Assembly and Packaging Systems Flashcards
7 cards from real MDRAO practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Assembly and Packaging Systems flashcards as text
What is the primary purpose of a tamper-evident seal on a sterile package?
Answer: To provide visual evidence if the package integrity has been compromised
Tamper-evident seals provide a visual indicator that the package has not been opened or violated after sterilization.
Which of the following is a critical parameter to monitor during heat-sealing of pouches?
Answer: Sealer temperature, pressure, and dwell time
Temperature, pressure, and dwell time are the three critical parameters that must be monitored and recorded to ensure a consistent, sterile seal.
A sterile package shows a peel-open seal that has partially delaminated before use. What should be done?
Answer: Remove and reprocess the device, as package integrity is compromised
Any compromise to package integrity means the sterility of the contents cannot be guaranteed, requiring removal from service and reprocessing.
What does the term 'dead-end' or 'closed-end' loading refer to in instrument tray assembly?
Answer: Placing sharp ends of instruments toward the closed end of the container
Closed-end loading means sharps face the closed end to protect workers during handling and retrieval.
Which material property of packaging film is most important for maintaining sterile barrier integrity during transportation?
Answer: Puncture and tear resistance
Puncture and tear resistance prevents accidental breaches that could compromise the sterile barrier during transport and storage.
When using a dual-layer wrapping technique, the second wrap serves which primary function?
Answer: Adds a second sterile barrier if the outer wrap is contaminated during opening
The second wrap creates a redundant sterile barrier, allowing aseptic presentation even if the outer wrap becomes contaminated during the opening process.
What is the recommended maximum weight for a wrapped instrument set according to most sterile processing guidelines?
Answer: 7 kg (15.4 lb)
Most guidelines, including AAMI ST79, recommend a maximum wrapped tray weight of approximately 7 kg (15.4 lb) to ensure adequate sterilant penetration and safe handling.