INTRODUCTION
INTRODUCTION
What is Medical Device?
The medical device industry is one of the biggest
industries in healthcare, driven by innovation and new
technologies. The last decade has seen an unprecedented
growth in innovative and improved technologies. Medical
devices are used in all branches of medicine, surgery and
community care to treat and diagnose diseases. It has various
definitions according to their respective regulatory authorities.
The era of newer development and technology has decreased
the morbidity and mortality of life. Medical device regulation
is complex, in part because of the wide variety of items that
are categorized as medical devices. The medical development
in terms of drugs and devices has brought about the robust
change in the life of the people (as offered by the cosmetic
treatment, dentist, face and cardiology devices). Medical
devices have extended the ability of physicians to diagnose
and treat diseases, making great contributions to health and
quality of life. According to World Health Organization
(Geneva), under Medical Device Regulations, the term
“medical devices” includes everything from highly
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sophisticated computerized medical equipment down to
simple wooden tongue depressors.
Medical Device – According ISO 13485
Any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or
other similar or related article, intended by the manufacturer
to be used, alone or in combination, for human beings for one
or more of the specific purpose(s) of diagnosis, prevention,
monitoring, treatment or alleviation of disease, diagnosis,
monitoring, treatment, alleviation of or compensation for an
injury, investigation, replacement, modification, or support of
the anatomy or of a physiological process, supporting or
sustaining life, control of conception, disinfection of medical
devices, providing information for medical purposes by means
of in vitro examination of specimens derived from the human
body and which does not achieve its primary intended action
in or on the human body by pharmacological, immunological
or metabolic means, but which may be assisted in its function
by such means.
Medical devices vary according to their intended use and
indications. Examples
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-Simple devices such as tongue depressors, medical
thermometers, and disposable gloves to
-Advanced devices such as coronary stent, implants,
and prostheses.
Demand for medical devices grows faster than expected in
recent years. The global medical device market reached
roughly $209 billion in 2006. All devices carry a certain
degree of risk and could cause problems in specific
circumstances. Many medical device problems cannot be
detected until extensive market experience is gained. For
example, an implantable device may fail in a manner that was
not predictable at the time of implantation.
The Medical Device Regulation Act or Medical
Device Amendments of 1976 was introduced by the 94th
Congress of the United States. Congressman Paul G.
Rogers and Senator Edward M. Kennedy were the chairperson
sponsors of the medical device amendments
History: (According to USFDA)
In 1906, Food & drug act was signed; it did not
apply to medical devices. The drug regulations were
significantly amended in 1962. At its core, the drug regulatory
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system requires FDA approval for every important step in the
product development process. Before the 1930’s medical
device industry was practically non-existent. Many medical
devices were sold directly to the public. Medical devices are
regulated under more recent legislation, which was amended
in 1976. Indeed, prior to World War II there was no device
industry to speak of. Several companies supplied instruments
to physicians and equipment to hospitals, but few thought that
these items presented risks other than those associated with
untrained use. Outside dentistry, few medical products were
intended for implantation in, or even prolonged application to,
the human body. Initially it was proposed to expand the new
act’s definition of drug to include devices, a merger that made
no difference at the time. It was not until reports of the Elixir
Sulfanilamide disaster in 1937 that Congress decided to
mandate premarket review of new drugs and medical devices.
Regulation under the 1938 act- The 1938 FD&C Act gave
the FDA jurisdiction over medical devices for the first time.
Agency paid little attention at devices marketed while a few
simple implants, such as surgical nails, had gained acceptance
in medical practice, the era of artificial organs, cosmetic
implants, and heart pacemakers lay in the future. The 1960’s
saw rapid innovation in medical technology, and FDA
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officials became convinced of the need to review some new
devices for safety and effectiveness before they were
introduced.
Enactment of the 1976 amendments- By 1970 there was
broad recognition that the existing law provided an inadequate
framework for regulating the rapidly expanding area of
medical devices. The first clear conception of a system for
regulating devices was offered in 1970 by an internal
Department of Health, Education, and Welfare (HEW)
committee chaired by Heart Institute Director Theodore
Cooper. The committee also called as Cooper committee.
During the 1960’s the cooper committee was instructed to
study the adverse effects of medical device for human use.
This command was given by the secretary of Health,
Education & welfare (HEW). The study committee
recommended a classification of medical device in 1970.
Classification was based on comparative risk.
The 1976 amendments were promoted as a new type
of regulatory statute, one that augmented the FDA’s weapons
against dangerous and worthless products and subjected high-
risk technologies to premarket review, but also authorized less
intrusive regulation of the majority of devices. The Safe
Medical Devices Act (or SMDA) was passed in 1990, which
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required healthcare facilities to report faulty medical devices
to the FDA. This act more importantly, allowed the FDA to
order medical device product recalls. In 1997, The Food and
Drug Modernization Act (FDAMA) adds exemption criteria,
clinical trials and Third-party review regulations. Further in
2002, Medical Device User Fee and Modernization Act
(MDUFMA) passed allowing and specifying fees structure for
regulatory review and registration process.
General Basis of Classification of Medical
Devices according to WHO
There are three classifications for medical devices: –
Low Risk Class – General Controls for devices may take
place. Medical device is not to be for a use in supporting or
sustaining human life, for a use which is of substantial
importance in preventing impairment of human health and
does not present a potential unreasonable risk of illness or
injury.
Medium Risk Class -Medical device cannot be classified as a
class I device because the controls authorized are insufficient
to provide reasonable assurance of the safety and
effectiveness of the device.
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High Risk Class -Medical device is to be for use in
supporting or sustaining human life, of substantial
importance in preventing impairment of human health, or
presents a potential unreasonable risk of illness or injury, is to
be subject, premarket approval to provide reasonable
assurance of its safety and effectiveness.
Classification Rules for Medical Devices
General classification of risk-based rules of medical device
according to WHO:
NON-INVASIVE DEVICES:
Rule 1.
All non-invasive devices which come into contact with
injured skin:
Class I if they are intended to be used as a mechanical
barrier, for compression or for absorption of exudates
only, i.e. they heal by primary intent;
Examples: simple wound dressings; cotton wool.
Class II if they are intended to be used principally
with wounds which have breached the dermis,
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including devices principally intended to manage the
microenvironment of a wound.
Examples: non-medicated impregnated gauze dressings.
Unless they are intended to be used principally with
wounds which have breached the dermis and can
only heal by secondary intent, in which case they are
in Class III
Examples: dressings for chronic ulcerated wounds;
dressings for severe burns.
Rule 2.
All non-invasive devices intended for channelling or storing
• body liquids or tissues,
• liquids or
• gases
for the purpose of eventual infusion, administration or
introduction into the body are in Class I
Examples: administration sets for gravity infusion; syringes
without needles.
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Unless they are intended for use of channelling blood, or
storing or channelling other body liquids, or for storing
organs, parts of organs or body tissues, in which case they
are Class II.
Examples: tubes used for blood transfusion, organ storage
containers.
They are blood bags, in which case they are Class III.
Example: Blood bags that do not incorporate an anti-
coagulant
Rule 3.
All non-invasive devices intended for modifying the
biological or chemical composition of blood, other body
liquids, or other liquids intended for infusion into the body are
in Class III
Examples: haemodialyzers; devices to remove white blood
cells from whole blood
The treatment consists of filtration, centrifuging or
exchanges of gas or of heat, in which case they are in
Class II.
Examples: devices to remove carbon dioxide; particulate
filters in an extracorporeal circulation system
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Rule 4.
All other non-invasive devices are in Class I.
Examples: urine collection bottles; compression hosiery; non-
invasive electrodes, hospital beds
Common Framework of medical device
regulation according to Global harmonization
task force (GHTF)-
Global harmonization task force was founded in 1993
by the governments and industry of various countries. GHTF
is the representative of Australia, Canada, Japan, the
European Union, and the United States of America. The main
aim of this voluntary group is to address the issues of various
regulatory authorities. The purpose of the GHTF is to
encourage standards and regulatory practices related to the
safety, performance and quality of medical devices
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Phases in the life span of a medical device-
Figure1.show the major phases in the life span of a medical
device from conception and development to disposal. There
are basically 7 stages comes under medical device processing.
It is important to maintain safety and performance during each
phase. Majorly 3 stakeholders are involved in this life span.
Figure 1. Major phases in the life span of a medical device
Conception & Packaging &
Manufacture Advertising Sale Use Disposal
Development Labelling
Manufacturer Vendor User
Conception and development-
The development phase includes development
planning, design verification/validation, prototype testing and
clinical trials.
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Conception and development based on scientific principles.
The more complex the device, the higher the risk of user
error. Manufacturer works as a stakeholder in this phase.
Manufacture-
Good manufacturing management can produce good
quality of medical device. Good manufacturing practices
(GMP) should follow during the manufacturing of medical
devices. Poor management can produce inconsistency in the
quality of products, such that non-conforming devices can
filter through the production line to the market.
Packaging and labelling-
Properly packaged medical devices pose little risk to
individuals handling them, even if the medical device is bio-
hazardous. This highlights the importance of well-designed
packaging systems in delivering clean, sterile and protected
medical devices to the point of use. Well-sealed packaging is
essential for those medical devices that must be maintained
sterile. Packaging and labelling medical devices properly is
important factor while shipping devices from one place to
another.
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Advertising-
Medical device marketing and advertising play important
role in creating expectation and influence the belief in the
medical device capabilities. Misleading or fraudulent
advertising medical device may help to increase sale of the
product but it will be hazardous to human health.
Sale-
The sale of medical devices by the vendor is a
critical stage that leads to the device being put into actual use.
If the vendor is not subject to regulation, then there is higher
risk of exposing the public to low quality or ineffective
devices.
Use-
Medical device should be use according to given
instructions. User of this device should have all the
information of their safety and effective performance. Within
the clinical engineering community it is widely believed that
user error
underlies at least half of all medical device-related injuries
and deaths. The lack of inappropriate, calibration and
maintenance of medical devices can seriously affect their
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safety and performance. These issues are often overlooked or
underestimated.
Disposal-
Disposal of certain types of devices should follow
specific and stringent safety rules. For example, devices that
are contaminated after use (e.g. syringes) or devices that
contain toxic chemicals can present hazards to people or the
environment and must be disposed of properly.
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Table 1. A common framework for medical device
regulations
STAGE PRE-MARKET PLACING ON- POST-MARKET
MARKET
Control/ Product Sale After- Sale/Use
Monitor
Person Manufacturer Vendor Vendor/ User
Items or Device Establishment Surveillance/vigilance
activities attributes registration *After-sale obligations.
regulated *Safety and *List products *Monitoring of
performance available or in device’s clinical
Manufacturing use. performance.
Quality systems *Requires *Problem identification
Labelling vendor to fulfil and alerts.
*Accurate after- sale
description of obligations
product.
*Instructions for Advertising
use Prohibits
misleading or
fraudulent
advertisement
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Global Trends in Medical Device Industry
The global market for medical devices is estimated over $ 220
billion for the year 2015. The United States of America, with
about 45% market share is the dominant market for medical
devices followed by European market share of 30% and Japan
with share of 10% and other 15% includes markets of Asia
Pacific and Latin America.
Figure 2. Market share of a medical device
Medical devices sector in India is relatively small as
compared to the rest of the manufacturing industry, though
India is one of the top twenty markets for medical devices in
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the world and is 4th largest market in Asia after Japan, China
and South Korea.
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