New AAMI Standards Impact the CS/SP Department

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New AAMI Standards Impact the CS/SP Department

By Frank Sizemore, ACSP, BS

The Association for the Advancement of Medical Instrumentation (AAMI) produces recommended practices for sterilization that upon implementation can make a significant impact on the daily life of the central service (CS) or sterile processing (SP) department. The standards, developed by industry leaders, professional organizations, interested users and consultants, are meant to provide guidelines to aid CS/SP departments in providing safe and effective patient care. The documents are periodically reviewed to assure the information is still valid and necessary. Since they are consensus documents, significant discussion and debate normally transpire during the review process.

The most recent document to be completed is Steam Sterilization and Sterility Assurance in Healthcare Facilities (ST46). This document, originally called Good Hospital Practice: Steam Sterilization and Sterility Assurance, was last approved by the American National Standards Institute (ANSI) in November 1993. The new document, which should be available for purchase soon, has been expanded in several areas to include new information.

The revised document contains information regarding the different classifications of chemical indicators (CI). AAMI currently recognizes five classes:

  • Class 1 (process indicator): chemical indicator intended for use with individual units (e.g., packs, containers) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units
  • Class 2 (Bowie-Dick test indicator): chemical indicator designed for use in a specific test procedure (e.g., the Bowie-Dick test)
  • Class 3 (single-parameter indicator): chemical indicator designed to react to one of the critical parameters of sterilization and to indicate exposure to a sterilization cycle at a stated value of the chosen parameter
  • Class 4 (multi-parameter indicator): chemical indicator designed to react to two or more of the critical parameters of sterilization and to indicate exposure to a sterilization cycle at stated values of the chosen parameters
  • Class 5 (integrating indicator): chemical indicator designed to react to all critical parameters over a specified range of sterilization cycles and whose performance has been correlated to the performance of the stated test organism under the labeled conditions of use

This type of information is extremely important to the CS/SP professional. In today's legal environment, many of us are concerned about under monitoring our sterilization loads. The standard has been the same for years -- biologically monitor at least weekly, preferably daily. An implantable device should be biologically monitored, and if possible, quarantined until the results are available. Those who have been involved with a product recall as a result of a positive biological know the expense and headaches associated with attempting to account for each item. Since recall procedures stipulate that all items be pulled since the last negative biological indicator, if the biological monitoring were done weekly, the majority of those items would have been used. Given that, the majority of hospitals are doing at least daily monitoring, and a few hospitals are monitoring every load. In today's economic environment, we are keenly aware of the expense of biologically monitoring every load. Given the impact of decreasing reimbursement to healthcare facilities, CS/SP professionals are often charged to providing a certain level of service while staying within fiscal budgets.

One option to maintain service and costs is to use an integrating indicator (a Class 5 device), which is correlated to a biological indicator, to monitor every load. This provides the CS/SP professional and the healthcare facility the opportunity to issue supplies with a higher level of confidence. Using an integrating indicator does not eliminate the need for biological monitoring. This should continue based on your policies, established by the infection control and safety committees. Additional information concerning chemical indicators can be found in ANSI/AAMI ST60, Sterilization of Healthcare Products -- Chemical Indicators Part 1: General Requirements.

Another significant area of the document to be expanded is the biological indicator section. Since this document was last updated, an addition of enzyme-based biological indicators with early readout capabilities became available. This capability allows the user to release loads in as little as three hours for prevaccum cycles -- a significant improvement over the previous 48-hour incubation period. Since these indicators use a naturally occurring enzyme, it is important to periodically "grow out" the culture. Simply following the manufacturer's recommendations should be adequate.

As stated earlier, the AAMI recommended practices are an important part of the CS/SP professional's resources. Since the AAMI documents evolve with time, the steam-sterilization working group is currently creating a new paper that could incorporate a number of different documents. This new document, designed to cover all aspects of the steam sterilization process, will include the following: Steam Sterilization and Sterility Assurance in Office-Based, Ambulatory-Care Medical and Dental Facilities (ANSI/AAMI ST42:1998), Steam Sterilization and Sterility Assurance in Healthcare Facilities (ANSI/AAMI ST46:2002), Good Hospital Practice: Flash Sterilization-Steam Sterilization of Patient-Care Items for Immediate Use (ANSI/AAMI ST37:1996), Good Hospital Practice: Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems (ANSI/AAMI ST33:1996). Its title will be Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities (ANSI/AAMI ST37). As you can tell, this will be an encompassing document and will require a great deal of work to complete.

For an undertaking like this to be truly effective, it is imperative to have user feedback. Many of the working groups have a small number of users actually contributing to the documents as they are developed. My challenge to you is to become involved, provide feedback and make these documents usable for your needs.

Frank Sizemore, ACSP, BS, is manager of central services at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. and is president-elect to the American Society for Healthcare Central Service Professionals (ASHCSP).

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