MDRAO Assembly and Packaging Systems 2

Question 1

What is the primary purpose of a tamper-evident seal on a sterile package?

Accepted Answer

To provide visual evidence if the package integrity has been compromised

Answer

Tamper-evident seals provide a visual indicator that the package has not been opened or violated after sterilization.

Question 2

Which of the following is a critical parameter to monitor during heat-sealing of pouches?

Accepted Answer

Sealer temperature, pressure, and dwell time

Answer

Temperature, pressure, and dwell time are the three critical parameters that must be monitored and recorded to ensure a consistent, sterile seal.

Question 3

A sterile package shows a peel-open seal that has partially delaminated before use. What should be done?

Accepted Answer

Remove and reprocess the device, as package integrity is compromised

Answer

Any compromise to package integrity means the sterility of the contents cannot be guaranteed, requiring removal from service and reprocessing.

Question 4

What does the term 'dead-end' or 'closed-end' loading refer to in instrument tray assembly?

Accepted Answer

Placing sharp ends of instruments toward the closed end of the container

Answer

Closed-end loading means sharps face the closed end to protect workers during handling and retrieval.

Question 5

Which material property of packaging film is most important for maintaining sterile barrier integrity during transportation?

Accepted Answer

Puncture and tear resistance

Answer

Puncture and tear resistance prevents accidental breaches that could compromise the sterile barrier during transport and storage.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test