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1. The main role of the sterile processing area is to:
A. Pick supplies for surgery
B. Enter and account for patient charges
C. Follow requests of the OR supervisor
D. Provide dependable, reliable services to enhance patient care
Answer: D. Provide dependable, reliable services to enhance patient care
Rationale: The primary goal of sterile processing is to ensure safe, sterile instruments to
support quality patient care.
2. Standards for sterile processing practice are developed by the:
A. Food and Drug Administration
B. State Departments of Health
C. Environmental Protection Agency
D. Association for the Advancement of Medical Instrumentation
Answer: D. Association for the Advancement of Medical Instrumentation
Rationale: AAMI sets widely accepted standards and guidelines for sterile processing practices.
,3. If healthcare facilities reprocess single-use devices, they must be cleared by the:
A. Occupational Safety and Health Administration
B. Environmental Protection Agency
C. Centers for Disease Control and Prevention
D. Food and Drug Administration
Answer: D. Food and Drug Administration
Rationale: The FDA regulates and approves reprocessing of single-use medical devices.
4. Which of the following single-use items is exempt from the FDA’s third-party reprocessing
regulation?
A. Arthroscopic shavers
B. Sequential compression sleeves
C. Pacemakers
D. Laparoscopic instruments
Answer: C. Pacemakers
Rationale: Pacemakers are not reprocessed due to their critical, implantable nature.
5. OSHA impacts sterile processing through exposure standards and also through:
A. Reprocessing of single-use devices
B. Communication of workplace hazards
,C. Reporting malfunctioning equipment
D. Chemical product approvals
Answer: B. Communication of workplace hazards
Rationale: OSHA’s Hazard Communication Standard ensures workers understand workplace
risks.
6. The Medical Device Reporting regulation requires:
A. Employees to report all injuries
B. Facilities to register reprocessed devices
C. Employees to report PPE failures
D. Facilities to report deaths or serious injuries
Answer: D. Facilities to report deaths or serious injuries
Rationale: MDR ensures serious device-related incidents are reported for safety monitoring.
7. Which agency requires eyewash stations for emergency use?
A. AAMI
B. FDA
C. CDC
D. OSHA
, Answer: D. OSHA
Rationale: OSHA mandates safety equipment like eyewash stations in hazardous work
environments.
8. OSHA’s Hazard Communication Standard requires Safety Data Sheets (SDS) for:
A. All instrument trays
B. All packaging materials
C. Chemicals that can harm you
D. Each chemical in the department
Answer: D. Each chemical in the department
Rationale: An SDS must be available for every chemical to ensure safe handling and emergency
response.
Which of the following establishes sterilization practice standards based on opinion, research
and/or theory?
a. Occupational Safety and Health Administration (OHSA)
b. Association for the Advancement of Medical Instrumentation (AAMI)
c. Environmental Protection Agency (EPA)
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1. The main role of the sterile processing area is to:
A. Pick supplies for surgery
B. Enter and account for patient charges
C. Follow requests of the OR supervisor
D. Provide dependable, reliable services to enhance patient care
Answer: D. Provide dependable, reliable services to enhance patient care
Rationale: The primary goal of sterile processing is to ensure safe, sterile instruments to
support quality patient care.
2. Standards for sterile processing practice are developed by the:
A. Food and Drug Administration
B. State Departments of Health
C. Environmental Protection Agency
D. Association for the Advancement of Medical Instrumentation
Answer: D. Association for the Advancement of Medical Instrumentation
Rationale: AAMI sets widely accepted standards and guidelines for sterile processing practices.
,3. If healthcare facilities reprocess single-use devices, they must be cleared by the:
A. Occupational Safety and Health Administration
B. Environmental Protection Agency
C. Centers for Disease Control and Prevention
D. Food and Drug Administration
Answer: D. Food and Drug Administration
Rationale: The FDA regulates and approves reprocessing of single-use medical devices.
4. Which of the following single-use items is exempt from the FDA’s third-party reprocessing
regulation?
A. Arthroscopic shavers
B. Sequential compression sleeves
C. Pacemakers
D. Laparoscopic instruments
Answer: C. Pacemakers
Rationale: Pacemakers are not reprocessed due to their critical, implantable nature.
5. OSHA impacts sterile processing through exposure standards and also through:
A. Reprocessing of single-use devices
B. Communication of workplace hazards
,C. Reporting malfunctioning equipment
D. Chemical product approvals
Answer: B. Communication of workplace hazards
Rationale: OSHA’s Hazard Communication Standard ensures workers understand workplace
risks.
6. The Medical Device Reporting regulation requires:
A. Employees to report all injuries
B. Facilities to register reprocessed devices
C. Employees to report PPE failures
D. Facilities to report deaths or serious injuries
Answer: D. Facilities to report deaths or serious injuries
Rationale: MDR ensures serious device-related incidents are reported for safety monitoring.
7. Which agency requires eyewash stations for emergency use?
A. AAMI
B. FDA
C. CDC
D. OSHA
, Answer: D. OSHA
Rationale: OSHA mandates safety equipment like eyewash stations in hazardous work
environments.
8. OSHA’s Hazard Communication Standard requires Safety Data Sheets (SDS) for:
A. All instrument trays
B. All packaging materials
C. Chemicals that can harm you
D. Each chemical in the department
Answer: D. Each chemical in the department
Rationale: An SDS must be available for every chemical to ensure safe handling and emergency
response.
Which of the following establishes sterilization practice standards based on opinion, research
and/or theory?
a. Occupational Safety and Health Administration (OHSA)
b. Association for the Advancement of Medical Instrumentation (AAMI)
c. Environmental Protection Agency (EPA)
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