Chapter 12 Preparation and Packaging

Preparation and packaging

A clean area of the SPD where instrument inspection, assembly and packaging are performed. The preparation and packaging area is sometimes called the prep and pack or assembly area

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 burn items in the sterilizer.

Chemical Indicators (CIs)

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

Process Challenge device (PCD)

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

Tamper-evident seals

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

Rigid Container System

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

Wet Pack

Package or container that contains moisture after the sterilization process is completed

Sterility (time related)

A package is considered sterile until a specific expiration date is reached

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. 

Protective Package

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.

[workbook] The FDA classifies sterilization packaging as a:

Class 2 medical devices

[workbook] Which of the following is not an acceptable sterilization packaging material:

Canvas

[workbook] Count sheets:

Provide a detailed list of tray contents

[workbook] When arranging paper/plastic pouches in a sterilizer, the pouches should be arranged:

Paper to plastic

[workbook] How often should the insulation of electrosurgical instruments be tested for integrity?

Every time the instruments is processed

[workbook] Some plastics, including formulations of spun-bonded polyolefin, are intended for use in this sterilization process:

Hydrogen peroxide

[workbook] When placing hinged instruments in an instrument tray:

Unlock the handles and open the instruments

[workbook] Instruments are placed into sets:

Dry

[workbook] Which of the following cannot be used in an instrument set to protect delicate instruments?

Plastic peel packs

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

Type 6

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

Sequential flat wrapper

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

Pre-packaged sterile towels

[workbook] Plastic containers take longer to dry because they:

Lack metal, which produces heat by conduction

[workbook] Which of the following is a disadvantage of rigid sterilization containers?

Additional cycle time may be required to thoroughly dry the contents

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

Sterilization indicator tape

[workbook] When double pouching using plastic peel pouches:

Seal a pouch, place it inside another slightly larger outer pouch and seal it the outer pouch

[workbook] Why is tape NOT recommended for sealing paper/plastic pouches?

Tape hinders aseptic removal

[workbook] Which of the following is NOT a primary objective of any sterilization packaging system?

Be lightweight to allow for safe handling ergonomics

[workbook] Which writing device is approved to label a paper/plastic pouch?

Felt-tip marker

[workbook] Peel pouches should be properly sized for the item being packages because:

Proper sizing allows for adequate air removal, sterilant penetration and drying

[workbook] Which is an acceptable sterilization practice?

Preparing instruments so the sterilant can easily contact all surfaces

What does positive airflow do?

It reduces the risk of airborne bacteria being introduced into the area. When the doors in the prep and pack area are opened, air flows outward.

To reduce the number of bacteria in the area, fixtures, worktables and furniture should be constructed out of what?

Non-porous, easy to clean materials.

How often should workstations be cleaned?

At each shift and as they become soiled.

What can lint do?

It can cause an infection

FAN

Functional, accurate, and neat

Assembly technicians should ensure the following information is available:

• Specific instructions for correct placement of items in the tray

• Sterilization method and required cycle used for processing the tray

• types and sizes of packaging to be used

• Type and placement of internal and/or external chemical process indicators

• destination or storage location of the tray

Type 4 chemical indicator:

Designed to react to two or more of the critical process variables.

Intended to indicate exposure to a sterilization process at stated values of the chosen critical process variables

Type 5 chemical indicator:

Designed to react to all critical parameters and be equivalent to or exceed performance requirements over a specified range of sterilization cycles.

Type 6 chemical indicator

Designed to react to all critical parameters of a sterilization cycle.

Designed to be run within one specific cycle (e.g., 270°F, four-minute exposure).