IAHCSMM Quality Management & Regulatory Compliance 1 — Questions and Answers
Question 1: Which federal agency regulates medical devices including sterilization equipment in the United States?
- OSHA
- CDC
- FDA (Food and Drug Administration) (Correct answer)
- CMS (Centers for Medicare & Medicaid Services)
Correct answer: FDA (Food and Drug Administration)
The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, including sterilizers, reusable medical devices, and their reprocessing instructions.
Question 2: What does the term 'Instructions for Use' (IFU) mean in the context of medical device reprocessing?
- Surgeon's preferred technique notes
- The manufacturer's validated, legally binding instructions for cleaning, disinfection, and sterilization of a device (Correct answer)
- Internal hospital reprocessing protocol
- A document created by CS technicians
Correct answer: The manufacturer's validated, legally binding instructions for cleaning, disinfection, and sterilization of a device
The IFU is the manufacturer's validated and legally binding document specifying exactly how a device must be reprocessed; deviating from it creates liability and may harm patients.
Question 3: What is the role of The Joint Commission (TJC) in sterile processing?
- Manufacturing medical devices
- Accrediting healthcare facilities and setting standards that include CS/SPD practices (Correct answer)
- Certifying individual CS technicians
- Publishing AAMI standards
Correct answer: Accrediting healthcare facilities and setting standards that include CS/SPD practices
TJC accredits healthcare facilities and surveys compliance with standards including sterile processing practices, which facilities must meet to participate in Medicare/Medicaid.
Question 4: What does a 'corrective action report' (CAR) document in a CS quality program?
- Routine sterilization cycle parameters
- Identification of a process deviation, root cause analysis, and corrective actions taken to prevent recurrence (Correct answer)
- Daily production volumes
- Staff attendance records
Correct answer: Identification of a process deviation, root cause analysis, and corrective actions taken to prevent recurrence
A CAR is a formal quality document that captures deviations from standard processes, investigates root causes, and records corrective actions to improve the system.
Question 5: OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires CS departments to:
- Sterilize all instruments regardless of risk level
- Provide PPE, training, hepatitis B vaccination, and exposure control plans to protect workers (Correct answer)
- Use only disposable instruments
- Document every instrument count
Correct answer: Provide PPE, training, hepatitis B vaccination, and exposure control plans to protect workers
OSHA's Bloodborne Pathogens Standard mandates that employers protect workers from exposure to bloodborne pathogens through PPE, training, vaccines, and written exposure control plans.
Question 6: Which document serves as the primary reference for steam sterilization practices in US healthcare facilities?
- CDC Guidelines for Hand Hygiene
- AAMI ST79 (Correct answer)
- FDA 21 CFR Part 820
- USP Chapter 797
Correct answer: AAMI ST79
AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) is the primary US standard for steam sterilization practice.
IAHCSMM Quality Management & Regulatory Compliance 1
Which federal agency regulates medical devices including sterilization equipment in the United States?