HSPA CRCST Exam Questions &
Answers (Grade A+)
Microbiology -
correct answer ✅The study of microorganisms
Contamination -
correct answer ✅The state of being soiled by contact with
infectious organisms or other materials.
Cross-contamination -
correct answer ✅The process by which microorganisms are
unintentionally transferred from one substance or object to
another, with harmful effect.
U.S. Food and Drug Administration (FDA) -
correct answer ✅responsible for ensuring that medical devices are
safe and effective for patient care. It regulates the manufacturing of
all medical devices. It regulates sterilant, high-level disinfectants,
packaging materials, sterilizers, and quality monitoring (e.g.,
biological monitoring).
Medical Device Classification -
correct answer ✅Class 1: Electric Toothbrushes
Class 2: Infusion Pumps
,HSPA CRCST Exam Questions &
Answers (Grade A+)
Class 3: Pacemakers
Class I Devices -
correct answer ✅Low risk - hand-held instruments, hospital beds,
ultrasonic cleaners
Class II Devices -
correct answer ✅Potential risk - sterilization equipment, biological
indicators, chemical indicators
MedWatch -
correct answer ✅This is the FDA reporting service for adverse
effects that occur from use of approved drugs.
Medical Device Recalls -
correct answer ✅Class I: high risk
Class II: Less serious risk
Class III:Low risk
FDA Enforcement Requirements for Healthcare Facilities
Reprocessing Single-Use Devices (SUD) -
, HSPA CRCST Exam Questions &
Answers (Grade A+)
correct answer ✅Requires compliance with FDA 510(k) directives
when reprocessing SUDs.
Emergency Use Authorization (EUA) -
correct answer ✅Allows the FDA to help strengthen the nation's
public health protections against chemical and biological threats,
including infectious diseases, and other threats.
Center for Disease Control and Prevention (CDC) -
correct answer ✅The CDC promotes health and quality of life by
preventing and controlling disease, injury, and disability and by
responding to health emergencies.
U.S. Environmental Protection Agency (EPA) -
correct answer ✅The EPA is responsible for minimizing
greenhouse gases and toxic emission, regulating the reuse of solid
wastes, controlling indoor air pollution, and developing and
enforcing chemical regulations. requires an EPA registration number
for every covered disinfectant and sanitizer and requires data
relating to labeling claims, efficacy, and safety
U.S. Department of Transportation -
correct answer ✅ensures a fast, safe, and efficient transportation
Answers (Grade A+)
Microbiology -
correct answer ✅The study of microorganisms
Contamination -
correct answer ✅The state of being soiled by contact with
infectious organisms or other materials.
Cross-contamination -
correct answer ✅The process by which microorganisms are
unintentionally transferred from one substance or object to
another, with harmful effect.
U.S. Food and Drug Administration (FDA) -
correct answer ✅responsible for ensuring that medical devices are
safe and effective for patient care. It regulates the manufacturing of
all medical devices. It regulates sterilant, high-level disinfectants,
packaging materials, sterilizers, and quality monitoring (e.g.,
biological monitoring).
Medical Device Classification -
correct answer ✅Class 1: Electric Toothbrushes
Class 2: Infusion Pumps
,HSPA CRCST Exam Questions &
Answers (Grade A+)
Class 3: Pacemakers
Class I Devices -
correct answer ✅Low risk - hand-held instruments, hospital beds,
ultrasonic cleaners
Class II Devices -
correct answer ✅Potential risk - sterilization equipment, biological
indicators, chemical indicators
MedWatch -
correct answer ✅This is the FDA reporting service for adverse
effects that occur from use of approved drugs.
Medical Device Recalls -
correct answer ✅Class I: high risk
Class II: Less serious risk
Class III:Low risk
FDA Enforcement Requirements for Healthcare Facilities
Reprocessing Single-Use Devices (SUD) -
, HSPA CRCST Exam Questions &
Answers (Grade A+)
correct answer ✅Requires compliance with FDA 510(k) directives
when reprocessing SUDs.
Emergency Use Authorization (EUA) -
correct answer ✅Allows the FDA to help strengthen the nation's
public health protections against chemical and biological threats,
including infectious diseases, and other threats.
Center for Disease Control and Prevention (CDC) -
correct answer ✅The CDC promotes health and quality of life by
preventing and controlling disease, injury, and disability and by
responding to health emergencies.
U.S. Environmental Protection Agency (EPA) -
correct answer ✅The EPA is responsible for minimizing
greenhouse gases and toxic emission, regulating the reuse of solid
wastes, controlling indoor air pollution, and developing and
enforcing chemical regulations. requires an EPA registration number
for every covered disinfectant and sanitizer and requires data
relating to labeling claims, efficacy, and safety
U.S. Department of Transportation -
correct answer ✅ensures a fast, safe, and efficient transportation
