Chapter 13 Sterile Packaging and Storage
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FIFO
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A METHOD OF STOCK ROTATION TO ENSURE OLDER PACKAGES ARE USED FIRST (FIRST IN-FIRST OUT)
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2 HOURS
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MINIMUM AMOUNT OF TIME THAT PACKAGING MATERIALS SHOULD BE HELD AT ROOM TEMPERATURE AND AT 35% - 70% RELATIVE HUMIDITY BEFORE STERILIZATION
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SEQUENTIAL
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FLAT WRAPPING TECHNIQUE THAT APPLIES ONE WRAP ON TOP OF ANOTHER TO CREARW A PACKAGE WITHIN A PACKAGE
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FDA
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GOVERNMENT AGENCY THAT REGULATES STERILIZATION PACKAGING MATERIALS AS CLASS 2 MEDICAL DEVICE
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SPUNBOND POLYOLEFIN-PLASTIC COMBINATIONS
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THIS TYPE OF PACKAGING CONTAINS NO CELLULOSIC MATERIALS AND WOULD BE USED TO PACKAGE SMALL ITEMS FOR LOW TEMPERATURE STERILIZATION
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2 MAIN TYPES OF STERILE PACKAGING
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REUSABLE AND DISPOSABLE
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2 TYPES OF REUSABLE STERILE PACKAGES
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WOVEN TEXTILES AND RIGID CONTAINERS
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2 TYPES OF DISPOSABLE STERILE PACKAGES
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POUCHES PAPER/POLYOLEFIN PLASTIC (PEEL PACKS) AND NONWOVEN WRAP (SMS BLUE WRAPS)
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TAMPER EVIDENT SEAL
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CLOSURE METHOD FOR STERILE PACKAGING THAT ALLOWS USERS TO DETERMINE IF THE PACKAGE HAS BEEN OPENED AND THEREFORE CONTAMINATED
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BROAD TERM DESCRIBING A WIDE VARIETY OF PLAIN-WEAVE COTTON / POLYESTER FABRIC HAVING ABOUT 140 THREADS PER SQUARE INCH. THIS IS A REUSABLE PACKAGING
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MUSLIN
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SUPERHEATING
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CONDITION THAT ARISES WHEN STEAM IS AT A TEMPERATURE WHICH EXCEEDS THAT OF SATURATED STEAM AT THE SAME PRESSURE
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RIGID CONTAINER SYSTEM
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BOX LIKE STRUCTURES WITH TAMPER EVIDENT SEALING AND REMOVABLE LIDS. REUSABLE DEVICES REGULATED BY THE FDA
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510K
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CERTIFICATION APPROVED BY THE FDA RELATING TO DEVICES HAVING \"SUBSTANTIAL EQUIVALENCE\" TO ONE OR MORE LEGALLY MARKETED COMPARABLE DEVICES
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WET PACK
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CONTAINERS THAT ARE MOIST FROM INADEQUATE DRYING AFTER THE STERILIZATION PROCESS IS COMPLETE. THESE ARE CONSIDERED CONTAMINATED
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PAPERS WHICH CONTAIN CELLULOSE
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CAN'T BE USED IN GAS PLASMA STERILIZERS BECAUSE CELLULOSE ABSORBS THE STERILANT AND SWELLS AND THIS REDUCES THE ABILITY TO PENETRATE THE PACKAGING AND STERILIZE THE INSTRUMENTS
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KRAFT TYPE PAPER
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MEDICAL GRADE PAPER PACKAGING MATERIAL USED FOR NUMEROUS STERILIZATION APPLICATIONS (PAPER BAGS FOR SMALL ITEMS IN TRAYS)
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SMS (SPUNBOND-MELTBLOWN-SPUNBOUND)
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A NON-WOVEN PACKAGING MATERIAL WHICH IS THE MOST POPULAR FLAT WRAP (BLUE WRAPS)
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PAPER/PLASTIC COMBINATION PEEL PACK PACKAGING
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BLUE PEEL PACKS-PAPER AND PLASTIC SYSTEM CONTAINING CELLULOSE AND USED FOR STEAM AND ETHYLENE OXIDE STERILIZERS. NOT USED WITH DRY HEAT OR GAS PLASMA STERILIZERS
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SPUNBOND POLYOLEFIN-PLASTIC COMBINATION
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WHITE PEEL PACKS-(TYVEK POUCHES) USED FOR GAS PLASMA STERILIZATION. POLYOLEFIN DOES NOT CONTAIN CELLULOSE THEREFORE WILL NOT ABSORB THE STERILANT DURING LOW HEAT PROCESSING BUT WILL MELT DURING HIGH TEMP STEAM PROCESSING
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ALUMINUM FOIL AND BOROSILICATE (PYREX) GLASS AND SOIL METAL CONTAINERS
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ARE USED FOR DRY HEAT STERILIZATION PROCESSES ONLY
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INDICATOR TAPE
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TAPE MADE TO WITH STAND THE STERILIZATION PROCESS AND CHANGE COLOR AFTER STERILIZATION EXPOSURE
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HEAT SEALS
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ARE USED FOR PAPER/PLASTIC OR PLASTIC/PLASTIC SEALING WHEN THE 2 SIDES ARE FUSED TOGETHER
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SELF ADHESIVE SEAL
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SOME PAPER/PLASTIC AND POLYOLEFIN/ PLASTIC PACKAGING CONTAIN SEALS THAT DO NOT REQUIRE HEAT TO SEAL THEM (SELF STICK)
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CREASES AND GAPS IN PACKAGING
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ALLOWS BACTERIA TO ENTER PACKAGES
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RIGID CONTAINER SEALS
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GASKET SEALS ARE DESIGNED TO BREAK AWAY FROM THE EDGING ON THE CONTAINER WHEN OPENED
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INSTRUMENTS SHOULD BE PACKAGED HOW
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UNLOCKED, IN THE OPEN POSITION, AND SHARP TIPS COVERED SO THAT STERILANT CAN REACH ALL PARTS
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COUNT SHEETS
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LIST OF CONTENTS SO THAT WHEN ASSEMBLING TRAYS ONE DOES NOT RELY ON MEMORY AND AVOID ERRORS
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COUNT SHEET INFORMATION INCLUDES
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WHAT KIND AND NUMBER OF INSTRUMENTS, VENDOR NAME AND CATALOGUE NUMBERS, NAME OF THE ASSEMBLER, NAME OF TRAY, (MANNER IN WHICH IT SHOULD BE PACKAGED AND STERILIZED)
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TRAY LINERS
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ARE USED TO ABSORB MOISTURE, PROVIDE CUSHIONING
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PEEL PACKS CAN NOT BE USED
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INSIDE INSTRUMENT TRAYS
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GAUZE SQUARES SHOULD NEVER BE USED AS PACKAGING MATERIAL
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SURGICAL STAFF MUST COUNT THESE SPONGES DURING PROCEDURES AND THEIR COUNT MUST BE EXACT
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SOLID BOTTOM CONTAINERS
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SHOULD BE STERILIZED ON EDGE TO ALLOW WATER DRAINAGE
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ANSI AND AAMI STANDARDS STATES THAT WRAPPED PACKAGES SHOULD NOT EXCEED WHAT WEIGHT
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7 POUNDS
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POWER SURGICAL INSTRUMENTS SHOULD BE PACKAGED
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WITH TRIGGERS IN A SAFETY POSITION AND POWER SWITCHES TURNED OFF
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TRAPPED AIR IN PEEL PACKS
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ACTS AS A BARRIER TO HEAT AND MOISTURE SO MOST AIR SHOULD BE REMOVED WHEN PACKAGING
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PEEL PACKS EXPAND AND CONTRACT DURING STERILIZATION
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LEAVE ABOUT 1 INCH OF SPACE BETWEEN THE ITEM AND THE SEALED EDGES OF THE PEEL PACK
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WRITING AND LABELS ON PEEL PACKS
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SHOULD ONLY BE ON THE PLASTIC SIDE
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DOUBLE PEEL PACKS FOR ASEPTIC PRESENTATION
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NEVER FOLD THE INTERIOR POUCH, IT CAN INTERFERE WITH AIR REMOVAL AND STERILANT PENETRATION
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POSITION PAPER/PLASTIC POUCHES FOR STERILIZATION
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ON THEIR EDGE, LOOSELY SPACED, PAPER TO PLASTIC SIDES
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SIMULTANEOUS
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PACKAGE IS ONLY WRAPPED ONCE USING 2 WRAPPERS
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SQUARE FOLD
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IN-LINE OR PARALLEL FOLD USED FOR LARGE PACKAGES AND INSTRUMENT TRAYS
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ENVELOPE FOLD
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WRAPPING USED FOR SMALL PACKAGES, MOST INSTRUMENT SETS AND INDIVIDUAL ITEMS
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WRAPPERS USED TO CREATE A STERILE FIELD
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MUST BE SUFFICIENT SIZE TO EXTEND AT LEAST 6 INCHES BELOW THE EDGE OF THE SURFACE BEING COVERED
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PAPERCLIPS
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ARE NOT AN ACCEPTABLE METHOD OF PACKAGE CLOSURE
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MAXIMUM DENSITY RECOMMENDED PER CUBIC FOOT OF A LINEN PACK
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7.2 POUNDS
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ANSI/ AAMI RECOMMENDS A MAXIMUM WEIGHT FOR RIGID CONTAINERS
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25 POUNDS
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TIME RELATED EVENTS
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THE PACKAGE IS CONSIDERED STERILE UNTIL A SPECIFIC EXPIRATION DATE
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EVENT RELATED EVENTS
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STERILIZATION OF A PACKAGE IS DETERMINED BY EVENTS SUCH AS IMPROPER HANDLING OR TRANSPORT RATHER THAN BY TIME ALONE
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BASIC CONCERNS OF STERILE PACKAGING
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MOISTURE, DIRT, DUST, DEBRIS, PHYSICAL DAMAGE TO PACKAGES
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STORAGE ROOM TEMPERATURE AND RELATIVE HUMIDITY
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POSITIVE AIR FLOW, 64-75 DEGREE F, AND LESS THAN 75% HUMIDITY
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PACKAGES SHOULD BE HOW FAR AWAY FROM THE FLOOR AND CEILING
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2 INCHES FROM EXTERIOR WALLS AND WINDOWS, 8-10 INCHES ABOVE THE FLOOR, AND 8-10 INCHES TOP OF THE PACKAGES AND THE CEILING, 18 INCHES FROM SPRINKLER HEADS
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CANVAS
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IS NOT AN ACCEPTABLE STERILIZATION PACKAGING MATERIAL
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WICKING MATERIALS ARE USED TO
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ALLOW AIR REMOVAL, STEAM PENETRATION AND FACILITATE DRYING
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CELLULOSE MATERIALS CANNOT BE PROCESSED IN
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A GAS PLASMA OR STERAD STERILIZER BECAUSE CELLULOSE IS A WET SUBSTANCE
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REUSABLE TEXTILE PACKAGING REQUIRES MORE LABOR THAN
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DISPOSABLE PACKAGING
