Ch. 7 – Preparation & Packaging of Instruments & Devices
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Prep & Pack
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A clean area where surgical instruments and other medical devices are inspected, tested, assembled, and packaged for sterilization
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Environmental Conditions
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-Air Exchange rate of at least 10 per hour under positive pressure -Temperature should be between 68-73F (20-23C) -Ideal humidity is 50%, should not be less than 35% -Temp and humidity should be documented daily
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Principles of Packaging
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-Main purpose is to allow proper sterilant penetration and removal and to maintain the sterility of an item until it is intentionally opened or used
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Woven Textiles
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-Made of either 100% cotton or cotton blend, and reusable -Laundered and delinted between uses -Two-ply wrapping must be used
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Nonwoven Materials
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-Made of cellulose fibers, plastic polymers, and/or paper pulp that are bonded together to form a sheet -Nonwoven wrappers are single use only -Prone to damage
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Wrapping Methods
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-If wrapper will be used as a sterile field in the OR, it must extend at least 6 inches over each side of the table it will cover -Square fold is used for laparotomy linen pack -Envelope fold is used for smaller packs and trays -CI tape is used to secure wrapped packages -Pins, staples, paper clips should never be used, because they can damage the material and cause contamination
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Paper-Plastic Pouches
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-Used to package lightweight, single items -Paper on one side, plastic film on the other -Various materials are medical-grade kraft paper, polyethelene, and tyvek -Must be large enough to allow at least one inch of space between the item and the edges of the package -Seals should be intact with no channels, open areas, wrinkles, or creases
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Packaging - Steam
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Textile, non-wovens, polyolefin wraps, paper-plastic pouches and rolls, rigid sterilization containers
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Packaging - Ethylene Oxide
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Textiles, non-wovens, polyolefin wraps, paper-plastic pouches and rolls, Tyvek (all-plastic) pouches, polyethylene, most rigid sterilization containers
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Packaging - Low-Temperature Gas Plasma
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Polyolefin wraps, Tyvek (all-plastic) pouches, certain rigid sterilization containers
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Packaging - Dry Heat
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Metal and glass containers, aluminium foil, glassine envelopes
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Packaging - Ozone
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Nonwoven cellulose wrap (paper) and certain containers
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Packaging - Low-Temperature Hydrogen Peroxide
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Polylefin wraps and Tyvek (all-plastic) pouches that have been validated for use with LTHP
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Heat Sealing
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Parameters are temperature, pressure and dwell time
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Rigid Sterilization Containers
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-Sterilization containment devices designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents -Most have perforations in the top and/or bottom to permit air removal and sterilant penetration. Perforations are protected from outside contamination by filters or valves -Regulated by FDA, Class II medical device
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Sterilization Maintenance Covers
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-Dust covers can be placed over a wrapped sterilized package to provide extra protection -Package should be handled as little as possible before the dust cover is applied
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Labeling Packages
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-Label should include name of the item, destination/department, initials of the preparer -Packages should be labeled on the indicator tape used to close the package, never on the wrapping material itself -Only non-toxic markers should be used
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Inspection of Instruments
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Inspection includes; cleanliness, functionality, and completeness (should not be missing screws, attachments, or other parts)
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Floor Trays
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-Allows physician to perform a procedure (cut-down) on a nursing unit. -Should be prepared using a recipe card that identifies the contents
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Chemical Indicators
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-Class 4 indicators should be placed inside EVERY package to be sterilized -Wrapped sets; CI should be placed in center of the set -Rigid sterilization; should be placed where IFU recommends -Multi-level sets; a CI should be on every level
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Textile Packs
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-Criteria: 12x12x20, no more than 12 lbs -Class 4 or higher CI should be placed in the middle of the pack
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300 Series
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-Austenitic -Basins, bowls, malleable retractors -Corrosion resistant
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400 Series
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-Martensitic -Scissors, forceps, osteotomes, chisels -Prone to corrosion
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Titanium
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-Strong, non-magnetic metal -Blue color -Generally found in cardiovascular and ophthalmology sets
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Classification of Surgical Instruments
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-Hand-held -Micro-surgical -Powered -Endoscopic -Laparoscopic (including robotic instruments)
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Hand-Held Instruments
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-Hemostats - Used to clamp arteries or to dissect tissue -Scissors - Used to cut and dissect tissue, dressings, and sutures -Needle Holders - Used to hold suture needles -Forceps - Used to manipulate and grasp tissue, sponges, and dressings -Retractors - Used to hold back tissue and organs -Laparoscopic Instruments - Used in minimally invasive surgery -Miscellaneous - Knife handles, towel clamps, sponge sticks
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Hand-Held Instruments (Structure)
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-Jaws - Part that comes into contact w/the patient -Box Lock - Weakest part of the instrument, most difficult to clean -Shanks - Provide the closing force -Ratchet - Holds the instrument closed, difficult to clean -Finger Rings - Used to grasp the instrument & control the action of the jaw
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Surgical Grade
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-Highest quality -Reusable -US & Germany makes highest quality
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Floor Grade
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-Reusable -Made from a lower grade of stainless steel -Usually have a mirror or shiny finish
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Disposable
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-Single use -Should never be reprocessed
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Passivation
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-Final stage in manufacturing surgical grade instruments -Chemical dip (nitric acid) removes all debris & creates a layer of chromium oxide -Chromium oxide makes the instrument more resistant to corrosion, rust & stains -Steam sterilization and water-soluble lubricant reinforces protective coating
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Tungsten Carbide
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-Gold finger rings -Strong metal that keeps scissors sharper longer -Tungsten carbide inserts can be replaced
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Supersharps
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-Black finger rings -Very sharp, one edge may be serrated
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Electrolysis
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-Occurs when dissimilar metals are exposed to a solution at the same time
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Trocar
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Used to create an opening into the patient to permit passage of the scope, which provides light inside the body cavity
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Endoscopes
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Rigid, flexible & semi-rigid
