Preparation and Packaging 8.1

chapter 8 in the basic of sterile processing 8th edition

the preparation and packaging area is in the location where SPD personnel?

inspect, test, assemble, and package surgical instruments and other medical devices for sterilization

the area used for prep and pack of instruments and devices should be physically

separated from decontamination

the prep and pack area should include space for

the supplies used to prepare trays and sets, hand washing facilities, and space for donning and doffing visitors cover attire.

personnel should perform hand hygiene or wear

clean gloves before handling instrumentation or devices for sterilization. or changing activites.

the air flow should be of a

down-draft type

materials such as Terry cloth towels or sterilization wrappers should not be used to

line workstations

back-up instruments should be stored in

closed cabinets or drawers

traffic in the preparation and packaging area is

restricted and must be kept to a minimum

facility designated personnel must ensure the environmental conditions

ventilation, temperature, air pressure, number of air exchanges

what must personnel do when changing activites, and before handling instrumentation?

hand hygiene or hand washing

what is the main purpose of sterile packaging?

to allow the sterilant to penetrate and be removed during sterilization and to maintain a device’s sterility until it is intentionally opened or used

the generic term packaging is also referred to as?

sterile barrier system (wrappers, paper plastic pouches, rigid containers)

not all packaging systems are

suitable for all types of sterilization methods

any packaging material used in the facility must be cleared by

FDA

packaging material should be able to withstand strong

physical forces, such as rapid moisture, vacuum, temp changes, etc.

packaging material should allow air removal because it is essential to the

sterilization process

packaging material should allow easy removal of the sterilant to

minimize residuals on sterile items

packaging should repel fluids, because moisture will

contaminate sterile items, by allowing liquid to flow into narrow spaces

it should not be possible to open a sterile barrier and then

reseal it without evidence

packaging material should be adaptable and neither

too large not too small

packaging should protect the instruments from

physical damage during handling and transport

two types of packaging materials

woven textiles and nonwoven materials

woven textiles are?

100% cotton, or cotton blend, and reusable

woven wrappers must be ? between each use?

laundered and inspected, delinted

what is the shelf life of most woven wrappers?

30 days

what are nonwoven materials

made of cellulose fibers, plastic polymers, and or paper pulp.

how many times can you use a nonwoven wrapper?

single use only

one type of nonwoven wrapper is known as?

two-ply or dual-ply wrap

two ply or dual ply wrap consist of

two wrappers bonded together at the edges

what is sequential wrapping technique?

wrapping with one wrapper then with a second wrapper, creating a package within a package

non sequential wrapping technique is?

two single-ply wrappers wrapped at the same time even if they are not bonded together

nonwoven materials are prone to damage from?

incorrect handling, the set is heavy, or when stacked

green standards

using products, methods, and processes that protect the environment

too large wrapping creates

too many layers of material, which can inhibit sterilant penetration and condensate removal

too small of wrapping will

not enclose the item entirely and can cause contamination

the envelope fold is used for

small packs and trays

the square fold is used for

large packs such as orthopedic and open-heart instrument sets and can often be used to create a sterile field

items should be wrapped in a manner to prevent

gapping, billowing, or formation of air pockets

“first in, first out” method

earliest expiration dates at the front and the newer items to the back

SPD personnel should only use tape that is

validated for the intended sterilization method and for tray wrapping

during sterilization cycle the package expands and contracts, any closure that restricts this action will

interfere with air removal, steam penetration, and steam removal

peel pouches are used to package

small light-weight items and not intended for heavy items

peel packs are frequently used as packaging because

they offer visibility of the sterile device

the pouch must be large enough to allow at least

one inch of space

what are self-sealing pouches

pouches have an adhesive strip above a fold or perforation where the top is folded over and sealed

the final seal should be flat and intact with no

gaps, channels, open areas, wrinkles, or creases

heat sealed pouches are

pouches that require heat sealing, and lacks the adhesive strip and fold perforation

what are gusseted pouches?

a specific type of pouch in which the plastic portion of the pouch had been pleated on both sides to allow the pouch to expand and accommodate bulkier items

bar type heat sealers have?

a bar that lift manually to provide the seal

double pouching

to place one pouch inside another pouch

rigid sterilization containers

sterilization containment devices “designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents”

in general containers equipped with paper filters are compatible with

steam and EO sterilization cycles

specialized polypropylene filters are available for containers validated for use in

low temp sterilization methods

dynamic air removal steam sterilization cycles generally only require filters on

top of the container

containers used in gravity-displacement steam sterilization cycles or in EO require filters on

both top and bottom of the container

the gasket inside of the container lid must be checked for

nicks, gouges, cracks, missing pieces and shrinkage

when checking gaskets, inspect ? also

filters

improperly maintained valves, worn gaskets, dents, or other damage could compromise both?

integrity of the container and the ability of the container to maintain sterility

an external CI is required on

all sterilized packages