IAHCSMM CCSVP Vendor Education Program

Module Three

Assembly and Packaging Introduction:

• Once items have been decontaminated and made safe to handle, they are assembled and packaged. While this may sound simple, it is a multi-step process that requires several technical skills.

• This module is designed to provide you with an overview of the inspection, assembly and packaging processes. Objectives: • Upon completion of this module, you will be able to: – List the steps in instrument inspection and assembly

– Explain the impact that positioning and placement of instruments has on sterilization processes

– Identify common packaging methods

– List factors that can impact assembly and packaging outcomes

Instructions

• Read Chapters 10, 11 and 12, in the IAHCSMM Central Service Technical Manual, Eighth Edition, 2016.

• Review this module.

• Complete the online quiz for Module Three . Central Service Technicians…

…are responsible for the quality of instruments. Instrument Manufacturing

• Forging • Note: Instruments are • Grinding and Milling inspected throughout • Assembly their manufacturing process. • Heat Tempering

• Polishing • Passivation • Final Inspection • Etching

Passivation

A chemical process applied during instrument manufacture that provides a corrosion-resistant finish by forming a thin transparent oxide film. Reminder:

• Be sure to watch the Instrument Manufacturing Process Video from “How It’s Made” that accompanies this unit. Post-operative Care of Surgical Instruments

• Keep instruments moist. Do not allow blood to dry on instruments.

• Transport to Central Service for cleaning as soon as possible. Solutions that Damage Surgical Instruments • Saline • Laundry Detergents • Betadine • Long-term Soaking in Rust • Peroxide Remover • Dish Soaps • Long-term Soaking in Stain • Soaking in Water Remover • • Soaking in Saline Surgeon’s Hand Scrubs • • Bleach Household Lubricants • • Iodine Household Powder Cleaners • Hand Soaps Inspection and Assembly Tips Instrument Assembly • Inspect for cleanliness

• Test for function

• Verify that all components are available on multi-part instruments

• Check the device’s manufacturer’s IFU for specific instructions

Tray Assembly Tips

• Select an instrument tray that allows adequate space for weight distribution.

• Place heavy instruments on the bottom or side of the tray.

• Place all curved instruments in the same direction.

• Nest tissue and dressing forceps.

• Protect delicate instruments.

• Use instrument stringers (holders) to keep instruments open and in place.

• Avoid metal to metal contact between laser finish instruments. Assemble instruments in a manner that will facilitate the sterilization method chosen Complex Surgical Instruments Powered Surgical Instruments (PSI’s) What We See and Don’t See Powered Surgical Instruments

Look Simple – Are Complex

Look Durable – Are Delicate

Look Plain – Are Expensive

Look Easy to Clean – Are Difficult to Clean Electrically Powered Instruments

• Cable attached to a motorized hand piece. Electrically Powered Instruments

• Require a cable that can be sterilized. One end attached to the instrument handpiece and the other to a motor or adapter that is connected to an electrical outlet. Pneumatic Powered Instruments

• Powered by Compressed Gas. Pneumatic Powered Instruments

• Powered by compressed gas. They require a hose that can be sterilized. One end attaches to the instrument handpiece and the other to a stand alone cylinder tank or a wall or column-mounted regulator panel. Battery Powered Instruments

• Least cumbersome because there is no cord or cable. Requires batteries and a battery charger. Example of a Battery Powered PSI and Two Styles of Batteries PSI Processing Concerns

• PSIs are complex instruments that are difficult to clean and easy to damage.

• Central Service Technicians should follow manufacturer’s processing instructions carefully. PSI Cleaning

• PSI’s must be processed manually.

• Care MUST be taken to prevent Fluid Invasion. Fluid Invasion

• Occurs when water or cleaning solution is allowed to enter PSIs.

• Fluid invasion can severely damage a PSI. Decontamination batteries and cords can protect PSIs from fluid invasion PSI Processing Concerns

• Do not immerse PSIs

• Inspect cords and air hoses for signs of wear or damage Check Moving Parts of PSIs Attachments are complex instruments too! PSI Accessories • Chucks • Keys • Burr Guards • Cords • Batteries • …and many other accessories

Common PSIs • Dermatomes/Dermabraiders – used to harvest skin grafts or reshape skin surfaces • Cebatomes – used to remove cement • Sternal Saws – used to split the sternum for open heart surgery • Dental Drills – used for teeth and jawbones • Micro Drills – used for middle ear bones and to drive very small wires • Wire Drivers, Drills and Saws – come in various sizes and are used to work on small to large bones. • Saws - designed to perform specific cutting actions such as reciprocating or oscillating Basic PSI Processing Procedure (You MUST Follow Manufacturer’s Specific Instructions)

• Remove all bits, burrs and blades from the unit, disconnect from the power source.

• Disassemble and remove debris at point of use, keep the instrument moist, but DO NOT immerse.

• Separate devices with internal mechanisms from simple devices. Generally, simple components can be soaked - always check the IFU.

• Attach hand piece to a hose or specialized cleaning attachment to reduce the risk of fluid invasion during cleaning.

• Clean the exterior with an approved germicidal detergent.

• Pay special attention to recessed areas, moving levers, switches etc.

• Clean recessions and cannulas using an appropriate brush.

Basic PSI Processing Procedure (You MUST Follow Manufacturer’s Specific Instructions)

• Clean, rinse and inspect the hose, cable or battery pack. Look for signs of damage or excessive wear.

• Lubricate and test as required by the manufacturer.

• Dry all components.

• Package and sterilize as recommended by the manufacturer.

Endoscopy Instruments

• Endoscopes greatly reduce patient trauma when physicians perform minimally invasive surgery. Endoscopeman* *with permission from Lighthouse Imaging Corporation Rigid Endoscopes

• Provide an optical view and in some cases minimal access through a rigid instrument. The scope is inserted through a sheath, inserted via a small incision.

Flexible Fiberoptic Endoscope

• Provides optical access using a flexible, maneuverable scope most commonly inserted through a mucous membrane opening. Infection Control Concerns

• Flexible endoscopes pose significant infection control challenges. Their configuration makes them difficult to clean and dry and they can harbor bacteria. Automatic Endoscope Reprocessors (AER)

Automated equipment designed to disinfect and rinse flexible endoscopes.

NOTE: Some AERs have a cleaning function. Check manufacturer’s IFU. A Closer Look at Endoscopes

• Although they look similar, endoscopes vary greatly in configuration.

• Some scopes are only used to visualize and do not have channels, while others have internal channels. Endoscope Channels

Optical Instrument Channel Channel

Air/Water Suction Channel* Channel

*Some Flexible Scopes have separate Air and Water Channels Distal Tip Video Monitor Flexible Fiberoptic Endoscope

Water Bottle Light Source

Suction Canister Rigid and Semi-Rigid Endoscopes An Important Note:

• The term “Rigid” is misleading! Rigid Endoscopes are VERY DELICATE and can be easily damaged. Laparoscopic Instruments Minimally Invasive Instrumentation

Inspect Insulation for Damage or Wear Insulation Testers are Available Loaner Instruments Contaminated • ALL loaner instruments should be considered contaminated and must be decontaminated before use. Loaner Trays:

• Must be documented upon receipt • Must arrive with current IFU • Must arrive with a tray listing • Must be decontaminated before use • Must be packaged and sterilized according to the IFU • Must be documented when they are removed from the facility

As technology advances, both instruments and the Central Service technician’s job become more complex. Sterile Packaging and Storage Packaging

• Like food packaging, sterile packaging must: – Protect contents from contamination – Provide a tamper- evident seal – Be appropriate for the type of item being packaged Objectives of the Sterile Packaging Process

Packaging Systems must:

• Allow penetration of the sterilant and be compatible with any other requirements of the process (such as drying)

• Maintain the sterility of the package contents until it is opened

• Create a package that can be opened aseptically Sterilization Packaging

• Is classified by the FDA as a Class II Medical Device.

• The consequences of a non-sterile item being used during surgery can be life-threatening. Selecting a Packaging Material

• Different types of packaging are needed for different types of sterilization.

• Styles of packaging may vary based on package contents.

• Only packaging materials approved as sterilization packaging by the FDA should be used for the sterilization of medical devices.

Reusable Sterilization Packaging Materials

Woven Textiles Rigid Sterilization Containers Woven Textiles

• Muslin – Broad term describing a wide variety of plain-weave cotton or cotton/polyester fabrics having approximately 140 threads per square inch. Other Woven Textiles

• Duck Cloth • Twills • Barrier Cloth • Treated Barrier Fabrics

• NOTE: Canvas should not be used as a sterile packaging material. Textile Packaging

• Must be inspected for holes between uses using a light table

• Holes must be patched using heat-sealed patches

• Textile packaging requires more labor than disposable packaging Rigid Container Systems

• Box-like structures that consist of an inner basket (to hold instruments) and an outer structure that acts as a bacterial barrier.

• Rigid containers allow sterilant penetration through disposable filters, ceramic filters, or valves. Rigid Container Advantages

• Provide an excellent barrier

• Easy to use

• Eliminate torn wrappers

• Protect instruments from damage Rigid Container Disadvantages • Ergonomic concerns due to container weight

• Additional cycle time may be needed for drying

• Plastic containers may need even more drying time

• Additional storage space required

• Additional labor may be required to clean containers between uses

• Latching mechanisms may become damaged

• Filter retention plates may become dislodged Example of a Rigid Sterilization Container

Locking Mechanism

Container Lid Filter Retention Plate

Disposable Filter Gasket

Container Bottom Tray Label

Security Lock Carrying Handle Locking Mechanism Examples of Disposable Rigid Sterilization Container Filters Cleaning of Rigid Containers

• Rigid Containers should be cleaned between uses.

• Remove disposable components.

• Disassemble.

• Clean according to manufacturer’s recommendations. Rigid Container Inspection

• Inspect all components Gasket according to manufacturer’s guidelines each time the container is assembled. Disposable Sterilization Packaging Materials

Pouches Nonwoven Wrap Disposable Packaging Materials

• Before Use: – Inspect for tears, holes, or damage that may have occurred during transport and handling. Kraft-type Papers

• Medical-grade paper approved for use as sterilization packaging.

• Used for small items. Non-woven Packaging Material

• Available in a wide variety of sizes and weights.

• Used for various items from small single item packs, to entire instrument trays. Paper/Plastic Combinations

• Generally used for steam and ethylene oxide sterilization.

• The plastic side allows the contents of the pack to be seen.

• The paper side allows sterilant penetration. Spunbond Polyolefin-Plastic Combinations

• Allows visibility of pack contents and penetration of sterilant.

• Contains no cellulosic materials and is therefore compatible with gas plasma sterilization processes. Methods of Package Closure Package Closure

• Must secure contents.

• Must be tamper-evident to prevent resealing the package. Tamper Evident Seals for Rigid Sterilization Containers Self-Seal and Heat-Seal Closures for Pouches Heat-Seal Caution

• Be sure to avoid creases or gaps in edges when heat- sealing pouches.

• Those openings can allow bacteria to enter the package. Tape Seals on Wrapped Packs Preparation of Pack Contents Preparation of Pack Contents

• Before packaging, inspect contents for cleanliness and function

• Apply lubrication or test as required by the instrument manufacturer

• Protect instruments from damage

• Assemble a pack that is neat, complete and will facilitate the sterilization process Protectors can protect packaging from the sharp points of some instruments. Use devices designed to protect instruments and hold them in position for sterilization. Reusable holders can help keep ring- handled instruments open. Basic Packaging Procedures

• Information needed for general packaging procedures includes: – Name of device being packaged – Steps for preparation and assembly of pack contents – Sterilization method to be used – Type and size of packaging to be used – Correct placement method for items within the package – Type and placement requirements for internal chemical process indicators Peel Pouches

• Used for lightweight items.

• Label only on the plastic side of the pouch using an approved felt tip marker.

• Package items so the handle of the item to be grasped first is presented first when the package is opened.

• Place pouches on edge for sterilization.

Excess Stress on the Sides of Peel-Pouches will Compromise the Integrity of the Pouch. Double-Pouching

• Use appropriately sized pouches. Never fold the inner pouch.

• Nest paper to paper and plastic to plastic for steam penetration. Flat Wrapping Techniques

• Sequential – Applying 2 wraps in sequence (one after the other). Creates a package within a package.

• Simultaneous – The package is wrapped once in double thickness wrap. Flat Wrapping Techniques

• Square-Fold – used for larger packs and trays, it is also called in-line or parallel fold.

• Envelope Fold – Most commonly used for small packs, most instrument sets and individual items.

Flat Wrapping

• Diagrams of flat wrapping methods and techniques can be found on pages 271 - 282 of the text. Package Labeling

• Should contain: – Description of Package Contents – Initials of Package Assembler – Lot Control Numbers – Identification of Sterilizer and Cycle to be used – Date of Sterilization – Requesting Department or Physician – Assigned Storage Location Terminology and Abbreviations

• Slang and Nicknames should not be used.

• Item information should be standardized.

• Handwriting must be neat and legible. Sterility Maintenance Sterility (Time-Related)

• A package is considered sterile until a specific expiration date is reached. Time-Related Sterility (Expiration Dating)

• Uses a calendar theory.

• Must be used in conjunction with an event- related philosophy.

• Relies on Product Rotation. Sterility (Event-Related)

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

• Concerns include: – Moisture contamination – Dirt, dust and debris – Physical damage – Breakdown of packaging material due to wear or age Time-Related Concepts must be used with Event-Related Concepts An example:

• Milk has a shelf-life.

• Events, such as failure to refrigerate the milk container, can impact shelf-life and render the milk unsafe, no matter what expiration date is printed on the carton.

• Events that happen to sterile packages may cause them to become unsterile even if their expiration date has not been reached. “Contents Sterile...

…unless package is damaged or opened.” Check ALL Packages Before Dispensing

• Check External Indicators

• Check for Package Integrity

• Check Expiration Date, if one is provided on the package. Package Integrity

• Clean • Puncture-free • Dry • Undamaged • Stress-free • Wear-free Product Handling

• Clean, dry hands

• Handle gently

• Do not drop, crush, etc.

• Keep storage area clean and organized

Even the most minor break in protocol... …can cause great harm to our patient. Assembly and Packaging Quiz

To gain access to Module 4, you must first complete the Module 3 online quiz.