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How to Clean Reusable Orthopedic Instruments

A piece of equipment that is used for preventing and treating deformities and injuries of the musculoskeletal system in man. Orthopedic devices include bandages, splints, prostheses, and special apparatus. Several types of orthopedic devices are distinguished. A fixing device is designed to either completely or partially restrict movements in a joint; examples are hinged splints, which preserve a certain range of movement in a joint, and rigid splints. Relieving devices are used to relieve pressure on an ailing part by transferring support to healthy parts of an extremity; examples include the Thomas splint and the Voskoboinikova apparatus. Corrective devices are used to gradually correct a deformity; these include corsets, splints, orthopedic footwear, and insoles and other devices to correct abnormal positions of the foot. Compression-distraction devices correct acquired or congenital deformities of the extremities, for example, curvature, shortening, and pseudarthrosis; they include the Gudushauri, Ilizarov, Sivash, and Volkov-Oganesian apparatus. Chisels, osteotomes, electric and pneumatic saws, and ultrasonics are used to dissect bones in order to eliminate deformities or to join bone fragments. Rods, pins, plates, and screws are used in osteosynthesis. Joint defects are replaced by plastic and metal internal prostheses.   Symmetry Medical has issued its own instructions for cleaning reusable surgical instruments, including devices that may contain one or more canted coil springs. According to “Recommended Care, Cleaning, and Sterilization for Reusable Instruments, Instructions for Use,” all Symmetry Medical instruments may be safely and effectively reprocessed using the manual or combination manual/automated cleaning instructions provided in the document “unless otherwise noted in instructions accompanying a specific instrument.”3   The company’s instructions are written in accordance with ISO 17664, “Sterilization of Medical Devices—Information to Be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices.”4 This standard sets out the specific information that medical device manufacturers must provide “on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor.” It defines the types of information required to ensure that a medical device can be processed safely so that it will continue to meet its performance specification.   Symmetry’s reprocessing instructions have been validated as being able to prepare the company’s reusable instruments for use. Its document provides specific warnings, precautions, and processing limitations, along with thorough cleaning instructions. While detailing those caveats is beyond the scope of this article, it is imperative that users read and understand them prior to implementing this cleaning process. All of the company’s protocols must be verified before they are put into practice.   In this method, excess biologic soil is removed from the instruments using a disposable wipe. Devices are then placed in a container of distilled water or covered with damp towels. The company notes that soaking devices in proteolytic enzyme solution facilitates the cleaning process, especially in the case of instruments with such complex features as lumens, mating surfaces, blind holes, and cannulae. Instruments that cannot be soaked or maintained in a damp state should be cleaned within 30 minutes of use to prevent them from drying out before cleaning. This method requires that multicomponent instruments be disassembled before cleaning.   Symmetry’s guide outlines both a manual and a combination manual/automated cleaning process. The manual process involves nine steps, while the combined process involves seven. The test discussed here involved the use of the manual process.   First, the instruments were completely submerged in a proteolytic enzyme solution prepared according to the manufacturer’s instructions, following which they were shaken gently to remove trapped bubbles. Instruments with hinges or moving parts were actuated to ensure that all surfaces contacted the solution. Lumens, blind holes, and cannulations were flushed with a syringe to remove bubbles and to ensure that complete contact was made with the solution. Instruments were soaked for a minimum of 10 minutes. Then, the surfaces were scrubbed using a soft nylon-bristle brush until all visible soil was removed.   Symmetry notes that particular attention should be given to crevices, roughened surfaces, cutting features, hinged joints, sharp edges, box locks, and areas with small components or springs. The company recommends that personnel insert a narrow nylon bristle brush or pipe cleaner into lumens, blind holes, or cannulae with a twisting motion and that they push it in and out multiple times to remove soil. Scrubbing devices below the surface of the enzyme solution minimizes the potential of aerosolizing contaminated solution.   At this stage, the instruments were removed from the enzyme solution, rinsed, and then actuated in tap water for a minimum of one minute. The company recommends that personnel flush lumens, holes, cannulae, and other difficult-to-access areas thoroughly and aggressively. This step applies equally to canted coil springs.   The instruments were then completely submerged in the cleaning solution—an ultrasonic bath containing detergent and de-gas—and shaken gently to remove any trapped bubbles. The lumens, blind holes, and cannulations were flushed with a syringe to remove bubbles and ensure that the solution contacted all the instrument surfaces. Sonic cleaning was performed for a minimum of 10 minutes.   The company recommends that stainless-steel instruments be separated from other metal instruments during the ultrasonic cleaning process to avoid electrolysis. The instructions also note that hinged instruments should be fully opened and that wire-mesh baskets or trays designed for ultrasonic cleaners should be used. Regular monitoring using an ultrasonic activity detector, aluminum foil test, test object surgical instrument, or SonoCheck is also recommended.   After the instruments were removed from the ultrasonic bath, they were rinsed in purified water for a minimum of one minute or until there was no sign of residue detergent or biologic soil. The instructions specify that all moveable and hinged parts should be actuated during the rinsing procedure and that lumens, holes, cannulae, and other hard-to-reach areas such as canted coil springs should be flushed thoroughly and aggressively.   Like the validated Bal Seal method, the Symmetry method specifies that all devices be thoroughly inspected for residual biologic soil or detergent. If contamination is still present, the cleaning process should be repeated. Symmetry requires that its devices be sterilized prior to use and provides specific sterilization instructions at the end of the manual. 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