Special Article

Does nonmedical grade power cord compromise

the safety of medical equipment?

Address for correspondence: V Padmavathi, PS Vishnu Prasad1, Pankaj Kundra2

Er. V Padmavathi, Division of Biomedical Engineering, JIPMER, 1Department of Biomedical Engineering, MGMCRI,
Division of Biomedical 2
Department of Anaesthesiology and Critical Care, JIPMER, Puducherry, India
Engineering, JIPMER,
Puducherry, India.
Email:jipmerbme@gmail.com ABSTRACT

Access this article online
Website: www.ijaweb.org
DOI: 10.4103/0019-5049.171556
Quick response code
A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth
approximately 41 million USD, while the power cords supplied along with the imported equipment
do not comply with countryspecific norms. Moreover, the local vendors procure power cords with
typeD/M plug to complete installation and also onsite electrical safety test is not performed.
Hence, this project was undertaken to evaluate the electrical safety of all lifesaving equipment
purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission
62353, the Association for the Advancement of Medical Instrumentation(AAMI) and National Fire
Protection Association(NFPA)99 hospital standard for the analysis of protective earth resistance
and chassis leakage current. This study was done with a measuring device namely electrical
safety analyser 612 model from Fluke Biomedical.

Key words: Device under test, electrical safety test, equipment leakage current, protective earth
resistance

INTRODUCTION integrity and leakage current can be monitored for

The power source for all equipment is alternating
current(AC) with frequency - 50Hz; unfortunately,
humans are most sensitive to this frequency.[1] Some of
the effects are tissue injury, burns, and fibrillation of
the heart.[2] The main cause for these effects are leakage
current which occurs naturally in all the electrically
operated equipment due to stray capacitance between
two wires or wire and metal chassis. This can be
eliminated by generating a low resistance path from
equipment to ground, ideally at zero potential.
Though the equipment is designed with the highest
degree of protection, safety is attained only when
there is a proper connection between the equipment
and hospital earth by a component called power cord.
If the protective earth resistance(PER) is not as per
the International Electrotechnical Commission(IEC)
norms, the safety of equipment is violated. Therefore,
during installation of medical equipment, electrical
safety test is highly required to conform various safety
parameters described by IEC 62353.[3] The initial tested
data serves as a reference guide for recurrent test
throughout the working lifetime of each equipment. In
future, on the recurrent test, the deviations of ground
necessary corrective actions. It is now clear that all the
lifesaving equipment must undergo electrical safety
test on recurrent intervals to ensure safe operation.
The purpose of this project was to find out the root
cause and influence of environmental factors for
equipment failures during the first year of purchase.
In addition, implementing electrical safety checks
on recurrent intervals to guarantee safe usage of
equipment on the patient are discussed.
METHODS
We conducted electrical safety study on 200 lifesaving
equipment purchased in the year 20122013 in
Jawaharlal Institute of Postgraduate Medical Education
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How to cite this article: Padmavathi V, Vishnu Prasad PS, Kundra
P. Does non-medical grade power cord compromise the safety of
medical equipment?. Indian J Anaesth 2015;59:769-73.

2015 Indian Journal of Anaesthesia | Published by Wolters Kluwer - Medknow 769

 Padmavathi, etal.: Power cord and medical equipment
and Research, Pondicherry [Table1]. They belonged to
ClassI category with detachable power cords of power
consumption<1.5 KVA(kilovolt ampere). ClassII
category, nondetachable power cord equipment and
permanently installed equipment were excluded
from the testing. Since all the tested equipment were
newly purchased, the influence of film resistance
was excluded.[4] The electrical safety analyser(ESA)
612 model was used which is capable of measuring low
resistance up to 2 with an accuracy of2% and leakage
current from 0 A to 1999 A with an accuracy of1%.
The analyser incorporates test algorithm of Association
for the Advancement of Medical Instrumentation(AAMI)/
National Fire Protection Association (NFPA)-99 hospital
standard and IEC 62353.[5] All the measurements were
manually obtained for better accuracy.
Test method
The standard test protocol involves two components;
visual inspection and electrical testing.
Visual inspection
The equipment in working condition can only be
tested for electrical safety. This method identifies the
equipment type, model, power consumption, power
cord typeD/M and fuse ratings. In addition, it also
checks site condition inclusive of input power and
electrical socket where equipment is being used.
Electrical safety test
The electrical safety test involves PER and leakage
current measurements. The device under test(DUT)
will be powered through the measuring device(MD)
and testing probe performs the measurement. While
testing, all other external communication/data lines
such as video graphics array and Ethernet cables
must be removed from the DUT to eliminate parallel
earth.[1]
Table1: List of equipment tested
Equipment name Quantity
Anesthesia machine 7
Anesthesia ventilator 3
Cardiac output monitor 1
Defibrillator 23
Diathermy 18
Portable multichannel ECG machine 6
Humidifier 16
Multiparameter monitor 60
Portable ultrasound machine 1
Pulse oximeter 6
Syringe pumps 29
Ventilator 30
770
Protective earth resistance/earth bond testing
Earth bond testing tests the integrity of the low
resistance connection between the earth conductor
and any metal conductive parts, which may become
live in case of a fault on ClassI medical devices.
Although many ClassI medical devices are supplied
with an earth reference point, most if not all medical
devices require multiple earth bond tests to validate
the connections of additional accessible metal parts of
the enclosure. The test current is applied between the
earth pin of the mains supply plug and any accessible
metal part(including earth reference point) via a
dedicated earth bond test lead(clip/probe). The test
method of ClassI equipment in reference to the 62353,
IEC 2007(IEC 683/07) guideline is shown in Figure1.
The MD ESA 612 applies a test current of 200mA
to determine PER and the highest reading will
determine pass or fail criteria.[1] The allowable test
limits are based on IEC 62353 and AAMI guideline:
100 mfor a detachable power cable up to 3m;
300 mfor a Class I device including power cable
(not exceeding 3m) and 500 mfor a medical
system as per AAMI/NFPA99 hospital standard.
An increase in resistance may indicate loosening/
corroded connection or damaged or nonstandard
cables, which need to be repaired before continuing
with the leakage test.
Deviation
Class II equipment and doubleinsulated devices do
not have a protective earth. It is, therefore, neither
necessary nor possible to measure earth continuity;
this poses no safety risk.[1]
Figure 1: Test method for protective earth resistance for Class I
equipment
Indian Journal of Anaesthesia|Vol.59|Issue 12|Dec 2015
 Padmavathi, etal.: Power cord and medical equipment
Leakage current
Research has shown that current, not voltage, is often
the source of injury or death.[2,6] It takes a small amount
of current to cause major consequences. For this
reason, the International Electrotechnical Committee
has set stringent rule on the design of medical
equipment, so as to prevent any patient or operator
being exposed to currents not part of the functional
operation of the device. These currents are referred
to as leakage currents. The guideline for an inservice
test of medical electrical equipment IEC 62353 defines
two different types of leakage current: equipment
leakage current and applied part/patient leakage
current.[3] To measure these currents, the guideline
describes three methods: direct methodthe current
flowing down the protective earth conductor of the
mains inlet to lead; differential methodthe result of
imbalance in current between the live conductor and
neutral conductor and alternative methodcurrent
flowing through a person to earth from the applied
part or current flowing from a person to earth via the
applied part by applying unintended voltage from an
external source.
The direct method is identical to the method used in
the IEC 606011 standard, measuring the true leakage
through a body model(MD) to earth(the measurement
of leakage current through body model circuit). This
method can measure both AC and direct current
leakage with the highest accuracy compared to all other
methods. Therefore, in the analysis, we have selected
this method for measuring equipment leakage current.
Equipment leakage current
The total leakage current is derived from the applied
enclosure and mains part. All applied(types B, BF
and CF) and nonearthed accessible conductive parts
are grounded together and connected to earth via 1
K MD(body model). The test is conducted with
the protective earth connection interrupted, to ensure
the measurements are done under worst conditions.
Measurements were carried out in both the polarities
and single fault condition. The allowable value for
leakage currents in single fault condition was 500 A,
and PER limit is 300 m referring to 62353 IEC:
2007(IEC 704/07).
RESULTS
Electrical safety test was performed on 200 critical
care equipment purchased in 2013 of 8 different
categories(anaesthesia delivery systems, defibrillators,
Indian Journal of Anaesthesia|Vol.59|Issue 12|Dec 2015
Intensive Care Unit ventilators, humidifiers,
electrosurgical unit syringe pumps, cardiac output
monitors and multiparameter monitors). Out of
200 equipment, 122(61%) passed the testing of PER
and leakage current as per the guideline IEC 62353 and
AAMI/NFPA99 hospital standard test. Further, 62(31%)
equipment failed as per IEC 62353 and 49(24.5%)
equipment failed as per AAMI/NFPA99 hospital
standard. Nevertheless, in both, 28 (14%) of equipment
failed with safety standards. The test result comparison
values for 200 equipment with IEC and AAMI/NFPA99
safe limit are shown in Figure2.
Out of failed equipment, 20 numbers were
again retested with medical grade power cord
(meeting IEC 60601 standards) and nonmedical
grade power cords(supplied by the vendor). The
comparative results of PER and leakage current are
presented in Table2. We applied MannWhitney
Utest, assuming the hypothesis there is no difference
between medical grade power cord and nonmedical
grade power cord with a significance level of 0.99.
The exact output significance of this test was 0.000,
hence the hypothesis was rejected. The results of PER
comparison are represented in Figure3. These values
were also represented in boxplot shown in Figure4.
DISCUSSION
The conduct of electrical safety test has identified
a range of causes that circumvent safety aspects in
lifesaving equipment. The test results confirmed that
28 equipment failed the tests and unsafe to use on the
patient as well. These failed equipment on further
investigation showed 80% failure due to deviant
power cord usage.
Figure 2: Protective earth resistance and leakage current values in
single fault condition for all the tested 200 equipment (IEC 62353 and
AAMl)
771
 Padmavathi, etal.: Power cord and medical equipment

Table2: Electrical safety test results of selected 20 equipment tested with medical grade power cord and nonmedical
grade power cord
Medical equipment details Protective earth resistance(m) Leakage current in singe fault condition(A)
Name Make/model Nonmedical grade Medical grade Nonmedical grade Medical grade
Monitor GES5 Anaesthesia 332 97 110.00 115.00
Anaesthesia machine GEAestiva 7100 445 152 142.00 139.00
Monitor GES5 Anaesthesia 214 101 111.00 115.00
Anaesthesia machine GEAestiva 7100 356 83 153.00 156.00
Anaesthesia machine GEAestiva 7100 234 90 188.00 176
Diathermy ERBEVIO 300 S 543 84 14.00 23.1
Monitor GES5 Anaesthesia 230 76 111.00 116
Diathermy ERBEVIO 300 D 220 85 126.00 131
Pulse oximeter L and TComet 790 77 304.00 317
Ventilator HamiltonGalileo Gold 905 81 79.30 81.5
Ventilator HamiltonGalileo Gold 1230 83 80.50 78.5
Ventilator HamiltonGalileo Gold 980 82 84.80 83.2
Ventilator HamiltonGalileo Gold 1040 83 83.40 79.8
Ventilator HamiltonGalileo Gold 2000 76 84.80 82.9
Ventilator HamiltonGalileo Gold 1850 79 83.00 82.2
Monitor L and TStar Plus 393 182 201.00 202
Ventilator Care fusionVela 1800 90 175.00 169
ECG machine PhilipsPage writer trim I 1700 392 49.70 45
Defibrillator Nihon KodhenTEC 5521K 610 190 199.00 203
Defibrillator Nihon KodhenTEC 5521K 550 175 380.00 389

Figure 3: Describes the protective earth resistance values of selected

20 equipment, which was tested with medical and non-medical grade
power cords

Guideline IEC 606011 defines that a medical grade

power cord must have plug typeD and a mains supply
cable of 3m length with a minimum crosssectional
area of 0.75mm and resistance of the cord <100 m.[1]
If the wire thickness or purity of copper or materials
used in the cable do not meet the IEC medical
equipment guidelines, the ground resistance value
may deviate and results in higher PER. Hence, to find
out significant differences between medical grade
and non-medical grade power cords, a comparative
study was performed. The hypothesis for this study
assumed no significant differences between the
power cords. However, the acquired MannWhitney
exact output significance was 0.000. The median of
PER value of medical grade power cord was 84.5 m
followed by a median of non-medical grade power
cord 580 m. From this analysis, it is clear that there
Figure 4: Illustrates the distribution of equipment between medical
grade power cord and non-medical grade power cord. The boxplot
illustrates the difference between protective earth resistance and
leakage current values obtained between medical grade power cord
and non-medical grade power cords for selected 20 equipment only.
Data shown as median (horizontal line), interquartile range (box), 25th
to 75th percentile (vertical line). *P=0.000 Non medical grade versus
medical grade power cord
is a significant difference in the usage of power cord
types B and A.
The study also confirmed that use of medical grade
power cord has maximized the flow of leakage current
to ground. Therefore, if PER increases, the fault/leakage
current will find unintended paths that could include
patient or operator. The other reasons of 18% failure

772 Indian Journal of Anaesthesia|Vol.59|Issue 12|Dec 2015

 Padmavathi, etal.: Power cord and medical equipment
were due to the instrumentation errors, harmonic
distortion issues and possible intermittent dilemmas.
It is wellknown that medical equipment is one of
the largest capital investments of every healthcare
organisation, often involved in patient incidents that
resulted in serious injuries or deaths.[7] At present,
our system guarantees preventive maintenance for
equipment, but safety is not ensured. International
Standard Guideline IEC 623532007 medical electrical
equipmentrecurrent test and test after repair of medical
electrical equipment, document applies to testing of
medical equipment and medical electrical systems, which
comply with IEC 606011 before putting into service,
during maintenance, inspection, servicing and after repair
or on occasion of recurrent test to assess the safety of such
medical equipment. Therefore, this study proposes to
implement an electrical safety test protocol in healthcare
organisations to get benefits in 3 ways from electrical
hazards. First, protect patient, user and equipment from
possible abuse to which the device may be exposed.
Second, it will save equipment from harmful influence
of harmonics caused by neighbouring equipment. Third,
equipments leakage current can be conformed to the safe
limit during any catastrophic failure.
Moreover, the conduct of electrical safety test will also
eliminate the subsequent incidents reported in our
operation theatre which was one of the reasons that
encouraged us to conduct this study. We experienced
a fire incident, where power cords plug top burnt off
completely. On root cause analysis, we found that the
plug type was nonIngress Protection(IP) rated; the
saline solution had entered into the socket and created
a short circuit path. This was because the supplier had
cutoff the plug typeF from the cord and replaced
with plug typeD(Indian standard). Both root
cause analysis and our study concur with the result.
Hence, we recommend using medical gradeIP 44 or
above rated power cord with typeD plugs; if not, it
compromises the safety of medical equipment.
Indian Journal of Anaesthesia|Vol.59|Issue 12|Dec 2015
CONCLUSION
On consideration of patient safety, this review provides
evidence that safety is attained only when there is a
proper connection between equipment and hospital
earth by a major component called power cord. Hence,
we recommend performing onsite electrical safety
test using a suitable electrical safety analyser during
installation and annual maintenance to validate and
confirm that medical equipment along with power
cord are safe and reliable to use in patient care.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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