1.4 Instrumentation
Author Isabel van Rie Richards
1.4 Instrumentation
A surgical instrument is a tool designed to perform a specific action during a surgical procedure. A surgical implant is designed to be left in the patient to perform a specific function (eg, fixing a fracture). All medical devices whether instruments or implants have to comply with a number of governmental and international regulations and standards to guarantee they are fit for the desired purpose. Medical devices are aimed at improving the medical condition of the patient and facilitating the surgical procedure. Their use must also qualify as safe for both the patient and healthcare professionals.
This chapter explains standards of care and maintenance of instruments in the preoperative, intraoperative, and postoperative phases. Standards for the decontamination process as well as guidelines for the organization and planning in the operating room (OR) are presented.
1.4.1 Preoperative preparation
Acquiring information
Information for an operation must be acquired before the procedure. Surgeons give the team details of the operation to be performed. They must provide clear and adequate information including the name, gender, age and general condition of the patient, the nature of the injuries, and the type of operation. Surgeons must also inform the operating room personnel (ORP) of the patients’ wishes. Checklists and a good general knowledge of the OR allow the team to prepare the instruments, equipment, and implants required for the procedure. Communicating with each other and obtaining this information is the key to effective preparation and a successful operation. Moreover, mutual respect for the patient and team members is imperative. Strengths and weaknesses of individual staff members must be identified and noted so that, if necessary, any deficiency in knowledge or professional experience can be compensated. When this is evident, additional training and information must be provided.
Preparing the operation Setting up material
Operating room time is the most expensive resource in a hospital. Having adequate, proper functioning instruments, and equipment ready at hand enhances patient safety, prevents delay, saves money, and increases staff and surgeon satisfaction and is therefore important. The selection of equipment depends on the patient, the operation, the surgeon’s preferences, and the equipment availability. Sets, instruments, and implants are prepared and set up according to institutional practice.
Each hospital should have checklists to simplify the task of the ORP when setting up for surgery, especially for emergency cases when items may be forgotten due to stress, or be performed out of hours by ORP unfamiliar with the procedure. These checklists should be regularly updated and all items correctly and clearly identified and labeled to simplify the setting-up process.
When an instrument set is on loan, it must be checked to ensure it is complete. On arrival in the OR, the transport packaging of the sets must be removed. As the material is usually not sterile at this point, the recipient must then check the contents to ensure nothing is missing or damaged. It is also highly recommended that the scrub ORP for the procedure and surgeon become familiar with the instruments and their order of use during surgery before it is sent for sterilization. In exceptional situations the set on loan is sterile on arrival (eg, when the set is borrowed from a neighboring hospital). In this case the sterile integrity of the set is mandatory and a thorough check of the contents is done preoperatively.
Checking and preserving integrity of sterile instruments
Once the decontamination and sterilization processes have been completed, the sterile sets are stored. The method of packaging, handling, transporting, and storing instruments determines the shelf-life of the material. Shelf-life is the length of time that a device is considered to remain safely sterile before its packaging integrity might have become compromised. It is not possible to give a general recommendation for the shelf-life of all sterile items because of the large variation in methods of packaging and storage.
All devices for sterilization must be packed using materials that are resistant to liquids and bacteria and maintain the sterility of the contents. The penetration of moist heat (steam) through the packaging permits the sterilization of the contents. Other methods of sterilization use gasses, such as ethylene oxide, formaldehyde, or plasma. High-dose radiation is used by some companies for single-use items but is not practical for resterilization of equipment. The choice of packaging depends on the content’s weight and shape. Heavier and longer instruments and sets are usually sterilized in metal containers; lighter and smaller items are wrapped in double sterilization paper or in pouches. The significance of the double wrapping is to facilitate the way the sterile contents are presented to the scrub nurse. Packaging with cotton linen is not recommended as it does not act as a barrier against microorganisms especially when there is contact with liquids. Cotton may be used as a protective layer only to prevent perforation of the packing paper. Sharp and pointed instruments must be protected so that damage caused by manipulation during sterilization process, transport, or storage is avoided. The packing and wrapping process must be performed according to institutional guidelines, meet national and international standards and is completed by using either suitable tape for wraps, a sealing procedure for pouches or locking tags for containers. The use of sterilization tape has a triple function. First, it closes the packaging. Second, the tape indicates that the product has passed through a sterilization process due to a color change on the tape; however, it does not prove that the sterilization process has been successfully carried out. Third, the tape also functions as a seal for the package. If the tape is not intact before use the packaging must be considered not to be sterile.
Each and every medical device must at all time, before, during, and after sterilization be handled with care. Heavy instrument trays should not be placed on lighter or fragile instruments. Maintaining the integrity of sterile supplies during transport is also important. During transportation trays and instruments must be protected in a closed container or trolley to reduce the risk of accidental damage and exposure to dust and other external influences. Storage of surgical instruments must also meet defined criteria and standards. They must be stored in a dry room, free of airflow and UV-light; and at a temperature between 20° and 25°C. The instruments should never be exposed to extreme temperature changes. In the storage room heavier trays should be stored on lower shelves and lighter devices on a higher level. If there is a lack of storage room and heavier items must be stored at a high level then the use of a mechanical lifting aid can facilitate the transfer. Stacking of containers is not recommended; unnecessary moving and shifting of containers is not ergonomically ideal and can cause back pain. Besides, the airflow produced by the excessive movement of sets must be limited to minimize the build up of dust particles in the storage area. Respecting the first-in first-out principle avoids regular expiry of sterile items. Regular checking of expiry dates and package integrity is obligatory. Nonsterile equipment must be stored in a different place or rather a different supply room than the sterile equipment.
Setting up the OR
Setting up the OR is the step that follows selection of the materials to be used for an operation. In most cases the scrub ORP prepare their own trolleys. Number of trolleys, equipment, containers, instruments, and implants necessary for the particular operation are organized within the OR so that work can be performed efficiently. The type and side of operation, for example, determine how trolleys and equipment are positioned and organized. All trolleys are placed beneath the laminar air flow. Sterile equipment is kept separate from nonsterile equipment and liquids necessary for rinsing and disinfecting the surgical-site. Equipment not needed for the operation should be removed from the OR, although medical records and x-rays of the patient should remain.
A final check on the integrity of all sets must be performed before unpacking. The wrapping or packaging must be undamaged and dry, tapes and locking tags intact, and tracing labels valid. The circulating ORP finalizes room set up and is responsible for presenting all material as it is required in a sterile and logical manner to his/her colleague. A good knowledge of the procedure and paying close attention to the operation is thus a prerequisite. The circulating ORP is also responsible for the continuous supervision of aseptic technique and needs of the patient. In a good team, the expertise of both scrub and circulating ORP complement each other.
The circulating ORP has to complete all administrative documentation. The scrub ORP will check and approve it. A count of all instruments, swabs, needles, and other small items should be done before and after surgery. Closing the wound at the end of surgery must be stopped if the second count does not match the first one. The scrub ORP organizes the sterile instruments on the table according to their use and the steps of the operation. Missing instruments will be reported and, if available, immediately replaced. If one or more instruments are contaminated the whole set must be discarded and needs to undergo a further decontamination cycle. Each incident of a missing, damaged, or unclean instrument must be reported so that the problem is avoided in the future.