IAHCSMM Quality Management & Regulatory Compliance

Question 1

Which federal agency regulates medical devices including sterilization equipment in the United States?

Accepted Answer

FDA (Food and Drug Administration)

Answer

OSHA

Answer

CDC

Answer

CMS (Centers for Medicare & Medicaid Services)

Question 2

What does the term 'Instructions for Use' (IFU) mean in the context of medical device reprocessing?

Accepted Answer

The manufacturer's validated, legally binding instructions for cleaning, disinfection, and sterilization of a device

Answer

Surgeon's preferred technique notes

Answer

Internal hospital reprocessing protocol

Answer

A document created by CS technicians

Question 3

What is the role of The Joint Commission (TJC) in sterile processing?

Accepted Answer

Accrediting healthcare facilities and setting standards that include CS/SPD practices

Answer

Manufacturing medical devices

Answer

Certifying individual CS technicians

Answer

Publishing AAMI standards

Question 4

What does a 'corrective action report' (CAR) document in a CS quality program?

Accepted Answer

Identification of a process deviation, root cause analysis, and corrective actions taken to prevent recurrence

Answer

Routine sterilization cycle parameters

Answer

Daily production volumes

Answer

Staff attendance records

Question 5

OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires CS departments to:

Accepted Answer

Provide PPE, training, hepatitis B vaccination, and exposure control plans to protect workers

Answer

Sterilize all instruments regardless of risk level

Answer

Use only disposable instruments

Answer

Document every instrument count

Question 6

Which document serves as the primary reference for steam sterilization practices in US healthcare facilities?

Accepted Answer

AAMI ST79

Answer

CDC Guidelines for Hand Hygiene

Answer

FDA 21 CFR Part 820

Answer

USP Chapter 797