Regulation and standards
Introduction
The healthcare organizations are obligated to follow regulations, national and
international guidelines and voluntary standers in order to maintain the minimum level
of safety and quality assurance. This has a major impact on the healthcare professionals,
CSSD as service and on the CSSD workers. If these guidelines are not followed the
outcome may vary from legal consequences to poor patient outcomes. This online
module layout the regulations and standards related to the CSSD and their influence on
the CSSD process. Moreover, definitions related to the topic will be given.
Learning Objectives:
• Explain the difference between regulations, voluntary and regulatory standards
• Explain the Saudi Food and Drug Administration SFDA/ U.S Food and Drug
Administration role and regulations in teams of:
§ Medical device classification and medical device reporting
requirements
§ Medical device recalls
• Explain the roles and responsibilities of other governmental agencies such as:
§ Centers for Disease Control (CDC)
§ Environmental Protection Agency (EPA)
§ Occupational Safety and Health Administration (OSHA)
• Discuss professional agencies and associations that develop regulations and
standards affecting Central Service:
§ Association for the Advancement of Medical Instrumentation
(AAMI)
§ American National Standards Institute (ANSI)
§ International Standards Organization (ISO)
§ Association of Operating Room Nurses (AORN)
§ Association for Professionals in Infection Central and
Epidemiology (APIC)
§ Society of Gastroenterology Nurses and Associates (SGNA)
Learning Outcomes
By the end of this module the student should be able to:
1. Understand the role of the Saudi Food and Drug Administration in the CSSD
2. Understand the difference between regulations, voluntary and regulatory
standards
3. Outline an important professional agencies and associations that have an affect
in the CSSD.
Regulation and standards
Regulation and Standards
In the field of CSSD, officers and healthcare professionals are mandated to adhere to
the national and international standards and the regulations. In order to translate
standards and the regulations into practice once must understand their meanings
and differences. Standards are divided into:
§ Regulatory Standards: defined as standards mandated by the government
and noncompliance with this type of regulations may subject the healthcare
facilities to citations and legal penalties.
§ Voluntary Standards: defined as a benchmark that is highly recommended by
a governing agency or professional organization that provides
recommendations and guidelines to provide evidence based patient care.
Saudi Food and Drug Administration SFDA/ U.S Food and Drug Administration
The Saudi Food and Drug Administration is a governmental regulatory body it was
established in 2003 and it directly reports to the President of Council of Ministers.
The main aims for the SFDA is to regulate the following:
I. The safety of food and drugs for human and animal.
II. The safety of biological and chemical substance.
III. The safety of electronic devices that related to human health.
IV. The accuracy and safety of medical and diagnostic devices.
V. The Control and supervise licenses procedures for food, drugs and medical
devices factories.
VI. The Disseminate and exchange information with local and international
scientific and legal agencies, and setting up a database for food and drug.
Medical device classification
The regulations placed on the Medical Devices depends on their classification as per
the FDA which are:
Regulation and standards
•Subject to the FDA’s general controls such as
device registerations. no effect on patient's health
•Suf_icient to provide reasonable assurance of the
Class I Devices safety and effectiveness of the device
•Examples: stethoscopes, Ultrasonic cleaners and
Low Risk hand-held surgical instruments
•Subjected to FDA's general and special controls
•May cause potential risks
Class II Devices •it requires special guidelines and special labeling
•Examples are : Sterilization machines, Biological
Intermediate Risk Indicators and Chemical Indicators
• Subjected to the FDs's highest regulations due to
ability to cause potential risk
Class II Devices •New products will require a Premarketing
Approval (PMA) from the FDA to assure product
safety and ef_icay
High Risk •Examples: Heart Valve, Pacemakers and life
sustaining devicess
Medical device reporting requirements
Healthcare facilities and medical device manufacturers are required to report to the
FDA any kind of medical device malfunction as per the Safe Medical Device Act of
1990.
Prior to this act, device manufacturers were only required to report medical device
with malefactions that led to patient illness or death to the FDA. MedWatch is
defined as a voluntary reporting program that was developed by the FDA in order to
receive any malefaction related to the medical devices by the public, healthcare
professionals, consumers or patients.
Medical device recalls
Medical device recall is the process of recollecting products due to malfunction or
patient harm and the manufacturers; distributors or the end-users can carry it. The
FDA monitors all the products that are mandated for recall in order to protect the
public.
FDA classifies product recall into three categories:
Regulation and standards
Class I Class II Class III
Less Seriouse
High Risk Risk Low Risk
Can cause
temporary or
Can cause patient medically reversible Not likly to cause
harm or death harm
adverse health
problem
Due to violation of
Details of recalled Must notify the the FDA guidlines
product custamers action must be
taken
Press release for No Press Relase No Press Relase
the Public needed needed
Governmental agencies
Centers for Disease Control (CDC)
It is a federal agency within the department of Health and Human Services in USA.
The aim of the agency is to promote the wellbeing and prevent injuries, diseases and
disabilities. CSSD professionals are in charge of developing infection control and
prevention guidelines and Isolation techniques. Although CDC is not a regulatory
body, majority of healthcare organizations incorporate the CDC recommendations in
their policy and procedures.
Environmental Protection Agency (EPA)
The USA congress developed the EPA department in 1970 as a regulating agency
that protects human health and the environment. The aim of the agency is to reduce
the greenhouse gases and toxic emissions, control indoor air pollution, create, and
reinforce pesticide regulations. In the Kingdome of Saudi Arabia, the Ministry of
Environment, Water and Agriculture is the national agency that provides the
environmental and water regulations for healthcare organization.
The goal is to maintain optimum human health and to reduce the greenhouse gasses
for the environment protection. Moreover, they ministry cooperates with other
Regulation and standards
ministers and authorities to create and implement national guidelines that aims to
protect and minimizes environmental, water pollution and response to
environmental emergencies. Greenhouse gasses are defined as gasses that absorb
solar radiation such as carbon dioxide, methane, ozone and fluorocarbons.
Occupational Safety and Health Administration (OSHA)
The OSHA organization was developed in 1971 under the U.S. Department of Labor.
Its main objective is to protect all kind of workers from occupation associated
injuries and illnesses. Many of the OSHA regulations and guidelines are
incorporated into the Saudi Labor Law. CSSD professionals must be aware of the
OSHA regulations that pertaining to their practices.
Guidelines and standards of OSHA related to the CSSD are:
I. The Occupational Exposure to Blood-borne Pathogens standards
II. Guidelines for the use of Ethylene Oxide Sterilization
III. The General Duty Clause of the Occupational Safety and Health Act
Healthcare Agencies and Associations
Healthcare agencies and associations create and promote voluntary guidelines and
standers that can be provide the fundamental process and practices of the CSSD
professionals. CSSD professionals are required to be aware of theses agencies and
their standards.
Association for the Advancement of Medical Instrumentation (AAMI)
The AAMI was established in 1967, its nonprofit organization that comprised of
multidisciplinary healthcare professional from technicians, engineers, scientists and
members of other organizations such as FDA. The aims is to develop a Technical
Information Reports (TIR) that are address the following:
• To develop, manage and the utilization of safe and effected reusable medical
devices
• To address the proper care and reprocessing of reusable medical devices.
• To develop standards related to medical products labeling and performance
requirement.
Although the standards from the AAMI are voluntary and not mandatory they are
considered critical elements in the CSSD practices, therefore CSSD personal must be
familiar with the AAMI guidelines and the new updates.
American National Standards Institute (ANSI)
The ANSI institution was established in 1918 with a mission “To enhance both the
global competitiveness of U.S. business and the U.S. quality of life by promoting and
facilitating voluntary consensus standards and conformity assessment systems, and
Regulation and standards
safeguarding their integrity”. American National Standards Institute is the only U.S.A
representative to the International Standards Organization (ISO).
International Standards Organization (ISO)
The ISO is considered as non-governmental organization with national standards
representing more than 163 countries. The standards from the ISO give
specifications related to products, service or practice. Although that ISO provides a
voluntary standers most of these standards are adopted and enforced by many
countries. Moreover, the ISO standers in regards to the CSSD are submitted by the
AAMI organization therefore it’s a trend by the healthcare organizations
internationally to become ISO- Certified in the field of CSSD.
Association of Operating Room Nurses (AORN)
Association of Operating Room Nurses (AORN) is a professional organization that
consists of Registered Nurses in the specialty of the Perioperative Care and other
professionals with an aim to enhance patient care related to surgery. The AORN
standards are reprinted annually and reviewed every five years.
Association for Professionals in Infection Central and Epidemiology (APIC)
It’s an international organization that voluntarily provides guidelines related to
infection prevention and control in order to prevent Hospital Acquired Infection
(HAI) in the healthcare organizations. The Infection Prevention and Control
Department can conduct CSSD departmental surveys annually depending on the
organization’s policy. Examples of the APIC guidelines are:
• Bioterrorist Readiness Plan.
• Guidelines for Infection Prevention.
• Control in Flexible Endoscope
Society of Gastroenterology Nurses and Associates (SGNA)
Society of Gastroenterology Nurses and Associates is non-profit organization that
develops voluntarily guidelines to assure safe and effective practice of the
gastroenterology and the endoscopy nursing services. Moreover, the organization
develops and reviews guidelines related to reprocessing flexible endoscopes.
Examples of the SGNA guidelines are:
• Guidelines for the Use of High Level Disinfectants and Sterilization for
Reprocessing of Flexible Gastrointestinal Endoscope
• Standard of infection Control in Reprocessing of Flexible Gastrointestinal
Endoscope.
Key points:
Regulation and standards
The CSSD personal has a major role in maintain regulations and standards.
The CSSD professional’s role is to protect the lives of the healthcare workers
and the patients.
At the end of this module, the students will be able to:
1. Understand the role of the Saudi Food and Drug Administration in the CSSD
2. Understand the difference between regulations, voluntary and regulatory
standards
3. Understand the importance of professional agencies and associations that have
an affect in the CSSD.
Reference
I. Laws and regulations. Laws and Regulations | Saudi Food and Drug
Authority. (2022, May 12). Retrieved August 27, 2022, from
[Link] Tags=1
Regulation and standards
II. The general authority of Meteorology and Environmental Protection. The
General Authority of Meteorology and Environmental Protection. (n.d.).
Retrieved August 27, 2022, from [Link]
III. Saudi Arabia - 2013. Country. (n.d.). Retrieved August 27, 2022, from
[Link]
IV. International Organization for Standardization. ISO. (2022, June 21).
Retrieved August 27, 2022, from [Link]
V. AAMI main page. Default. (n.d.). Retrieved August 27, 2022, from
[Link]
VI. Home. APIC. (n.d.). Retrieved August 27, 2022, from [Link]
VII. List of NFPA Codes & Standards. List of NFPA Codes and Standards. (n.d.).
Retrieved August 27, 2022, from [Link]
Standards/All-Codes-and-Standards/List-of-Codes-and-Standards.
VIII. IAHCSMM. (2016). Central Service Technical Manual. The International
Association of Healthcare.
IX. Occupational Safety and Health Administration. [Link], 2019,
[Link].
X. “ANSI Introduction.” American National Standards Institute - ANSI,
[Link]/about/introduction.