CHAPTER 1

Care and Handling of Surgical Instruments*

Although evidence exists that stone knives were used to perform surgery as early as 10,000 bc, modern surgical instrumentation began with the introduction of stainless steel in the early 1900s. Approximately 85% of all surgical instrumentation is now made of stainless steel. Although stainless steel continues to compose the bulk of instrumentation used in surgery today, there have been dramatic changes over the past several decades. One has been the addition of new materials. In addition to stainless steel, titanium, Vitallium, and various polymers are also used. The introduction of minimally invasive surgery coupled with the availability of space-age materials have wrought instrumentation once only dreamed of. Cameras, flexible and rigid endoscopes, minimally invasive surgery techniques, and advanced imaging technology now make it possible to explore almost every crevice within the human body without having to perform open surgery and without requiring a hospital stay. Instrument design has focused on enhancing the surgeon’s ability to visualize, maneuver, diagnose, and manipulate tissue with increasingly smaller instrumentation. In particular, the working channel of a flexible endoscope can be as small in diameter as 0.1 mm and as long as 2200 mm. It is possible to repair an aortic aneurysm, perform a coronary artery bypass, operate on a fetus, and so forth, without making a major incision. Advances in instrumentation design have contributed significantly to improved patient outcomes, early discharge, reduced recuperation time, and less physical trauma and pain. The consequence of improved instrument design, however, is higher cost, less inventory of like instrumentation, and greater cleaning, decontamination, and sterilization challenges. When surgical volume increases without a corresponding increase in inventory, instruments will experience increased utilization, handling and processing. This in turn increases the risk of damage, which can lead to expensive repair costs and possible cancellation of a surgical procedure. In today’s environment of cost consciousness, proper care and handling of surgical instrumentation is more critical than ever.

In addition to improvements in instrument design, several new sterilization and instrument processing technologies are now widely used. As a result, the required knowledge base of the person responsible for the care and handling of instruments has expanded significantly. The person caring for instruments must know the instruments’ intended uses, their functions, and their compatibility with various cleaning, disinfecting, and sterilizing methods, and must have an understanding of the disinfecting and sterilizing technologies. In recognition of the skill required to process surgical instruments properly, certification of processing personnel is required in many facilities, and certification is a requirement for employment in at least one state, with other states to soon follow. Although the care and handling of surgical instrumentation is not revenue producing, appropriate and meticulous care and handling can result in lower overall costs for a surgical department by preventing damage and consequently reducing expenditures for repair and replacement. However, the primary concern should be that the instrument be truly patient ready—that is, safe and free of microorganisms. Instruments must be in excellent working condition and adequately cleaned and processed in preparation for surgery. Instrumentation that malfunctions or is not appropriately cleaned and sterilized or disinfected can result in extended surgery time, poor technical results, patient infection, patient injury, and even death. The November 1999 report issued by the Institute of Medicine stated that as many as 98,000 injuries to patients occur each year in hospitals. The report was a wake-up call to health care providers to institute mechanisms that prevent errors. As a result, there is an ongoing intense focus on patient safety throughout the health care industry. Proper care and handling of instrumentation are critical components of patient safety.

In summary, the proper care and handling of surgical instrumentation is not a simple rote task; it requires specialized knowledge, competence, judgment, and a commitment to excellent patient care.

Evolution of Surgery and Surgical Instrumentation

Surgery was practiced long before the development of sophisticated surgical instruments. Stone knives and sharpened flints and animal teeth were the instruments of choice for trephination, circumcision, and bloodletting in prehistoric times. In Corpus Hippocraticum, Hippocrates (460-377 bc) wrote of the use of iron and steel in instrument making; however, there are no existing examples of surgical instruments before the early Roman period. Excavations begun in 1771 in the city of Pompeii reveal surgical instruments that bear amazing resemblances to contemporary instrumentation. Among the instruments found were a foreign-body remover, a speculum, retractors, probes, a periosteal elevator, forceps, and hooks. Metal analysis indicates three materials: copper, bronze, and iron.

Until the 1790s, surgery was not a strict discipline, and surgeons were not afforded equal status with physicians. Instruments were made by blacksmiths, cutlers, and armorers. However, as surgery evolved into a scientific discipline and achieved a measure of status, the specialty of instrument making also emerged. Surgeons employed coppersmiths, steelworkers, silversmiths, wood turners, and other artisans who handcrafted instruments to individual specifications. Instruments often had ornate ivory or carved wooden handles and were cased in velvet.

The introduction of anesthesia in the 1840s and the adoption of Lister’s antiseptic technique in the 1880s greatly influenced the making of surgical instruments. The use of anesthesia enabled the surgeon to work more slowly and accurately and to perform longer, more complex procedures. The variety of surgeries performed increased, as did the demand for specialized instruments. The ability to sterilize instruments also had an impact on instrument design. When steam sterilization became a standard process, carved wood or ivory handles were replaced with all-metal instruments made of silver, brass, or steel. Velvet-lined boxes were replaced by trays that could be lowered into steam sterilizers.

Manufacture of Stainless Steel Instrumentation

The development of stainless steel in the 1900s provided a superior material for the manufacture of surgical instruments. Subsequently, instrument making evolved into a highly skilled occupation. Shortly thereafter, crafters from Germany, France, and England were brought to the United States to instruct apprentices in their craft. Even today, many of the delicate, high-quality, stainless steel instruments are manufactured in Europe. Germany is often considered the home of high-quality surgical instruments. Other metals like Vitallium and titanium are used today, but the bulk of surgical instrumentation is made of stainless steel and is manufactured in the United States.

Stainless steel is a compound of varying amounts of carbon, chromium, and iron. Small amounts of nickel, magnesium, and silicone may also be incorporated. Varying the amount of these materials produces a variety of qualities, such as flexibility, temper, malleability, and corrosion resistance. There are more than 80 different types of stainless steel. The American Iron and Steel Institute uses three-digit numbers to grade steel based on its various qualities and composition. The most commonly used steel alloys for the manufacture of heat-stable, reusable surgical instruments are stainless steel series 300 and 400, with 400 being the most common. The 300 series is generally used for noncutting surgical instruments requiring high strength, such as speculums and large retractors. The 400 series is used for both cutting and noncutting instruments. Both series resist rust and corrosion, have good tensile strength, and will retain a sharp edge through repeated use. The chromium content in stainless steel provides the stainless quality. Stainless steel is really a misnomer. The degree to which the steel is “stainless” is also determined by the chemical composition of the metal, the heat treatment, and the final rinsing process.

The first step in the manufacture of stainless steel instruments is the conversion of raw steel into sheets that are milled, ground, or lathed into instrument blanks. These blanks are then die-forged into specific pieces and, where appropriate, male and female halves. Excess metal is trimmed away and the pieces are milled and hand-assembled. Jaw serration and ratchet, and shank alignment are achieved, after which the instrument is hand-assembled and then ground and buffed. It is then heat-treated to reach its proper size, weight, spring, temper, and balance. Following testing for desired hardness, jaw closure, and ratchet and locking action, a finish is applied.

The final two processes are passivation and polishing. Passivation is the immersion of the instrument in a dilute solution of nitric acid that removes carbon steel particles and promotes the formation of a coating of chromium oxide on the surface. Chromium oxide is important because it produces corrosion resistance. When carbon particles are removed, tiny pits are left behind. These are removed by polishing that creates a smooth surface upon which a continuous layer of chromium oxide may form. Passivation and polishing effectively close the instrument’s pores and prevent corrosion.

There are three types of instrument finishes: highly polished, satin or dull, and ebony. The highly polished finish is the most common, but it does reflect light and can cause glare that may interfere with the surgeon’s vision. The satin finish does not reflect light and eliminates glare. The ebony finish is black and also eliminates glare. The ebony finish is suitable for laser surgery, in which it is critical that the laser not be accidentally reflected, creating the potential for burn or fire.

Quality of Stainless Steel Instruments

Stainless steel instruments may appear to be of uniform quality when they are new. However, there are various grades of quality, ranging from high quality and premium grade to operating room and floor grade. Some instruments appearing to be stainless steel are of such poor quality that they are sold as single-use instruments. In the United States, there is no agency that sets standards for instrument quality. Quality is determined by the manufacturer. In addition, an instrument labeled “Germany” may have been forged in Germany but actually assembled in a country where quality standards are minimal or nonexistent. Because instruments represent a substantial portion of a surgical suite’s budget, it is important to be knowledgeable about buying and selecting products with the desired quality. Many factors affect quality. Two major factors are a balanced carbon-chrome ratio and the process of passivation. A balanced carbon-chrome ratio is important for instrument strength and long life. Instruments that are classified as premium have the correct balance. The passivation process is important to create a protective coat on the outer layer of an instrument to prevent corrosion and extend its life. Electropolishing is sometimes substituted for passivation. The result is a less expensive instrument but one that will not last as long. When purchasing stainless steel instruments, it is best to deal with a reputable manufacturer who will explain the variation in quality of the products available.

It is important to verify that an instrument manufacturer has clearance from the U.S. Food and Drug Administration (FDA) to market its products. Instruments manufactured in some countries outside the United States have been known to enter the American market without this clearance and without adequate instructions for use and processing. Another reason to deal with a reputable instrument manufacturer is authenticity. In recent years, counterfeit products have found their way into hospitals in the United States. When an instrument that usually sells for $150 is being offered for $50, the buyer should beware and should check for FDA clearance before considering purchase.

Instruments manufactured of materials other than stainless steel present an additional set of factors to consider before purchasing. These include their ability to be disassembled, cleaned, and reassembled; their life expectancy; and their compatibility with the existing cleaning, disinfecting, and sterilizing capabilities of the institution.

Care and Handling of Basic Surgical Instruments: Overview

A well-made, properly cared for instrument can be expected to last 10 years. The most important considerations in extending the life of an instrument are appropriate use, careful handling, and proper cleaning, decontamination, and sterilization. Other considerations are disinfection, packaging, and storage. Every instrument is designed for a specific purpose. Using it for an unintended purpose is a sure method of damaging an instrument. Examples of misuse include securing surgical drapes or opening a medicine vial with an instrument designed to grasp tissue.

The proper cleaning of instruments during and after surgery can help to prevent stiff joints, malfunctions, and deterioration of the instruments’ material, including stainless steel. During surgery, instruments contaminated by blood or tissue should be properly wiped and rinsed in the sterile distilled water in the sterile field. Thorough rinsing is important to ensure removal of blood and other contaminants from hinges, joints, and crevices. Blood and foreign matter that are not removed or are allowed to dry and harden may become trapped in jaw serrations, between scissor blades, or in box locks, making final cleaning more difficult and the sterilization or disinfection process ineffective. It can cause instruments to become stiff and eventually break. Channels, or lumens, within instruments—such as suction tips—should be irrigated periodically to prevent blood from drying and adhering to the inside of the lumen. Neglecting this action can cause blood and other debris to remain in lumens throughout the postoperative cleaning, decontamination, and sterilization processes. A syringe should be present in the sterile field for the purpose of flushing lumens with water throughout the procedure. Flushing the lumen should be done below the surface of the water to prevent the aerosolization of debris. Instruments should be rinsed in distilled water. Saline should not be used for this purpose. Prolonged exposure to saline can result in corrosion and can eventually lead to the pitting of stainless steel. Pitting can permit entrapment of debris, interfere with sterilization, and result in the destruction of an instrument.

Instruments should be handled carefully and gently, either individually or in small lots, to avoid possible damage caused by their becoming tangled, dented, and misaligned. During and after surgery, they should be placed, not tossed, into the basin. Heavy instruments should be on the bottom, with the lighter, more delicate and fragile ones on top. Rigid endoscopes and fiberoptic cables should also be placed on top or separated. Fiberoptic cables should be loosely coiled, never wound tightly. When the procedure is complete, instruments that can be immersed are disassembled and all box locks are opened. Care should be taken to ensure that they are not tangled or piled high. Instruments should be returned to their respective containers or baskets to prevent sets from becoming incomplete, and they should be contained or covered for transport to the decontamination area. All disposable blades and sharps should be removed and placed in a designated sharps container. Delicate instruments, endoscopes, and other specialty instruments may have to be separated and transported to the decontamination area in containers specifically designed to prevent damage to these devices. Instruments with cutting edges, pointed tips, or other sharp components should be placed in such a manner that sharp edges are protected and personnel responsible for cleaning and decontamination are not injured when reaching into the container.

Manufacturer’s Instructions for Use

Personnel responsible for instrument processing should always refer to the manufacturer’s instructions for use (IFU). The IFU should contain explicit instructions for disassembly, cleaning and/or decontamination, and disinfection or sterilization. IFUs should be routinely reviewed as well. Instructions may change when manufacturers make modifications to their devices, when new regulatory requirements become effective, or when new processing technologies come to market.

In addition to IFUs for processing devices, IFUs for packaging materials and for sterilization technologies should also be reviewed before processing. In instances in which instructions are not compatible with each other, the vendor(s) should be contacted in an attempt to reconcile the incompatibilities. When it is not possible to reconcile instructions, product testing (see Sterilization section later in this chapter) should be performed.

Everyone responsible for instrument processing should have ready access to all necessary IFUs and should refer to them routinely. Surveyors, such as those from the Joint Commission, have indicated that they will be asking to see IFUs and will be checking to see if personnel are adhering to them.

Cleaning and Decontamination

The Association for the Advancement of Medical Instrumentation (AAMI) defines cleaning as “removal of contamination from an item to the extent necessary for further processing or for the intended use.” AAMI further notes that, “In health care facilities cleaning consists of the removal, usually with detergent and water, of adherent soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.”

Decontamination is defined by the Occupational Safety and Health Administration (OSHA) as “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.”

Proper cleaning can result in a decontaminated device—that is, one that is safe to handle. Mechanical washing machines typically follow the washing phase of the cycle with a thermal or chemical application that renders a device safe to handle. Although manual cleaning does not include a chemical or thermal process, if done in accordance with the device manufacturer’s instructions, it can also render a device safe to handle. The IFU should be consulted to determine if a further step beyond cleaning is required to render the device safe to handle.

After Surgery: Cleaning

Whenever possible, instruments should be taken apart at the point of use. Unless otherwise specified in the device manufacturer’s IFU, anything that can be disassembled must be disassembled before cleaning. After surgery, instruments are transported in leak-proof containers or trays encased in plastic bags to a designated area for cleaning and decontamination. Instruments should not be transported in basins containing water because the water may spill. Instruments should be cleaned away from patient care areas or areas where clean activities are performed. The decontamination area may be within the operating suite or, more commonly, in the Central Processing Department, also referred to as the Sterile Processing Department. Instruments that can tolerate immersion and cannot be cleaned immediately should be treated with an enzymatic foam or gel to prevent debris from drying and adhering to the device and to prevent formation of biofilm, or they should be submerged completely in a warm, noncorrosive enzymatic solution and allowed to soak until cleaning can be performed. Generally, instruments should be placed horizontally beneath the water; however, some types of lumened instruments may have to be soaked vertically, with the entire shaft submerged. Horizontal soaking of lumens can cause air bubbles to form that can prevent the solution from traveling the length of the inner lumen.

All instruments placed in the sterile field for use in a surgical procedure are considered contaminated and should be cleaned whether or not they were actually used. Blood, saline, or debris can be splashed or inadvertently deposited on any of the instruments; therefore, they all require decontamination and processing.

There are several methods of decontaminating instruments, but all begin with thorough cleaning. The usual steps in the decontamination process include sorting, soaking, washing, rinsing, drying, and lubricating.

Cleaning is the removal of adherent visible soil from the surfaces, crevices, serrations, joints, and lumens of instruments. Cleaning may be manual or automated and is accomplished with detergent, water, and friction. Proper use of the detergent is essential. Detergents should always be mixed according to the proportions indicated on the label or in the manufacturer’s IFU. Enzymatic detergents that are over- or underconcentrated or have been improperly rinsed can interfere with subsequent disinfection and sterilization. Regardless of how heavily soiled instruments appear to be after use, adding more detergent to the water is inappropriate. To ensure proper detergent concentration, it is advisable to obtain an exact measuring device for the detergent and to mark the sink with a piece of tape or a nontoxic, permanent marker to indicate the correct water level. For example, if the instructions call for a mix of 1 ounce of detergent to 1 gallon of water, a 1-ounce container should be obtained and kept next to the detergent bottle or sink. A 1-gallon container should be filled with water and poured into the sink in which instruments are washed manually, and the water level marked. The presence of the 1-ounce container and the mark in the sink should help to ensure the correct preparation of the detergent solution. Instructions for rinsing are also important. Some products call for multiple rinses. When a choice is made to switch to an alternative detergent, it is important to ensure that all personnel responsible for instrument processing receive the appropriate notification and information.

When possible, mechanical cleaning is preferred. However, some specialty instruments and those that cannot tolerate immersion or mechanical processing require manual washing. Some instruments, because of their design, require manual as well as mechanical cleaning. Examples are some laparoscopic instruments and bone reamers. Debris and tissue can easily become trapped in these devices, and mechanical cleaning alone may not be sufficient to remove the debris. Soaking in an enzymatic detergent can help to break down organic soil. Reamers with many crevices tend to trap debris and may have to be soaked and manually brushed before automatic cleaning. Much will depend upon the capability of the mechanical cleaners in the decontamination area. Laparoscopic and other lumened instruments should be flushed and brushed. Flushing can be achieved by attaching a Luer-Lok syringe filled with an enzymatic detergent solution to one of the instrument’s ports. Brushing must be carried out using a brush that is long enough to exit the distal end of the shaft and wide enough in diameter to cause friction on the walls of the lumen so soil is loosened. Mechanical washers and ultrasonic irrigators designed for laparoscopic and lumened devices do an excellent job of cleaning and are preferable. When instruments cannot tolerate immersion, high temperatures, or the pressures of mechanical cleaning units, or if no such unit is available, the instruments must be cleaned manually. Instruments that are washed manually should always be completely immersed and allowed to soak in a cleaning agent intended for manual cleaning of surgical instruments. Instruments should be disassembled and box locks, hinges, and joints should be opened. Serrations, box locks, crevices, and lumens must be brushed to remove imbedded particles. Scouring pads, stiff brushes, abrasive powders and soaps, and sharp implements should not be used to remove debris because they can destroy the protective coating on surgical instruments.

Instruments that are washed manually should always be washed one at a time beneath the surface of the water to prevent the aerosolization and splashing of debris.

Personnel responsible for cleaning must wear personal protective attire to prevent contact with blood or with fluid that might contain blood and/or other body fluids. Protective attire consists of a head cover, face shield, heavy-duty cuffed decontamination gloves, and a waterproof gown that covers the scrub suit underneath. Aprons are not acceptable. Masks are recommended when cleaning items that can create aerosols (e.g., lumened devices). Fluid-resistant shoe coverings or waterproof boots are appropriate when fluid may be expected to pool on the floor.

Ultrasonic cleaning is another component of instrument cleaning. Ultrasonic cleaners should be used only on devices that can tolerate this process and only after gross debris has been removed. Ultrasonic washers use a process called cavitation to remove fine soil from difficult-to-reach areas of a device that manual cleaning may not remove. High-frequency sound waves are captured and converted into mechanical vibrations in the solution. The sound waves generate microscopic bubbles that form on the surfaces of the instruments. These bubbles expand until they become unstable and collapse or implode (collapse inwardly), creating minute vacuums that rapidly disrupt the bonds that hold debris to instrument surfaces. The tiniest particles are rapidly drawn from every crevice in the instrument. Ultrasonic cleaning is especially effective for box locks and instruments with serrations and interstices that are not easily accessible.

Ultrasonic cleaning does not kill pathogens; it only removes them and deposits them in the ultrasonic bath. The energy created in an ultrasonic cleaner is not biocidal, and unless the solution is changed frequently, the bioburden on instruments can actually increase. To prevent this, ultrasonic solutions should be changed between cycles. The cover of the ultrasonic cleaner should be closed during operation to prevent the spread of microorganism-containing aerosols that are created during the cleaning process and that may be harmful to personnel.

Instruments made of dissimilar metals can be damaged if cleaned together in the ultrasonic cleaner. The electroplating of the more active metal onto the less active metal can result in permanent discoloration of the less active metal (e.g., brass plating on stainless steel turns the steel a golden color) and will eventually weaken the instrument from which the metal is being removed. In addition, some instruments cannot tolerate the energy waves of the ultrasonic cleaning process, and manufacturers of delicate instruments do not always recommend ultrasonic cleaning.

Personnel responsible for processing instruments should check with the manufacturers of both the instrument and the ultrasonic cleaner before employing this process.

At the completion of the ultrasonic cycle, the instruments are placed in a mechanical washer or rinsed and dried.

The most common mechanical cleaning machine in use is the washer-decontaminator/disinfector. Washer-sterilizers are also available. These machines offer a variety of cycles, including cool-water rinse, enzyme soaking, washing, sonication (ultrasonic cleaning), hot-water rinse, germicide rinse, and drying. Washer-decontaminators have, to a great extent, replaced manual cleaning and the use of washer-sterilizers.

In a washer-sterilizer, the instruments are washed and rinsed and then subjected to a short flash-sterilization process. Debris that may not have been removed during the wash phase may become hardened onto the instrument due to the high temperature during the sterilization phase. For this reason, washer-decontaminators/disinfectors, which do not include a sterilization phase, are generally preferred.

For lumened devices, washers with connection ports that facilitate cleaning lumens should be utilized.

Instruments should be placed in a mesh-bottom or perforated tray prior to placement within mechanical washing systems. Detergent should be selected according to the type of debris and the tolerance of the instrument. The manufacturer of both the instrument and the mechanical cleaner should be consulted. A detergent’s pH can be alkaline, neutral, or acidic. A mildly alkaline or neutral detergent is generally preferred. Acidic or heavily alkaline detergents should not be used routinely because they can destroy the passivation layer and promote corrosion. When high-alkaline detergents are used, they must be completely and thoroughly neutralized.

Enzymatic detergents usually consist of a detergent base with a neutral pH in combination with one or more enzymes and a surfactant. Surfactants lower the surface tension of water and allow the detergent to more easily penetrate into crevices and serrations. There are many enzymatic detergents on the market. Some formulations contain only one enzyme; others contain multiple enzymes. There are enzymatic detergent products suitable for ultrasonic cleaners, mechanical washers, and manual cleaning. Some can be used for manual and mechanical cleaning. Some are intended for specialties, such as orthopedic procedures or endoscopies, or for specific instruments such as those used in laparoscopic surgery or cholecystectomies. Some target blood, fat, or organic soil. As a general rule, a low-foaming detergent with a neutral pH is preferable. High-foaming detergents may not be completely rinsed off and can leave spots and stains on instruments. In areas where the water is hard, a water softener should be used to minimize scum and scale formation.

Although verification that an instrument has been cleaned is through visual inspection, there are commercially available products that can be used to test the ability of the washer to clean effectively. Mechanical cleaning equipment should be tested at least weekly, and preferably daily.

As a final step before inspection and packaging for sterilization, instruments should be lubricated with a nonsilicone, water-soluble lubricant. Mechanical washers often include a lubrication process as part of the cycle, in which case additional lubrication is probably not required. In manual lubrication, instruments are dipped into a milky-white solution or bath similar in appearance to milk. The manufacturer’s instructions for dilution of the lubricant should be followed, and the expiration date after mixing should be noted and indicated on the instrument milk bath.

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