Electrical Safety During Transplantation

G.L. Amicucci, L. Di Lollo, F. Fiamingo, V. Mazzocchi, G. Platania, D. Ranieri, R. Razzano, G. Camin,

G. Sebastiani, and P. Gentile
ABSTRACT
Technologic innovations enable management of medical equipment and power supply
systems, with improvements that can affect the technical aspects, economics, and quality of
medical service. Herein are outlined some technical guidelines, proposed by Istituto
Superiore per la Prevenzione e la Sicurezza del Lavoro, for increasing the effectiveness of
the power supply system and the safety of patients and surgeons in the operating room,
with particular focus on transplantation. The dependence of diagnoses and therapies on
operation of the electrical equipment can potentially cause great risk to patients.
Moreover, it is possible that faulty electrical equipment could produce current that may
ow through the patient. Because patients are particularly vulnerable when their natural
protection is considerably decreased, as during transplantation or other surgery, power
supply systems must operate with a high degree of reliability and quality to prevent risk,
and must be designed to reduce hazards from direct and indirect contact. Reliability of the
power supply system is closely related to the quality of the project, choice of materials, and
management of the system (eg, quality and frequency of servicing). Among the proposed
guidelines, other than normal referencing, are (1) adoption of a monitoring system to
improve the quality of the electrical parameters in the operating room, (2) institution of
emergency procedures for management of electrical faults, (3) a procedure for manage-
ment of res in the operating room, (4) and maintenance interventions and inspections of
medical devices to maintain minimal requirements of safety and performance.
D
URING TRANSPLANTATION, electrical safety is
fundamental, and each member of the operating staff
must be able to recognize and manage the associated
specic risks.
1
In some medical procedures, low current is
sufcient to cause respiratory paralysis (10 mA) or poten-
tially fatal ventricular brillation (20 mA). The low-
resistance pathway via skin penetration and decreased
patient defenses because of medication or anesthesia in-
crease the risk of electric shock under faulty conditions. The
greatest danger is associated with interrupted equipment-
to-earth connections.
During open heart surgery and when catheters are in use,
the risk is increased. It is necessary to minimize leakage of
current that may ow into the patient. Current as low as 10
A through the heart to the earth may be fatal, and the risk
increases considerably at 50 A (microshock).
During transplantation, major risks to patient safety due
to electrical hazards include (1) macroshock and micro-
shock due to direct or indirect contact; (2) voltage inter-
ruption that affects life-supporting medical equipment; (3)
deterioration in performance of medical equipment be-
cause of a poor power supply; and (4) re or explosion due
to electrical ignition. The rst risk can be decreased by
designing the power supply system to avoid direct or
indirect contact; the second risk is suppressed by designing
the power supply system to have a high level of reliability,
not comparable to that of common systems; the third risk is
resolved if the power supply is of high quality, with limited
From Istituto Superiore per la Prevenzione e la Sicurezza del
Lavoro, Dipartimento Tecnologie di Sicurezza, Rome (G.L.A.,
L.D.L, F.F., V.M., G.P., D.R., R.R.), Azienda Provinciale per i
Servizi Sanitari Trento, Trento (G.C.), Azienda Sanitaria della
Provincia Autonoma di Bolzano, Comprensorio Sanitario di Bres-
sanone, Ripartizione Tecnica, Bressanone (G.S.), and Comando
Nazionale Vigili del Fuoco, Rome (P.G.), Italy.
Address reprint requests to Giovanni Luca Amicucci, Istituto
Superiore per la Prevenzione e la Sicurezza del Lavoro, Diparti-
mento Tecnologie di Sicurezza, Via Fontana Candida 1,00040
Monteporzio Catone, Rome, Italy. E-mail: giovanniluca.amicucci@
ispesl.it
2010 by Elsevier Inc. All rights reserved. 0041-1345/see front matter
360 Park Avenue South, New York, NY 10010-1710 doi:10.1016/j.transproceed.2010.05.133
Transplantation Proceedings, 42, 21752180 (2010) 2175
variability in voltage and frequency, and negligible distor-
tion of the current waveform; and the fourth risk requires
application of electrical components that are compliant
with the ATEX Directive (from the French ATmospheres
EXplosible).
METHODS
Health care locations are categorized as group 0, 1, or 2 by the IEC
60364-7-710 (International Electrotechnical Commission, Geneva,
Switzerland).
2
Group 0 includes locations in which no medical
electrical equipment with applied parts are used. Group 1 includes
locations in which medical electrical equipment with applied parts
may be used outside or inside any part of the body except the
cardiac area. In group 1 locations, discontinuity of supply is not a
threat to human life. Group 2 includes locations for performance of
intracardiac procedures, operations, or vital treatment in which
discontinuity (failure) of the supply can cause danger to life or
necessary repetition of the examination or treatment. In group 1
and 2 medical locations, the patient area is dened as any place in
which a patient could come into contact, intentionally or not, with
another electrical equipment or conductive element, bringing the
ground reference voltage, or other persons touching such elements.
Reduction of Risk of Macroshock or Microshock
To reduce the risk of direct or indirect contact and to prevent
untimely voltage interruption due to the action of residual-current
devices, 2 special safety requirements should be applied:
13
(1) in
group 2 locations, connection of the electrical equipment to a
medical IT system (isolated power supply) in the patient area, and
(2) in group 1 and 2 locations, installation of a supplementary
equipotential bonding to eliminate even small but potentially
dangerous voltage due to current leakage or faults at the main
isolation.
In the event of an earth fault at the isolated power supply, the
fault current is negligible, minimizing the hazards from touch
voltage. The power system may continue to function without an
unannounced trip, which is dangerous to patients on life-support
equipment. A second fault would be dangerous because high fault
current passing through the circuits will cause opening of the
protection; thus, patients are potentially endangered rst by the
high current and second by the voltage interruption. Thus, an
insulation monitoring device that emits audible and visual alarms
for the rst fault, and for its disconnection from the isolated power
supply and for overload and high temperature of the insulation
transformer, is placed either within or adjacent to the group 2
location.
Reduction of Risk of Voltage Interruption
To avert untimely voltage interruption due to lack of the electric
grid, it is necessary to have a standby independent power system
(safety power supply service), taking into account the permissible
changeover time according to standard IEC 60364-7-710,
2
as
follows: (1) Safety power supply service with changeover time no
more than 1.5 seconds (short interruption) that is energized to feed
the equipment of interest for a minimum of 3 hours, for example,
operating table lights and other essential lights such as on endo-
scopes, and for vitally important equipment. The 1.5-second
changeover time also applies to no-break supplies required when a
vital treatment involves use of medical equipment. (2) Safety power
supply service with changeover time of 1.5 to 15 seconds (medium
interruption time) that is energized to feed the equipment of
interest for a minimum of 24 hours. This includes electrical
equipment for the gas supply, compressed air, vacuum supply,
anesthetic exhaust, medical devices of vital importance in group 2
locations, and re alarms, re-extinguishing systems, ventilating
systems for smoke extraction, and selected lifts for reghters. (3)
Safety power supply service with changeover time of more than 15
seconds (long interruption) that is energized to feed the equipment
of interest for a minimum of 24 hours. This includes sterilization
equipment, and technical building installations such as air condi-
tioning and ventilation systems, building services, waste disposal
systems, and storage battery chargers.
Reduction of Risk From Poor Quality of Power Supply
When the voltage of one or more line conductors at the main
distribution board has decreased by more than 12% of the nominal
value of supply voltage for longer than 3 seconds, a safety power
supply source should be connected within 15 seconds to those
services that need it. However, it is not sufcient to intervene when
there are dips in voltage. In addition, variations in frequency and
distortion of absorption must be avoided. High-frequency surgical
equipment includes switching power suppliers, transformers, and
diodes to raise the voltage and high-frequency oscillators, all
components that introduce current distortion and voltage spikes.
For such kinds of disturbances, potentially capable of compromis-
ing the functioning of other medical equipment connected to the
same circuit without sufcient immunity, it is possible to adapt for
the emitting equipment dedicated socket-outlets with suitable
lters.
Reduction of Risk of Fire From Electrical Ignition
During transplantation, in the operating room, the 3 elements of
the re triangle are combustible materials, a heat or ignition
source, and an oxidizer-enriched environment. Operating rooms
contain combustible materials of all types including patient and
staff linens, preparation agents and solutions, skin degreasers,
tinctures, aerosols, ointments, collodion, petrolatum, parafn,
white wax, plastic and rubber products, blood pressure and tour-
niquet cuffs, gloves, stethoscope tubing, anesthesia components,
breathing circuits, masks, airway and endotracheal tubes, and
patient body tissues and hair. The oxygen-enriched environment is
due to inhalation anesthesia (oxygen or nitrous oxide) or in the
case of regional or local anesthesia, supplemental oxygen to
counteract the respiratory-depressant effects of sedation.
According to the ATEX Directive, if there is the possibility of
creating an explosive atmosphere, the electrical components and
power supply system should be used such that the atmosphere is
not ignited. When the electrical components and the power supply
system are in compliance with the relevant directive, the risk of re
or a blast is dramatically decreased. There remains only the
possibility of ignition due to equipment that requires high energy to
operate, which cannot be avoided. Recourse to specic procedures
can reduce the risk.
RESULTS
Increase in Quality of Power Supply Using a
Monitoring System
To reduce the risk of deterioration in the performance of
medical electrical equipment due to poor quality of the
power supply, it is possible to adapt information technology
2176 AMICUCCI, DI LOLLO, FIAMINGO ET AL
to build automated solutions for a monitoring system that
helps, in real time, to supervise and check the performance
of the more important components of the power supply
system. Monitoring of such components to nd anomalies
or failures in real time facilitates management of ordinary
and extraordinary maintenance, thus reducing unexpected
costs and unplanned stops due to malfunction.
This is possible because many components of the power
supply system (eg, UPS [uninterrupted power supply] and
diesel generator) have standard ports (RS 232, IEEE 488, and
USB) through which data can be obtained about the most
important parameters of the component. For older compo-
nents or those that do not have a communication port, an
acquisition systemboard with sensors can be used for the input
and communication ports for the output. For the simple
purposes and performances that they serve, such boards may
also be inexpensive. Moreover, it is possible to adapt network
analyzers such as those used for building automation applica-
tions to measure the quality of the electrical parameters in the
key points of the power supply system.
The monitoring system is divided into 2 subsystems con-
nected by a LAN (local area network). One subsystem is
composed of a set of sensors interconnected to the main
components, which acquire electrical parameters and other
important data such as the residual charge of the UPS battery
pack, the level in the fuel tank of the electric generator, and
the open/closed status of the circuit breakers. The other
subsystem is composed of the central unit for data acquisition
and elaboration, and alarm notication, which is placed in
either the operating room or an adjacent location.
The monitoring system should also have actuation capa-
bility, in which switches and interrupters are used via
remote control, representing a complete control system.
Thus, the central unit would be able to change the topology
of the power supply system, choosing the safety power
supply services and seeking temporary solutions, such as
redirection of circuits, insertion of lters, or disconnection
of the part of the main board where a fault is located, to
manage possible electrical failure.
Electrical Emergency Procedures for failure of Power
Supply System in Operating Room
Notwithstanding the adopted applications, it is still possible
that a fault in the power supply circuits will cause voltage
interruptions. When this happens during transplantation or
any other surgery, it is necessary to x the status of the
patient as best as possible and to quickly restore the voltage.
To be successful in restoring the voltage, adequate knowl-
edge of the power supply system is necessary including the
specic response of each subsystem to failure. Reliability of
the power supply system is assessed by weighting its com-
patibility with the requirements of essential medical ser-
vices. As compared with normal electrical failures that do
not require special urgency or actions beyond ordinary
maintenance, suspension of power to an operating room,
especially during transplantation, is an electrical emer-
gency.
Reduction of the risk during emergencies is possible in 2
ways, either by decreasing the probability that the unwanted
event will happen or reducing its harmful effects. Thus,
suitable emergency procedures can be prepared to reduce
to a minimum the hazard created by power faults, either
interruption of the external power source or failure of the
electrical circuits internal to the medical institution. Such
procedures together constitute the Risk and Emergency
Management Program of the medical institution. Any pro-
cedure shall characterize unequivocally the emergency
situation, beginning with the identiable signs, and fore-
see a coherent use of existing resources to obtain optimal
benets.
The following lists the steps common to each emergency
procedure: (l) locate and recognize the fault so that it is
possible to choose the relevant emergency procedure; (2)
check availability of the safety power supply services; (3)
make power provisions for the duration of the emergency
condition; (4) have a suitable alarm procedure to alert for
the need for external assistance (eg, to reghters for
additional diesel generators); (5) repair the fault; and (6)
restore the normal power supply. Insofar as these steps, the
following considerations are proposed: careful management
of an emergency reduces its harmful effects; emergency
management is based on immediate recognition of the
event; and personnel who operate the power supply must be
highly qualied.
In the emergency procedures, the following factors are
important. A synthetic board with the steps outlined for
qualied operators must be in place before the detailed
procedure; unambiguous description of particular emer-
gency situations should make it impossible to execute steps
that are relevant to unrelated faults; all possible conse-
quences of involved medical services and locations must be
listed so that the health staff and patient at risk are warned
and informed about each action to be taken; and possible
difculties that can arise during restoration of normal
power must be described.
Management of Fire in Operating Room During
Transplantation
If a re occurs, different layers of in-depth defense provide
a response proportionate to the magnitude of the incident.
Fires are extinguished by separating combustible materials
from the oxidizer and, to a lesser extent, by cooling the
reactants. After prevention, the rst step in defense is the
portable re extinguisher. Various types of re extinguish-
ers are intended for different types of res. Proper selec-
tion, maintenance, and training in their use are essential.
Operating rooms are equipped with class A, B, and C
extinguishers (carbon dioxide), which can be used in all 3
types of re (Fig 1).
Delay in making a decision about ghting the re or
evacuation may put the patient at extreme risk. Depending
on what is burning, toxic products such as carbon monoxide,
ammonia, cyanide, isocyanates, and hydrogen chloride can
be released by combustion of various materials.
ELECTRICAL SAFETY DURING TRANSPLATATION 2177
To manage res in the operating room during transplanta-
tion, the following procedure is suggested. First, recognize the
signs of re early. Second, halt the procedure, sound the
alarm, and, if possible, remove the burning material from
contact with the patient. Third, make appropriate attempts to
extinguish the re. Burning drapes or other materials should
be placed on the oor or in another location where they
cannot ignite other materials. If any burning materials cannot
be removed from contact with the patient or if the re is not
quickly extinguished or continues to spread, a re extinguisher
should be used. Fourth, follow an evacuation protocol when
medically appropriate. If the decision is made to evacuate the
operating room, the gas supply valves for the room should be
turned off. If the decision is made to remain in the operating
room, at least the sources of supplemental oxygen directed at
the re should be turned off. Fifth, provide post-re care to the
patient.
Safety of Medical Devices Used During Transplantation
Basic safety and essential performance of medical, active
implantable, and in vitro diagnostic medical devices must be
guaranteed. Satisfactory performance of such equipment is
in the interest of patient and operator safety. The CE mark
(Conformit Europenne [European Conformity]) guaran-
tees compliance of suitable essential requirements of per-
formance and safety standards, which are listed in the
appendices to the relevant directive: Directive 93/42/EEC,
4
amended by Directive 2007/47/EC,
5
concerning medical
devices; Directive 90/385/EEC,
6
amended by Directive
2007/47/EC,
5
concerning active implantable medical de-
vices; and Directive 98/79/EC,
7
concerning in vitro diagnos-
tic medical devices.
The devices must be designed and manufactured so that
when used under the appropriate conditions and for the
intended purpose, they will not compromise the clinical
Fig 1. Fire extinguisher suitability and effectiveness in the operating room. Faces indicate the effectiveness of an extinguisher in
various classes of re: black, suitable; gray, unsuitable.
2178 AMICUCCI, DI LOLLO, FIAMINGO ET AL
condition or safety of the patient or the safety and health of
the users or other persons. The manufacturer must ensure
that any risk associated with use of a device is acceptable
when weighed against the benets to the patient. The
devices must conform to a high degree of health and safety
protection. The end user must be informed by the manu-
facturer of any residual risk. Devices with a measurement
function must be designed and manufactured so as to
provide sufcient accuracy and reliability within appro-
priate limits, taking into account the intended purpose.
According to cited Directives, Member States of the
European Union are directed to take the necessary steps
to record and evaluate information about incidents in-
volving devices.
Characteristics and performance must not be adversely
affected to such degree that the clinical condition and safety
of patients and other persons are compromised during the
lifetime of the device when it is subjected to the stresses
that can occur during normal use, as indicated by the
manufacturer. Maintenance is fundamental and compul-
sory for preservation of device characteristics and perfor-
mance. Each device must be accompanied by the informa-
tion needed to use it, taking into account the training and
knowledge of potential users. Moreover, the manufacturer
must provide all information needed to verify whether
the device is properly installed and can operate correctly
and safely, and details of the nature and frequency of
maintenance and calibration needed to ensure that the
device always operates properly and safely. If mainte-
nance is not performed correctly, the keeper is liable for
any eventual malfunction. To preserve characteristics,
performance, and safety, adequate servicing is necessary.
Controls and periodic checks serve to establish when
maintenance is needed and if a maintenance intervention
has been performed, to verify the restoration of safety
and standards performance.
8
Usually, a certain amount of visual inspection, measure-
ment, and functional tests must be performed to ensure
safety of the device. After such testing, measured data
should be recorded on a suitable board that also contains
the previous test results. Comparison of the latest results
with past results enables determination of whether the
device is still usable. According to IEC EN 62353,
9
visual
inspection should include attention to damage or contam-
ination; integrity of mechanical parts; relevant accessories
(eg, detachable or xed power supply cords, patient leads,
and tubing), which should be assessed along with the
medical device; required documentation that reects the
current revision of the device; safety-related markings and
labeling, which should be legible and complete; and all
fuses, which should be compliant with the data provided by
the manufacturer (eg, rated current and characteristics). In
addition, visual inspection should include attention to the
conditions of any existing protective device; cleanliness of
any lters; condition of coupling and supply cables includ-
ing any appliance coupler, plug, and socket-outlet; condi-
tion of the protective earth conductor; and functional status
of indicator lights and of audible and visual alarms.
If testing is performed before the equipment is put into
service, attention should be ensured that the equipment
delivered is that which was purchased, including markings;
that it is compatible with the available power, hydraulic, and
pneumatic supplies; that installation is in accord with
accompanying documents; that a technician, qualied by
the manufacturer, is present during installation of complex
systems; that training of operators is completed, according
to the purchase order; that protection against electrical
hazards is veried according to IEC EN 60601-1;
8
that
safety requirements according to the relevant standard are
veried; and that functional tests comply with the accom-
panying documents or relevant guidelines.
Measurements are established using the following tests:
protective earth resistance; insulation resistance; and device-
earth leakage current, applied part leakage current, patient
leakage current, and patient auxiliary current.
Measurements must be accomplished under normal con-
ditions and under single-fault conditions. As a result of
testing, equipment should be labeled as usable, tempo-
rarily usable with restrictions (waiting for upgrading or
repair), or not usable (waiting for upgrading, repair, or
replacement).
Frequency of testing, as stipulated by the manufacturer,
should be every 6 to 36 months. However, for testing of
equipment and systems used in the operating room, the
minimum period should not exceed 24 months.
DISCUSSION
Electrical safety is required during transplantation or any
other surgical procedure. When their natural protection is
considerably decreased, patients are particularly vulnerable
to electrical hazards. Even low current may be sufcient to
cause respiratory paralysis or potentially fatal ventricular
brillation (microshock). The reliability of the power supply
system is closely related to patient health because of the
dependence of diagnoses and therapies on the functioning
of the electrical equipment. Voltage interruptions and poor
quality of the power supply can affect life-supporting equip-
ment and cause deterioration of the performance of elec-
trical devices. The hospital administrator is responsible for
preservation of the characteristics and performance of
medical devices. This must be accomplished via adequate
servicing, maintenance checks, and so forth.
In addition to normative references, the following guide-
lines have been proposed: adoption of a monitoring system
to improve the quality of electrical parameters in the
operating room; institution of emergency procedures for
management of electrical faults; development of a proce-
dure to manage res in the operating room; and mainte-
nance interventions and inspections of medical devices to
maintain minimal requirements of safety and performance.
ELECTRICAL SAFETY DURING TRANSPLATATION 2179
REFERENCES
1. Carrescia V: Fundamentals of electrical safety [in Italian].
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2. IEC 60364-7-710 Ed 1.0 b:2002: Electrical installations of
buildings: part 7710, Requirements for special installations or
locations:medical locations. 2002
3. Holme C: Healthcare interpretation of IEE guidance note 7
(chapter 10) and IEC 60364-7-710 for Electrical Installations in
Medical Locations. The Engineering Team, Quarry House, 2005
4. Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (with amendments).
5. Directive 2007/47/EC of the European Parliament and of the
Council of 5 September 2007 amending Council Directive 90/385/
EEC, Council Directive 93/42/EEC, and Directive 98/8/EC.
6. Council Directive 90/385/EEC of 20 June 1990 on the approx-
imation of the laws of the Member States relating to active
implantable medical devices (with amendments).
7. Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
8. IEC EN 60601-1:2006: Medical Electrical Equipment: part 1;
General requirements for basic safety and essential performance.
9. IEC EN 62353: 2008. Medical Electrical Equipment: recur-
rent test and test after repair of medical electrical equipment.
2180 AMICUCCI, DI LOLLO, FIAMINGO ET AL