MDRAO Assembly and Packaging Systems 3

Question 1

Which internal chemical indicator (CI) class provides the most process challenge information when placed inside a complex instrument tray?

Accepted Answer

Class 5 (integrating indicators)

Answer

Class 5 integrating indicators react to all critical sterilization variables and correlate with biological indicator performance, providing the most comprehensive internal CI data.

Question 2

During assembly, which action best prevents sharp instrument tips from perforating a peel pouch?

Accepted Answer

Using tip protectors or guards approved for sterilization

Answer

Sterilization-compatible tip protectors physically shield sharp points and prevent puncture of the packaging material without compromising sterilant access.

Question 3

What is the consequence of placing too many instruments in a single peel pouch?

Accepted Answer

Overfilling can break the seal and compromise sterility

Answer

Overfilling stresses the seal integrity and can cause micro-channels or complete seal failure, rendering the package non-sterile.

Question 4

A technician notices that the ink on an external chemical indicator (CI) label is smeared and unreadable after steam sterilization. What is the correct action?

Accepted Answer

Quarantine the pack; do not release until CI result is confirmed by reprocessing

Answer

If the CI result cannot be read, sterility cannot be confirmed for that package; it must be reprocessed with proper documentation.

Question 5

Which statement about event-related sterility (ERS) is correct?

Accepted Answer

Sterility is maintained as long as packaging integrity is preserved under proper storage

Answer

ERS holds that a sterile item remains sterile until the package is physically breached or compromised by improper storage conditions.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO Assembly and Packaging Systems 3