INTRODUCTION What is Medical Device PDF

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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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