CIS Lesson Plans provide members with ongoing education in the complex and ever-changing area of surgical instrument care and handling. These lessons are designed for CIS technicians, but can be of value to any CRCST technician who works with surgical instrumentation.
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Certified Instrument Specialist (CIS) technicians must effectively clean, decontaminate and sterilize surgical instruments. While all instrumentation poses specific challenges, they must assemble instrument sets that can be safely lifted and handled. This requires knowledge of original equipment manufacturer (OEM) recommendations and guidelines developed by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI). This lesson provides background information helpful to implement strategies that address instrument set weight and density concerns.
The term “weight” refers to a measure of the gravitational force on an object, and it indicates how heavy the object is in comparison to a standard. The United States uses the avoirdupois measurement system for most items, and the basic element of weight is one pound, which weighs 16 ounces or 7,000 grains.
“Density” refers to a measure of mass per unit of volume, which is the amount of matter in an object that creates its weight per unit of volume (three-dimensional size). Consider, for example, the difference in the volumes of a one-pound loaf of bread, which is comprised in large part of air, and a gold bar the size of a candy bar that weighs six pounds. In the same way, two fully-loaded rigid containers of the same size (interior dimensions) can have different weights, depending upon the density (mass) of their contents.
ANSI/AAMI ST79 addresses the weight and density of surgical instrument sets used within healthcare settings.1 For example, it states that the preparation and assembly of instrument sets are dependent upon a variety of conditions and variables with which each CIS technician should be familiar. The purpose is to ensure adequate cleaning, decontamination and sterilization to provide a safe product for patient use.
Instrument sets processed entirely inside a configured metal or molded plastic tray may not be adequately cleaned. Therefore, during sterilization, the instruments may not be subjected to adequate steam contact on all surfaces, thereby, causing a sterilization failure. The OEM must provide documented success with processing the particular instrument set in this fashion, and this documentation should remain on file in your facility. However, it should not be used as ‘blanket proof’ for all sets of this nature because it is only applicable to this specific set from the OEM. Sets without this documentation should be removed from the container for cleaning. Individual instruments require visual inspection to ensure they are fully functional and clean with each processing.
The general health and safety of the staff that handle sets within Central Sterile Supply Department areas and transport them to surgery suites may also be impacted. Instrument sets are moved many times in a full cycle of processing – all the way to utilization. They must be lifted into soak sinks, then onto conveyors or carts for washing, and then to the workbench. Sets then move to the sterilizer cart and on to the transfer cart or case cart. From this point, they may possibly move onto a storage shelf, after which they must be transported to the point of use for presentation to the sterile field. The sterile scrub person lifts them onto the sterile field to begin the procedure and then finally loads the used set onto a transport vehicle for return to the CSSD. As just seen, then, there is a minimum of nine times that staff can be injured while moving just one instrument set.
Overweight sets might also be dropped and cause injuries to staff members and damage the instruments themselves. As well, heavier-than-appropriate set weights, including those provided by vendors, can cause back and shoulder injuries to those handling them. Rigid containers owned by the facility or provided by vendors are relatively heavy, and their empty weights must be considered when handling procedures are developed.
These concerns are addressed by a revised standard within ANSI/AAMI ST79 that considers the weight and the density of instrument sets being sterilized. It establishes a 25-pound maximum allowable weight for an instrument set that meets the manual lifting standard proposed by the National Institute for Occupational Safety and Health (NIOSH) and based on NIOSH calculations for manual lifting.2
ANSI/AAMI ST79 provides detailed information about instrument set preparation and sterilization, while recognizing that the most common concern confronting CIS technicians is the prevention of cleaning and sterilization errors. One special challenge is to prevent wet packs (residual moisture) within sets. Moisture compromises barrier protection, serves as a reservoir to promote bacterial growth, and causes pitting and rusting on instrument surfaces and articulation points which, in turn, impact instrument performance.
ANSI/AAMI ST79 stresses that wet packs are a top priority of the sterilization department. It specifies that any set containing moisture or with visible water inside the container system should be considered contaminated. CIS technicians must randomly open sets at the end of prescribed drying/cooling times to determine if processing procedures are in place to consistently prevent residual moisture condensation within sets. Policies are required to address strategies that reduce the incidence of wet packs and establish requirements to report and track their occurrence.
The weight of an instrument set is also addressed within ANSI/AAMI ST79. For example, it indicates that the weight of an instrument set should be based on four factors: whether personnel can use proper body mechanics in carrying the set; on the design and density of the individual instruments comprising the set; on the recommendations of the medical device and sterilization manufacturers; and on the distribution of mass (density) in the set and sterilizer load. Note: Total set weight includes the combined weight of the container and the instruments it contains and, as noted above, the maximum limit is 25 pounds.
CIS technicians operating sterilizers must be mindful of the need for equal weight and dimension distribution of loads to allow for adequate air circulation, steam penetration and instrument surface contact. Steam sterilization failure can result when sets are packed too tightly, even if they are below maximum allowable weights. Original equipment manufacturers of sterilizers and containers typically offer guidelines for set and rack placement to prevent wet packs, and they should be consulted to help assure effective sterilization and maximize throughput.
ANSI/AAMI ST79 also addresses load drying and cool-down times. Steam quality affects the drying time of sterilizer loads and must be addressed in applicable protocols. Sample load configurations must also be utilized to establish guidelines for positioning trays and peel packages of specified weights to minimize steam sterilization failures.
Placement of specific instruments within sets should follow guidelines established by ANSI/AAMI ST79. Always consult the OEM’s instructions about instrument placement, the use of specialized containers, and instrument set assembly. All instruments should be disassembled unless the OEM provides instructions supported by test results to the contrary. Instruments should be open, unlocked and positioned to allow for maximum steam penetration and surface contact. Lumens should be moistened with distilled or demineralized water to assure adequate moisture and steam generation along the entire length of the lumen. Heavy instruments should be placed on the bottom of the tray with their lighter and more delicate counterparts placed above them and secured from movement by devices, such as baskets, instrument racks, tip protectors, and silicone mats. Note: Silicone mats or similar devices may cause moisture pooling, and they should be used sparingly (and then only after audits confirm that sets are dry after sterilization).
Four steps are important in managing set weights and densities. The first and most important step is to audit sets in their current configuration. The audit methodology and the actual evaluations should be consistently conducted and with the customers’ cooperation and knowledge. Sets weighing more than 25 pounds should receive a priority as action plans are developed to make sets compliant with ANSI/AAMI ST79. The best times to conduct audits including the weighing of sets is when there is likely to be minimal customer need for them. A dedicated team can be tasked with the audit process and with the next step in the set audit process.
The second step involves identifying sets that weigh less than the 25 pound standard, but which are too dense (tightly-packed). These sets include those with a high failure rate due to wet packs and those with a high rate of instrument damage due to density. These, along with excessive weight sets, should receive a priority for reconfiguration.
One tactic to achieve compliance is to break sets down into smaller components. For example, heavy retractors that can damage delicate instruments can be placed into secondary containers and labeled accordingly. Figure 1 shows the contents of an overweight set used for a hysterectomy. It has been broken down into two trays. The one in the foreground is used for open abdomen hysterectomies, and the tray in the background was constructed for the instruments and retractors used for vaginal hysterectomies.
These sets for open abdomen hysterectomies (foreground) and for vaginal hysterectomies
(background) were previously combined into one tightly-packed set.
After set reconfiguration, the third step involving the education and training of OR and CSSD staff about set changes becomes vital. Tray inventory and pick sheets will require revision, and they can be used during training to identify specific set changes.
Instrument sets can be audited as they begin the decontamination and cleaning process. Used instruments can be identified and tallied onto laminated copies of tray inventory audit sheets. Note: Lamination allows for easy cleaning and reuse. CSSD and Surgical team members must consider all surgical procedures for which each set is used and consider any other information to determine actual instrument usage. With agreement of CSSD and Surgical managers, instruments with no usage during the audit period might be removed from the set and made available in peel packages.
The configuration of sterilization racks with loads of instrument sets, peel packages, wrapped basins, and other items is another important consideration. This comprises the fourth step in managing set weights and densities. Photos of loads compliant with the reduction of wet packs can be used to template a standard load configuration. Note: Many sterilizer manufacturers provide illustrated guides of standard load configurations and can provide expert assistance about load parameters. Instrument and device manufacturers should provide exposure and dry time data, along with temperature recommendations, to develop sterilizer settings that meet OEM guidelines. These can be used to template the load and achieve compliance with ANSI/AAMI standards.
Sets weighing between 18 and 25 pounds should be stored on shelves at waist level, while lighter items can be stored at higher and lower levels. Ergonomic studies of CSSD areas to discover ways to reduce fatigue, discomfort and injuries should be part of plans to provide a safer work environment. CIS technicians should not carry more than one set at a time, and they should use racks and rolling carts to safety transfer in-process instrument sets. Note: Figure 2 illustrates two common problems. First, the technician should bend at the knees and use leg (not back) muscles to lift this heavy soiled tray. Also, surgery staff should have placed the tray on the top (not lower) cart shelf to make the tray about waist high.
Can you identify two problems in this photo?
CIS technicians and operating room personnel will realize decreased risks of back and shoulder lift injuries when instrument sets are properly designed. Repetitive motions including lifting, turning and carrying can lead to work-related injuries, and reductions in the weight and density of instrument sets can minimize these risks.
Additional benefits of correctly designed instrument sets include a reduction in wet packs and sterilization failures and decreases in instrument damage caused by moisture or impact damage. CIS technicians handling instrument sets of proper weight and density will also be able to do so more quickly and efficiently.
1. ANSI/AAMI ST79. 2006. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Note: Section 8.4.2 relates to instrument set weights and densities.
2. National Institute for Occupational Safety and Health. Applications Manual for the Revised NIOSH Lifting Equation. NIOSH Publication No. 94-110. 1994. Available online at: http://www.cdc.gov/niosh/docs/94-110
David Narance, RN, BSN, CRCST
Nurse Manager, Sterile Reprocessing
Med Central Health System
Carla McDermott, RN, ACE
Morton Plant Mease Healthcare
Jack D. Ninemeier, Ph.D.
Michigan State University
East Lansing, MI