Regulatory Compliance and Standards Flashcards
6 cards from real CIS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulatory Compliance and Standards flashcards as text
What does the term 'IFU' mean in the context of instrument reprocessing?
Answer: Instructions for Use — the manufacturer's directions for cleaning, disinfection, and sterilization
IFU (Instructions for Use) are mandatory manufacturer-provided documents that specify validated methods for reprocessing each device; following the IFU is required by AAMI, TJC, and the FDA.
A facility reprocesses a single-use device (SUD) against the manufacturer's labeling. Who then bears regulatory responsibility for that device?
Answer: The reprocessing facility becomes the manufacturer and must comply with FDA device regulations
Under FDA policy, when a facility reprocesses a SUD, it becomes the legal manufacturer and must comply with FDA's 21 CFR 820 quality system regulations for that device.
Which AAMI standard specifically addresses high-level disinfection and liquid chemical sterilization processes?
Answer: ANSI/AAMI ST58
ANSI/AAMI ST58 provides guidance on chemical sterilization and high-level disinfection in health care facilities, covering glutaraldehyde, OPA, peracetic acid, and other agents.
What does the Spaulding Classification System categorize?
Answer: Medical devices by the level of disinfection or sterilization required based on their risk of infection transmission
The Spaulding Classification System divides medical devices into Critical, Semi-critical, and Non-critical categories, each requiring a corresponding level of reprocessing to prevent infection.
According to OSHA, which PPE is REQUIRED when handling contaminated instruments in the decontamination area?
Answer: Heavy-duty gloves, fluid-resistant gown, face shield or mask and eye protection
OSHA's Bloodborne Pathogens Standard requires appropriate PPE including puncture-resistant gloves, fluid-resistant gown, and face/eye protection when handling contaminated instruments.
What is the primary reason sterilization records must be maintained for a minimum period as required by regulation?
Answer: To support traceability and recall investigations if a sterilization failure is identified
Sterilization records enable traceability — if a sterilizer malfunction is discovered, records allow identification of all affected loads and patients who received instruments from those loads.