CIS Regulatory Compliance and Standards 2 — Questions and Answers
Question 1: What does the term 'IFU' mean in the context of instrument reprocessing?
- Instructions for Use — the manufacturer's directions for cleaning, disinfection, and sterilization (Correct answer)
- Instrument Functional Update — a maintenance log for each instrument
- Infection Follow-Up — post-procedure decontamination report
- Internal Facility Use — the hospital's internal reprocessing protocol
Correct 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.
Question 2: A facility reprocesses a single-use device (SUD) against the manufacturer's labeling. Who then bears regulatory responsibility for that device?
- The reprocessing facility becomes the manufacturer and must comply with FDA device regulations (Correct answer)
- The original manufacturer retains full liability
- No one — reprocessing a SUD is unregulated if done by a licensed technician
- The surgeon who uses the device
Correct 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.
Question 3: Which AAMI standard specifically addresses high-level disinfection and liquid chemical sterilization processes?
- ANSI/AAMI ST58 (Correct answer)
- ANSI/AAMI ST79
- ANSI/AAMI ST41
- ANSI/AAMI TIR34
Correct 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.
Question 4: What does the Spaulding Classification System categorize?
- Medical devices by the level of disinfection or sterilization required based on their risk of infection transmission (Correct answer)
- Surgical instrument alloys by their corrosion resistance rating
- Sterilizer types by their chamber size and throughput capacity
- Biological indicators by the organism used in the test
Correct 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.
Question 5: According to OSHA, which PPE is REQUIRED when handling contaminated instruments in the decontamination area?
- Heavy-duty gloves, fluid-resistant gown, face shield or mask and eye protection (Correct answer)
- Sterile surgical gloves only
- Standard latex examination gloves and a surgical mask
- A face shield alone is sufficient if instruments are fully submerged
Correct 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.
Question 6: What is the primary reason sterilization records must be maintained for a minimum period as required by regulation?
- To support traceability and recall investigations if a sterilization failure is identified (Correct answer)
- To satisfy billing requirements for insurance reimbursement
- To track the number of cycles each sterilizer has completed
- To meet OSHA documentation requirements for workplace injuries
Correct 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.
CIS Regulatory Compliance and Standards 2
What does the term 'IFU' mean in the context of instrument reprocessing?