medical product safety and regulation

8/13/2019 Medical Product Safety and Regulation

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Medical device safety and

RegulationsBy: Yassir Eltayeb Ali Hassan

http://www.inquisitr.com

www.brokerbanksecurities.com


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Medical device safety and

Regulations

Objectives of the lecture

1. Know the definition and classifications of medical device

2. Know the Risks associated with medical devices

3. Describesthe nature of medical device safety as a riskmanagement process

4. Know the life span of medical devices from their

conception to disposal

5. Know the Participantsin ensuring the safety of medicaldevices

6. Know common framework for medical device regulations

, regulatory tools and general requirements


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Medical device

Medical devices are manyand varied in regardto

compositionand complexityand may be instruments,

apparatuses, software, material or other articles.

Definition

Medical device means any instrument, apparatus,appliance, software, material or other article, whether

used aloneor in combination, together with any

accessories, including the software intended by its

manufacturer to be used specifically for diagnostic

and/or therapeutic purpose and necessary for its

proper application, intended by the manufacturer to

be used for human beings.


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Medical device

Medical devices do not achieve their principal

intended action in or on the human body bypharmacological, immunological, or metabolic

meansbut may be assisted in their function by

such meansmedical devicesact by other means like

physical, mechanical, or thermal


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Me ca ev ce purposesMedical device are intended by

the manufacturer to be used for

human beings for one or more of

the specific purposes :

1. Diagnosis,prevention,

monitoring, treatment or

alleviation of disease(Cope/

Deal with human disease)

2. Diagnosis, monitoring,

treatment, alleviation of or

compensation for an injury

(Care for human injuries)

3. Investigation, replacement,

modification, or supportof the

anatomyor of a physiological

process (Meet human

4. Supportingor sustaining life

(Maintain human physiological

functions.)5.Controlof human conception

6. Disinfectionof medical device

7. Providing information for

medical purposes


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Medical device groupsThe standardsaddr

essesseveral groups of medical devices.

The groups are as follows:

1. Generalmedical device.2. Active medical device.

3. Activeimplantable medical device.

4. Implantable medical device.

5. In vitro diagnostic device.

6. Non-activemedical device.


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Medical device groups

General medical device

Any instrument, apparatus, appliance, material, or otherarticle, whether used alone or in combination, including the

software necessary for its proper application, intendedby the

manufacturer for human use for thepurpose of: diagnosis,

prevention, monitoring, treatment, or alleviation of disease

Active medical device

Any medical device relyingfor its functioning on a source of

electrical energy or any source of power other than thatdirectly generated by the human body or gravity.


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Groups of medical devices.An active implantable medical device(AIMDs)

Any active medical device which is intendedto be totallyor

partiallyintroduced, surgicallyor medically, into the human

bodyor by medical instrumentation into a natural orifice, and

which is intended to remainafterthe procedure

Examples of AIMDs

1. bladder stimulators

2. cochlear implants

An implantable medical device

Any medical device intended: to be totallyor partiallyintroduced into the human body or a natural orifice, or to

replace an epithelial surface or the surface of the eye by surgical

intervention, which is intended to remain after the procedure

for at least 30 days and which can only be removed by medical

or surgical intervention.


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Groups of medical devices.

An in vitr o diagnostic device

Any device which is a reagent, reagent product, kit,

instrument, equipment, or system, whether used

alone or in combination, intended by the

manufacturer to be used in vitro for the examinationof samples derived from the human body with a view

to providing information on the physiological state.

A non-active medical device

Any medical device which is neitheran active

medical device noran in vitro diagnosticdevice


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Electromedical devices are different from universal

electric appliances

1. Because they are intended to alleviate or heal apatients disease

2. Enablehis/her further survival.

3. Have to interact with patients body

4. Have to be introducedintothe patients body

5. Remain even for long periods in direct contact

with the body


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Demarcation

1. Personal protective devices: X-ray skirts ,Gloves

2. Cosmetics ; dental brushes

3. Universal products; general power supply units

supplying medical devices

4. Multipurpose disinfectants: disinfectants

dedicated to medical devices such as endoscopes

or contact lenses, are medical products.


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Demarcation aspects


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International Electro medical Commission (IEC)

Responsibility for medical electrical equipment

standards is within the purview of Technical

Committee

The IEChas developeda series of safety standards

and regulations specifically for electro medicalequipment.

The IEC defines medical electrical equipment in

IEC 60601-1


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Medical device classes

Classi f ied by IEC depending on:-

Methodical risk

Invasiveness

(uninterrupted) contact time

Way of interaction with the patient

Classes :

1. class I no or insignificant risk

2. class IIa small risk

3. class IIb elevatedrisk

4. class III highrisk

Classification is performedby themanufacturer himself

based on product characteristics, intended purpose and

intended use as defined by him


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e ca ev ce c asses

Exampleofhow

cla

ssificationisdo

ne


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Class I and class II DevicesClass I:-

Non-life sustaining devices, whose failure posed no risk to life, and

thus required no need for performance standards .

Examples

Tongue depressors and stethoscopes

Class I I devices :-also non-life sustaining devices, they must meet specific controls

or performance standards.

Examples of class I I devices:-

physiologic monitors, X-ray machines, gas analyzers, bloodpressure cuffs, oxygen masks, infusion pumps, electrically

powered wheelchairs

www.robertburridge.com

l


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Class III Devices

Class I I I Devices

They are supporting life so that their failure is lifethreatening

Examples of class I I I medical devices are :-

1. replacement heart valves

2. Pacemakers

3. Defibrillators

4. drug -eluting stent

A li d P t


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Applied PartA partof the equipment which in normal use:

1. Comes into physical contactwith the patient

2. Can be brought into contact with the patient

3. Needs to be touchedby the patient

Types of the applied parts:-

1. B

2. BF

3. CF

Type B

Type B is the least stringent classification, and is used for

applied partsthat are generally not conductive and can be

immediatelyreleasedfrom the patient.

A li d P


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Applied Part

Body floating BF

For devices that have conductive contact with the patient, orhave applied parts that are fixed in medium or long term

contact with the patient, e.g. ECG electrodes

Cardiac f loating

Type CF is the most stringent classification, being required for

those applications where the applied part is in direct conductive

contact with the heart.


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Which requirements must be met(in medical device) ?

1. acceptable risk/benefit ratio; the manufacturermust

implementa risk management process

2. The MD must achieve the medicalperformance intended by

the manufacturer

3. The MD must be designed and constructed in conformity

with generally acknowledged state of the art of science and

technology and following the principles of integrated safety

4. The MD must meet requirements 13 during their whole

expected lifetime.

5. The MD Must fulfill their intendedcharacteristics and

performance also after storage and transport.

6. The MD must be accompaniedby all informationrequired forsafe useduring the intended lifetime


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Risks in medical devices

1. Electrichazards

2. Physicalhazards3. Biologichazards due to over dosage of highly

effective drugs

4. Hygienic hazardsby transmitting pathogenic germswhen touching contaminated parts

5. Functional hazards through inaccuracies, malfunction

and/or breakdown


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Medical device safety

To reach optimumassurance of MD safetywe must

consider several essential elements:1. Absolute safety cannot be guaranteed

2. Safetyis a risk management issue3. Safety is closely aligned with device

effectiveness/performance

4. Safety must be consideredthroughout the life span of

the device5. Safety requires shared responsibility among the

stakeholders


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Medical device safety and risk management

Hazard is a potential for an adverse event, a sourceof

dangerRiskis a measure of the combinationof

1. The hazard

2. The likelihood of occurrence of the adverse event3. The severity or overall impact.

Risk assessment:

Begins with risk analysis to identify allpossible hazards

Followed by risk evaluation to estimatethe risk of each

hazard


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Risk management process

According to ISO 14971

This should assurethat risksof a device will sufficiently

be managedby:-

Systematic risk analysis

Risk assessment

Risk evaluation

Risk reduction

Risk monitoring including risks caused by a usersmisuse, mistake or ignorance


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Risk assessmentThe current approach to device safety is to estimate the

potentialof a devicebecoming a hazard that could result insafety problems and harm

Risk assessmentisbased on:-

1. Experience.

2. Evidence.

3. Computation.

4. Guesswork (An estimate based on little or no

information).

Ri k t


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Risk assessment

Risk assessment is complex, as it can be influenced by:-

1. Personalperception / knowledge2. Cultural background.

3. economicconditions, and political climates.

In practice, risk assessment of medical devices is based on:-1. The experienceof health careprofessionals

2. Safety design engineering

Ri k t d l ifi ti


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Risk assessment and classification In the United States, governmental risk assessment of

medical devices is based mainly on recommendations

from members of 16 medical specialty panels, and devicesare categorized into three classes.

The European Union and Canada categorize medical

devices according to theirperceived potential hazards1. Canada assigns four classes of devices based on the level

of risk class I, II, III, and IV

2. The European Union assigns three classes with class II

being sub-divided into IIa and IIb


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Risk assessment and classification

In classifying devices, potential areas of hazard

that needs consideration include:-

1. The degree of invasiveness

2. Durationof contact

3. Thebodysystem affected

4. local versus systemic effects

Ri k l i


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Risk analysisManufacturers need to adopt measures that can identifyand

quantifyrisks.

Twocommon techniquesare used for identifyingrisk:-

1. Fault Tree Analysis (FTA)

2. Failure Mode Effect Analysis (FMEA)

FMEA approach

Considerationis given to what would be the end-consequence

of failure of a component or element of the device

Fault Tree Analysis approach

Considers a fault in the devices and asks what are the

different causes that could result in the failure

/


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Risk/Benefit nature of medical devicesMedical devices should be designed and manufactured in

such a way that:

1. When used under the conditions and for the purposes

intended with technical knowledge, experience,

education or trainingof intended users, they will not

compromisethe clinical condition or the safety andhealthof (patients and users )

2. Risks which may be associated with their use constitute

acceptable risks when weighed againstthebenefits

Ri k M t P Fl h t


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Risk Management Process FlowchartRisk management planning

Risk analysis

Risk evaluation

Risk control

Evaluation of overall residual risk

Risk management reporting

Production /post

production informationcollection

The (ISO) has produced a document

(ISO 14971:2000) providing

manufacturers with a frameworkIncluding:-

1. Risk analysis

2. Risk evaluation

3. Risk control

This framework is for :-1. Risk management in medical

device design, development,

and manufacturing

2. Monitoring the safety and

performance of the device after sale

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PDCA Cycle

Plan

Do

Check

Act

Always remember this


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Effectiveness/performanceof medical devices

A device is clinicallyeffective when itproducesthe

effect intendedby the manufacturer relative to the

medical condition

Clinical effectiveness is a good indicatorof device

performance

Performance,may include technical functions inaddition to clinical effectiveness.

Performanceis closely linkedto safety

Example:-A patient monitor that does not perform well couldpose

serious clinical safety problems to the patient. Thus, the

safety and performance of medical devices are normally

considered together

Phases in the life span of a medical device


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Phases in the life span of a medical deviceThe major phases in the life span of a medical device from

conceptionand development to disposal

1. Conceptionand development

2. Manufacturing

3. Packaging and labelling

4. Advertising

5. Sale

6. Use

7. Disposal

Ph i h lif f di l d i


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Phases in the life span of a medical deviceConception and development

The scientific principles upon which a device is based are fundamental

to its safety and performance

For example, a cardiac pacemakershould deliver a minute electrical

impulse of a certain size and shapethat simulates the natural

functioning of the heart. Significant deviationfrom this may

compromise safety and performance

Manufacture

Good, functional medical devices areproducedwhen the manufacturing

processis adequatelymanaged

GMP is more commonly referred to as quality systems in

manufacturing



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Packaging and labelling

The importance of well-designed Packaging systems in deliveringclean,

sterile and protected medical devices is granted by:-

1. Properly packaged ; this will Cause little risk to individuals handling

them, even if the MD isbiohazardous.

2. Properly Shipping; aMD and its packaging must survive because

damage can result during transportation and handlingunless the total

packaging system is designed robustly and can withstandvarious

stresses.

3. Well-sealed packaging is essential for those medical devices that

must be maintained sterile.

4. Labelling; is crucialin identifyingthe medical device and

specifyinginstructionsfor itsproper use.

5. Putting hazard warnings,cautionsand clear instructions.


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P ases in t e i e span o a me ica evice


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P ases in t e i e span o a me ica eviceAdvertising

Advertisement has thepotentialto create expectations andpowerfully

influencethebelief/ impression in a medical devices capabilities

medical device marketing and advertisingare regulatedtoprevent

misrepresentation of a medical device and its performance

Sale

The sale of medical devicesby the vendor is a critical stage that leads tothe device beingput into actual use.

If the vendor is not subject to regulation, then there is higher riskof

exposingthepublicto low quality or ineffective devices.

DisposalDevices that are contaminated after use (e.g. syringes) or devices that

contain toxic chemicals, can present hazards to people or the

environment and mustbe disposed of properly.

Participants in ensuring the safety of medical devices


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Participants in ensuring the safety of medical devices

1. The manufacturer usually manages the first three phases

of the medical devices life span

2. The Vendor includes importers, distributors, retailers andmanufacturerswho sellmedical equipment

3. The User is usually aprofessionalin a health care

facility, but may also be thepatients.4. The Public/Patient and the Governmentare also key

interested parties

Thepublicare the ultimate beneficiary of medical devices

while the government has the responsibilityof overseeingthat medical devices sold in the country are safe and

effective.

R ibilit f P ti i t


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Responsibility of Participants

CONCEPTION

AND

DEVELOPMENT

MANUFACTURE

PACKAGING

AND

LABELLING

ADVERTISING

SALE

USE

DISPOSAL

VENDOR USER

Manufacturer

The role of the manufacturer


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The role of the manufacturer

The manufacturer

As the creator of the device, must ensurethat it ismanufacturedto meet or exceed the required standardsof

safetyandperformance

This includes the three phases:-1. Design/development/testing

2. Manufacturing

3. Packaging and labelling

product being ready for the market

The role the vendor


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The role the vendor

The vendor should:-

1. Ensure that theproductssold comply/ followwith regulatory

requirements

2. Avoidmaking misleadingor fraudulent/deceitfulclaimsabout

their products

3. Avoid issuing false compliance certificates

4. Clearly labelled the refurbished/ reneweddevices

5. Provideafter-saleservice

6. Maketraininga condition to the manufacturer or importer in

accepting to sell the device7. Take responsibility in supportingor training their customers

8. Participating inpost-market surveillance

The role of the user and the public


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The role of the user and the public

The user should make sure that

1. He has qualifications and trainingin theproper use of the device2. He is familiar with the indications, contra-indicationsand operating

proceduresrecommended by the manufacturer

The public

They should:-

1. Be fully aware that all devices carry a certain risk

2. Promotesafetyand performancethrough:-

I. Self education

II. Putting customer pressure on manufacturersto comply with

standards.

The role of the government


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The role of the government

The government

Has the responsibility to:-1. Ensure that medical devices sold or made available in the

country are safe and effective.

2. Provide leadership in creating healthy cooperation

among stakeholdersin establishingpolicies and

regulations that are fair and clearto all.

Policiesand regulationsshould be reviewed periodically

to respondto changesin technologiesby makingappropriate (amendments/ corrections).

overall safety of Electromedical devices


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overall safety of Electromedical devices

1. Device safety (constructive safety and functional safety);

2. Safe application (with consideration of users knowledge,

foreseeable errors and misuse)

3. Safe supply (safe electric installation and reliable power

supply);

4. Safe disposal (environmentally conscious design and waste

management).

Good service or good intended purpose


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A common framework for medical device regulations


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Governmental regulation

of medical devices

Critical elements for regulatory attention


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Critical elements for regulatory attention

PRODUCT USE

The safety and performance of medical devices depend on two

critical elements

Product

representation

The third critical element

Definition of standard


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Definition of standard

What are standards

Standards are documented agreements containing technicalspecificationsor other precise criteria to be used consistently as

rules, guidelines or definitions of characteristics, to

ensure that materials,products, process and services are fit for their

purpose.Types of specifications in standards

1. Prescriptivespecifications

2. Design specifications

3. Performancespecifications

4. Managementspecifications


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Purposes of Standards

1. Provide reference criteria

2. Provide informationthat enhances safety, reliability and

performance of products, processes and services

3. Assure consumers about reliabilityor other characteristics of

goods or services provided in the marketplace.

4. Giveconsumers more choice by allowing one firms products

to be substituted for, or combined with, those of another.

Wh t i th diff b t t d d d l ti ?


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What is the difference between a standard and a regulation?

Regulation

A Rule that we must follow

Rules that the Government makes under an Act

Rules are made real and enforceable by the power that the Government

gives itself under an Act e.g. Health & Safety Act Regulation for Hearing

Protection

Standards

Not written by Government

Are written by organizations such as CSA, ANSI, CGSB, etc.

Typically refer to product performance or how to do a jobHave no authority on their own, but may be adopted into regulations making

them legal requirements

May be referred to specifically in a regulation or through a General Duty

Clause

Regulatory bodies may adopt all or a part of an existing standard

References


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References1. Higson, G. R., & Publishing, I. of P. (2002). Medical device

safety The Regulation of Medical Devices for PublicHealth and Safety. London: IOP Publishing Ltd 2002.

2. Tobin, J. J., & Walsh, G. (2008). Medical Product

Regulatory Affairs Pharmaceuticals, Diagnostics,Medical

Devices. Weinheim: WILEY-VCH Verlag GmbH & Co.KGaA.

3. Leitgeb, N. (2010). Safety of Electromedical Devices Law

RisksOpportunities. Leipzig: Springer-Verlag/Wien.4. World Health Organization - WHO. (2003). MEDICAL

DEVICE REGULATIONS Global overview and guiding

principles. Geneva

d l d l ff


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Medical Product Regulatory Affairs

R l ti


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Regulations

Regulation of medical devices is intended to protect

consumer'shealth and safetyby attempting to ensure

that marketedproducts are effective and safe

Standards establish basic requirements for safe

development and implementationof medical devices,minimizingthe riskcaused to the patients when used.

The new device must beprovennot only safebut also

effectivein curing a specific disease

Regulatory bodies


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Regulatory bodies

Food and Drug Administration (FDA) in the United

States

European Commission (EC) in Europe

FDA toregulate nearly every aspect of medicaldevices, from testing through marketing

Medical Product Regulatory Affairs


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Medical Product Regulatory AffairsThe medical product regulatory affairs aimsto introduceand overview the regulatory affairs framework governing

thedevelopment,approval, manufacturing and surveillanceof bothpharmaceuticalsand medical devices

Purpose and Principles of Regulation

The fundamental purpose of regulation is theprotection ofpublic health.

Regulation try to insures:-

1. Safe construction of equipment

2. safe installation3. Instruction and training of users (safe use)

4. Regular and careful maintenance (safe use +excellent performance )

principles and concepts of Regulation


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principles and concepts of Regulation

1. Safety2. Efficacy

3. Purpose

4. Risk/benefit ratio

5. Quality

The core principles and concepts are :-

To achieve their goal, the regulations rely on a

number of core principles and concepts

Product safety


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Product safety

Product safety

Is an underlying principle for all products.Ideally, the product should do no harm

Thus, the regulations requirethat the

developeror manufacturer must take appropriate

steps to demonstrateand ensurethe safety of the

productunder development

Efficacy /effectiveness and Risk/benefit


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Efficacy /effectiveness and Risk/benefit

To evaluate effectivenessyou must also considerthepurpose of the product as expressedin either an

indications for use statementin the case of drugs, orintended use statementin the case of medical devices

Risk/benefit

you will have to apply the concept of Risk to Benefitwhenmaking ajudgment whether a product should be marketedand what limitations should apply to its use.

from a regulatory point of view you must ask thesequestions:

1. Do the benefits outweigh the risks

2. Does the product enhance public health (the overallbalance)

Risk benefitE l


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Example:-Chemotherapy drugs used to fight cancer are known to be have

significant side effects, including serve nausea and hair loss, while

they are rarely effective in all cancer patients. However, despitetheir limitations they still provide a vital element in the fight

against cancer as they can contributeto the cure of what could

otherwise be a fatal disease

Quality


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Quality

The final element which regulations address is quality

The two characteristics that you would associate with a qualityproduct

1. Safety

2. fitness for purpose

However, you would also expect product to be

reliable and consistent

In the context of medical products, quality means

a requirement to demonstrate conformanceto agreed

specificationsor applicable standards

U d t f th D i Di ti


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Updates of the Device Directives

Basic Regulatory Strategy


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g y gy

The basic regulatory strategy employed to

safeguard public health relies on focusing attentionon three main areas of activity:

1. product development

2. product manufacture3. market vigilance

Product Development


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Product Development

Beforea product can be marketed, product

developers must generate sufficient data to :-Demonstrate that the newproducts they wish to bring

to market are safe and effective

In the case of all drugs and high-risk medicaldevices these data must be

1. Presented to the regulatory authorities for review

if it is satisfactory

The regulatory authorities will grant a marketing

authorizationto enable commercial sale

Product Manufacture and Market Vigilance


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g

1. All manufacturingsites must be registered with theauthorities

2. Regular visits from inspection bodies must be carried out.The purpose of such audits is to Verify: -1. That manufacture is conducted under hygienic conditionsin suitable facilities

2. Appropriate quality systems are applied to control theprocessMarket Vigilance:-1. Over the lifetime of the product the regulatory authoritiesput in place systemsso that all adverse incidents

encountered in the market-place can be reported2. The manufacturer is also required to have a system forcapturing such incidents

3. The manufacturer is obliged to report(the adverseincidents ) to the regulatory authorities.

The regulatory strategy


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The regulatory strategy

EU vigilance communication systems


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EU vigilance communication systems

Quality Assurance Systems


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Quality Assurance Systems

Different quality systems are specified

depending on the activities involved, such as :-

Good manufacturing practice (GMP)

Good laboratory practice (GLP)

Good clinical practice

or more general quality assurance systems for

design, development, production, installation

and servicing ((e.g.ISO9001)

Element of quality systems


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q y y

Personnel

People are a key element

in all quality systems

Documentation

If any thing is notdocumented it does not

exist or it never

happened.

1. Personnel

2. Documentation

3. Facilities and

Equipment

4. Corrective and

Preventive Action

Element of quality systems


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PersonnelEvery single individual in an organization must

understand:-1. What their responsibilities are2. How the task that they perform can affect quality

Jobdescriptions

should be created to define theduties, responsibilities andauthority levelof each position in an organizationJob specif ications

are used to identify the qualifications, skills and experience thatare required.

E ement o qua ty systems


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q y yPersonnel

Review of an individual's qualifications, skillsand experiencein comparison to the job

description will identify the training needsfor

that individual

Recordsof all training delivered should be

documented and maintained in a training record

that can be made available to auditors for

examination during an inspection

Documentation


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Documentation

Documentation can be spli t into

two main categories:-

1. Proceduresoutlining

what must be done

2. Records showing

what has been done.

The performance of all tasks must

be described in detai led

1. Proceduresdescribing

recurringtasks are

usually referred(SOPs)2. General Operating

procedures (GOPs)

3. Protocols:- procedures

describingnon-repetitive

tasks

ocument contro unct onDocument control function


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Required to regulatethe

authorizationand circulationof

documents.This involves

1. The sign-off on a master copy of

the document by authorized

personnel2. Recorded circulation of official

copies to relevant departments.

3. If a document needs to be

updated, the revised versionshould be reviewed and approved

by the same functions that

approved the original.

4. The revised version is then issued

Documentation summary

Facilities and Equipment


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q pQuality systems require that facilities and equipment should

be appropriateto the activities undertaken

Examples :-1. Surfacesthat are easy to clean and maintain in hygienic

conditionare a requirement in many situations

2. Cloth-backedchairs would not be acceptable in a

laboratory that handled potentially biohazardous materials3. Equipment should be checked at installationto

demonstratethat it can perform its desired function

Corrective and Preventive Action


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1. Quality systems are intended

to be self-correcting and self-

improving

2. The regular internal auditing

of a quality system is a

fundamental requirement.

3. These audits should be

conducted by personnelindependentof the operational

area being audited

4. quality department should

not audit its own activities.5. The results of such audits,

together with those from outside

inspection bodies, will invariably

identify areas for improvement.

6. Feedbackfrom the market is

another key data source through

customer comments orcomplaintsor through the

vigilance systems that are

mandatory for drugs and devices

7. Data collected on the day-to-day operation(recording of all

non-conformances, procedure

deviations, product failures, or

product recalls)8. A variety of statistical tools

may be used to analyzethe data

and identifyunderlying trends.

Validation &Verification


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Validation:-Providing confirmation by

examinationand objectiveevidence that the particularrequirementsfor a specificintended use can be consistently

fulfilledApplied to either a productdesign or a process.For product validation, the

objective is to demonstratethatthe productwillmeet the usersneeds when operated undertheintended use conditions

Verification :-

Means confirmation byexamination or directmeasurement thatspecified

requirements are met

Verif ication tests:-

1. Nondestructive

2. Destructive

References


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References1. Higson, G. R., & Publishing, I. of P. (2002). Medical device

safety The Regulation of Medical Devices for PublicHealth and Safety. London: IOP Publishing Ltd 2002.

2. Tobin, J. J., & Walsh, G. (2008). Medical ProductRegulatory Affairs Pharmaceuticals, Diagnostics,MedicalDevices. Weinheim: WILEY-VCH Verlag GmbH & Co.KGaA.

3. Leitgeb, N. (2010). Safety of Electromedical Devices LawRisksOpportunities. Leipzig: Springer-Verlag/Wien.

4. World Health Organization - WHO. (2003). MEDICALDEVICE REGULATIONS Global overview and guidingprinciples. Geneva

5. www.brokerbanksecurities.com

medical product safety and regulation

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