Module 8 Preparation, Packaging, and Instrumentation

Chemical indicators

*A Class 4 or higher CI should be placed inside every package to be sterilized. *For wrapped sets (including organized trays), the CI should be placed in the center of the set or pack, where sterilant penetration is the most difficult to achieve. For a rigid sterilization container system, the container manufacturer should be consulted for the recommended locations for chemical indicators. If the container manufacturer does not provide recommendations, the following instructions should be adhered to: *Two CI's should be placed in opposite corners of the inside basket. *For multi-level set, a CI should be placed on each level. *Whenever instruments are separated inside a set (e.g., placed in an organizing basket, autoclaveable bag, or surgical towel), a CI should be placed inside the immediate container.

Labeling packages

*All packages must be labeled completely and correctly *Label should include; -the name of the item, -its destination, and -the initials of the preparer *Written on autoclave tape only with non-toxic permanent ink, never on wrapping material *Tape used to seal package must be labeled before sterilization *Peel pouches should be labeled on plastic side or on autoclave tape

Basin Set

*Basin sets are prepared with non-linting absorbent material between basins and all other contents (e.g., emesis basins, paint cups) to help steam pass between the items (Figure 7-53); this is referred to as "wicking." *All basins in a set should face the same direction (upward). *A CI should be placed in the middle of the basin set. For a double basin set (two large basins with components), an additional CI should be placed in the bottom basin to help verify that steam reached this surface during the sterilization process. The diameters of the two basins should differ by at least 1 inch (2.5 cm). *If the two basins have the same diameter, several clean, non-linting, folded surgical towels should be placed inside the bottom basin to elevate the top basin. Wrapped basin sets SHOULD NOT WEIGH MORE THAN 7 POUNDS (3.2 kg)

Instrument Loss

*Instrument loss is a major financial burden for a healthcare facility. Every department using surgical instruments is responsible for accounting for instruments at the end of a procedure. There should be a process to ensure that each using department is accountable and can document that all instruments were returned to SPD. *It is the responsibility of each using department to ensure that instruments are not damaged or lost. Instrument sets should be kept together at the end of the case/procedure and placed back into their respective containers or baskets. Four major factors are associated with missing instrument problems: *Poor or lacking communication between the OR and SPD *Personnel considerations (are SPD personnel trained in the identification, care, handling, inspection, and testing of surgical instruments?) *Operations (e.g., the use of correct and accurate count sheets; traceability to the preparer of the set) *Administrative issues (support for SPD for needed processing equipment and staffing)

Changes in packaging system

*It is essential to obtain and follow the packaging material manufacturer's IFU before implementing any packaging system, whether woven wrappers, nonwoven wrappers, paper-plastic pouches, TYVEK pouches, or rigid sterilization container systems *Not all packaging systems are alike. Some have been validated for use with; -gravity-displacement steam sterilization cycles, -some for low-temperature gas plasma cycles , and -some for other sterilization technologies *It is important to obtain and interpret the manufacturer's instructions to ensure that the packaging system is compatible with the sterilization methods being used *When major changes are made in packaging systems or materials product testing should be performed

Separation of Instruments Inside Sets

*Items that need to be separated in sets should be placed in absorbent, non-packaging material such as lint-free surgical towels or autoclavable bags or 100% medical-grade paper envelopes or bags (not paper-plastic pouches) *Paper-plastic (peel) pouches should not be placed inside an instrument tray/set, whether the tray/set is wrapped or in a rigid container. To ensure adequate contact with the sterilant, they must always stand on edge, paper to plastic.

Count Sheets and Tray Lists

*Markers w/ permanent, non-toxic ink should be used to write on count sheets or tray lists *Processing personnel need to verify the accuracy of the number and type of instruments placed in the set *Inaccurate counts can delay cases in the OR *Whenever items are missing the outside of the set should be labeled to alert OR PERSONNEL, who might wish to use another set or to see if a single wrapped replacement is available *Notification can be in the form of a preprinted label, or it can be provided on the autoclave tape

Sterilization maintenance cover

*Plastic covers or "DUST COVERS" are used for added protection over sterilized wrapped sets and should be at least 2 to 3 MILS thick *Designed specifically for the purpose of keeping dust, moisture, and other contaminants out of sterile packages *It is not considered a sterile cover *It can either be heat sealed or self-sealing

Textile Packs

*Textile packs should be no larger than 12 INCHES x 12 INCHES x 20 INCHES (30.5 X 30.5 X 51 cm), WEIGH NO MORE THAN 12 POUNDS (5.5 kg), and have a maximum density of 7.2 pounds (3.3 kg) per cubic foot. *Before being assembled into a pack, textiles should be inspected on a LIGHTED WORK TABLE for holes and tears. *All textiles must be de-linted. *Packs should be assembled so that the first item to be used is on top. *All textiles should be fan folded to facilitate air removal, sterilization, and aseptic presentation. *A Class 4 or higher CI should be placed in the middle of the pack *The tab of the CI should be visible so that the end user can easily remove it for inspection before using the textiles in the pack.

Preparation and packaging area Three basic principles of packaging:

1. The type of material used must allow the sterilant to reach the contents of the package 2. The material must provide a good barrier to all types of microorganisms and other contaminants (e.g., moisture) 3. The package must be able to be opened without contamination of the contents (aseptic presentation).

Types of Surgical Instruments

300 SERIES STAINLESS STEEL This type of steel is heated/hardened once (austenitic). VERY CORROSION RESISTANT. Used to manufacture: *trays *basins *bowls *malleable retractors: capable of being shaped 400 SERIES STAINLESS STEEL This type of steel is heated/hardened twice with extreme heat and can become magnetic (martensitic) More prone to corrosion. Used in such instruments as: *scissors *forceps *osteotomes *chisels Whether the stainless steel is of the 300 series or the 400 series, it is only stain resistant and will pit and corrode if improperly handled. Titanium Much STRONGER than stainless steel, LIGHT IN WEIGHT and NON-MAGNETIC metal. Recognized by its BLUE COLOR. Found in "cardiovascular" & "ophthalmology" sets.

Floor Trays

A floor tray permits the physician to perform a procedure (e.g., a cut-down) in a nursing unit. The tray contains instruments and supplies for an entire procedure, and prepared using a "RECIPE CARD" that identifies the contents. It may consist of the FF items: *skin preparation (paint cup, cotton balls, sponge stick) *local anesthesia (needles, syringes) *surgical instruments (e.g., knife handle, blade, clamps, scissors, needle holder, probe) *surgical drape and surgical towels *gauze and cotton balls

Preparation and packaging area Environmental conditions in the Preparation and Packaging Area

Air exchange = 10 per hour Temperature = 68F and 73F Pressure = Positive Humidity = 35% to 60% (Ideal = 50%) The temperature and humidity should be documented daily.

BREAST IMPLANT SIZER

Breast implant sizers are designed for temporary intraoperative placement to assist in evaluating the appropriate breast implant shape and size for each patient. The sizers are not intended to be implanted. The gel sizers are generally provided sterile for the first use, but must be resterilized before each subsequent use. One manufacturer states that the gel sizers can be resterilized up to 10 times after the first use for a total of 11 uses, after which the device should be discarded.

Package closures

Closures used to secure packages should be selected to allow the steam sterilization process to occur, avoid constriction of the package and maintain package integrity. Sterilization tape is the common method of closure for wrapped packages. The tape should be specific to the sterilization process for the tray or package. Sterilization tape is available in several widths; the size used is determined by the size of the tray and facility preference.

INSPECTION OF HAND-HELD INSTRUMENTS

Each and every time an instrument is handled, it should be inspected for: *Cleanliness and proper working order *When received new in the department *Whenever they enter the decontamination area *When they are being assembled *Packaged for sterilization Before use, they should be inspected by the OR staff The best means of performing a thorough inspection is to use a lighted magnifying lamp to check for: *cleanliness *functionality *alignment *tension of ratchets *stiffness *cracks *loose screws *burrs Lighted magnifying lamp benefits: *Facilitates the detection of defects and improper cleaning *Reduces eye fatigue *Enhances visualization of the manufacturer's catalog number etched on the instrument MICROSURGICAL EYE INSTRUMENTS Should be inspected using a microscope to detect defects. Any signs of pitting, rust, chipped or missing plating or cracks in the box lock the instrument must be removed from the service and replaced. NEW INSTRUMENTS When new instruments are purchased and received, they should be inspected for damage, and it should be verified that they are the correct instruments (as ordered). Cleaning new instruments before use is important because instrument manufacturers coat the instruments with an oily material to protect the instruments during shipment and storage. This residue can be toxic to patients if not removed. New instruments that will not be used immediately should be cleaned, allowed to dry, and stored. During storage, ratchets should be kept open to avoid excessive pressure on the box lock, which can damage the instrument. Inadequate cleaning can result in the buildup of debris in the box lock, which can cause the instrument to "freeze" or stiffen. Lubrication does not solve this problem. The instrument needs to be returned to the decontamination area for thorough cleaning. Manual cleaning should be followed by thorough rinsing, ultrasonic cleaning, and another rinsing. NOTE: After new instruments are washed, they cannot be returned to the manufacturer. MEASURING GUIDELINES It is important to measure instruments to ensure that the correct instrument is placed in the set or package. The length of hinged instruments is determined by measuring from the tip of the finger rings to the end of the jaws. For retractors, several measurements are needed; the distance from the tip of the handle to the tip of the blade is measured, then the length and width of the retractor blade. For scissors, the blade length is measured from the screw point to the tip of the blades. It is helpful to keep instrument catalogs in the preparation and packaging area as a reference for verifying catalog numbers and instrument sizes and other characteristics.

Assembly of Sets

General Procedures: Instruments and sets should be assembled according to AAMI standards; *All instruments, including towel clips, should be in the open position when placed in the set or tray *Keep an instrument in an open position when packed in a paper-plastic pouch. *Delicate instruments on top and heavy on the bottom. *Instruments composed of more than one part or with sliding pieces or removable parts should be disassembled. For sterilization to occur, the sterilant must contact all surfaces of the instruments being sterilized. General Procedures *In small procedure trays, instruments can be kept open by STRINGERS or by FOLDING A TOWEL AND MAKING A POCKET OR CUFF *Basins or bowls should not be placed in instrument sets, sterilant must contact all surfaces of the instruments being sterilized WRAPPED SETS WITH LARGE NUMBERS OF INSTRUMENTS *Large sets are placed in a perforated mesh basket and PLACED FLAT in the sterilizer PREVENTING DAMAGE TO INSTRUMENTS *Non-perforated trays (or Mayo trays with small holes) MUST BE TILTED ON EDGE when placed in the sterilizer to ensure proper drainage *Non-linting surgical towel or tray liner is placed on bottom of tray or basket to help absorb moisture and prevent instruments from poking through the basket *Rectangle metal pans should not be used for instruments sets due to DIFFICULTY IN DRYING TIME *SIZE AND PLACEMENT of the instrument within the set affect sterilization and drying. *CONDENSATION can form due to many heavy or large instruments in one area making it MORE DIFFICULTY TO DRY *AAMI recommends that LOANER SETS NOT EXCEED 25 POUNDS IN WEIGHT, including the weight of the container, which will assist healthcare workers in 2 very important ways: -ERGONOMICS *personnel are able to lift the set without INJURY AND SAFER TO TRANSPORT *STERILIZATION *utilize standard cycle parameters-"drying" *Most rigid sterilization containers manufacturers have certified their containers only 16-25 pounds of instruments not including the weight of the container *Heavy individual items having a large metal mass (e.g., weighted vaginal specula) should be wrapped in an absorbent material, such as a delinted surgical towel, TO ABSORB MOISTURE and ENHANCE DRYING

Assembly of Specialty Devices

Glass Syringes: When glass syringes are being processed, the barrel should be removed and placed side by side with the syringe; the barrel and syringe should be separated with 4x4 non sterile radiopaque gauze. (If the gauze is not radiopaque, it cannot be detected if inadvertently left in the patient.) Procedure Needles: The stylette should be removed. Whether the lumen should be flushed depends on the manufacturer's instructions (see "Devices with Lumens" below). Procedure needles should be packaged so as to prevent the needle from puncturing the packaging and/or injuring personnel. Most facilities today have discontinued the use of reusable procedure needles because of the risk of puncture injuries to reprocessing personnel. Devices with Lumens: Unless recommended by the manufacturer, devices with lumens (e.g., needles and catheters) need not be flushed with water before prevacuum steam sterilization. If the manufacturer does recommend flushing of the device (which might be the case if a gravity displacement cycle is to be used), distilled or deionized water should be used and sterilization should follow immediately after packaging. (Regular tap water, which can contain pyrogens, should not be used.) Multipart Instruments: Instruments with removable parts must be disassembled before being placed in trays unless the manufacturer's instructions specify otherwise. If the instruments to remain disassembled, all of the parts must be present and should be listed on the count sheet. Complex instruments: Trays containing more than one complex instrument should be BIOLOGICALLY TESTED to ensure that proper sterilization conditions occur inside the tray Eye Instruments: *Use of sterile, deionized or distilled water for the rinsing of eye instruments prior to sterilization is highly recommended *Eye instruments are delicate and must be handled carefully *Tips of the instruments should be inspected, not be placed on top of each other in the tray, and the tips should not protrude through the basket Dental Instruments: *Categorized as critical or semi-critical devices *Should be inspected for cleanliness and functionality *Assembled into sets or trays and wrapped, packaged, or placed into a container system for sterilization Laryngoscope Handles and Blades: *Blade must be protected from recontamination after processing *Blades should be placed in a peel pack for storage only; peel packs should only be used if the blades will be sterilized *Handles are considered contaminated after use and must be processed before use on the next patient

SPECIAL CONSIDERATIONS FOR SPECIFIC TYPES OF HAND-HELD INSTRUMENTS

HEMOSTATS Box-lock is the weakest part of the instrument and the most difficult part to clean. Jaws should align correctly, with no gaps. Debris often occurs and can lead to corrosion and cause pressure on the box lock causing a fracture/crack. The function of the ratchet can be checked by closing on the first ratchet, holding the instrument by the tips, and gently tapping the handle on a table; the instrument should not open. This test need not be performed each time the hemostat is processed; it is mainly done when OR personnel complain that the hemostat does not "feel right" when handled. SCISSORS Must be checked for sharpness each time they are processed by cutting through a latex product using the upper 1/3 of the blade where scissors often dull the most quickly. Latex is used to simulate tissue. Instruments needing the most frequent sharpening include: *Scissors *Bone cutters *Osteotomes *: *Chisels *Knives *Punches LAPAROSCOPIC SCISSORS Should not be tested with latex but through a single layer of facial tissue DISSECTING SCISSORS Should never be used to cut suture, dressing or wire. Misuse can result in dullness and permanent damage. BONE CUTTERS Should be able to cut through a wood tongue depressor,. BIOPSY PUNCH Use of tissue paper will determine sharpness NEEDLE HOLDERS: *Stainless steel Jaws If they are worn-out, they are discarded *Tungsten Carbide Inserts Worn inserts can easily be repaired, removed and replaced with new insert INSPECTION: *Holding up to the light to see if jaws are worn *They must be able to hold suture material *Placing suture needle in the jaw and closing tightly while twisting and pulling (same applies to forceps) FORCEPS *Tissue Forceps Have teeth (tips that bite) *Dressing Forceps Do not have teeth (jaws only) Forceps used in surgery are considered "atraumatic" meaning they can hold tissue without damaging it RETRACTORS Used to hold an incision open so that the surgical site can be visualized. THREE BASIC TYPES *hand-held Requires an assistant. Typically used in pairs and must be identical. Can be sharp or blunt. *Self-retaining Have a self-retaining mechanism *Table retractors Usually are large, have a variety of blades, and are used primarily in major surgical procedures. Bookwalter retractor: Used for cholecystectomy, retroperitoneal resections, nephrectomy, abdominal aortic aneurysms, iliac femoral grafts, abdominal hysterectomy, appendectomy, hernia repair, and transplant procedures. -The Thompson-Farley retractor is used primarily in anterior cervical, posterior lumbar, anterior lumbar, and other spine procedures. *The Omni-Tract retractor can be used in general, gynecological, vascular, urological, and orthopedic procedures *Multi-part retractors (e.g., Balfour retractors) might have to be disassembled for cleaning and sterilization and reassembled before use; the manufacturer's IFU should always be followed. *When being inspected, retractors should be checked for cleanliness, loose or missing screws RONGUERS *Kerrison Rongeurs Tested with a 3x5 index card Used to remove bone in neurosurgery, taking small bites of bone at a time. RASP Used to smooth, cut and clean bone. Prone to entrapping bone in the serrations. Should be carefully inspected and routinely sharpened. SUCTION TUBES Used to remove blood, tissue and fluids DEMAGNETIZATION Instruments become magnetized when they are exposed to a motorized device or are used near a magnetic pad or needle counter Instruments can be demagnetized by an instrument repair service or a reusable demagnetizer Manufacturer's instructions for use should be followed

Preparation of instruments for packaging

Inspection of Instruments Preparing surgical instruments for packaging includes the following inspection: *Cleanliness *Functionality *Completeness All instrumentation should be inspected using a lighted magnifying lamp to visualize defects and limit eye fatigue. Instruments with defects also cause delays in the OR, which can have an impact on patient care. Later in this chapter, specific information will be provided on the types of inspection and testing that should be performed for various types of instruments and devices. ORGANIZATION OF INSTRUMENTS *Instruments can be packaged; 1. SINGLY -usually in paper-plastic pouches -Also known as "Peel Pouches" 2. In small procedure trays or larger instrument sets -trays and instrument sets can be either "WRAPPED" or not -When placing instruments in sets, personnel should use a count sheet or tray list, which should include the names of the instruments, their type and size, the quantity, the manufacturer, and a catalog number. These details are critical to the correct construction of an instrument set and will assist in identifying instruments for replacement, when necessary.

LUBRICATION

Instrument manufacturers recommend regular lubrication of surgical instruments to keep them in good working order. Lubricant should be water-soluble and should be recommended for use on instruments. NEVER USE oil, grease or petroleum based lubricant, because it will interfere with the sterilization process. Lubricant is referred to as "instrument milk" because most of these products are white in color. Instrument "milk" bath should be located in the preparation and packaging area, not in the decontamination area where it could be contaminated. Proper and routine lubrication can prolong the life of an instrument by providing protection from staining and pitting and by adding a repassivation coating when steam sterilized and allowed to air-dry, not wiped off.

Wrapping methods

Instruments and supplies are wrapped to keep them sterile until used. This is why proper wrapping technique is so important. If the wrapper will be used as a sterile field in the operating room, it must be large enough to extend at least 6 INCHES over each side of the table it will cover. The packaging manufacturer's IFU should always be consulted.

Marking instruments

Instruments must never be engraved. Engraving mars the metal, destroys the protective passivation layer, and starts an area where bacteria can grow as well as rust and corrosion. SPD personnel can mark instruments with instrument marking tape. Tape should be wrapped-not more than one and one half times-around an area that will not contact the patient and not interfere with the surgeon. The instrument manufacturer or instrument repair service might: *chemically etch an instrument *color-bond its handles The bonding must be checked because chipping or peeling can occur after repeated cleaning and sterilization. When the bonding needs to be replaced, the instruments must be removed from service and returned back to the manufacturer for rebonding.

LOANER INSTRUMENTS

Instruments or sets borrowed from a vendor for emergency or scheduled surgical procedures that will be returned to the vendor following use. Due to high cost of orthopedic instrument specialty sets, more and more "loaner instruments sets" are being brought into hospitals and surgery centers Sets are kept together for the same case and labeled correctly for a specific surgical procedure. Upon arrival at the facility, loaner instrument sets must be thoroughly inspected and cleaned. For new sets, the vendor should provide an in-service on all sets, focusing on items that can be problematic. Even if the instrument sets arrive already wrapped and sterilized, "Standard Precautions" must be followed. Sets must be opened, inspected, and completely reprocessed according to the manufacturer's instructions. CS/SPD personnel have no real knowledge of how the instruments were cleaned, sterilized, and transported. For sets that contain implants, a biological indicator must be run with the sterilization cycle. Facility should have a comprehensive loaner policy detailing notification of CS/SPD of the following information: *Date and time of surgery *Surgeon *Procedure to be performed *Loaner company *Names and number of trays due to arrive *How the sets will arrive (e.g., courier, express delivery) *Expected delivery date Upon arrival, loaner instruments should be logged in and inventoried to ensure that all instruments and anticipated sets are present and in good condition (i.e., there is no damage, rusting, pitting, or missing plating). Any damage and any missing instruments or implants should be documented on the sign-in sheet, and the vendor should be notified before the set is processed. A COUNT SHEET should accompany every loaner tray. During set assembly, all instruments should be inspected for cleanliness and functionality (e.g., rotating instruments function properly). Each instrument should be lifted out of the container and individually inspected. Bone chips are often hidden beneath instruments, so lifting each instrument out of the container will reveal any debris. Cannulated devices or instruments should be carefully inspected for cleanliness of the lumens. After the surgical procedures, all devices and sets should again be processed and inventoried to ensure that all items are present. The CS/SPD manager or supervisor should be notified immediately if any items are missing or damaged.

Hand-held instruments (continued) Category of uses: CLOSE OR REJOIN

Instruments used to close or rejoin a wound or an area (e.g., blood vessel, nerve, or tissue) Products used: *staples *clips *suture *suture needles *ligating clips

Hand held instruments (continued) Category of uses: SHARPS

Instruments used to cut or incise. Examples: *scissors *knives *scalpels *chisels *osteotomes

Hand-held instruments (continued) Category of uses: CANNULATE/DRAIN

Instruments used to dilate/enlarge openings or to find and area or foreign object. Examples: *probes *catheters *drains and cannulas

Hand-held instruments (continued) Category of uses: ASPIRATE, INJECT OR INFUSE

Instruments used to remove unwanted fluids or to inject needed fluids into a patient. Examples: *needles *trocars *cannulas

Endoscopic Equipment

Instruments used to view internal organs through existing opening or very small incisions. Endoscopy means looking inside and typically refers to looking inside the body for medical reasons using an endoscope. Endoscopic equipment include the following: *Rigid and flexible endoscopes *Fiberoptic light cables *Cameras *MIS instruments Specialized endoscopes are named depending on where they are intended to look. Examples include: *Cyctoscope (bladder) *Nephroscope (kidney) *Bronchoscope (bronchi) *Laryngoscope (larynx) *Otoscope (ear) *Arthroscope (joint) *Laparoscope (abdomen) *Gastrointestinal endoscopes (stomach + small intestine) Endoscopes, whether rigid or flexible, should never be placed beneath other instruments. In general, protective sleeves and special containers should be used to keep rigid endoscopes in place during sterilization and transport; however, the endoscope manufacturer's instructions for use should be consulted to verify that protective sleeves can remain on the instrument or scope during sterilization. Rigid endoscopes should be SEPARATED FROM TROCARS and other instruments that could damage the endoscope's optical lens (eyepiece). The manufacturer's instructions for inspection, testing, and sterilization should always be followed. RIGID ENDOSCOPE Rigid endoscopes include such equipment as: *Arthroscopes (joints) *Hysteroscopes (uterus) *Resectoscopes (prostate) *Laparoscopes (abdomen) *Cystoscopes (bladder) Rigid endoscopes are much easier to clean than flexible endoscopes. The optical element of a rigid endoscope is called the TELESCOPE. The most EXPENSIVE AND DELICATE PART of the instrument, the telescope provides light and images to the surgeon. Rigid endoscopes should not be bent or flexed. Note: The diameter of the telescope decreases, its fragility can increase because of fracturing or misaligned of the smaller glass rods. Rigid endoscopes After a surgical procedure has been completed and the rigid endoscope has been properly decontaminated, all areas of the endoscope must be inspected for scratches, dents, burns, and any other visible damage. The endoscope must also be checked for visual clarity. Ways to perform endoscope tests: *The first way is to hold the tip of the endoscope about 3 inches above a non-glare, printed, white surface. The tip of the endoscope is moved progressively closer until it is approximately 1/4 of an inch away from the surface. *Second way is to hold the endoscope up to the light source and look to see if the image is cloudy or distorted *A third way, is to use a rigid endoscope tester FIBER OPTIC LIGHT CABLES Transparent fibers or thin glass rods used in an endoscopic instrument to transmit light. If cable is damaged, some of the glass rods are broken and numerous black dots will be noticed The cable needs to be repaired if 15% to 20% of the viewing surface is obstructed. CAMERAS Used in conjunction with rigid endoscopes to enable the surgeon to see the images on a screen and perform the surgery while the instruments are inside the body. It is essential to handle the cameras with extreme care during transport, cleaning, and sterilization. Particular attention should be paid to the lens, which should be free of water, spots, and defects. FLEXIBLE ENDOSCOPES When flexible endoscopes are reprocessed, the manufacturer's instructions for inspection, leak testing, and sterilization (or high-level disinfection) must be followed carefully. Flexible endoscopes can be checked for functionality by looking at the tip of the endoscope to make sure that it has proper movement and checking the covering of the endoscope for cracks or defects. Examples are: *Colonoscope (colon/large intestine) *Sigmoidoscope (sigmoid colon) *Bronchoscope (lungs) *Gastroscope (stomach) Flexible endoscopes are much harder to clean than rigid endoscopes, because they have numerous moving parts and small channels. Because of the sophistication of these devices, only those employees who have been thoroughly trained, with competencies verified, should process them.

MISCELLANEOUS INSTRUMENTS

Knife handles

LAPAROSCOPIC INSTRUMENTS

Laparoscopic surgery (minimally invasive surgery - MIS) is much safer than open surgery>> patients recover quicker with less chance of infection. After cleaning, they must be carefully inspected for cleanliness and functionality according to the manufacturer's instructions Laparoscopic instruments can be insulated or non-insulated. Insulated instruments must be checked with an insulation tester, also called a "lap tester", each time they are used. Poor insulation can cause serious threat to the safety of the patient and surgeon. If the insulation is cracked or nicked, electricity can arc through the insulation and burn the patient's tissue or organs. If the insulation on the handle is damaged, the surgeon could receive an electrical shock. Most laparoscopic instruments must be disassembled for cleaning, so all parts must be checked to ensure that they have been correctly reassembled. Laparoscopic instruments should be reassembled for sterilization only if it is specified by the manufacturer. Some laparoscopic instruments cannot be reassembled for sterilization; some can be reassembled for steam sterilization, but not for other sterilization processes. The laparoscopic instrument manufacturer's instructions for reassembly and sterilization should always be followed. ROBOTIC INSTRUMENTS Newest generation of laparoscopic instruments and require very special cleaning procedures using a magnifying lamp. Must be lubricated after cleaning. Must also follow manufacturer's specific instructions for cleaning.

Preparation and packaging area Types of Packaging Materials: Nonwoven Materials:

Nonwoven materials are made of cellulose fibers, plastic polymers, and/or pulp that are bonded together to form a sheet. Nonwoven wrappers, which are intended for single use only, are considered to provide an excellent barrier to microorganisms. One type of nonwoven wrapper consists of two wrappers bonded together at the edges. This type of wrapper is equivalent to two single wrappers, so the "simultaneous" wrapping technique (wrapping with both wrappers at the same time) can be used. For nonwoven wrappers that are single-ply, two separate wrappers are needed. The "sequential" wrapping technique is generally used; i.e., items to be sterilized are first wrapped with one wrapper, then with the second wrapper. However, it is acceptable to apply two single-ply wrappers at the same time even if they are not bonded together. One problem with nonwoven materials is that they are prone to damage (tears and abrasion) from improper handling, especially when the set is heavy. Such damage frequently occurs when trays are pulled off a sterilizer cart or storage shelf rather than lifted. To reduce the incidence of damage, some manufacturers of nonwoven packaging material provide reusable PLASTIC TRANSFER TRAYS. After the set is wrapped, it is placed on the tray and then sterilized, stored, and distributed with the tray.

Hand-held instruments (continued) Category of uses: STRUCTURE

PARTS OF A HAND-HELD INSTRUMENTS 1. Jaws The part that comes into contact with patient 2. Box Lock Weakest part of the instrument and the part most difficult to clean 3. Shank Provides the closing force 4. Ratchet Holds the instrument closed which is difficult to clean 5. Finger rings Used to grasp the instrument and control the action of the jaw and which can be open or closed, round or oval

SPOTTING AND STAINING OF INSTRUMENTS

PASSIVATION LAYER Final step in the manufacturing process. It protects high-quality instruments from corrosion, however, it can still damage easily. Ways to damage Passivation layer: *Improper Handling Dumping instruments, scratching the surface, using metal brushes for cleaning *Improper Cleaning using saline solution, bleach, residues from textiles, hard water deposits and even by flash sterilization due to the rapid temperature change. SPOTTING Can be easily removed by simply wiping off with a cloth or using a pencil eraser, then washing instruments afterwards Causes are due to: *poor water quality *steam residues *poor cleaning STAINING Located on instruments surface that cannot be removed. Causes are due to: *Electrolysis occurs when dissimilar metals are exposed to a solution at the same time *Black or rust colored stains due to high-alkaline detergents or iron *Iodine-based solutions RUSTING *occur when floor-grade instruments (which tend to rust quickly) and surgical-grade instruments are mixed together *can also be caused by high rust content in the water

Paper-Plastic Pouches

Paper-plastic pouches (peel pouches) are used to package lightweight, single items. They are usually made of paper on one side and plastic film on the other. Various materials are used, such as medical-grade craft paper, polyethylene and Tyvek. Paper-plastic pouches are frequently used because of the visibility of the device inside. A paper-plastic pouch of appropriate size should be chosen. It must be large enough to allow at least ONE INCH (2.5 CM) of SPACE between the item and the edges of the packages. All air should be expelled from the package before it is sealed. Selecting a pouch of the correct size is important. If the pouch is too large, the contents can move around and damage the seals on the pouch. *self sealing *Heat sealing Paper-plastic material is also available in rolls to permit cutting the pouch to the desired length. Because this type of packaging requires heat-sealing at both ends, it is important to leave enough space at the end where the package will be opened to allow the end-user to open the package aseptically. Paper clips, staples, pins, and similar items should never be used as closures because they can damage the paper-plastic pouch and thereby cause contamination. Likewise, rubber bands should not be used to hold a group of pouches together before, during or after sterilization, because they can damage the side seals of the pouches and interfere with seam making contact with all surfaces of the instruments.

Powered equipment

Powered equipment used in Operating Rooms include: *Saws *Reamers *Dermatomes *Drills Power Source can be: *Batteries *Compressed gas/air *Electricity Powered equipment should never: *Be immersed in a cleaning solution or water *Be processed in an instrument washer or an ultrasonic cleaner Inspection of ARTHROSCOPIC SHAVERS is essential for proper performance. The shaver cord should be inspected for damage or defects such as nicks or cracks. If such defects are present, the shaver should not be used. The suction lumen should be checked for cleanliness according to the shaver manufacturer's instructions. The manufacturer's instructions should always be checked for guidance on preparation for sterilization. It is usually recommended that the suction button be in the "On" position before sterilization.

Instrument repairs

Quality repair service is needed to keep surgical instruments in good working order. As part of a good preventative maintenance (PM) plan, sharps should be routinely sharpened to keep them in optimum condition for use. There should be a method of identifying instruments that need repair or sharpening. It is important for CS/SPD personnel to remove the instrument from service after cleaning and to place it in the appropriate repair box. After repair, the instrument must be thoroughly cleaned before it is placed back into circulation.

Hand Held Instruments

Seven basic categories of hand-held instruments: *Hemostats *Scissors *Needle Holders *Forceps *Retractors *Laparoscopic Instruments *Miscellaneous Instruments

Limited-use instruments

Some manufacturers of instruments and other medical devices recommend a maximum number of uses. It is important to carefully read the manufacturers IFU for this information. A mechanism will be needed to ensure that the instrument or device is not used more than the recommended number of times. Some manufacturers provide a mechanism for this purpose, such as the cards that accompany laryngeal mask airways (LMA) to document the number of uses. Sometimes it is possible to mark the instrument with a non-toxic marker each time it is used; when the instrument is processed, it is easy to find out how many uses it has had by counting the number of marks. When the instrument has reached the maximum number of uses, it must be discarded and the using department advised that it needs to be replaced.

MISCELLANEOUS INSTRUMENTS

Sponge sticks

The two most common methods of wrapping:

Square fold and Envelope fold

Packaging suitable for use in various sterilization methods:

Sterilization Method/Packaging Steam/textile, nonwoven, polyolefin wraps, paper-plastic pouches and rolls, rigid sterilization containers Ethylene Oxide/Textiles, nonwovens, polyolefin wraps, paper-plastic pouches and rolls, Tyvek (all-plastic) pouches, polyethylene, most rigid sterilization containers Low-temperature gas plasma (LTGP)/Polyolefin wraps, Tyvek (all-plastic) pouches, certain rigid sterilization containers Dry Heat/Metal and glass containers, aluminum foil, glassine envelopes Ozone/Nonwoven cellulosic wrap (paper) and certain containers

In CS/SPD, double wrapping can be done sequentially or non-sequentially (simultaneous wrapping)

The SEQUENTIAL wrap uses two sheets of the standard sterilization wrap, ONE WRAPPED AFTER THE OTHER. (This procedure creates a package within a package) The SIMULTANEOUS process uses TWO SHEETS WRAPPED AT THE SAME TIME so that the wrapping needs to be performed only once. This latter method provides multiple layers of protection of surgical instruments from contamination and saves time since wrapping is done only once.

Summary

The care and handling of surgical instruments plays a crucial role in the successful outcome of a surgical procedure. The SPD technician is responsible for ensuring that all surgical instruments are clean, functional, complete and safe to use before sterilization may begin. Every technician must understand that their role in preparing and packing surgical instruments is critical in terms of patient care. Knowledge about the categories, function and inspection of each instrument is imperative. Following proper packaging, protocols is critical because it is the last time the instruments will be handled before being dispatched to the OR. Attention to detail and following best work practices is mandatory in the assembly process.

Preparation and packaging area Principles of Packaging

The main purposes of sterile packaging are to allow proper sterilant penetration and removal and to maintain the sterility of an item until it is intentionally opened or used. The generic term "Package" refers to: *Wrappers *Paper / plastic pouches *Rigid sterilization container systems

Preparation and packaging area

The preparation and packaging area is a clean area where surgical instruments and other medical devices are inspected, tested, assembled, and packaged for sterilization. In most facilities, the preparation and packaging area is adjacent to the sterilization area (not physically separated). The area used for the preparation, inspection, testing and sterilization of instruments and devices should be physically separated from the decontamination area. This is known as a physical barrier.

Classification of Surgical Instruments

There are five basic categories of surgical instruments: *Hand-held *Microsurgical *Powered *Endoscopic *Laparoscopic (including robotic instruments) Microsurgical instruments are usually classified as hand-held instruments, but they require special care and handling.

Surgical instruments represent a large portion (about 40%) of the healthcare facility's budget.

They are the tools that surgeons rely on to help ensure a positive outcome of a surgical procedure. Regardless of the skill of the surgeon, surgical procedures cannot be effectively performed without properly cleaned, functional, complete, properly packaged, and sterile surgical instruments and devices. Reprocessing surgical instruments and devices is the direct responsibility of the CS/SPD technician.

Grades and other characteristics of hand-held instruments

Three Grades of Surgical Instruments *SURGICAL GRADE Instruments of highest quality and are reusable. Usually made in United States and Germany. The country of origin, the catalog number, and the name of the manufacturer are usually etched on the instrument. *FLOOR GRADE Instruments are made from a lower grade of stainless steel. They usually have a mirror or shiny finish, and the serrations are not finely filed. Because of their lower quality and their tendency to rust quickly, floor-grade instruments should not be used in OR sets. Usually made in Pakistan. NOTE: Some OR grade instruments are now made in Pakistan. It is important to differentiate these instruments from floor-grade instruments. *Disposable Disposable instruments, which are intended to be used only once, are stamped "single use" and should never be reprocessed. Differences between surgical-grade instruments and floor-grade instruments is the manufacturing process. PASSIVATION PROCESS: Final stage in manufacturing surgical-grade instruments is passivation, a process in which a chemical dip (usually nitric acid) removes all debris from surface and creates a layer of chromium oxide making it more resistant to corrosion, rust and stains. Steam sterilization and the regular use of a water-soluble lubricant reinforces this protective coating. Rust and corrosion can occur if the passivation layer is damaged. Instruments with gold fingers rings have tungsten carbide edges or inserts Tungsten carbide is a very strong metal that keeps scissors sharp longer and prevents the jaws of needle holders from wearing out quickly. Inserts can be replaced when they are worn or broken; the entire needle holder need not be replaced. Scissors with black fingers rings are often referred to as "supersharps" These scissors are very sharp, and one edge may be slightly serrated; they must be sharpened with great care to prevent permanent damage TYPES OF FINISHES *SHINY: Do not show stains as quickly but they reflect bright light in the operating room. Causes eye fatigue to surgeons and OR staff *SATIN: Used in OR (preferred over a shiny finished instrument). *BLACK (ebonized): Used in laser procedures, as black coating absorbs the light.

MISCELLANEOUS INSTRUMENTS

Towel clamps

LAPAROSCOPIC INSTRUMENTS

Used in minimally invasive surgery (MIS).

HEMOSTATS

Used to clamp arteries to stop the flow of blood. Can be used to dissect tissue. Also called arterial forceps, hemostatic clamp, hemostatic forceps.

SCISSORS

Used to cut and dissect tissue and cut dressings and sutures.

Hand-held instruments (continued) Category of uses: HEMOSTATS/FORCEPS

Used to grasp, hold or occlude tissue Examples: *Hemostats *Dressing tissue *Bone-holding forceps

RETRACTORS

Used to hold back tissue and organs

NEEDLE HOLDERS

Used to hold suture needles

FORCEPS

Used to manipulate and grasp tissue, sponges and dressings

Hand-held instruments (continued) Category of uses: RETRACTORS

Used to retract tissue or organs. Can be hand-held or self-retaining Examples: skin hooks bone hooks

Instrument damage

With proper care and handling, most surgical instruments will be usable for 20 years and more. To maximize the use life of instruments: *Use the instrument only as intended *Never "dump" instrument from a tray *Keep instruments as clean as possible during use *Place the instruments in their respective containers *Place the items in their designated locations to protect them from damage during transport *Do not stack instrument trays unless they are in a rigid sterilization container *Protect delicate items and items with fine or sharp tips *When assembling sets, place heavier items on the bottom and lighter items on top *To prevent physical damage, separate endoscopes from instruments.

Preparation and packaging area Types of Packaging Materials: Woven textiles:

Woven textiles are made of either 100% cotton or a cotton blend, and they are reusable. At one time, muslin wrappers were the most widely used packaging material. Muslin is unbleached, 140-thread-count, 100% cotton. The use of muslin for wrappers and for protective garments such as surgical gowns has been virtually abandoned because of Muslim's poor barrier properties. Newer types of woven materials have much better barrier properties through the use of various blends and treatments. WOVEN WRAPPERS MUST BE LAUNDERED BETWEEN USES AND INSPECTED EACH TIME FOR HOLES AND TEARS, USING A LIGHTED WORK TABLE. They must be de-linted after each laundering. If the wrapper is one-ply, two wrappers must be used for each package. Most woven materials used as wrappers are considered outdated at 30 days.

Rigid Sterilization Containers

are sterilization containment devices "designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents." Containers vary in size and are intended for use in various sterilization methods. Containers are of complex design and consist of the following parts: *A container bottom *An inner basket *A container lid *Silicone gaskets around the container perimeter to ensure a secure seal *Latches to secure the container *Filter retention plates (for single-use filters) or valves (the number of filters or valves depends on the size of the container and on whether the container bottom is solid)) NOTE: Some containers have silicone gaskets around the filter retention plates for added security. *Handles with which to transport the container *reuseable *A load card holder (a place to put a lot control label) *Tray ID name tags (there might be one on the front and one on the back) *A locking mechanism An indicator card and an ID plate can be attached. A lot control sticker and the initials of the person who prepared the container are placed on the indicator card. Never apply any tape on the outside of the surface of the container - it may attract dirt and microorganisms. Most containers have perforations on top and/or bottom of the container to permit air removal and sterilant penetration. Containers equipped with filters are compatible with steam and ethylene oxide sterilization cycles. Pre-vacuum Steam Sterilization requires only filter on top of container. Gravity Displacement /EOCycles/LTGP Sterilization require filters on both top and bottom of containers to permit air removal and sterilant penetration Rigid Sterilization Containers: -Use only the filter paper of the correct size recommended by the device manufacturer. -Filters are to be disposed after each use and never reused. -Filters used for LTGP must be non-cellulose based material. Rigid Sterilization Containers: must be dissembled and cleaned after each use can be cleaned manually, in a mechanical washer, or even in a cart washer (using the appropriate carts) Locks should always stay on until the container is ready to be opened. It serves as a tamper-evident seal. If the locks are broken or missing, its assumed that the container has been compromised and "standar Precaution" must be followed. Before any container is placed into routine use, biological testing must be performed. *Containers should be PLACED FLAT ON THE STERILIZER CART and never stacked unless otherwise noted by the manufacturer *They're REGULATED BY THE FDA and considered to be CLASS 11 MEDICAL DEVICES *It's important to evenly distribute large instruments in a set to ELIMINATE ANY EXCESS CONDENSATION

Square fold

is used for large packs such as laparotomy linen packs and is often used to create a sterile field

The envelope fold

is used for smaller packs and trays and is the most widely used in SPD today

Double Pouching

is used mainly for purposes of aseptic presentation in the operating room. If double pouching is necessary, the two pouches must be appropriately sized so that the inner pouch lies flat in the outer pouch. The inner pouch should never be folded over, because this configuration could interfere with air removal and sterilant penetration. The inner pouch must be sealed before it is placed in the outer pouch, and it should be placed paper-to-paper (paper side facing the paper side) in the outer pouch. Pouches should not be cut (altered) to fit inside a second pouch. The chemical indicator should be placed in the inner (first) pouch.