Module: VII

Patient Safety
and Electrical
Hazards
Dr. Kishor Lakshminarayanan
SENSE
Medical technology
• Achievements
– Significant improvement of health care in all medical specialties
– Reducing the number of seriously ill people

– Reduction of mortality

• Consequences
– increased complexity of medical devices and their applications

– increased incidence of adverse effects of implementation of MT

– in the U.S. approx. 10,000 cases of patient injury due to the application of MT

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Medical technology
• Causes of unintended consequences:
– improper handling

– insufficient or improper staff practice (training) in handling with MT

– insufficient experience
• example, medical staff rarely read manuals for the users
(User Manual)
– equipment malfunction
• Demand for MT developers
– developement of safe devices (failure-safe)

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Danger to patients
• In a clinical environment patient is exposed to various risks, more than a
typical workplace or at home
– frequent invasive (blood) operations - penetration through skin or mucous membranes
– presence of potentially hazardous chemicals and substances - anesthetics, medicines, medical
gases
– sources of infection - particularly "hospital infection"
– various sources of energy that penetrate into or through the patient: current, voltage, ionizing and non-
ionizing radiation, sound and ultrasound, electric and magnetic field, UV radiation, lasers, microwave
radiation, mechanical stress, etc.

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Safe MT development
• Electrical MT security is considered:
– physiological effects of electricity
– possibility (risk) of failures and their consequences
– methods of patients and staff protection
– Standards describing electrical safety
– electrical safety testing modes

• Understanding the possible dangers and risks

• Implementation in achieving security

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Physiological effects of electricity
• Body (tissue) becoming a part of an electrical circuit

• The amount (amplitude) of electricity often depends on the ratio of

voltage present and the sum of all (serially connected) impedance

• Usually, the highest impedance is the impedance of the skin

• The consequence of current flow:
– Nerve and/or muscle tissue stimulation
– heating of tissues (a result of tissue resistance)
– burns

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Physiological effects of current

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Electricity grid
• Unintended consequences are usually a result of human involvement in
the circuit, in some way connecting to the grid (inattention, failure)
• Several levels of action
– perception
– contractions (let-go)
– paralysis (respiratory), pain, fatigue
– ventricular fibrillation
– tetanic contraction
– burns and physical injuries

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Consequences of dangerous voltage

• Consequences depends on
the voltage – current
relation, but also on
individual susceptibility
Fibrilation • Expected values
– Intact skin,
RK = 2-5 kΩ

– Damaged skin - injuries,

Convulsion surgical procedures,

RO = 100 Ω – 1 kΩ

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Safe voltages - AC
• Security measures in designing
– defining voltage values that may not appear on the conductive parts
of instruments or equipment coming into contact with the patients
skin or user
– For alternating current:
• safety extra low voltage, SELV of 50V, 50/60Hz
• medical safety extra low voltage, MSELV of 25V, 50/60Hz

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Safe voltages - DC
• Security measures in designing
– defining voltage values that may not appear on the conductive parts
of instruments or equipment coming into contact with the patients
skin or user
– For direct current:
• safety extra low voltage, SELV of 120V,
• medical safety extra low voltage, MSELV of 60V, 50/60Hz

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Ventricular fibrillation
In cases of shock due to unwanted
connection to power grid voltage, current
passing through the heart is considered the
most dangerous effect and can cause
ventricular fibrillation (ventricles) with fatal
consequences

• Ventricular fibrillation is completely irregular, asynchronous heartbeat; no synchronism in ventricular contractions,

blood flow stops and if such heart work does not stop, it leads to death within a few minutes

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Microshock vs. macroshock

• Macroshock is caused by current passing through the body through the skin, and the current
that can cause harmful effects is relatively high and significantly depends on the point of
contact
• Microshock is caused by the passage of relatively low current, but the source of electricity
was brought directly into contact with the heart, for example, during cardiac catheterization
(catheter in the heart is a diagnostic procedure). Electricity sufficient to induce fibrillation is
of n x 10μA. Another point of contact can be anywhere on the body (eg limbs). Current of
10 μA is considered safe limit to prevent microshock
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Leakage currents
• Occur between conductors that are not in direct contact (touch) and are
at different potentials
• For devices that are powered from the grid, leakage currents are:
– capacitive character (spreading capacity)
– operative character (current through the insulation, dust, humidity ...)

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Leakage currents pathways

• Pathways of leakage current through

the patient
a) Intact ground lead
b) Broken protective ground lead,
patient connected to ground through
a catheter
c) Broken protective ground lead, patient
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Leakage currents

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Regulations, standards and
recommendations
• Regulations are subordinate legislation which are obligatory and are related
to the characteristics of devices and equipment that must be assured
• Standards stipulate features that must be assured, but their appliance is
voluntary. Contain instructions on how to accomplish / verify compliance
with the standard
• Recommendations (usually manufacturers) stipulate how to ensure the
safety and prescribe manner and frequency of testing safety of devices

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Standards 60601
• Various standards institutes prescribe standards for electromedical
devices and equipment
• These standards are mostly aligned, due to the global market
• The fundamental norm in Europe, IEC 60601-1 , Medical Electrical
Equipment, Part 1:General requirements for basic safety and essential
performances

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Design Recommendations for Safety
• Reliable grounding for equipment
• Reduction of leakage current
• Double – insulated equipment
• Operation at low voltages
• Driven right leg circuit
• Current limiters
• Electrical isolated heart connectors

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