Electronic Devices for Medical
Applications: Safety, Reliability,
and Biocompatibility
Requirements
July 31, 2020 by Emmanuel Ikimi
Electronics engineers working in industries that
design equipment for the healthcare industry are
responsible for ensuring their safety and reliability
in line with standards of the medical industry.
This article will explore the most critical
considerations in designing electronics for medical
use.
ARTICLE
What is Medical Electronics Engineering?
Medical electronics engineering (aka biomedical engineering) is a
specialty of electrical engineering that involves the design and
maintenance of electronic devices and equipment for the healthcare
industry. Electronic applications in the medical field help to assist
healthcare professionals in performing their duties, modifying medical
treatments, and improving both clinical outcomes and the overall
quality of life of patients.
As treatments become more advanced, electronics have become more
efficient, too. Thanks to rapid miniaturization, electronic equipment has
become smaller and more component-dense. As covered below,
medical electronics broadly cover life support instrumentation, hearing
aids, pacemakers, and patient monitoring equipment.
Life Support Instrumentation
Life support machines help to sustain a patient’s critical body functions
until biological systems can regain control. A good example is
a medical ventilator that aids respiration in patients with breathing
problems. The device comprises gas sensors (for detecting oxygen
and carbon dioxide levels), power converters (for converting AC input
to DC and DC-to-DC), an electric pump for ventilation, and a control
panel (which serves as a human-machine interface, or HMI.
A top-down view of left and right-ear hearing aids, including their
microphone and speaker sections. Image Credit: Pixabay.
Hearing Aids
Hearing aids fall into the category of implantable medical devices.
They are portable, battery-powered devices that aid the hard of
hearing by amplifying the sound that reaches the user’s ear. Hearing
aids contain a microphone that intercepts sound waves from the
environment and converts them into digital signals. An amplifier then
increases the strength of the input signal and passes it to a speaker
inside the device placed in the ear.
Pacemakers
A pacemaker is a life-critical, battery-powered device that sends an
electronic signal to the heart to help it beat more regularly. The main
components of these devices are the leads and the pulse generator.
The former are small wires that pass through a patient’s veins and into
the heart muscles. They transmit electrical impulses from the pulse
generator, which is a small battery-powered device located on the
patient's chest.
Patient Monitoring Systems
Patient monitoring systems are electronic devices and equipment that
measure the health status of patients, such as their insulin levels, heart
rate, and oxygen saturation. A standard biomedical signal acquisition
system comprises sensors, amplifiers, filters, and analogue-to-digital
converters.
A doctor shows her patient his readings on a patient monitoring
system. Image Credit: Pxfuel.
Why Electronic Device Reliability is Critical in Healthcare
In the medical industry, errors often prove fatal. Therefore, electronic
devices and equipment must operate at a high degree of precision. To
facilitate the sound decision making of healthcare professionals, the
data obtained from electronic sensors and signal-processing systems
must have a low margin of error over a large number of samples.
Reliability is also critical. Some electronic equipment utilized in
hospitals, clinics, and long-term care facilities (such as insulin pumps,
pacemakers, and defibrillators) perform life-critical functions. Moreover,
many treatment processes that require the use of electronic medical
equipment must carry on continuously, with predictable downtime for
scheduled maintenance.
Biocompatibility of Electronic Medical Equipment
Biocompatibility measures the level of compatibility that an electronic
medical device has with the biological systems of the host or patient.
Meeting the healthcare industry’s biocompatibility requirements is one
of the most challenging aspects for engineers designing implantable
medical electronic devices.
Biocompatibility testing determines the impact of electronic medical
devices on the human body, particularly by identifying potentially
harmful physiological effects. The ISO 10993-1:2018 is a recognized
standard within the healthcare industry that allows manufacturers and
design engineers to gain a better understanding of how the nature of
device parts, manufacturing processes, sterilization, and so on, all
affect the biocompatibility of medical electronics.
Factors That Affect the Reliability of Electronic Medical
Equipment
Even in the most efficient devices, failures are inevitable and
recognized as such. Nevertheless, due to the sensitive and life-critical
nature of medical applications, failures must be highly predictable. The
partial or total failures of medical devices may stem from
manufacturing defects or failures (whether they are latent or
catastrophic) in electronic components, e.g. fuses, relays, contactors,
and metal oxide semiconductor field-effect transistors (aka MOSFETs).
Electromagnetic interference can also affect the operation of both
implantable devices and fixed electronic equipment. Disturbances from
radio-frequency sources, such as local area networks, metal detectors,
and Bluetooth devices, can cause medical devices to malfunction and
compromise the health of patients.
Predicting Failures
Mean time to failure (MTTF), mean time between failures (MTBF), and
mean time to repair (or recover) (MTTR) are some essential metrics for
determining the uptime of electronic medical equipment. Let us take a
closer look at these metrics below:
MTTF is the time taken between the initial deployments of a medical
device up to its end of life. It is one of the best ways to assess the
reliability of non-repairable medical devices. Determining the MTTF
allows for a timely replacement of sensitive devices to minimize the
impact of failures on the health of patients.
MTBF assesses the time that passes between an electronic device’s
previous failure and its next failure under normal operating conditions.
Engineers usually calculate the MTBF to schedule routine inspections
for replacements. After they establish that an asset will run for a certain
number of hours before the next failure, they can carry out preventive
actions, such as recalibration (i.e. the revision of the relevant industrial
measurements and specifications), to minimize failure and extend its
uptime.
MTTR assesses the mean time taken to restore a piece of electronic
medical equipment to optimal functionality following a failure. Consider,
for example, the importance of measuring the time it takes to
recalibrate an electrocardiogram (aka ECG).
A patient’s first-person view as he applies a portable blood glucose
meter to his middle fingertip. Image Credit: Pixabay.
Summarizing How Crucial Electronic Medical Devices Are to
Healthcare
Ultimately, electronic medical devices play an integral role in modern
healthcare, enabling healthcare professionals to perform their duties
more efficiently and reliably. Like the military, the healthcare industry
has standards that promote the safe manufacture and operation of
medical-grade devices to protect the safety and health of patients.
After all, reliability, accuracy, and biocompatibility are the most critical
considerations for designing electronics for medical use.
