MDRAO Assembly and Packaging Systems 5

Question 1

According to AAMI ST79, how should peel pouches be oriented when loaded into a steam sterilizer?

Accepted Answer

On edge, paper-to-plastic, to allow steam penetration and condensate drainage

Answer

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?

Accepted Answer

Replace the gasket before using the container

Answer

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?

Accepted Answer

The arrangement and density of packages placed in a sterilizer chamber for a single cycle

Answer

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?

Accepted Answer

Peel-strength and seal-integrity testing per ASTM F88 or ISO 11607

Answer

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?

Accepted Answer

To ensure consistent accountability, familiarity, and accuracy in count and configuration

Answer

Consistent assignment builds familiarity with set configuration, reducing assembly errors and improving count accuracy and accountability.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO Assembly and Packaging Systems 5