Chapter 12

3 primary objectives for any sterilization packaging system

1. Allow penetration of the chosen sterilant 2. Maintain the sterility of the package contents until the package is opened 3. Create a package that can be opened aseptically by the user

2 types of combination peel pouches

1. Paper/plastic combinations: these are typically accepted for use with steam and EtO sterilization processes. They have a paper side and a plastic side (plastic side allows for visibility, paper side allows for sterilant penetration) 2. Spunbond polyolefin-plastic combinations: used for hydrogen peroxide and ozone sterilization. Also has a plastic side for visualization, but the other side is composed of polyolefin which makes it compatible with hydrogen peroxide and ozone sterilization processes.

2 methods of using flat wrapper packs

1. Sequential: the package is wrapped twice and is a "package within a package". This method is used for muslin, Kraft-type paper and single layers of SMS wraps. 2. Simultaneous: The package is only wrapped once, but it requires a special double-layered synthetic nonwoven material bound on two or four sides.

2 techniques for wrapping packages

1. Square fold: aka the in-line or parallel fold; frequently used for larger packs and instrument trays 2. Envelope fold: commonly used for individual items, small packs, and most instrument sets.

IUSS documentation should include:

1. The name of the patient 2. Sterilizer number and cycle 3. Name of the instrument sterilized

Advantages of rigid sterilization containers

1. provide an excellent barrier to microorganisms 2. easy to use 3. eliminate torn wrappers 4. help protect instruments from damage during processing, storage, and transport

Disadvantages of rigid sterilization containers

1. very heavy 2. additional cycle time required 3. longer dry times 4. additional space needed 5. additional labor required 6. latching mechanisms create potential problems 7. filter retention plates may become dislodged and contaminate instruments

What are the height/weight/length limits for assembling linen packs?

12 in (height) x 12 in (weight) x 20 in (length), and they are not to weigh more than 12 pounds

All packaging materials should be held at a temp of 68-73 degrees with 30-60% humidity for a minimum of how many hours prior to sterilization?

2 hours

Packaging used for steam sterilization must be capable of withstanding high temperatures of:

250-275 degrees

Assemble area

A clean area of the CS department where instrument inspection, assembly, and packaging are performed.

What are wet packs and what is most likely to experience this problem?

A package or container with moisture after the sterilization process is complete. Heavier sets and those with greater metal mass are more likely to experience this problem.

Class 6 emulating indicators

AKA verification indicators or cycle specific indicators, are designed to react to all critical parameter of a sterilization cycle. Class 6 are designed to be run within one specific cycle.

_____________ should be assembled in a way that allows moisture to drain from them during sterilization

Basin sets

How do demagnetizers work?

By reversing the magnetic field away from the instrument

What are small, disposable tests that help the user verify that the pack contents were exposed to a sterilant.

CI

What is not an acceptable sterilization packaging material?

Canvas

Commonly used internal CIs include:

Class 5 integrating indicators and Class 6 emulating indicators

The FDA classifies sterilization packaging as a

Class II medical device

Chemical indicators (CIs)

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

Which type of packaging materials have an expiration date?

Disposable

Why is dry steam not an effective sterilant?

Due to the lack of moisture, it will often char or burn items in the sterilizer

T/F: the inclusion of disposable (single use) items such as needles, scalpel blades, and suture, in trays is common

False: uncommon, used to be common

T/F: the term "single instrument" is used to describe instruments that are to be packaged alone

False; also can refer to like instruments packaged together (ex: 6 kelly clamps)

T/F: Towels should be laundered when obtained from the towel manufacturer

False; check IFU because it may only allow for single use

What does FAN stand for when creating an instrument pack?

Functional, Accurate, and Neat

What is the advantage of sequential wrap? Disadvantage?

It affords a "second chance " for sterile presentation. But also requires more time for wrapping and unwrapping.

Why shouldn't latex tubing be used to protect instrument tips?

It may prevent the sterilant from making direct contact with the isntruments

Why is moisture harmful for Hydrogen peroxide and ozone cycles?

It will cause the cycle to abort

Why is moisture harmful for Ethylene oxide cycles?

It will form ethylene glycol, which is harmful to staff and patients

Sterility (event-related)

Items are considered sterile unless the integrity of the packaging is compromised or suspected of being compromised.

________________ are generally smooth surfaced, and they are available in sizes to accommodate many medical devices, and porous or soft-good items

Kraft-type papers / medical grade(crepe paper)

Sometimes, instruments may become _____________. This is a source of frustration for the surgeon especially with needle holders

Magnetized

_______________ is a concern when preparing basins for sterilization

Moisture

4 common names for fabrics made of 100% unbleached, loosely woven cotton fibers

Muslin, Type 140 cotton, calico, and barrier cloth

What should be done if holes, punctures or worn spots are discovered on a linen wrap?

Must be repaired using a heat sealed patch designed to cover the hole

Process challenge device (PCD)

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

Super heat

Occurs when dry steam becomes too hot compared to saturated steam. Dry steam rises temperature higher than the boiling point of saturated steam.

Sterility (time-related)

Package is considered sterile until a specific expiration date is reached.

What type of packaging is most common for small instruments and lightweight items?

Paper/plastic and spunbond polyolefin-plastic combinations (called peel packs or peel pouches)

Trays for smaller groups of instruments used for smaller procedures in areas outside of the OR, such as suturing, wound irrigation or cutdowns are often called:

Procedure trays or floor trays

What can be applied to packages after sterilization to protect the package from dust, moisture, or other contaminants?

Protective plastic overwraps (called dust covers or sterility maintenance covers)

What is the advantage for simultaneous wrap? Disadvantage?

Reduced labor costs and increased output int he CS and OR. But the absence of the second layer removes the "second chance" aspect.

SMS

Spunbond-meltblown-spuinbound; a popular flat wrap that is exposed to high heat and are pressure-bonded together to form sheets. Must never be reused.

Why shouldn't gauze sponges be used as additional packaging (wicking) in trays or packs?

Surgery staff may count gauze sponges during procedures, and if their counts must be exact.

T/F: If approved single-use items are sterilized in the healthcare facility, they must not be resterilized if they are returning unused

True

T/F: Muslin wrappers are generally made of two ply fabric fastened together as one wrap

True

When does super heat occur?

When dehydrated linen is processed in a steam sanitizer.

When multiple basins are sterilized together, ________________, such as a surgical towel can be used to facilitate drying

Wicking material

2 basic types of reusable packaging material

Woven fabric and rigid containers

Packaging choices for ethylene oxide (EtO) sterilization must allow:

adequate penetration of the gas sterilant and removal of the residual gas (aeration)

Wicking material

an approved absorbent material that allows for air removal, steam penetration and facilitates drying

Packaging choices for ozone sterilization should:

be cellulose free, such as spunbond-meltblown-spunbond and spunbond polyolefin

Rigid container systems

box like structures with sealable and removable lids that hold devices during sterilization and also protect devices from contamination during storage and transport.

Muslin

broad term describing wide variety of plain-weave cotton or cotton/polyester fabrics having approx. 140 threads per square inch

Sterilizing at point of use, abbreviated cleaning may be used due to need for instruments

false

How can Kraft-type papers be sterilized?

in steam and EtO sterilzation

Why is moisture harmful for steam cycles?

it will change the wet/dry steam ratio

Towels should be ________________ after sterilization to rehydrate the fibers prior to sterilization

laundered

Why is it uncommon now to place gauze sponges and surgical towels in procedure trays?

lint from those items can be transferred to a patient wound, causing complications such as blood clots or infection

When multiple basins are sterilized, there should be at least a _____ inch size difference in basins that will be placed together to allow for condensate drainage and drying.

one inch

Some plastics including formulations of spun-bonded polyolefin are solely in these sterilizers:

ozone and hydrogen peroxide

The standards for manufacturing today's packaging materials have been based on:

penetration and microbial barrier capability measurements for a minimum of 140 thread count muslin.

What is another name for the assembly area?

preparation and packaging area

Class 5 integrating indicators are designed to:

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

The best way to transport items that have been processed using immediate use steam sterilization at the point of use is

rigid container designed for IUSS

What are some ways sharps can be protected?

special holders, tip guards, silicone mats, holding brackets, posts or foam sleeves

Rigid containers have lids and filters that allow:

sterilant penetration while providing a microbial barrier

Prepackaged sterile towels purchased from an outside vendor or processed in house should not be opened and used on trays because they may ________________ with the sterilization cycle

super heat

Sterile packaging is designed with _________________, so users can tell if the package has been opened

tamper-evident seals

Both AORN and the Joint Commission recommend that:

the use IUSS must be minimized or decreased

When transporting items that have been immediate use steam sterilized, it is required that:

they are transported in a manner to reduce potential of contamination

Packaging choices for hydrogen peroxide sterilization must:

tolerate a deep vacuum draw without absorbing the sterilant, interrupting the cycle or damaging the contents. Must also be cellulose free.

If basin sets are too dense, the excess amount of metal may cause condensation, thereby creating a ____________________

wet pack