Chapter 12: Preparation and Packaging
Clean and free of contaminants
Airflow plays a critical role in keeping the prep and pack area:
IFU
Ensure all instruments are dry unless otherwise indicated in the
Sterilization
Instruments that have been disassembled for cleaning should be reassembled and tested for functionality, and then disassembled again for:
Sterilization and optimal functioning
Organic material, such as blood or other contaminants, will interfere with
perform inspection, testing and assembly duties
The work area in preparation and packaging should be adequately sized to :
Chemical Indicator (CI)
Users will not use a pack that does not contain a
Stem penetration and drying
Canvas is not recommended as a packaging material because it's tight weave impedes:
Type 5 integrating indicators
Designed to react to all critical parameters and be equivalent to or excess performance requirements over a specified range of sterilization cycles. When used inside a process challenge device (PCD), non implant loads may be released with the appropriate results indicated on the CI.
Type 6 emulating indicators
Designed to react to all critical parameters of sterilization cycle. Class 6 indicators are designed to be run within one specific cycle (e.g. 270 degrees Fahrenheit, four minute exposure). This is the only cycle in which this specific indicator may be use. If a 275 feds Fahrenheit, three minute exposure cycle is to be run, an emulator specifically made for that cycle must be used.
Type 4 multi critical process variable indicators
Designed to react to two or more of the critical process variable and are intended to indicate exposure to a sterilization process at state values of the chose critical process variables.
Chemical Indicators (CIs)
Devices used to monitor the presence of attainment of one or more of the parameters required for a satisfactory sterilization process
Proper cleaning
If a soiled instrument is detected during the inspection process, it should be sent back to the decontamination are for:
Unsterile
If super heating occurs, the tray they are in (and other trays with the load) will potentially be:
Penetrating the pack and making direct contact with the items inside
Incorrect placement of pack contents, incorrect packaging methods or improper loading can impede the sterilization process by creating air pockets or barriers that can prevent the sterilant from:
Rigid Container System
Instrument containers that hold medical devices during sterilization and also protect devices from contamination during storage and transport.
Chips or cracks
Instrument handle should be inspected for
Instrument identification (instrument testing)
Instrument scanning systems, approved instruments marketing systems and instrument tape can help so technicians identify devices and assist with pack assembly
Cuts, cracks and nicks
Instrument shafts should be inspected for
Functionality
Instruments that have been disassembled for cleaning should be reassembled and tested for:
All parts
Instruments that open, such as scissors and hemp stats, should be kept in an unlocked or unlatched and opened position to enable the sterilant to reach:
Metal collar and at the distal end of the instrument
Insulation should fit tightly against the:
All times
It is imperative that protocols for inspection, assembly and packaging are followed at:
Air entrapment and pooling of condensate during the sterilization process
It is important to disassemble multi part items and place all items in trays in a manner that prevents:
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.
Sterilized
Once items have been cleaned, dried, inspected and assembled they are ready to be
-Duck Cloth -Twill -Treated barrier fabrics
Other woven fabrics used in sterilization are:
Do not overcrowd the holding tray (instrument testing)
Overcrowding often occurs when instruments are added to and existing tray. Over time, physicians need may change, and instruments may be added to trays, creating a situation where the holding tray is too small for contents. When this happens, there is a greater risk of instruments becoming damaged. In so cases, severe overcrowding may negatively affect sterilization and drying
Quickly locate contents
Pack standardization helps endure packs are organized and uniform so users can:
Sterilant Penetration
Part of the assembly process for every pack includes a quality assurance text designed to measure:
Photographs (instrument testing)
Photos of instruments and instruments configuration can help ensure that items are assembled correctly
In the tray
Power switched should be turned off before place the instruments:
Manufacturer
Powered surgical instruments often use a sterilization container supplied by the
Minor procedure
Procedure trays are often designed to include all of most of the items needed for a:
Opened
Some sterile packaging is designed with tamper evident seals so users can tell if the package has been:
Sterile Processing Technician
Specialty instruments such as laparoscopic instruments, robotics, endoscopes and cameras are of special concern for
Each tray is important
Standardization of the instrument arrangement within:
Contaminated through contact with the unclean instrument
The tray in which a soiled instrument was located, should also be sent back to the decontamination area because other instruments may have also been:
Sterilized
The ultimate goal list always be to create a tray that can be successfully
Bacteria and Lint
The work area should be routinely cleaned to reduce:
Non-porous, easy to clean materials
To reduce the number of bacteria in the area, all fixtures, work tables and furniture should be constructed of:
Internal Chemical Indicator (CI)
Users will not use a pack that has a failed:
Verification indicators or cycle specific indicators
What are Type 6 emulating indicators also called?
F-Functional A-Accurate N-Neat
What does the acronym FAN stand for?
To create a pack that meets the users needs
What is the first goal in the SPD prep and pack area?
25 pounds
What is the maximum weight for containerized trays; this includes both the weight of the instruments and the instrument container
Accurate
What letter in the FAN acronym means Instruments must be correct, and quantities must be exact. Technicians meet this goal by learning to identify specific instruments, working from an up to date pack bound sheet and verifying that all specifications for the pack, including quantities and configuration, are correct.
Functional
What letter in the FAN acronym means Each item in the pack must function as it was designed. This means scissors must be sharp, clamps must hold securely, and multiparty items must be complete and functional when assembled. Technicians reach the goal by understanding how instruments operate and by relying on specific text methods to ensure they work properly
Neat
What letter in the FAN acronym means Pack contents must be organized, and instruments must be easy to locate. Disorganized packs may waste time or delay treatment and care.
The US Food and Drug Administration
What organization classifies sterilization packaging as a Class 2 medical device (a device that presents a potential risk)
Demagnetizers
What works by reversing the magnetic field away from the instrument?
Lint
When (blank) introduced into a sterile field, it can settle into a wound and cause infection
Preparation and Packaging
When instruments have been cleaned, they are transferred to what area of the Sterile Processing Department?
Checked by the user
When the pack is opened at the point of use it is:
Once each shift and as they become soiled
Workstations should be cleaned at least:
Soiled
All staff members in the area must monitor their cleanliness and change scrub attire if it becomes
Primary objective for any sterilization packaging system
Allow penetration of the chosen sterilant and be compatible with any other requirement of the specific sterilization process such as drying
Instrument assembly
As with all procedure trays, each instrument tray should have a detailed count shred available during:
Assembly Area
Attention to detail is critical in the:
Don't create overweight trays (instrument testing)
Be aware of tray weight and density recommendations from the manufacturers of sterilizers, instruments and packaging systems. In addition to possible issues associated with heat up and drying, excessive tray weight can present ergonomic challengers for those who must life the trays. A maximum weight of 25 pounds for containerized trays; this includes both the weight of the instruments and the instrument container.
Alone
The term "single instrument" is used to describe instruments that are to be packaged
Is designed to detect
A CI's color changes when exposed to the specific sterilant it:
Preparation and Packaging
A clean area of the SPD where instrument inspection, assembly and packaging are performed
A a sealing method that is tamper evident
A packaging system must have what?
Chemical Indicator (CI)
A small, disposable test that helps the user verify that the pack contents were exposed to a sterilant
Positive
Airflow in the prep and pack area should be:
A surgical type hair covering
All head and facial hair (except for eyebrows and eyelashes) should be completely covered with:
Assembly
All instruments should be inspected before:
Protect instruments from damage (instrument testing)
All instruments should be protected from damage when handled. Delicate and sharp instruments are special concern. Sharp points may be protected with special holders, commercially available tip guards, silicone mats, holding brackets, posts or foam sleeves.
-Muslin -Type 140 Cotton -Calico -Barrier cloth
Common names for fabric made of 100% unbleached, loosely woven cotton fibers
Lint
Compromised of fine fibers and separate from items such as wraps, textiles, paper and more
Exact specifications
Count sheets provide specific information that help ensure all packs are assembled, packaged and sterilized according to:
Primary objective for any sterilization packaging system
Create a package that can be opened aseptically (without contaminating the contents)
Properly in the tray
Each instrument should be identified, inspected, verified against the count sheet and placed:
Some soils were not removed
Even though instruments have been cleaned, there may still be instances where
Instrument holding trays (instrument testing)
Group of instruments for a specific procedure or specialty are contained together in trays specifically designed to protect the devices and facilitate the sterilization process.
Frequently in this area
Hand hygiene should be performed:
Harbor microorganisms
Jewelry (all types, including wedding bands) and wristwatches should not be worn in the area because they can
Tools for inspection (instrument testing)
Lighting magnification, computer magnifiers and bore scopes can enlarge areas to help detect residual soil, wear and damage
Primary objective for any sterilization packaging system
Maintain the sterility of the package contents until the package is opened
Packs, Sets, Trays or Kits
Most instruments are prepared in groups called:
Each level of the tray
Multi level trays should have a CI planes in the most difficult area for sterilant penetration on
One wrap
Muslin wrappers are generally made of two ply (double thickness) fabric fastened together as:
Process Challenges Device (PCD)
Object that simulates a predetermined set of conditions when used to test sterilizing agents.
Use the holding trays correctly (instrument testing)
Read the manufacturer IFU and use the tray as instructed. Failure to do so can damage instruments or cause the sterilization process to fail. For example, trays with silicone finger mats must be aligned with drainage holes to help ensure air and water removal
Damage to surrounding tissue, lead to infections and cause irrefutable damage to the patient
Retained surgical items can cause:
Sealable and removable lids
Rigid container systems are box like structures with
A combination of these materials
Rigid container systems are made of anodized aluminum, stainless steel, plastic or:
Sterilant penetration while providing a microbial barrier
Rigid containers have lids and filters that allow
Sterilization Process
SP technicians must also arrange pack contents in a manner that facilitates the appropriate:
Sterilized successfully and maintain sterility until opened
SP technicians must select the appropriate packaging material and apply it correctly to create a pack that can be:
-Sterilant penetration -Barrier effectiveness -Aseptic opening
SP technicians must understand how to use sterilization packaging properly to achieve the desired results:
Sharpness
Scissors should be tested for
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
Procedure Trays (also known as Floor Trays)
Smaller groups of institutions used for minor procedures in areas out of the OR are often called
Previous use
Textile packaging requires more labor because it must be laundered and inspected to ensure that there are no tears, punctures, worn spots or stains from:
Sterilant in the pack
The color change in a CI provides a visual indication of the presence of:
Packaging material and method
The first step in the packaging process is selecting the appropriate
Integrity between uses
The insulation of electrosurgical instruments must be tested for
Patient care
The most important thing to remember with pack preparation is that all items must be functional, accurate and organized because the next time the pack is accessed it will be used for
Cleanliness
The preparation and packaging area is designated clean area, and meticulous care must be taken to maintain that:
