RF Filters and Shielding
The use of RF
filters preceding the input circuitry of an implanted medical device is
uncomplicated and basic. However, patient-connected medical devices, which are
powered by an AC line, must accommodate the safety requirements for electrical
leakage currents, as well as RFI immunity requirements. Therefore, patient
connection leads on devices that obtain power from AC lines must utilize special
techniques to simultaneously meet both types of safety requirements. Techniques
for isolating patients, which incorporate optical or transformer coupling, may
be required. In addition, designers can add interference recognition and
fail-safe circuitry to their medical devices. For example, many cardiac
pacemakers are protected from erratic operation by being programmed to revert to
a fixed rate when RFI is detected.
Mobile RF and wireless communications systems can be optimized for
compatibility with medical electronics. The modulation frequencies of RF
transmitters should be outside the physiological passband of most or all medical
devices. Digital modulation schemes that use time division multiple access
(TDMI) and the associated amplitude modulation pulses, should be carefully
designed to avoid RFI. Frequency modulation, or non-pulsed, spread spectrum
modulation techniques, such as certain forms of code division multiple access
(CDMA) can be used.
Managers of facilities where sensitive medical devices are used should
control RFI by careful planning and system design. For example, the radiated
power of many modern handheld and portable cellular phones is under the control
of the base station. When close to a base station, handheld and portable phones
may operate at power levels far lower than the maximum power of 600 miliWatt
(for handheld phones) or 3 Watt (for portable phones). Thus, when a base station
is located near a health care facility or when low power base stations
(microcells) are used within the facility, cellular phones will normally operate
at low power. However, the base station itself must be properly sited to avoid
causing RFI. If deemed necessary, RF sources can be restricted from the more
sensitive areas of a hospital, such as intensive care units.
Administrators of healthcare facilities can impose restrictions on the use of
mobile RF transceivers. The concept of a specific minimum separation distance
for each type of mobile transceiver has recently been proposed. For example,
handheld cellular phones that radiate 600 mW would have to be kept at least one
meter from a medical device that is immune to 3 V/m. A 3 Watt handheld
transceiver would have to be kept 2.4 meters from the same device. In practice,
an additional safety factor should be required to account for enhancement of
signals by field reflections.
FDA Recommendations on Dealing with RFI Issues
FDA recommendations which were published in 1994 can still be considered as
the proper guidelines on how to deal with RFI problems:
• Be aware that EMI
can cause steady, momentary, or intermittent disruption of the performance of
medical devices.
• Follow the recommendations of the device manufacturer for avoiding EMI.
• Purchase equipment that conforms to EMC standards.
• Consider preventing known sources of interference (e.g. cellular phones, hand-held transceivers) from coming too close to patient monitors and other sensitive electronic medical devices.
• When an EMI problem is suspected, contact the device manufacturer for assistance. Local clinical engineers may also be able to assist in identifying and correcting the problem.
• Report device problems to FDA’s MedWatch Program and note if the problem is believed to be linked to interference from a recognizable source of EM energy in the vicinity.
.
• Follow the recommendations of the device manufacturer for avoiding EMI.
• Purchase equipment that conforms to EMC standards.
• Consider preventing known sources of interference (e.g. cellular phones, hand-held transceivers) from coming too close to patient monitors and other sensitive electronic medical devices.
• When an EMI problem is suspected, contact the device manufacturer for assistance. Local clinical engineers may also be able to assist in identifying and correcting the problem.
• Report device problems to FDA’s MedWatch Program and note if the problem is believed to be linked to interference from a recognizable source of EM energy in the vicinity.
.
Source: http://www.medwow.com/articles/
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