Chapter 12

Preparation and Packaging

A clean area of the SPD Ware instrument inspection, assembly, and packaging are performed. The preparation in packing area is some times called the prep and pack or assembly area.

protective packaging

A configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.

Temperature in the preparation packaging area is based on:

ANSI/ASHRAE/ASHE 170 guidance specifically, for when the heating, ventilation and air conditioning (HVAC) system was initially installed or last upgraded

Which of the following is a disadvantage of a rigid containers?

Additional cycle time may be required to thoroughly dry the contents

Peel pouches should be sized and applied properly to:

Allow for adequate air removal, sterilant penetration, and drying

must be inside every sterile package

Chemical indicators (CIs)

The US food and drug administration (FDA) classifies sterilization packaging as a:

Class II medical device

Chemical indicators (CIs)

Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process.

How often should the insulation of electro surgical instruments be tested for integrity?

Each time the instrument is processed

The wrapping technique most commonly used for small packs and most trays

Envelope fold

Some plastics, including formulations of spun bonded polyolefin, are intended for use solely in these sterilization process:

Hydrogen peroxide

Sterility (event-related)

Items are considered sterile unless the integrity of the packaging is compromised (damaged) or suspected of being compromised, regardless of the sterilization date. This is sometimes abbreviated as ERS.

Plastic containers can take longer to dry because they:

Lack metal, which provides heat by conduction

Which of the following cannot be used to protect delicate instruments tips during packaging?

Latex tubing

Process challenge device (PCD)

Object that simulates a predetermined set of conditions when used to test sterilizing agents.

Super-heated steam

Occurs when dry steam becomes too hot, compared to saturated steam; dry, steam rises to a temperature higher than the boiling point of saturated steam. This commonly occurs when dehydrated linen is processed in a steam sterilizer. Due to the lack of moisture, dry steam, is not an effective sterilant and will often char or burn items in the sterilizer

wet pack

Package or container with moisture after the sterilization process is completed.

This is not an acceptable method of package closer

Paper clips

Type of packaging that can be used in steam and ethylene oxide (EO) sterilization but is not recommended recommended for other types of sterilization

Paper/plastic combination

Which of the following cannot be used in a Inst set to protect delicate instruments?

Plastic peel packs

In a peel pack, instruments tips be placed toward the:

Plastic side of the package

Airflow in the preparation and packing (assembly) area should be:

Positive

Tamper-evident seals

Sealing method that allows users to determine if sterile packages have been open (contaminated) and helps users identify packages that are unsafe for patient use.

Which of following is an acceptable seal for paper/plastic pouches?

Self-seal closure systems

Flat-wrapping technique that applies one wrap on top of another to create a package within a package

Sequential

Type of packaging that contains no cellulosic materials and is used to package small items for low-temperature sterilization

Spinning polyolefin-plastic combinations

Which of the following can be used to close sterile packages?

Sterilization indicator tape

What information is not required on the label of a sterilize package?

Surgeon identification

What does not have an effect on event-related sterility?

The manner in which the device is used

This type of chemical indicator (CI) is also called a verification indicator and a cycle-specific indicator. It is designed to react to all critical parameters of a sterilization cycle.

Type 6

Government agency that regulates sterilization packaging materials

U.S. Food and Drug Administration (FDA)

Sterility (time-related)

a package is considered sterile until a specific date is reached.

Clean multi-part instruments that have been assembled to test for functionality should:

be disassembled and sterilized following manufacturer's IFU

Which of the following is not an acceptable, sterilization packaging material?

canvas

Instruments are placed into sets:

dry

When assembling instruments trays:

heavier instruments should be placed on the bottom of the tray

An acceptable method of package closure that is also used as an external indicator.

indicator tapes

rigid container system

instrument containers that hold medical devices during sterilization and also protect devices from contamination during storage and transport.

When arranging paper/plastic pouches in the sterilizer, the pouches should be arranged:

paper to plastic

When using paper/plastic combination pouches, package content, information should be written on this side of the pouch

plastic

Which of the following items can cause superheating within a sterilization cycle?

pre-packaged sterile towels

Count sheets:

provide a detailed list of tray contents

Muslin is an example of this type of packaging material

reusable

Which of the following packaging systems is required to be packaged twice and provides a second chance for sterile presentation?

sequential flat wrapper

When a soiled instrument is found during the assembly process, the:

the instrument and the tray it was in should be sent to the decontamination area for re-cleaning

when placing hinged instruments in an instrument tray:

unlock the handles and open the instruments