University of Zagreb

Faculty of Electrical Engineering and

Computing

Biomedical Instrumentation
Safety of electrical medical devices

prof.dr.sc. Ratko Magjarević

 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
 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)
 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.
 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
 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
 Pulsed current
• I – t curves for sensory and motor responses
Physiological effects of current
 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
Consequences of dangerous voltage
• Consequences
depende on the
voltage – current
relation, but also on
individual
Fibrilation susceptibility
• Expected values
– Intact skin,
RK = 2-5 kΩ
– Damaged skin -
Convulsion injuries, surgical
procedures,
RO = 100 Ω – 1 kΩ
Consequences of dangerous voltage
• Focus on the worst
possible scenario, for
example, a person holding
two conductors at
different potentials in his
hands  resulting muscle
spasms, inability to release
captured conductors
• In case of intact skin, RK =
2-5 kΩ, cramps can occur
even at a voltage of few
dozen mA
• In case of damaged skin -
injuries, surgical
procedures, RO = 100 Ω – 1
kΩ, fibrillation may occur
at voltages of several volts
and current of few dozen
mA
 Excitability dependence of the
pulse waveforms
• Monopolar vs. bipolar pulses, sinusoidal current

Extrapolation of sinusoidal
current

What is the duration of the

half-cycle sine current to
achieve
maximum excitability?
 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
 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
 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
 Microshock vs. macroshock
• The consequences of current passage through
the tissue depend on the contact point with
the source of voltage

Even greater power

will not necessarily
cause fatal
consequences, eg.
fibrillation, when
going through the
limbs
 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
 Protective grounding
• Generally, patients are only occasionally and accidentally exposed
to risk of getting in touching with devices whose conductive parts may be
energized
• In hospitals, especially in intensive care units,
patients are deliberately connected to the
diagnostic and/or therapeutic electrical devices/equipment
– particularly careful with the isolation of
any conductive parts connected to the heart or its vicinity from all
other conductive parts
– all conductive parts in the vicinity of the patient must be connected
to a single point grounding (eg, metal bed, cupboard, etc.)
– periodic testing of the grounding impedance must be provided
• Tolerable difference in potential between the grounded conductive parts
in clinical areas:
– in the general - of 500 mV
– intensive care and other critical cases- of 40 mV
 Power in clinical environments
• Under normal conditions, increasing patient safety is
provided by:
– formation of isolated parts of the grid
– installation of automatic monitoring of impedance
grounding (line isolation monitor)
 Power failure
• In case of grid power failure, in critical areas in
hospitals power is automatically provided
within 10s after stoppage
• Critical components are:
– lighting
– alarms
– equipment in intensive care
Equipment safe during the first
failure • The principle of
redundancy can be
applied to the safety of
medical devices and
equipment (KEU)
• For example, it is
required that electrical
medical equipment is
safe even in case of a
breakdown on the
conductive contact with
patient
• Grounding impedance
must be sufficiently low
so that the patient may
not get in touch with
any dangerous voltage
 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 ...)
•
Leakage currents pathways

• Pathways of leakage current

through the patient
a) Intact ground lead
b) Broken protective ground
lead, patien connected to
ground through a catheter
c) Broken protective ground lead,
patien connected to ground by
an electrode or unintentianally.
Leakage currents
 Conductive paths to / from the heart
• In clinical settings there are current flow
pathways that cause heart microshock:
– The external pacemaker connected to epicardial
(heart area) or endocardial (inside heart)
electrodes
– Intracardial ECG measuring electrodes
– Catheters for invasive
• heart pressure measuring
• taking blood samples
• injection of contrast or medication into the heart
 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
 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
• These codes are followed by the standard 60601 -2-
xxx, Particular requirements for ........
 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 isolationisolated heart connectors
 Safety checking
• Electrical Safety Analysis:
– general
– for certain types of electrical medical devices and
equipment
• Demo practice:
– "General" analyzer according to 60601-1
– Defibrillator analyzing operation
Determination of device categorie
 Price/performance
• Mind the costs,
but satisfy safety
requirements !
 Literature
• J. Webster: Medical Instrumentation, Chapter
14, Electrical Safety