Lecture 8: Government Standards, Regulations and Compliance on Medical Equipment

Presented by:

Eng. Cecile Matienzo

Bureau of Technical Devices

Department of Health

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Quality Systems, Standards and

Assurance in Medical Equipment

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Outline Quality Assurance Begins With Procurement Quality Assurance of Maintenance Services Quality Assurance Through Other Personnel Standard Development

International Organizations Doing Standardization Works International Electrotechnical Commission International Organization for Standardization

Standard Development in the Philippines The Bureau of Product Standards The Technical Committee Method Relationship Between General Standard and Particular Standard

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Quality Assurance Begins With Procurement Prepurchase evaluation of the manufacturer’s

literature or of the instrument itself can be considered as the first step of Quality Assurance (QA)

For most equipment the first step begins with the incoming inspection to the requirements of the specifications and to the clinical engineer’s requirement

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Quality Assurance of Maintenance Services Delicate aspect to QA program is that

concerned with services provided by outside vendors such as warranty work, preventive maintenance, and repair

Selection of outside vendors involves to some extent, the same kinds of criteria employed in the selection of instrumentation

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Quality Assurance of Maintenance Services Procedures in QA Contract to be used by the vendor

Should check on the clinical engineer prior to performing any Preventive maintenance (PM) or repair work and check out afterward

Leave whatever documentation that is required and discuss the Pm or repair performed and turn over any parts replaced; payment then can be initiated

There must be an understanding that, should not vendors not communicate in this manner, payment will not be authorized

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Quality Assurance of Maintenance Services Organize PM and repair services in such

manner that the work performed in each area acts as a check and balance on the other.

Another aspect of QA arises from observation, conversation, PM experience: Discovery of operator errors that result in less

than optimum use of equipment

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Quality Assurance of Maintenance Services Restrictions of QA functions

Could not be filled by other personnel within the institution who are not engineers

Rarely possible for outside consultant to fulfill this function in all but the smallest institution

QA can be effectively performed only if the function has the support of top management and is accomplished by competent personnel

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Quality assurance Through Other Personnel In establishing QA program it is necessary to consider

the role of other hospital personnel in providing QA

Should expect the user of any equipment to know when it is functioning properly and to distinguish its routine operation from circumstances in which the instrument is malfunctioning

Staff should know that QA procedures are established in the equipments they used

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Standard Developmen

t

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INTERNATIONAL ORGANIZATIONS DOING STANDARDIZATION WORKS

1906 International Electrotechnical Commission

(IEC) - electrotechnical field

History

1926 InternationalFederation of the National

Standardizing Associations (ISA) - mechanical eng’g; ceased in 1942

1946 delegates from 25 countries decided to create a new int’l org., ISO, which was officialy began on 23 Feb 1947

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INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC)

A world organization that prepares and publishes international standard for electrical, electronics and related technologies

One of the bodies recognized by the World Trade Organization

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Its Charter embraces

- all electrotechnologies including electronics, magnetics and electromagnetics

- electroacoustics - multimedia - telecommunication

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- energy production and distribution

- associated general disciplines

such as terminology and symbols, electromagnetic compatibility, measurement and performance

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Partners1. International Partners ISOITU ( International Telecommunication Union)WHO ( World Health Organization)ILO ( International Labour Office )UNECE ( United Nations Economic Commission for Europe )CIGRE ( International Council on Large Electric Systems )IMO ( International Maritime Organization )

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OIML ( International Organization of Legal Metrology ) EURELECTRIC ( Union of the Electric Industry ) IFAN ( International Federation of Standards Users ) ILAC ( International Laboratory Accreditation Cooperation ) Mercosur Governmental Agencies ( World Trade Organization, International Monetary Fund, European Bank for Reconstruction and Development, World Bank, United Nations Development Programme ) 415

2. Regional Partners

CANENA ( Council for Harmonization of Electrotechnical Standardization of North America ) CENELEC ( European Committee for Electrotechnical Standardization Comitte European de Normalisation Electrotechnique ) COPANT ( Pan Americam Standards Commission )

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2. Regional Partners

EASC ( Euro Asian Interstate Council for Standardization, Metrology and Certification ) ETSI ( European Telecommunications Standard Institute ) PASC ( Pacific Area Standards Congress )

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Kinds of Members

1. Full Membership

allows countries to participate fully in international standardization activities.

has equal voting rights

with 52 members

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2. Associate Membership

allows for limited participation of countries with limited resources

may participate in all technical meetings

have access rights and can comment on all IEC technical documents

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members may request the IEC General Secretary to become Participating member (P-members) on a maximum of four technical committees and/or subcommittees with the right to vote on technical work emanating from their committees of choice

with 14 associate members

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INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

A network of the national standards institutes of 148 countries, on the basis of one member per country.

It is a non-governmental organization, its members are not. It covers all technical fields except electrical and electronic engineering which is the responsibility of IEC.

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PARTNERS

1. INTERNATIONAL

- ISO collaborates with IEC

- ISO and IEC cooperate on a joint

basis with the ITU (International

Telecommunication Union)

- building a strategic partnership

with the World Trade

Organization

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2. REGIONAL

3. Liases with some 500 International

and regional organizations interested in specific aspects of its standardization work.

- Africa, the Arab countries, the area covered by the Commonwealth of Independent States, Europe, Latin America, the Pacific Area, and the South-East Asians nations

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3 CATEGORIES OF ISO MEMBERS

A. Member body

- is the national body “ most

representative of standardization in its

country”

- entitled to participate and exercise

full voting rights on any technical

committee and policy committee of ISO

- with 100 member bodies

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- is usually an organization in a country, which does not yet have a fully developed national standard activity

B. Correspondent Member

- does not take an active part in the technical and policy development work, but are entitled to be kept fully informed about the work of interest to them

- has 37 correspondent members

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- for countries with very small economies

C. Subscriber membership

- pay reduced membership fees that nevertheless allow them to maintain contact with international standardization

- ISO has 11 subscriber membership

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STANDARD DEVELOPMENT

IN THE

PHILIPPINES

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The Consumer Act of the Philippines(RA7394)

mandates 3 Government Agencies to

develop National Standards.

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Department of Agriculture (DA) for Agricultural Products such as fertilizers and pesticides

Department of Health for Drugs, Food, Cosmetics and Health Devices

Department of Trade and Industry (thru the Bureau of Product Standards or BPS) for all other products not covered by DA and DOH

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THE

BUREAU OF

PRODUCT STANDARD

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empowers the BPS to take the lead

in the development, promotion, coordination

and promulgation of standardization activities

in the country.

Philippine Standardization LawRA 4109

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BPS is the National Standard Body of the Philippines

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Philippine National Standards

BPS APPROVAL

DOH

DA

Other Government

Agencies

Professional Organizations

Industry Organizatio

nStandards Developed

or Adopted

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BPS represents the country in ISO and

IEC memberships

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Any Body who would like to

purchase/acquire the standards

BPS

IEC ISO

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The BPS Standards development policy

To harmonize the Philippine National Standards with International Standards

- To eliminate technical barriers to

trade (TBT)

- To facilitate international free trade

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Standard Development

1. Formulation and development of own standard.

2. Adoption of International Standard.

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Formulation & Development of own standard:

before a standard is drafted, a working group must first gather relevant data necessary for the development of the standard.

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for a medical device, most of the data are obtained through experimental researches

the experimental research requires

facilities, time, effort and money.

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Methods of Adopting International

Standard Technical Committee Method

Fast Track Method

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Technical Committee Method

Fast Track Method

YES

Deliberation by the TC

IEC/ISO/PNSOther

Standards

DPNS

Circulatio

nWith

COMMENTS?

Publication

BHDT

Approved by BPS?

YES NO

IEC/ISO/PNSOther

Standards

Circulation

With COMMENTS?

Publication

NO

YESNO

PNSPNS

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Advantages of Adopting IS vs Developing Own Standard

Less time Less financial resources Less effort

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Establishment of Technical Committee

To develop and determine the adaptibility

To review and deliberate

To recommend for adoption

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THE

TECHNICAL COMMITTEE

METHOD

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Membership of the TechnicalCommittee

Consumer/ User Trade/ Industry Associations Academe Professional Organizations Testing Laboratories Government Institutions

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Election of Chairman and Vice-chairman

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This guide provides the methods for adoption of international standard as regional or national standard and includes a system for indicating the degree of correspondence

IEC/ISO Guide 21

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Identical

Modified

Not Equivalent

3 Degrees of Correspondence

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Identical

The regional or national standard is identical in technical content, structure and wording.

The regional or national standard is identical in technical content, although it may contain the following minimal changes;

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Substitution of decimal point for a decimal comma;

Correction of any misprints

Deletion of text in one or several languages from a multilingual International Standard.

Minimal Changes

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Minimal Changes

Inclusion of any technical corrigenda or amendments issued to the International Standard

Changes to the title to be consistent with an existing regional or national series

Substitution of “this regional/national standard” for this “this International Standard”

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Inclusion of any regional or national informative materials

Minimal Changes

Deletion of informative preliminary material from the International Standard.

Changes in wording

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Addition, for informative purposes, of recalculated values of quantity units where a different measurement system is used in an adopting country.

Minimal Changes

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Modified

The regional or national standard contain less

The regional or national standard contain more

The regional or national standard alters part of the “International Standard”

The regional or national standard provides an alternative choice.

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Not Equivalent

The regional or national standard is not equivalent to the International Standard in technical content and structure and the changes have not been clearly identified

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RELATIONSHIP

BETWEEN

GENERAL STANDARD

AND

PARTICULAR STANDARD

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TC 62Electrical Equipment in Medical

Practice

SC 62ACommon Aspects

of Medical Electrical

Equipment used in Medical Practice

SC 62BDiagnostic Imaging

SC 62CEquipment for Radiotherapy,

Nuclear Medicine and Radiation

Dosimetry

SC 62DElectromedical

Equipment

IEC 60601-1Medical Electrical Equipment Part 1:

General Requirement -for Safety

IEC 60601-2-XRequirements

for a Particular Equipment

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IEC 60601-1 General requirements

Particular requirements for

ECG

IEC 60601-2-x

Particular requirements for

Defibrillator

Particular requirements for Infant Incubator

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General Requirements for safety applicable to all medical electrical equipment.

General StandardIEC 60601-1

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Contains safety requirements and compliance tests on:

- Electrical Safety- Mechanical Safety- Radiation Safety

- Fire Safety* Protection against hazards of

ignition of flammable anesthetic mixtures.

* Protection against excessive temperature.

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Abnormal operation and fault condition.

Accuracy of operating data and protection against hazardous output.

Constructional requirements

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PARTICULAR STANDARD The particular standard specifies safety

requirements applicable only to the particular equipment.

Examples:

- IEC 60601-2-4 : Particular Requirements for the Safety of Defibrillators

- IEC 60601-2-19 : Particular Requirements for the Safety of Infant Incubator

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The particular standard states if the safety requirements in the general standard (IEC 60601-1) are applicable to the equipment or not.

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If a certain requirement in the general

standard is not applicable, necessary

amendment or replacement is made in

the particular standard.

The particular standard also supplements the general standard. It specifies additional requirements needed to complete the safety of the equipment.

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Mini-Case

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Mini-case

Research on the quality assurance and standards of other countries (Europe and US) concerning the government standards, regulations, and compliance on medical equipment.

Make an comparative analysis: Philippines against Europe and US.

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Short Quiz: based on the lecture provided by Eng. Cecile Matienzo

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Reference

Webster, J.G. & Cook, A.M. (Ed.). (1979). Clinical engineering: principles and practices. Englewood Cliffs, N.J..: Prentice-Hall, Inc.

Eng. Cecile Matienzo of the Bureau of Technical Devices, Department of Health.

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