33 Questions
What is the main impact of not following healthcare regulations and standards in the CSSD?
Increased risk of legal consequences and poor patient outcomes
Which organization is responsible for medical device classification and reporting requirements in Saudi Arabia?
Saudi Food and Drug Administration (SFDA)
Which agency is associated with developing regulations and standards affecting Central Service?
Association for Professionals in Infection Control and Epidemiology (APIC)
What are the primary roles of the Occupational Safety and Health Administration (OSHA) regarding healthcare organizations?
Ensuring safe and healthy working conditions
Which organization is involved in developing regulations and standards for the advancement of medical instrumentation?
Association for the Advancement of Medical Instrumentation (AAMI)
What is the significance of understanding the difference between regulations, voluntary, and regulatory standards in healthcare?
It helps in minimizing legal consequences
Which governmental agency is responsible for protecting human health and the environment?
Environmental Protection Agency (EPA)
What is the role of the Centers for Disease Control (CDC) in healthcare organizations?
Preventing and controlling disease outbreaks
Which organization focuses on setting voluntary standards for healthcare professionals?
International Standards Organization (ISO)
What is the significance of voluntary standers in maintaining safety and quality assurance in healthcare organizations?
They are optional but can contribute to improved safety and quality assurance
Which organization aims to enhance patient care related to surgery?
Association of Operating Room Nurses (AORN)
Which organization develops and reviews guidelines related to reprocessing flexible endoscopes?
Society of Gastroenterology Nurses and Associates (SGNA)
Which organization is considered the only U.S.A representative to the International Standards Organization (ISO)?
American National Standards Institute (ANSI)
Which organization provides voluntarily guidelines related to infection prevention and control?
Association for Professionals in Infection Control and Epidemiology (APIC)
Which organization focuses on developing standards related to medical products labeling and performance requirements?
Association for the Advancement of Medical Instrumentation (AAMI)
Which organization is a non-profit organization comprised of multidisciplinary healthcare professionals?
Association for the Advancement of Medical Instrumentation (AAMI)
Which organization represents more than 163 countries with national standards?
International Standards Organization (ISO)
Which standards are submitted by AAMI and adopted by healthcare organizations internationally?
AAMI standards
Which organization develops guidelines to assure safe and effective practice of gastroenterology and endoscopy nursing services?
SGNA
Which organization conducts CSSD departmental surveys annually depending on the organization’s policy?
APIC
Which organization aims to develop, manage, and utilize safe and effective reusable medical devices?
AAMI
What is the main aim of the Saudi Food and Drug Administration (SFDA)?
To regulate the safety of food and drugs for human and animal consumption
What is the classification of Class I medical devices according to the FDA?
Low risk, sufficient to provide reasonable assurance of safety and effectiveness
What is the purpose of the Safe Medical Device Act of 1990?
To report medical device malfunction to the FDA
What is the role of the Centers for Disease Control (CDC) in the USA?
To develop infection control and prevention guidelines and isolation techniques
Which agency aims to reduce greenhouse gases and toxic emissions?
Environmental Protection Agency (EPA)
What is the main objective of the Occupational Safety and Health Administration (OSHA)?
To protect workers from occupation-associated injuries and illnesses
What type of standards are regulatory standards?
Mandated by the government with noncompliance subjecting healthcare facilities to citations and legal penalties
What is the purpose of the Medical Device Reporting requirements?
To report medical device malfunction to the FDA
What classifies a product recall as Class III according to the FDA?
Can cause patient harm or death
Which agency develops infection control and prevention guidelines and isolation techniques?
Centers for Disease Control (CDC)
What are greenhouse gases defined as?
Gases that absorb solar radiation such as carbon dioxide, methane, ozone, and fluorocarbons
What does MedWatch refer to?
A voluntary reporting program developed by the FDA to receive any malfunction related to medical devices
Explore the fundamental regulations, national and international guidelines, and voluntary standards that healthcare organizations must adhere to for maintaining safety and quality assurance. Understand the impact of these regulations on healthcare professionals and CSSD workers, as well as the potential consequences of non-compliance.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
