Question 1

What is the primary purpose of packaging systems for medical devices?

Accepted Answer

The sterile barrier system must allow the sterilant to penetrate, kill microorganisms, and then maintain that sterility during storage and handling until the point of use.

Question 2

Which wrapping technique is most commonly used for small packs and trays to allow for an aseptic presentation?

Accepted Answer

The envelope fold (diagonal fold) is preferred for most packs because it allows the end user to open the package aseptically without reaching over the sterile field.

Question 3

Peel pouches are designed for:

Accepted Answer

Peel pouches are appropriate for single instruments or small, light items. Heavy items can tear the paper or break the seals during the sterilization process.

Question 4

When using a heat sealer for peel pouches, it is critical to check:

Accepted Answer

A continuous, intact seal is vital. Creases or bubbles create channels for air and bacteria to enter, compromising sterility.

Question 5

The ideal temperature for the sterile storage area is:

Accepted Answer

Sterile storage should be kept between 68°F and 75°F to prevent condensation and microbial growth, while remaining comfortable for staff.

Question 6

Event-Related Sterility (ERS) means:

Accepted Answer

ERS recognizes that sterility is maintenance-dependent, not time-dependent. As long as the barrier is intact and dry, the item is sterile.

Question 7

Which material is NOT suitable for Hydrogen Peroxide Gas Plasma sterilization packaging?

Accepted Answer

Cellulose absorbs hydrogen peroxide, causing the cycle to abort. Paper pouches and linen wraps cannot be used in plasma sterilizers.

Question 8

A 'Lot Control Number' (Load Control Number) on a package label must include:

Accepted Answer

The lot number allows for traceability. In the event of a recall, the facility must be able to identify which sterilizer and cycle processed the item.

Question 9

If a sterile package falls on the floor, it should be:

Accepted Answer

The force of hitting the floor can force air (and dust/bacteria) into the package through the microscopic pores of the wrapper. It is considered contaminated.

Question 10

Rigid sterilization containers must be biologically tested:

Accepted Answer

Facilities must verify that their specific sterilizers can effectively sterilize instruments inside the rigid containers before putting them into service (Pre-purchase/Pre-use testing).

Question 11

When double-peel pouching (placing one pouch inside another), it is critical to:

Accepted Answer

To ensure steam penetration and visibility, the packaging materials must align (paper-to-paper, plastic-to-plastic). The inner pouch must not be folded, as this entraps air.

Question 12

Which type of marker should be used to write on the plastic side of a peel pouch or on monitor tape?

Accepted Answer

Ballpoint pens can puncture pouches. Standard markers may run or fade. Only approved, non-toxic indelible markers should be used, and writing should be on the plastic or tape, not the paper (to prevent bleeding through).

Question 13

Tip protectors are used to:

Accepted Answer

Tip protectors serve a dual purpose: protecting the asset (instrument) and protecting the sterile barrier (pouch/wrap) from punctures.

Question 14

The relative humidity in the sterile storage area should not exceed:

Accepted Answer

High humidity (>70%) promotes microbial growth and can compromise the integrity of paper/woven wrappers. Low humidity (<20%) can dry out tapes and seals.

Question 15

Sterile packages should be stored at least how far from the floor?

Accepted Answer

Bottom shelves must be 8-10 inches off the floor to prevent contamination from floor cleaning (mops/splashes) and dust.

Question 16

The 'Sequential' wrapping method involves:

Accepted Answer

Sequential wrapping creates a package within a package. This is distinct from 'Simultaneous' wrapping, which uses two sheets (often bonded) applied at the same time.

Question 17

When stacking rigid containers on a storage shelf, you should:

Accepted Answer

Rigid containers are designed to be stacked, but they become heavy and unstable. Follow manufacturer limits. Wrapped trays should NEVER be stacked (compression leads to contamination).

Question 18

Air flow in the sterile storage area should be:

Accepted Answer

Positive pressure pushes air *out* of the clean storage room when the door opens, preventing airborne contaminants from hallway/general areas from entering.

Question 19

Count sheets should generally NOT be placed inside wrapped trays unless:

Accepted Answer

Standard copier toner can contain toxins. Only validated materials can go inside the sterile field.

Question 20

If a technician finds a rigid container with a broken tamper-evident seal in the sterile storage area:

Accepted Answer

The tamper-evident seal is the only proof that the container has not been opened since sterilization. If broken, sterility is compromised.

Question 21

Canvas (heavy woven textile) is no longer recommended for steam sterilization packaging because:

Accepted Answer

Canvas is too dense. It causes wet packs and prevents steam contact. Modern woven fabrics are specifically engineered for sterilization.

Question 22

Sterile items should be stored how far from the ceiling (or sprinkler heads)?

Accepted Answer

Fire codes typically require 18 inches of clearance below sprinkler heads to ensure proper water distribution in a fire.

Question 23

Paper/plastic peel pouches are used for which sterilization methods?

Accepted Answer

Standard paper/plastic pouches are compatible with Steam and EtO. Tyvek/plastic pouches are required for H2O2 Plasma (STERRAD).

Question 24

When handling sterile packages, technicians should:

Accepted Answer

Dragging packages can create friction heat or tears, compromising the barrier. Always lift and place.

Question 25

Muslin wraps (woven textiles) must be inspected before each use. How is this inspection performed?

Accepted Answer

A light table illuminates the fabric from behind, making pinholes and thinning fabric visible. Even small holes compromise the sterile barrier.

Question 26

The chemical indicator tape on the outside of a package indicates:

Accepted Answer

External indicators (Class 1) distinguish processed items from unprocessed items. They do NOT prove sterility; they only prove the pack went through the machine.

Question 27

What is 'wicking'?

Accepted Answer

Wicking occurs when moisture allows bacteria to travel through a package barrier (like a wet string). This is why wet packs are considered contaminated.

Question 28

If a sterile tray feels damp/moist on the outside after cooling:

Accepted Answer

External moisture suggests internal moisture or a compromise of the barrier. It is a wet pack and is non-sterile.

Question 29

Plastic dust covers (sterility maintenance covers) should be applied:

Accepted Answer

Applying a plastic cover to a warm package traps moisture (condensation) inside, creating a breeding ground for bacteria. The item must be cool and dry first.

Question 30

Wire shelving in sterile storage is preferred because:

Accepted Answer

Solid shelves collect dust. Wire shelves stay cleaner and allow airflow.

Question 31

A technician drops a wrapped sterile tray on the floor of the sterile storage area. The floor is clean and the wrapper looks intact. The technician should:

Accepted Answer

Dropping a tray forces air out and sucks non-sterile air (and dust) in upon impact (bellows effect). It also risks breaking internal instruments. It must be completely reprocessed.

Question 32

When processing a rigid container, the technician notices the retention plate is loose. This could result in:

Accepted Answer

The retention plate holds the filter in place. If loose, the filter may shift or fall out during the pressure changes of the vacuum cycle, leaving the container unsealed and contaminated.

Packaging & Storage Practice Questions

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