BME-2516

Electronics in Bioelectrical
Applications
Lecture 5 part 2 Patient Safety Part I
Sari Ahokas
sari.ahokas@tut.fi
Department of Biomedical Engineering
Tampere University of Technology
Spring 2011

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Patient safety

Patient safety is of major concern in medical electronics, must

be considered and certified
SAFETY: freedom of hazards or risks (minimized)
Absolute safety cannot be achieved in medicine

freedom of non-acceptable risk factors

risk minimized with respect to the benefits

Total safety = safety of the device and its use + environmental safety
(effect of the environment)

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Safety

Safety of the medical device concerns:

Normal use
intended use

Normal condition
all protecting tools are in condition

One-fault condition
one protection tool out of two tools in condition

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Hazard risk increases

Increased use and complexity of electrical equipment in diagnosis

and therapy
increase in risk associated to the use of the equipment
a direct effect to the patient safety

hospital environment cannot be made risk-free

risk is always present (inherent), because medical devices perform
invasive or non-invasive diagnostic, therapeutic, corrective, or monitoring
inventions
Fire, air, drugs, waste, electricity
Risk group: patients and medical staff

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Hazards associated with the medical devices I

Electrical

patients are surrounded and connected to electrical devices

low-level electrical hazards (currents and voltages)

230 V
ECG

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Hazards associated with the medical devices II

Mechanical
mechanical-assist devices, patient transfer devices, support devices

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Hazards associated with the medical devices III

Environmental

waste products, noise (EMI), gases

Burn caused to the patient due to electric

breakdown because of poor contact of
defibrillating electrode on skin and leak of
oxygen.
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Hazards associated with the medical devices IV

Biological

infections, sterilization, biological reactions

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Hazards associated with the medical devices V

Radiation

radiotherapy sources, x-ray, gamma radiation

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Factors affecting the safety

safety of the devices

electrical, mechanical, chemical safety

maintenance, intended use
human interface
Fail safe devices

safety of the premises (environment)

operation temperature, vibration, humidity, moisture protection, pressure,

EMI

operating instructions

Improper use of the devices because of lack of experience or inadequate

training leads to errors
Medical personnel rarely reads manuals before there is problem

expert use of the devices

personnel training
advance service of the devices

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Nature of the hazards

Human mistake in the use of the device

Functional failure in the device
Failure caused by the environment (EMI)
Falling under the expected life time (performance)
Malfunction in the device
Biological hazard (biocombatibility)
Hospital environment

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Important aspects to emphasize the safety

Patient or operator is not able to react naturally in some dangerous situation
(electrical current, radiation)
continuation and maintenance of vital functions depends on the reliability of
the equipment
high-power therapy devices can affect the operation of sensitive recording
devices
normal reactions of the patient are lacking because of anesthesia, loss of
conciousness
protective skin impedance can be absent (openings, incisions, skin abrasion,
electrode gel)

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Physiological effects of electrical current

Conditions for the electrical hazards

potential difference must be present

the individual must be a part of the electrical current
voltage, impedance
current
Current dependent on body impedances and skin impedance

Electric current flow through biological tissue

Electric stimulation of excitable tissue (nerve or muscle)
Resistive heating of tissue
Electrochemical burns and tissue damage

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Department of Biomedical Engineering

Macroshock

current applied on the surface of the body

cardiac fibrillation risk depends on the location of the entry points and skin
resistance

Microshock

current applied directly to the heart (catheterization, open-chest surgery)

Safety limit to prevent microshocks is 10A

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Next week

Patient safety part II

Standards
Embedded programming

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