Which
Which agency is responsible for safeguarding patient medical records?
CMS Center for Medicare and Medicaid Services
What guidelines does our sterile processing department follow for sterilization?
ANSI/AAMI ST79:2017/(R)2022; Comprehensive guide to steam sterilization and sterility assurance in health care facilities
When soiled instrumentation is transported between healthcare and repair facilities, the _________ regulations for labeling and packaging must be followed.
Department of Transportation (DOT)
Following OSHA regulations, wearing PPE in the central service decontamination area is optional. TRUE OR FALSE
FALSE
Name agency which imposes very strict labeling requirements on manufacturers of chemicals used by Central Service department.
U.S. Environmental Protection Agency (EPA)
What is the name of the act that governs this protection?
HIPAA Health Insurance Portability and Accountability Act
Who determines our recommendations for temperature and humidity in the Sterile Processing Department?
ANSI/ASHRAE Standard 170-2017, Ventilation of Health Care Facilities
Who regulates emission standards for ethylene oxide (EO) sterilization?
Environmental Protection Agency (EPA)
Who enforces laws from clean water, air and land and also regulates the disinfectants?
Environmental Protection Agency (EPA)
According to the medical device classification, class III device are the most stringently regulated devices. Give examples of these type of devices.
These devices include heart valves, pacemakers and other life-sustaining devices.
Which regulatory agency that governs us wearing our PPE in decontamination, and for our workplaces to be free of recognized hazard?
OSHA Occupational Safety and Health Administration
Who regulates the manufacturing of all medical devices and regulates sterilants, high-level disinfectants, packaging materials, sterilizers, and quality monitors such as biological indicators (Bis)?
Food and Drug Administration (FDA)
Who's responsible for pre and post market medical device requirements, MedWatch, medical device classification, medical device recall.
The FDA (Food and Drug Administration) is responsible for pre and post-market medical device requirements, including the classification of medical devices and the implementation of medical device recalls. The FDA plays a crucial role in ensuring the safety and effectiveness of medical devices in the market.
Where do we get our processional society guidelines, for example: doing the right thing
Association for the Advancement of Medical Instrumentation (AAMI)
Chemical indicators are classified as FDA class ___ devices
Class II devices
Providing fatigue mats on the floor for staff working in decontamination, where they often stand for extended periods, would be considered a _________________ modification for a sterile processing technician.
Ergonomics
Who developed the first practical recommendations for isolation techniques and guidelines for infection control?
Centers for Disease Control and Prevention (CDC)
All EPA-approved products must contain directions for storage and disposal.
TRUE Labeling must be on the bottle
This FDA program is designed for the voluntary reporting of device-related problems.
MedWatch
Who requires that preventative maintenance (PM) standards be established for medical equipment?
The Joint Commission (JC)
A mock surveyor visits the department to ask questions in preparation for the official survey conducted every three years by the voluntary professional society known as _______________.
The Joint Commission (TJC)
Failure to follow this agency can result in the loss of all federal funding to a facility, including Medicare and Medicaid payments.
Centers for Medicare and Medicaid Services (CMS), Joint Commission (JC), Department of Human Services (DHS)
The use of a product is not likely to cause adverse health consequences is categorized as a _______________________
FDA Recall Class III
Which of the following items is not regulated by the FDA?
Medical Devices, Sterilizers, High Level Disinfectants, or Detergents
Detergents
Which of the following is not considered a professional association?
FDA, AAMI, AORN, or APIC
Food and Drug Administration (FDA)