Last word
Technological advances in surgical techniques, from invasive to minimally invasive surgery, have evolved over the years and have required that surgical instrumentation keep pace. In today’s health care setting, hundreds of thousands of dollars are invested in surgical instruments and instrument inventories usually contain a vast array of devices, ranging from the simple to delicate microsurgical instruments and highly complex instruments in different sizes, shapes and materials.
Some instruments require special cleaning and decontamination processes and/or specific sterilization methods. Additionally, some sets require extended sterilization exposure time, and some pose weight issues.
Set procedure policies
Two key elements should be in place to address and meet these instrument and instrument set challenges: effective processing policies and procedures and a knowledgeable, competent staff who demonstrate consistent performance in accordance with those procedures.
Department managers have an ongoing responsibility to ensure that clearly defined, accurate and up-to-date policies and procedures are developed, implemented and maintained. In addition, managers must ensure that staff receive the necessary education and training to perform the job correctly. Every device manufacturer has the responsibility to provide complete and comprehensive instructions for cleaning/decontamination and sterilization of its product. A summary and interpretation of test results should also be provided to verify that the products can be safely and effectively cleaned and sterilized.
Users have the responsibility to obtain the written manufacturer’s instructions and follow them. Information is needed regarding acceptable cleaning products and cleaning methods for the instruments. Instructions also should be included for the appropriate disassembly of instruments composed of more than one part or with sliding pieces or removable parts and packaging requirements. If rigid sterilization containers are used as packaging, manufacturer instructions regarding set preparation and assembly need to be obtained as well. There are resources that provide general guidelines to assist health care professionals in developing policies and procedures for processing medical devices, including the Association for the Advancement of Medical Instrumentation (AAMI).
There is a newly published standard and recommended practice, AANSI/AAMI ST79: 2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The document is a consolidation of five previous recommended practices that were reviewed, revised and incorporated into the new standard.
The recommended practice provides general guidelines for cleaning and decontamination, assembly, packaging, sterilization and process controls, as well as staff qualifications and education. A section with reference to weight and density of sets is included in the recommended practice. It states that the weight of a set should be based on several factors, including whether staff can safely carry a set, a set’s design, recommendations of the medical device and sterilizer manufacturer and the distribution of mass in the set and sterilizer load.
A maximum weight limit of 25 pounds for a set inside a container is recommended in the AAMI ST77 document. The weight and organization of instrument sets are important factors to take into account.
Heavier instrument sets may have to be divided into more than one set. Devices such as partitions, brackets, posts or silicone mats can be used to organize instruments within a set. Organization helps protect instruments from damage, simplifies the process of replacing missing instruments and helps ensure that complete instrument sets are in service.
As instrument technology advances, instrument-processing protocols will require revisions to meet the changing demands. Staff will require continuous education and training to keep current with the latest data and techniques.
Efforts will not only impact instruments and instrument sets, but also patient safety, quality of care and a facility’s bottom line.
Arlene Carlo, R.N., is a consultant and clinical specialist and educator for Case Medical Inc., Ridgefield, N.J.
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