Evelyn Hone College of Arts and commerce

Biomedical Engineering Technology

Regulations Standards and Ethics
Tutorial sheet (2019)

1 Identify different participants in ensuring the safety of medical equipment

 Manufacturer
 Vendor
 User
 Government
 Public
Communication and interactions between Participants in ensuring the safety of medical equipment
1. Participants that directly manage phases in the equipment life cycle: Manufacturer,
Vendor and User
2. Government that is ultimately responsible for making the regulations that must ensure
safety
3. The Public (patient) that is the direct beneficiary (‘customer’) of equipment safety.

2 Define the term regulations

An official rule or the act of controlling something by government or authority.
3 Outline stages of regulatory control associated with equipment life cycle

4 Describe the medical regulations and standards medical devices must adhere to ensure
safety and effectiveness
 Medical devices should be designed and manufactured in such a way that, when used under
the conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of users
or, where applicable, other persons, provided that any risks which may be associated with
their use constitute.
 Acceptable risks when weighed against the benefits to the patient and
 Are compatible with a high level of protection of health and safety.
 Risk needs to be assessed all devices carry a certain degree of risk and could cause problems
in specific circumstances

5 State the roles of Radiation Protection Regulatory Board for x-ray equipment
6 Discuss medical devices regulations in Canada, US, Europe, Australia
7 Vendor establishment is an important factor in medical equipment safety and regulations.
Explain how vendor establishments are regulated in the US, Canada and EU.
8 Explain the roles of FDA in medical equipment regulation
The US Food and Drug Administration (FDA) is responsible for regulating and supervising
the safety of foods, dietary supplements, drugs, vaccine, biological medical products, blood
products, medical devices, radiation-emitting products, veterinary products, and cosmetics.
Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for
ensuring the safety and effectiveness of medical devices and eliminating unnecessary
exposure to radiation-emitting products.

FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and
monitors the safety of all regulated medical products.

In the U.S., FDA regulates the sale of medical device products. Before a medical device can
be legally sold in the U.S., the person or company that wants to sell the device must seek
approval from the FDA. To gain approval, they must present evidence that the device is
reasonably safe and effective for a particular use.

9 Contrast between voluntary and mandatory standards with examples

Most standards are voluntary.” standards, which carry no inherent power of enforcement, but
provide a reference point of mutual understanding,”
A standard may be mandated by a company, professional society, industry, government or
trade agreement.
A standard is called a regulation when it becomes mandatory.
When a standard is mandated by a government or an international trade agreement, it normally
becomes legally obligatory based on regulations or a law established by the government or the
contracts between international bodies.
10 Discuss international standards for medical device risk management and criteria of medical device
classification
A country may have many voluntary standards bodies but normally there is one official national organization that
coordinates and accredits the standards development bodies in the country. This official national organization
would have the authority to endorse a document as a national standard in accordance with official criteria, and it
also represents the country in the various international standards organizations.
US- American National Standards Institute (ANSI)
Canada- Standards Council of Canada (SCC), a crown (government) corporation.
Europe - CEN (Comité Européen de Normalisation), CENELEC (the European Committee for Electrotechnical
Standardization) and ETSI (the European Telecommunication Standards Institute).

For developing countries, reference to a standards system not only helps medical device administration, it is also
important for other industrial and economic developments.
A standardized infrastructure is a basic requirement for the success of economic policies that will improve
productivity, market competitiveness and export capability.

The three major international standardization organizations

International Organization for Standardization (ISO),
International Electrotechnical Commission (IEC), - electrical and electronic engineering
International Telecommunication Union (ITU). - telecommunications,
information technology, risk management, quality systems and many other areas, joint ISO/IEC technical
committees manage standardization.
Other organizations also produce documents on international standardization. Their documents are usually
adopted by ISO/IEC/ITU as international standards if they have been developed in accordance with international
consensus criteria

11 World Health Organization has produced a set of guidelines to assist governments and organizations
dealing with medical equipment donation. Explain six (6) guidelines set by World Health Organization.
12 What roles does the government play in medical equipment safety
13 Discuss briefly the GHTF and its benefits in relation to quality healthcare technology.
the Global Harmonization Task Force, founded in 1993, was a voluntary international group of
representatives from medical device regulatory authorities and trade associations from Europe, the
United States of America (USA), Canada, Japan and Australia.
purpose
The purpose of the GHTF is to encourage a convergence in standards and regulatory
practices related to the safety, performance and quality of medical devices. The GHTF
also promotes technological innovation and facilitates international trade. The primary
means by which its goals are accomplished is via the publication and dissemination of
harmonized guidance documents for basic regulatory practices. These documents, which
are developed by four different GHTF Study Groups, can then be adopted/implemented
by member national regulatory authorities or others. Technical committee members include
 representatives from national medical device regulatory authorities and the regulated
industry.
It also eliminates differences between jurisdictions decreases the cost of gaining regulatory
compliance and allows
patients earlier access to new technologies and treatments.
To promote technological innovation and facilitates international trade
•Harmonization also reduces the cost of implementing regulations for governments and local
industry.
•minimize regulatory barriers, facilitate trade and improve access to new technologies.
Benefits
1. By following recommendations from the GHTF, countries can ensure that their regulatory controls
are not in significant conflict with global harmonization recommendations. The GHTF is directing and
converging the harmonized guidance
documents.
2. Critical issues such as safety and performance requirements, quality systems, standards
and procedures of post-market surveillance are studied in-depth by experts from different
countries to reach consensual recommendations and these are incorporated into the
GHTF final guidance documents.
3. Global harmonization and cooperation in post-market surveillance will facilitate an
international devices data bank that allows rapid, global access to device information,

alerts or recalls. This will promote the safety and effectiveness of medical devices.
4. Where a country’s program is harmonized with the programs of other countries,
regulatory burdens and costs for local government and industry will be significantly
reduced, while regulatory cooperation, commerce and international trade will be
enhanced.
5. Other emerging issues of international significance can be put to the GHTF for a common
solution.
6. GHTF provides an opportunity for countries to participate and observe regulatory
developments that they could adopt.

14 Outline types of specifications covered in standards

1. Prescriptive specifications obligate product characteristics, e.g. device dimensions, biomaterials, test or
calibration procedures, as well as definitions of terms and terminologies.
2. Design specifications set out the specific design or technical characteristics of a product, e.g. operating room
facilities or medical gas systems.
3. Performance specifications ensure that a product meets a prescribed test, e.g. strength requirements,
measurement accuracy, battery capacity, or maximum defibrillator energy.
4. Management specifications set out requirements for the processes and procedures companies put in place, e.g.
quality systems for manufacturing or environmental management systems.
A standard may contain a combination of specifications. Prescriptive, design and performance specifications have been
commonplace in standards. Management specifications are also rapidly gaining prominence.

15 Briefly explain the Helsinki declaration

he Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the
medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone
document on human research ethics.
It is the duty of the physician to promote and safeguard the health of the people. The physician’s
knowledge and
conscience are dedicated to the fulfillment of this duty.

16 Describe four (4) basic principles that should be followed in donating medical equipment

 Define national or organizational guidelines for health care equipment donations.

 Define detailed administrative procedures, with clear responsibilities, for receiving health care
equipment donations, in addition to general guidelines about selection, quality and management of
health care equipment donations.
 Specify the need for donated health care equipment, providing as much information as possible.
 Identify a lead donor, if this can be done.

17 Justify the importance of standards in healthcare technology.

1. Provide reference criteria that a product, process or service must meet.
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 firm’s products to be substituted for, or combined with, those of
another.

18 Explain the importance of following established Electromagnetic compatibility (EMC) and electrical
safety standards made under IEC 60501 harmonized standard.
Electromagnetic compatibility (EMC) is essential for any electrical device to function reliably. Thus, it is
important to protect electrical devices such as processors, integrated circuits, information processing
equipment, and telecommunication units against electromagnetic interference (EMI).
Electrical safety is a system of organizational measures and technical means to prevent harmful and
dangerous effects on workers from electric current, electric arc, electromagnetic field and static electricity
19 Name The three major international standardization organizations and their functions
 International Organization for Standardization (ISO),
The International Organization for Standardization (ISO) is a global organization that
works to provide standardization across an array of products and companies. Its main goal
is to facilitate trade, but its focus is on process improvement, safety, and quality in several
areas.
 International Electrotechnical Commission (IEC), - electrical and electronic engineering
The International Electrotechnical Commission is an international standards organization[4][5]
that prepares and publishes international standards for all electrical, electronic and related
technologies – collectively known as "electrotechnology". IEC standards cover a vast range
of technologies from power generation, transmission and distribution to home appliances
and office equipment, semiconductors, fiber optics, batteries, solar energy, nanotechnology
and marine energy as well as many others.
 International Telecommunication Union (ITU). - telecommunications,
The International Telecommunication Union (ITU) is an agency of the United Nations (UN) whose
purpose is to coordinate telecommunication operations and services throughout the world.
20 Define the terms hazard and risk
A hazard is something that can cause harm, e.g. electricity, chemicals, working up a ladder, noise, a
keyboard, a bully at work, stress, etc. A risk is the chance, high or low, that any hazard will actually cause
somebody harm.
21 Outline how to perform a risk assessment on an ECG machine
22 Describe the international standard for medical devices risk management and criteria of medical
classification.
23 How does preventive maintenance enhance medical equipment safety?
keeps your equipment in good condition, it will last longer, and makes you aware of needed repairs and
replacements.
24 Outline the process of developing and meeting standards for quality services in healthcare.
25 Explain importance of standards in Zambian hospitals and how they can be applied to the maintenance
and management of medical equipment
26 Explain the importance of post-market surveillance and reporting
27 Discuss medical research ethics and their recent trends
28 State how classification of medical devices in the US differ from the EU

29 Define the term standard

30 List four (4) benefits of medical devices harmonization by GHTF
31 State briefly 6 types of specifications established by standards
a) Describe the Global Harmonization Task Force and its purpose and benefits
b) Discuss global medical equipment nomenclature systems
i) Purpose of a nomenclature system and benefits
ii) Application of a nomenclature within the hospital (standard equipment lists)
iii) UNMDS
iv) GMDS
32 State the importance of ethics in healthcare systems
33 A new ECG machine is received at a local hospital. Describe how a clinical engineer would carry out a
risk assessment of the device
34 Define:
i) Risk assessment
ii) Risk analysis
iii) Risk evaluation
35 Explain the roles of government and manufacturers in medical equipment safety.
36 Explain the purposes of standards
37 Write brief notes on three (3) regulations boards that deals with health and medical equipment standard
regulation in Zambia.