MDRAO Assembly and Packaging Systems 5 — Questions and Answers
Question 1: According to AAMI ST79, how should peel pouches be oriented when loaded into a steam sterilizer?
- Horizontally, stacked face-to-face
- On edge, paper-to-plastic, to allow steam penetration and condensate drainage (Correct answer)
- Sealed end down, open end up
- Flat with the plastic side facing up
Correct answer: On edge, paper-to-plastic, to allow steam penetration and condensate drainage
Pouches should be loaded on edge, paper-to-plastic, to prevent pooling of condensate and to allow adequate steam penetration through the paper side.
Question 2: A reusable rigid container's gasket shows visible cracking and deformation. Which action is required?
- Continue use and schedule replacement at next maintenance interval
- Apply silicone lubricant to restore the seal temporarily
- Replace the gasket before using the container (Correct answer)
- Use the container only for gravity steam cycles, not prevacuum
Correct answer: Replace the gasket before using the container
A damaged gasket cannot form a reliable seal, allowing post-sterilization contamination; it must be replaced before the container is placed back into service.
Question 3: What does the term 'sterilization load' configuration refer to?
- The total monetary value of instruments in a sterilizer
- The arrangement and density of packages placed in a sterilizer chamber for a single cycle (Correct answer)
- The number of biological indicators used per cycle
- The temperature setting chosen for the sterilization cycle
Correct answer: The arrangement and density of packages placed in a sterilizer chamber for a single cycle
Load configuration refers to how items are arranged within the sterilizer chamber, which directly affects sterilant penetration, air removal, and drying.
Question 4: Which packaging validation test confirms that a peel pouch seal meets strength and integrity requirements?
- Bowie-Dick test
- Biological indicator challenge
- Peel-strength and seal-integrity testing per ASTM F88 or ISO 11607 (Correct answer)
- Lethality calculation (F0 value)
Correct answer: Peel-strength and seal-integrity testing per ASTM F88 or ISO 11607
ASTM F88 and ISO 11607 specify standardized peel-strength and seal-integrity tests used to validate that packaging systems maintain sterile barrier function.
Question 5: Why should instrument sets be assembled by the same sterile processing technician whenever possible?
- To reduce overtime costs
- To ensure consistent accountability, familiarity, and accuracy in count and configuration (Correct answer)
- To comply with union rules
- To allow faster decontamination turnover
Correct answer: To ensure consistent accountability, familiarity, and accuracy in count and configuration
Consistent assignment builds familiarity with set configuration, reducing assembly errors and improving count accuracy and accountability.
Question 6: What is the role of a count sheet (instrument checklist) in the assembly process?
- It documents the sterilization cycle parameters
- It serves as a reference for instrument identification, quantity, and tray configuration verification (Correct answer)
- It tracks which clinician last used the tray
- It records the cleaning agent concentration used
Correct answer: It serves as a reference for instrument identification, quantity, and tray configuration verification
Count sheets provide a standardized reference that technicians use to verify each instrument is present, functional, and correctly positioned before packaging.
Question 7: Which condition would cause a technician to reject a pre-formed peel pouch before loading an instrument?
- The pouch is stored at 18°C (65°F)
- The pouch has a small hole or channel visible along the heat seal line (Correct answer)
- The pouch is within its manufacturer expiry date
- The pouch contains a Class 1 process indicator
Correct answer: The pouch has a small hole or channel visible along the heat seal line
A hole or channel in the seal creates a direct pathway for microbial ingress, rendering the pouch unable to maintain the sterile barrier.
MDRAO Assembly and Packaging Systems 5
According to AAMI ST79, how should peel pouches be oriented when loaded into a steam sterilizer?