GOALS AND OBJECTIVES By the end of this File, you will be able to: Understand the role of the Saudi food and drug administration in the CSSD. Understand the difference between regulations, voluntary and regulatory standards. Outline an important professional agenciesand associations that have an affectin theCSSD.

1. ALL YOU NEED
TO KNOW ABOUT
CENTRAL
STERILE SUPPLY
DEPARTMENT

2. TALAL ALBUDAYRI
REGULATION AND
STANDARDS
CSSD
•
2024
01

3. GOALS AND OBJECTIVES
By the end of this File, you will be able to:
Understand the role of the Saudi food and drug
administration in the CSSD.
Understand the difference between regulations, voluntary
and regulatory standards.
Outline an important professional agenciesand
associations that have an affectin theCSSD.

4. INTRODUCTION
Statutes, regulations and voluntary standards impact every
healthcare professional, including those working in central
service (CS). These laws and guidelines establish minimum
levels of quality and safety. When these laws an guidelines
are not followed, the results can vary from legal
consequences to poor patient outcome.

5. MUST IMPORTANT TERMS TO
KNOW AND THEIR DEFINITIONS:
Statute
Regulation
Standard
Regulatory standards
Voluntary standards
Best practice

6. RULES ARE EVERYWHERE IN CS!
WHERE DO THE
“RULES” COME FROM?

7. Statute
A written law adopted by a
legislative body that governs a
city, county, state or country.

8. Regulation
Rules issued by administrative
agencies that have the force of
law.

9. Standard
A uniform method of defining basic
parameters for processes, products,
services and measurements.

10. Types of standards
Regulatory standards: A comparison benchmark that is mandated by a
governing agency. Noncompliance with regulatory standards may lead
to citations and legal penalties.
Voluntary standards: Guidelines or recommendations for best practices
to provide better patient care. Industry, nonprofit organizations, trade
associations and others develop these.

11. Best practice
A method or technique that
has consistently shown
results superior to those
achieved by other means.

12. IN GENERAL YOU MUST KNOW…
Regulatory standards are requirements imposed by government
agencies, and if not followed can lead to legal penalties.
Voluntary standards are strongly suggested but no legal consequences
if not followed.
Statutes and regulations are laws that must be followed. Violations of
them may have legal penalties.
Generally, voluntary standards are not LOW. They are developed
according to best practice.
Voluntary standards can be statute or regulation when they
incorporated into law by governmental bodies.

13. WHY CS TECHNICIANS MUST BE FAMILIAR
WITH REGULATIONS AND STANDARDS?
Compliance with statutes and regulations is mandatory
and failure to comply can lead to serious legal
consequences for the healthcare facility.
Many regulations and voluntary standards focus on
workplace safety.

14. WHY CS TECHNICIANS MUST BE FAMILIAR
WITH REGULATIONS AND STANDARDS?
Regulations and voluntary standards may include
disinfection and sterilization practices. They may be
helpful in pre-purchase product evaluation.
Careful compliance with standard and regulations
protects the health and safety of patients.

15. Thank
Thank
YOU!
YOU!