Unit-8

Electrical Safety of medical equipment

8.1 Introduction

A hospital is more than simply a building in which healthcare service is delivered. It is a centre
which should be well organized in order to operate effectively. This modern well organized
medical centre uses 100s of electrical and electronics biomedical equipment. If these
equipment is installed as per electrical safety standards, then it will be safe for the patient as
well as clinicians and for equipment itself as well. Hazardous situation may arise due to faulty
equipment, negligence and misuse which can be avoided by proper technical planning and
awareness.

8.2 Physiological effects of electrical current

Electrical shock will occur if a human body is in tough with the live wire and ground or in touch
with live wire and neutral. The physiological effect of electrical current through human body
depends upon the magnitude of the current and the path of the current through body.
Electrical current through human body may affect the human body system in two ways:

I. It will increase the temperature and may burn the tissue.

II. It may induce action potential in sensory and motor nerves. This induced action
potential can cause a tingling or prickling sensation and fibrillation in the body. E.g.
cardiac fibrillation, respiratory paralysis.

Both the effects on human body depends upon threshold of the current, higher the current
more the effect and lesser the current less the effect. A term “let-go current” is used to define a
current whose maximum flow does not affect a person and can withstand this threshold. The
current smaller than 20mA is considered as “Let-go current”. The table below shows the effect
of current through healthy human body for duration of one second.
There are two types of electric shock that may happen in hospital. They are microshock and
macroshock. Macroshock is defined as electric shock due to contact of live conductor by the
skin of a person who is subjected to shock where as micro shock is caused due to flow of shock
current from lead or electrical conductor of diagnostic and therapeutic equipments like lead
wires of ECG and pacemakers. Microshock is a more serious issue than Macroshock as a
continuous small flow of current reduces the contact resistance between body and the lead
wire and even a small current as low as 50uV can produce cardiac fibrillation.

8.3 leakage currents

Current of extremely small magnitude can be fatal to the patient when a direct localized path
exists to the heart. The major source of potentially lethal currents in any instrument or
equipment is the leakage current. Leakage current can be defined as an inherent flow of non-
functional current from the live electrical part of an instrument to the accessible metal part.
They occur by presence of a finite amount of insulation impedance, which consist of two parts:
capacitance and resistance. Leakage current due to capacitance developed because of the
presence of capacitance between any two conductors separated in space. Current flow shall
take place if an alternative voltage is applied between them. Leakage current of this type
mostly originates due to capacitive coupling from the power transformer primary to other parts
of the transformer or other parts of the instrument.

The resistive component of leakage current arises because no substance is a perfect insulator
and small amount of current will always flow through it. However, this type of leakage current
is usually very small as compared to the capacitive leakage current and can be safely ignored.

Type of leakage current

Leakage currents are divided according to the current path into following types:

Enclosure Leakage current: This type of current flows from enclosure or part of the
enclosure through a person in contact with an accessible part of the enclosure to the
earth or another part of enclosure.

Earth leakage current: It is a current flow, in normal condition, to earth from the mains
parts of an apparatus via the earth conductor.

Patient Leakage current: The patient leakage current is the current which flows through
the patient from or to the applied parts of the patient circuits. This current does not
include any functional patient current.

8.4 Physiological effects due to magnetic fields

Magnetic fields have been used for various therapy and diagnostic purpose. The magnetic field
used for this purpose various advantages in comparison to other diagnostic and therapy
methods. There is no disadvantage that has been documented officially. However, some cases
may require extra care and precautions. High magnetic field may introduce some changes in
ECG of patient but for very short duration and these changes are not clinically significant.
Magnetic field may be hazardous in patients with artificial valves, pacemakers, stents and other
implants of metallic nature.

8.5 Safety code for the electro-medical equipment

Various countries have laid down codes of practice for equipment intended to be used in
hospitals. The international Electrotechnical commission (IEC) has brought a voluminous
document, the IEC 601 (General requirements for the safety of medical electrical equipment) to
provide a universal standard for manufacturers of electromedical equipment as well a
reference manual on good safety practice.

Based on IEC Document, The bureau of Indian standards (BIS) has issued the IS:8607 standard
for electromedical equipment. The standard issued in eight parts, covers the following aspects:

Part I General
Part II Protection against electrical shock
Part III Protection against Mechanical hazards
Part IV Protection against unwanted or excessive
radiation
Part V Protection against explosive hazard
Part VI Protection against excessive temperature, fire
and other hazards
Part VII Construction
Part VIII Behavior and reliability

8.6 Basic approaches to protection against shock

There are two fundamental methods of protecting patients against shock. First, the patient can
be completely isolated and insulated from all grounding objects and all sources of electrical
current. Second, all conductive surfaces within reach of the patient can be maintained at the
same potential, which is not necessarily ground potential. Neither of these approaches can be
fully achieved in most practical environments, so some combination of the two methods must
usually suffice.

Not only must all hospital patients can be protected from macroshocks, but all visitors and
staffs must be protected as well. Patient with reduced skin resistance, invasive connections or
exposure to wet conditions need extra protection. The small number of patient with accessible
electric connections to the heart needs additional protection from microshock currents. Many
of the specific methods of protection described here can be used in combination to provide
redundant safeguard. It is also necessary to consider cost-benefit ratios with respect to both
the purchase cost of safety equipment and the periodic maintenance costs of such equipment.

8.7 Safety aspect in electrosurgical units

The risk associated with electrosurgery fall into main 4 category, they are burns, electrical
interference with heart muscles & other medical electronics equipment and danger of
explosions caused by spark.

Burns is predominant hazard caused by the ESU. Burns are caused by excess current density at
a rate other than that at which it is meant to be present. Burns occur if the dispersive
electrodes cannot form good contact with the body or if moisture is present.

Another hazard can occur due to possible electrocution of the patients from faulty mains
operated equipment, when one side of the circuit is connected to mains. This can be avoided by
including a capacitor between indifferent lead and earth.

Explosion hazard can develop through use of cleansing agents such as ether and alcohol, and by
using explosive anesthetic gas or mixture with oxygen. When the spark generated by ESU meets
with these agent, explosion might occur. Use of non explosive anesthetic agent is
recommended to prevent these kind of hazard. Some modern ESU are fitted with automatic
anti-explosion device which make the sparks occurring at the active electrode safe. This is
achieved by releasing release of nitrogen which forms cloud and prevents spread of spark.

8.8 Protection of the hospital equipment

 Grounding System: Proper ground is most important method of protection from

electrical hazard. The principle behind this method is to keep ground resistance as low
as possible than the fault resistance. This will by pass the majority of fault current
through the ground and the current through the person will be in safe limit. The current
through the ground is called leakage current and if there is no grounding connection the
current will flow through any conductive path to ground through human body.
 Figure (a) Ungrounded System Figure(b) Grounded system

 Distribution of electrical power: Electrical power is needed in healthcare facilities not

only for the operation of medical instruments but also for lighting and other purposes. A
first step in providing electrical safety is to control the availability of electrical power
and the grounds in the patients’ environment. A simplified diagram of an electric power
distribution system is shown below:
 High voltage enters the building; the secondary of the step-down transformer develops
440 V. This secondary grounded center tap provides two 220V circuits between ground
and each side of the secondary winding. For the heavy-duty equipment the power can
be provided from the 440V, where as for light equipments power can be provided form
the power sockets.
 Isolated power system: Even installing good separate grounding system for each patient
ca not prevent possible hazardous voltages that can occur from a short circuit between
live and ground (Ground fault). Hence it is very important to avoid such situation and
this kind of situation can be avoided by the use of isolation transformer.
 Ground fault circuit interrupter: Most of the accidents due to electric shock are mainly
due to the body act as a conductor. It obvious that the total current through live wire is
equal to the total current through neutral wire. If any shock hazard happens, the current
through the human body will not return through neutral wire. Hence imbalance
between the hot wire and neutral and a circuit, called earth-fault circuit breaker
monitors this difference and trips the circuit that supplies the current to faulty
equipment. The usual set value is 5mA.
 Protection: Equipment design: The protection of the medical equipment can be
achieved from design prospect by considering the below listed factors:
o Reliable grounding for equipment
o Reduction of leakage current
o Double insulated equipment
o Operate at low voltage
o Electrical isolation
 Test of electrical appliances: The basic test for electrical appliances can be done by
following ways:
o Ground Pin to chassis resistance check: The resistance between the ground pin
of the plug and the equipment chassis and exposed metal should not excess 0.15
Ohm and the power cord must be flexible.
o Chassis leakage current: Leakage current from the chassis should be measured
during its preventive maintenance and it should not exceed 500uA.