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SAFETY ASPECTS OF
MEDICAL DEVICES
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Dr G L Jain |
Medical devices are the health
care products used by a patient as well as a healthy
individual. Hence, the device shall not only be
functional but also safe. Although it is not always
possible to attain 100 % safety, the risk associated
with the use of a device shall be within acceptable
limits when weight against the benefits to the
patient.
Safety principles may include
i) identification of hazards and the associated risks
arising from the intended use and foreseeable misuse,
ii) elimination or reduction of risks as far as
possible (inherently safe design and construction),
iii) risk indication systems especially where the risk
cannot be avoided and information to user about the
possible risks. The following aspects needs to be
addressed to ensure that the device is safe : |
Chemical and
Physical Safety
The devices should be designed
and manufactured in such a way as to ensure the
characteristics and performance taking care of various
aspects mentioned above and for that purpose,
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the choice of materials used,
particularly as regards toxicity and, where appropriate,
flammability,
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the compatibility between the
materials used and biological tissues, cells and body
fluids, taking account of the intended purpose of the
device and
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the choice of materials used
should reflect, where appropriate, matters such as
hardness, wear and fatigue strength.
The devices should be
designed, manufactured and packed in such a way that
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the risk posed by contaminants
and residues to the persons involved in the transport,
storage and use of the devices and to the patients is
minimized, taking account of the intended purpose of the
product. Particular attention should be paid to the
tissues exposed and to the duration and frequency of
exposure.
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they can be used safely with
the materials, substances and gases with which they enter
into contact during their normal use or during routine
procedures; if the devices are intended to administer
medicinal products they should be designed and
manufactured in such a way as to be compatible with the
medicinal products concerned according to the provisions
and restrictions governing these products and that their
performance is maintained in accordance with the intended
use.
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the risks posed by substances
that it leaches is minimum.
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The risks posed by the
unintentional ingress or egress of substances into or from
the device is minimum
Biological
Safety
The devices and manufacturing
processes should be designed in such a way as
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to eliminate or reduce as far
as possible the risk of infection to the patient, user
and, where applicable, other persons.
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The design should allow easy
handling and, where necessary, minimise contamination of
the device by the patient or vice versa during use.
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Devices delivered in a sterile
state should be packed appropriately to ensure that they
are sterile when placed on the market and remain sterile,
under the storage and transport conditions laid down,
until the protective packaging is damaged or opened.
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The packaging and/or label of
the device should distinguish between identical or similar
products sold in both sterile and non sterile condition.
Environmental safety
If the device is intended for
use in combination with other devices or equipment, the
whole combination, including the connection system should
be safe and should not impair the specified performance of
the devices. Any restrictions on use should be indicated
on the label or in the instructions for use.
Devices should be designed and
manufactured in such a way as to remove or minimise as far
as is practicable the risk :
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of injury, in connection with
their physical features, including the volume/pressure
ratio, dimensional and where appropriate ergonomic
features,
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of connected with reasonably
foreseeable environmental conditions, such as magnetic
fields, external electrical influences, electrostatic
discharge, pressure, temperature or variations in pressure
and acceleration,
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of reciprocal interference
with other devices normally used in the investigations or
for the treatment given,
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arising where maintenance or
calibration are not possible (as with implants), from
ageing of materials used or loss of accuracy of any
measuring or control mechanism
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of fire or explosion during
normal use and in single fault condition.
Radiation Safety
Exposure of patients, users
and other persons to radiation should be reduced as far as
possible. Where devices are intended to emit potentially
hazardous, visible and/or invisible radiation, they should
be fitted, where practicable, with visual displays and/or
audible warnings of such emissions.
Devices emitting ionizing
radiation shall minimize radiation exposure of the patient
and user.
Electrical
Safety
Devices incorporating
electronic programmable systems should be designed to
ensure the repeatability, reliability and performance of
these systems according to the intended use. In the event
of a single fault condition in the system, appropriate
means should be adopted to eliminate or reduce as far as
possible consequent risks.
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Devices with an internal power
supply should be equipped with a means of determining the
state of the power supply.
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Devices with an external power
supply should include an alarm system to signal any power
failure.
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Devices intended to monitor
one or more clinical parameters of a patient should be
equipped with appropriate alarm systems to alert the user
of situations which could lead to death or severe
deterioration of the patient's state of health
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There should be minimum risks
of creating electromagnetic fields
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The risk of accidental
electric shocks during normal use should be avoided
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Protection against mechanical
and thermal risks shall be available
Mechanical Safety
The patient and user should be protected against
mechanical risks connected with, for example, resistance
to movement, instability and moving parts.
Accessible parts of the
devices (excluding the parts or areas intended to supply
heat or reach given temperatures) and their surroundings
should not attain potentially dangerous temperatures under
normal use.
Protection against the risks
posed to the patient by energy supplies or substances.
Devices for supplying the
patient with energy or substances should be designed and
constructed in such a way that the delivered amount can be
set and maintained accurately enough to guarantee the
safety of the patient and of the user.
Devices should be fitted with
the means of preventing and/or indicating any inadequacies
in the delivered amount which could pose a danger. Devices
should incorporate suitable means to prevent, as far as
possible, the accidental release of dangerous levels of
energy from an energy and/or substance source.
The function of the controls
and indicators should be clearly specified on the devices.
Where a device bears instructions required for its
operation or indicates operating or adjustment parameters
by means of a visual system, such information should be
understandable to the user and, as appropriate, the
patient.
If you have questions related to
this subject, please write to Dr G L Jain at
drgljain@medisourceasia.com
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Dr G L Jain A Gold Medalist in M. Sc., Dr.
Jain was inclined towards industry right from the
beginning of his career. He joined Shriram Chemical
Industries, Kota as Foreman & thereafter completed Ph.
D. from I.I.T., New Delhi. Dr. Jain got his training
in the field of Pharmaceutical and Medical Devices
through Technical Courses; visiting Manufacturing
units & Laboratories world-over; Regulatory Agencies
like USFDA; Health & Welfare, Canada; BSI, UK;
National Drugs Control Organization, Finland; WHO,
Geneva; CEN; Brussels. He was with USFDA for two
months for training on various aspects of GMP/PMA/NDA
& Inspection.
Besides 17 years in academic institutions like, IIT
and AIIMS, New Delhi, he has hands-on experience of
working in industries for 9 years.
He is an expert on cGMP. In last 15 years, he has
conducted more than two dozen Training Courses on
Quality Assurance & GMP. Amongst his topics of
interest are Building & Premises; Documentation; Clean
Room Concepts; Microbiology & Industrial
Sterilization; Statistical Sampling, Validation and
Quality Management Systems. He has set-up two Medical
Device Manufacturing Facilities. One of the facilities
is certified for WHO-GMP and is a model manufacturing
facility in the country. He has also set up a
Consultancy Service Provider firm ‘ Centre for Active
Learning, Guidance & Solutions’ at Udaipur, India.
He is well known for his high teaching, management,
planning, organizing & leadership capabilities. He has
been Technical Consultant to many industries. |
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