Medical device safety and Regulations

By: Yassir Eltayeb Ali Hassan

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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. Describes the nature of medical device safety as a risk management process 4. Know the life span of medical devices from their conception to disposal 5. Know the Participants in ensuring the safety of medical devices 6. Know common framework for medical device regulations , regulatory tools and general requirements

Medical device
Medical devices are many and varied in regard to composition and complexity and may be instruments, apparatuses, software, material or other articles. Definition Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or 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.

Medical device
Medical devices do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic meansbut may be assisted in their function by such means medical devices act by other means like physical, mechanical, or thermal

Medical device purposes

Medical 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 support of the anatomy or of a physiological process (Meet human

4. Supporting or sustaining life (Maintain human physiological functions.) 5.Control of human conception 6. Disinfection of medical devices 7. Providing information for medical purposes

Medical device groups

The standards addresses several groups of medical devices. The groups are as follows:

1. General medical device.

2. Active medical device. 3. Active implantable medical device. 4. Implantable medical device. 5. In vitro diagnostic device. 6. Non-active medical device.

Medical device groups

General medical device
Any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer for human use for the purpose of: diagnosis, prevention, monitoring, treatment, or alleviation of disease

Active medical device

Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Groups of medical devices.

An active implantable medical device(AIMDs)
Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical instrumentation into a natural orifice, and which is intended to remain after the procedure Examples of AIMDs 1. bladder stimulators 2. cochlear implants

An implantable medical device

Any medical device intended: to be totally or partially introduced 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.

Groups of medical devices.

An in vitro 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 examination of 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 neither an active medical device nor an in vitro diagnostic device

Electromedical devices are different from universal electric appliances

1. Because they are intended to alleviate or heal a patients disease 2. Enable his/her further survival. 3. Have to interact with patients body 4. Have to be introduced into the patients body 5. Remain even for long periods in direct contact with the body

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.

Demarcation aspects

International Electro medical Commission (IEC)

Responsibility for medical electrical equipment standards is within the purview of Technical Committee The IEC has developed a series of safety standards and regulations specifically for electro medical equipment. The IEC defines medical electrical equipment in IEC 60601-1

Medical device classes

Classified 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 elevated risk 4. class III high risk Classification is performed by the manufacturer himself based on product characteristics, intended purpose and intended use as defined by him

Example of how classification is done

Medical device classes

Class I and class II Devices

Class 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 II devices :-

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also non-life sustaining devices, they must meet specific controls or performance standards. Examples of class II devices:physiologic monitors, X-ray machines, gas analyzers, blood pressure cuffs, oxygen masks, infusion pumps, electrically powered wheelchairs

Class III Devices

Class III Devices
They are supporting life so that their failure is life threatening Examples of class III medical devices are :1. replacement heart valves 2. Pacemakers 3. Defibrillators 4. drug -eluting stent

Applied Part
A part of the equipment which in normal use: 1. Comes into physical contact with the patient 2. Can be brought into contact with the patient 3. Needs to be touched by 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 parts that are generally not conductive and can be immediately released from the patient.

Applied Part
Body floating BF For devices that have conductive contact with the patient, or have applied parts that are fixed in medium or long term contact with the patient, e.g. ECG electrodes Cardiac floating Type CF is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart.

Which requirements must be met(in medical device) ?

1. acceptable risk/benefit ratio; the manufacturer must implement a risk management process 2. The MD must achieve the medical performance 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 intended characteristics and performance also after storage and transport. 6. The MD must be accompanied by all information required for safe use during the intended lifetime

Risks in medical devices

1. Electric hazards 2. Physical hazards 3. Biologic hazards due to over dosage of highly effective drugs 4. Hygienic hazards by transmitting pathogenic germs when touching contaminated parts 5. Functional hazards through inaccuracies, malfunction and/or breakdown

Medical device safety

To reach optimum assurance of MD safety we must consider several essential elements: 1. Absolute safety cannot be guaranteed 2. Safety is a risk management issue 3. Safety is closely aligned with device effectiveness/performance 4. Safety must be considered throughout the life span of the device 5. Safety requires shared responsibility among the stakeholders

Medical device safety and risk management

Hazard is a potential for an adverse event, a source of danger Risk is a measure of the combination of 1. The hazard 2. The likelihood of occurrence of the adverse event 3. The severity or overall impact. Risk assessment: Begins with risk analysis to identify all possible hazards Followed by risk evaluation to estimate the risk of each hazard

Risk management process

According to ISO 14971 This should assure that risks of a device will sufficiently be managed by: Systematic risk analysis Risk assessment Risk evaluation Risk reduction Risk monitoring including risks caused by a users misuse, mistake or ignorance

Risk assessment
The current approach to device safety is to estimate the potential of a device becoming a hazard that could result in safety problems and harm Risk assessment is based on:1. Experience. 2. Evidence. 3. Computation. 4. Guesswork (An estimate based on little or no information).

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

1. Personal perception / knowledge

2. Cultural background. 3. economic conditions, and political climates. In practice, risk assessment of medical devices is based on:1. The experience of health care professionals 2. Safety design engineering

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 devices are categorized into three classes. The European Union and Canada categorize medical devices according to their perceived potential hazards 1. 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

Risk assessment and classification

In classifying devices, potential areas of hazard that needs consideration include:1. The degree of invasiveness 2. Duration of contact 3. The body system affected 4. local versus systemic effects

Risk analysis
Manufacturers need to adopt measures that can identify and quantify risks. Two common techniques are used for identifying risk:1. Fault Tree Analysis (FTA) 2. Failure Mode Effect Analysis (FMEA) FMEA approach Consideration is 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

Risk/Benefit nature of medical devices

Medical 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 training of intended users, they will not compromise the clinical condition or the safety and health of (patients and users ) 2. Risks which may be associated with their use constitute acceptable risks when weighed against the benefits

Risk Management Process Flowchart

The (ISO) has produced a document (ISO 14971:2000) providing manufacturers with a framework Including: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
Risk management planning Risk analysis

Risk evaluation

Risk control

Evaluation of overall residual risk

Risk management reporting

Production /post production information collection

PDCA Cycle
Always remember this
Plan

Act

Do

Check

Effectiveness/performance of medical devices

A device is clinically effective when it produces the effect intended by the manufacturer relative to the medical condition Clinical effectiveness is a good indicator of device performance Performance, may include technical functions in addition to clinical effectiveness. Performance is closely linked to safety Example:A patient monitor that does not perform well could pose 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

The major phases in the life span of a medical device from conception and development to disposal 1. Conception and development 2. Manufacturing 3. Packaging and labelling 4. Advertising 5. Sale 6. Use 7. Disposal

Phases in the life span of a medical device

Conception and development
The scientific principles upon which a device is based are fundamental to its safety and performance For example, a cardiac pacemaker should deliver a minute electrical impulse of a certain size and shape that simulates the natural functioning of the heart. Significant deviation from this may compromise safety and performance

Manufacture
Good, functional medical devices are produced when the manufacturing process is adequately managed GMP is more commonly referred to as quality systems in manufacturing

Phases in the life span of a medical device

Packaging and labelling
The importance of well-designed Packaging systems in delivering clean, sterile and protected medical devices is granted by:1. Properly packaged ; this will Cause little risk to individuals handling them, even if the MD is biohazardous. 2. Properly Shipping; a MD and its packaging must survive because damage can result during transportation and handling unless the total packaging system is designed robustly and can withstand various stresses. 3. Well-sealed packaging is essential for those medical devices that must be maintained sterile. 4. Labelling ; is crucial in identifying the medical device and specifying instructions for its proper use. 5. Putting hazard warnings, cautions and clear instructions.

Phases in the life span of a medical device

Advertising
Advertisement has the potential to create expectations and powerfully influence the belief/ impression in a medical devices capabilities medical device marketing and advertising are regulated to prevent misrepresentation of a medical device and its performance

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.

Disposal
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.

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 and manufacturers who sell medical equipment 3. The User is usually a professional in a health care facility, but may also be the patients. 4. The Public/Patient and the Government are also key interested parties The public are the ultimate beneficiary of medical devices while the government has the responsibility of overseeing that medical devices sold in the country are safe and effective.

Responsibility of Participants
CONCEPTION AND DEVELOPMENT MANUFACTURE

PACKAGING AND LABELLING

Manufacturer
ADVERTISING

SALE

VENDOR USE

USER

DISPOSAL

The role of the manufacturer

The manufacturer
As the creator of the device, must ensure that it is manufactured to meet or exceed the required standards of safety and performance

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

The vendor should:1. Ensure that the products sold comply/ follow with regulatory requirements 2. Avoid making misleading or fraudulent/deceitful claims about their products 3. Avoid issuing false compliance certificates 4. Clearly labelled the refurbished/ renewed devices 5. Provide after-sale service 6. Make training a condition to the manufacturer or importer in accepting to sell the device 7. Take responsibility in supporting or training their customers 8. Participating in post-market surveillance

The role of the user and the public

The user should make sure that
1. He has qualifications and training in the proper use of the device 2. He is familiar with the indications, contra-indications and operating procedures recommended by the manufacturer

The public
They should:1. Be fully aware that all devices carry a certain risk 2. Promote safety and performance through :I. Self education II. Putting customer pressure on manufacturers to comply with standards.

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 stakeholders in establishing policies and regulations that are fair and clear to all. Policies and regulations should be reviewed periodically to respond to changes in technologies by making appropriate (amendments/ corrections).

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

A common framework for medical device regulations

Governmental regulation of medical devices

Critical elements for regulatory attention

The safety and performance of medical devices depend on two critical elements

PRODUCT

USE

The third critical element

Product representation

Definition of standard
What are standards
Standards are documented agreements containing technical specifications or 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. Prescriptive specifications 2. Design specifications 3. Performance specifications 4. Management specifications

Purposes of Standards
1. Provide reference criteria 2. Provide information that enhances safety, reliability and performance of products, processes and services 3. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace. 4. Give consumers more choice by allowing one firms products to be substituted for, or combined with, those of another.

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 job Have 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
1. Higson, G. R., & Publishing, I. of P. (2002). Medical device safety The Regulation of Medical Devices for Public Health 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 Risks Opportunities. Leipzig: Springer-Verlag/Wien. 4. World Health Organization - WHO. (2003). MEDICAL DEVICE REGULATIONS Global overview and guiding principles. Geneva

Medical Product Regulatory Affairs

Regulations
Regulation of medical devices is intended to protect consumer's health and safety by attempting to ensure that marketed products are effective and safe Standards establish basic requirements for safe development and implementation of medical devices, minimizing the risk caused to the patients when used. The new device must be proven not only safe but also effective in curing a specific disease

Regulatory bodies
Food and Drug Administration (FDA) in the United States European Commission (EC) in Europe FDA to regulate nearly every aspect of medical devices, from testing through marketing

Medical Product Regulatory Affairs

The medical product regulatory affairs aims to introduce and overview the regulatory affairs framework governing the development, approval, manufacturing and surveillance of both pharmaceuticals and medical devices

Purpose and Principles of Regulation

The fundamental purpose of regulation is the protection of public health. Regulation try to insures:-

1. 2. 3. 4.

Safe construction of equipment safe installation Instruction and training of users (safe use) Regular and careful maintenance (safe use + excellent performance )

principles and concepts of Regulation

To achieve their goal, the regulations rely on a number of core principles and concepts

The core principles and concepts are :1. Safety 2. Efficacy 3. Purpose 4. Risk/benefit ratio 5. Quality

Product safety
Product safety Is an underlying principle for all products. Ideally, the product should do no harm Thus, the regulations require that the developer or manufacturer must take appropriate steps to demonstrate and ensure the safety of the product under development

Efficacy /effectiveness and Risk/benefit

To evaluate effectiveness you must also consider the purpose of the product as expressed in either an indications for use statement in the case of drugs, or intended use statement in the case of medical devices Risk/benefit you will have to apply the concept of Risk to Benefit when making a judgment whether a product should be marketed and what limitations should apply to its use. from a regulatory point of view you must ask these questions: 1. Do the benefits outweigh the risks 2. Does the product enhance public health ( the overall balance)

Example:-

Risk/benefit

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, despite their limitations they still provide a vital element in the fight against cancer as they can contribute to the cure of what could otherwise be a fatal disease

Quality
The final element which regulations address is quality
The two characteristics that you would associate with a quality product

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 conformance to agreed specifications or applicable standards

Updates of the Device Directives

Basic Regulatory Strategy

The basic regulatory strategy employed to safeguard public health relies on focusing attention on three main areas of activity: 1. product development 2. product manufacture 3. market vigilance

Product Development
Before a product can be marketed, product developers must generate sufficient data to :Demonstrate that the new products they wish to bring to market are safe and effective In the case of all drugs and high-risk medical devices these data must be 1. Presented to the regulatory authorities for review if it is satisfactory The regulatory authorities will grant a marketing authorization to enable commercial sale

Product Manufacture and Market Vigilance

1. All manufacturing sites must be registered with the authorities 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 conditions in suitable facilities 2. Appropriate quality systems are applied to control the process

Market Vigilance:1. Over the lifetime of the product the regulatory authorities put in place systems so that all adverse incidents encountered in the market-place can be reported 2. The manufacturer is also required to have a system for capturing such incidents 3. The manufacturer is obliged to report (the adverse incidents ) to the regulatory authorities.

The regulatory strategy

EU vigilance communication systems

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

1. Personnel 2. Documentation 3. Facilities and Equipment 4. Corrective and Preventive Action

Personnel People are a key element in all quality systems Documentation If any thing is not documented it does not exist or it never happened.

Element of quality systems

Personnel
Every single individual in an organization must understand:1. What their responsibilities are 2. How the task that they perform can affect quality

Job descriptions
should be created to define the duties, responsibilities and authority level of each position in an organization Job specifications are used to identify the qualifications, skills and experience that are required.

Element of quality systems

Personnel

Review of an individual's qualifications, skills and experience in comparison to the job description will identify the training needs for that individual
Records of 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
Documentation can be split into two main categories:The performance of all tasks must be described in detailed

1. Procedures outlining 1. Procedures describing recurring tasks are what must be done usually referred(SOPs) 2. Records showing 2. General Operating what has been done.

procedures (GOPs) 3. Protocols:- procedures describing non-repetitive tasks

Document control function

Document control function

Documentation summary

Required to regulate the authorization and circulation of documents. This involves 1. The sign-off on a master copy of the document by authorized personnel 2. Recorded circulation of official copies to relevant departments. 3. If a document needs to be updated, the revised version should be reviewed and approved by the same functions that approved the original. 4. The revised version is then issued

Facilities and Equipment

Quality systems require that facilities and equipment should be appropriate to the activities undertaken Examples :1. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations 2. Cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials 3. Equipment should be checked at installation to demonstrate that it can perform its desired function

Corrective and Preventive Action

1. Quality systems are intended 6. Feedback from the market is to be self-correcting and selfanother key data source through improving customer comments or 2. The regular internal auditing complaints or through the of a quality system is a vigilance systems that are fundamental requirement. mandatory for drugs and devices 3. These audits should be 7. Data collected on the day-toconducted by personnel independent of the operational day operation(recording of all non-conformances, procedure area being audited 4. quality department should deviations, product failures, or product recalls) not audit its own activities. 5. The results of such audits, 8. A variety of statistical tools together with those from outside may be used to analyze the data inspection bodies, will invariablyand identify underlying trends. identify areas for improvement.

Validation &Verification
Validation:Providing confirmation by examination and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled Applied to either a product design or a process. For product validation, the objective is to demonstrate that the product will meet the users needs when operated under the intended use conditions

Verification :Means confirmation by examination or direct measurement that specified requirements are met Verification tests:1. Nondestructive 2. Destructive

References
1. Higson, G. R., & Publishing, I. of P. (2002). Medical device safety The Regulation of Medical Devices for Public Health 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 Risks Opportunities. Leipzig: Springer-Verlag/Wien. 4. World Health Organization - WHO. (2003). MEDICAL DEVICE REGULATIONS Global overview and guiding principles. Geneva 5. www.brokerbanksecurities.com