CRCST
Technical Continuing Education (TCE)
SELF-STUDY PLANS

This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 91
Getting to Know AAMI
[Reprinted from Communiqué: November/December 2006]

The overall mission of the Association for the Advancement of Medical Instrumentation (AAMI) is to advance medical instrumentation. The AAMI is a unique alliance of over 6,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation. AAMI is a voluntary consensus organization whose members include health care institutions, research and teaching facilities, government agencies, trade associations, manufacturers, health care professionals, regulators, scientists, and others that develop guidelines for the proper processing of medical devices. The AAMI standards program consists of over 100 technical committees and working groups that produce guidelines to help ensure that medical instrumentation is safe for patient use. AAMI provides two basic types of resources for Central Service personnel: its series of Standards and Recommended Practices, which is referenced most often, and its Technical Information Reports (TIRs).

AAMI Standards and Recommended Practices represent a national consensus, many of which have been approved by the American National Standards Institute (ANSI) as American National Standards. The AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGS).

AAMI fulfills its mission to advance medical instrumentation through:

• continuing education and conferences
  
  
• certification of health care technical specialists (biomedical)
  
  
• the publication of technical documents, periodicals, books, and software
  
  

Objective 1: Explain the purpose of AAMI Standards and Recommended Practices.

The publication of an AAMI-recommended practice or standard suggests a consensus of those substantially concerned with its scope and provisions. An AAMI recommendation does not, however, prevent anyone—whether or not they have approved the recommended practice or standard—from manufacturing, marketing, purchasing, or using products, processes, or procedures that do not conform to the recommended practice.

Users are cautioned to obtain the latest editions of AAMI-recommended practices and standards because they are subject to periodic review and revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw a recommended practice or standard no later than five years from the date of the publication. (Information on obtaining AAMI publications appears at the end of this lesson.)

Standards, recommended practices, TIRs, and other technical documents developed by the AAMI are voluntary; it is up to the document's user whether or not to apply its content. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations.

A recommended practice provides guidelines for the use, care, or processing of a medical device or system, but does not directly address device performance. Instead, it provides procedures and practices that will help ensure that a device is used safely and effectively, and that its performance will be maintained.

Although a device standard is directed primarily at the manufacturer, it may also be of value to the potential purchaser and user as a frame of reference for device evaluation. Similarly, although a recommended practice is usually oriented toward health care professionals, it may also help the manufacturer to better understand the environment in which a device will be used. Also, some recommended practices which do not address device performance factors do provide industrial personnel with guidelines on subjects such as sterilization processing, human engineering, methods of collecting data to establish safety and efficacy, and other processing or evaluation techniques. These guidelines may help health care professionals understand industrial practices.

Objective 2: Discuss the purpose of AAMI Technical Information Reports and explain how they differ from AAMI Standards and Recommended Practices.

AAMI publishes Technical Information Reports (TIRs) developed by technical committees under the auspices of the AAMI Standards Board. Each TIR addresses a specific aspect of medical technology. While a TIR may need further evaluation and development by experts, the report is still valuable because the health care industry has an immediate need for the information it contains.

A TIR differs markedly from an AAMI standard or recommended practice publication, and Central Service managers should understand the differences between these documents.

First, standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments before being released. This consensus process is supervised by the AAMI Standards Board. Many AAMI standards and recommended practices are developed in conjunction with ANSI, which coordinates the development of voluntary standards in the United States. (Those standards developed in conjunction with AAMI are then referred to as ANSI/AAMI standards.) By contrast, TIRs are not subject to the same formal approval process, but are approved for distribution by a technical committee of the AAMI and by the AAMI Standards Board.

There are other important differences between standards, recommended practices, and TIRs. For example, although both are periodically reviewed, a standard or recommended practice must be acted on (either reaffirmed, revised, or withdrawn), and the action formally approved (usually every five years, but at least every ten years) by the AAMI working committee members. In contrast, a TIR receives a technical committee review about five years after its publication date, and periodically thereafter, to assess whether the document's guidance is still useful. If so, the AAMI continues to endorse and circulate the TIR; if not, the TIR is removed from circulation.

TIRs may be revised or withdrawn at any time. Because they address rapidly-evolving fields of technology, readers must always ensure that they are using the most recent TIR, along with any additional information that may be more recent than that TIR. Therefore, the TIR's date of issue is critical in establishing the context for and accuracy of the report's information.

TIRs may be developed because they are more responsive to underlying safety or performance issues than an applicable AAMI standard or, alternatively, because achieving consensus on a specific topic may be extremely difficult, or even unlikely. Unlike AAMI standards and recommended practices, a TIR permits the inclusion of differing viewpoints about technical issues.

Objective 3: Discuss ways in which AAMI Standards and Recommended Practices affect the operation of Central Service departments.

AAMI device standards such as those for hospital steam and ethylene oxide sterilizers and biological indicators are used primarily by equipment manufacturers. However, they can be beneficial to device users or processing personnel. For example, AAMI has developed a standard for containment devices for reusable medical device sterilization which addresses design, performance, labeling criteria and weights for reusable rigid sterilization containers and instrument cases, cassettes, and organizing trays, including loaner instrumentation. Its provisions stem from practical reprocessing concerns such as drying times and the need to achieve sterilization within standard exposure paramenters.

Recommended practices, by contrast, are intended to be used by health care facilities. For example, ANSI/AAMI ST79,¹ Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, was released in 2006. It combines information previously published in five separate recommended practice documents, and provides a comprehensive and crucial resource for steam sterilization in healthcare facilities regardless of the size of sterilizer or facility. Every Central Service manager and staff member should be familiar with this document because it details a basic foundation of requirements necessary for the safe handling, processing, decontamination, and sterilization of medical instruments and devices.

Let’s use ANSI/AAMI ST79 as a “case study” to learn more about its coverage of sterilization procedures that must be known and practiced by Central Service staff. This comprehensive document contains approximately 115 pages of general information, and an additional 65 pages of specific annexes (appendices), figures, and tables. Contents are organized into eleven major sections:

• Scope – This introduction reviews the general purpose of ANSI/AAMI ST79: to provide decontamination and steam sterilization guidelines for hospitals and other healthcare facilities to promote sterility assurance and assist personnel in the proper use of processing equipment.

• Definitions and abbreviations – An extensive list of key terms applicable to steam sterilization suggests vocabulary basics for Central Service professionals.

• Design considerations – Sterilization workplace design and maintenance guidelines facilitate effective and efficient processing, promote personnel safety, minimize environmental contamination, and maintain the sterility of processed items. The use of centralized processing, whenever possible, is encouraged. The reason: sterilization is a complex process that requires environmental controls, appropriate equipment and supplies, adequate space, qualified and competent personnel, and quality assurance monitoring that is best centralized rather than replicated in different areas. In situations where centralized sterilization processing is not possible, consistent policies and procedures should be maintained, sterilization processing should be under centralized control, and work practices recommended in ANSI/AAMI ST79 should be followed in each location. Details relating to work area design and functional workflow, physical facilities, and applicable housekeeping procedures are provided.

• Personnel considerations – Guidelines for personnel qualification, training, and education are provided, and minimum criteria for personnel health, personal hygiene, and attire are identified. All aspects of steam sterilization processing must be performed and supervised by knowledgeable personnel to minimize bioburden and contain (control) environmental contamination. This section details qualifications and training/continuing education needs for supervisory and non-supervisory personnel, addresses health and hygiene concerns, and explains attire and precautions to supplement infection control practices relating to the OSHA blood-borne pathogen regulation.²

• Receiving – Sterility assurance “begins at the loading dock:” the point where the facility assumes responsibility for incoming medical equipment, devices, and supplies. Sterility assurance measures must be in place and consistently implemented from the time items are received until used. Recommendations applicable to recently purchased and repaired reusable items, rigid sterilization container systems, and disposable products are presented as is the disposition of sterile items which have been issued but not used.

• Handling, collection, and transport of contaminated items – Contaminated items must be segregated and carefully handled at the point of use and from this location to the decontamination area. The possibility of items being contaminated with infectious material is greatest at the point of use (patient contact). However, procedures for safely transporting items are important because people, including those not wearing personal protective equipment (PPE), can be exposed to potentially disease-producing microorganisms during transport. The support of and input from the facility’s infection control and hazardous materials committees are necessary to protect personnel, patients, and the environment from contamination and to comply with OSHA regulations that limit occupational exposure to blood-borne pathogens. Process audits are required to insure that procedures are followed, and action plans addressing problems noted must be developed. As well, follow-up audits can help insure that observed problems, if any, are corrected. Recommendations address the separation of waste and reusable items and the care and handling of contaminated reusable items at point of use, containment to prevent personnel contact during transport, and the transport process itself.

• Cleaning and other decontamination processes – To be safe to handle, some medical devices require only thorough cleaning; others must be cleaned and subjected to a microbiocidal process. Some reusable devices will be ready for patient reuse after being decontaminated, and others will require terminal sterilization. ANSI/AAMI ST79 notes that the type of decontamination required for a particular device depends upon the biohazard presented. Then the appropriate cleaning and/or microbiocidal process depends upon the device manufacturer’s written instructions, the necessary level of microbial kill, the design and other characteristics of the device, and whether it was exposed to prions including those causing Creutzfeldt-Jakob disease (CJD). This section provides information relating to policies, procedures, and manufacturers’ instructions, and to presoaking, disassembly, and cleaning. It also presents recommendations about microbiocidal processes and others for servicing and repairing devices in the health care facility.

• Packaging, preparation, and sterilization – This section details alternative methods and techniques for packaging medical devices, the assembly and preparation of instrumentation for sterilization, the sterilization process itself, and sterilization storage and distribution. Not surprisingly, this is a major section of ANSI/AAMI ST79, and it provides detailed guidelines about the selection of packaging materials, package configurations and preparation, and the preparation and assembly of surgical instrumentation. It also provides guidelines for loading the sterilizer, sterilization parameters, monitoring sterilization cycles, and unloading the sterilizer. Follow-up activities (sterile storage, general distribution procedures, transport of sterile packaged items and aseptic presentation of sterile instruments) are also discussed.

• Installation, care, and maintenance of sterilizers – Effective care and maintenance of steam sterilizers minimizes down time and helps prevent sterilizer malfunctions. The maintenance and operating instructions specified by the manufacturer must be consistently followed regardless of whether the equipment is new, remanufactured, refurbished, or reconditioned. Recommendations relate to installation, routine care, preventive maintenance, equipment calibration, and recordkeeping requirements.

• Quality control –In its broadest sense, quality control involves the continuous supervision of personnel performance and work practices, and the on-going verification of adherence to established policies and procedures. This section provides guidelines relating to the monitoring of mechanical cleaning equipment, product identification/traceability, and the use of physical, chemical, and biological monitoring of steam sterilization cycles. Guidelines are also noted for residual air (Bowie-Dick type) testing of dynamic air removal sterilizers, periodic quality assurance, product recalls, and other quality control measures. Sterility assurance requires continuous attention to both sterilizer performance and all aspects of the steam sterilization process, because the abuse or misuse of sterile packaging or the lack of standardized inspection and monitoring programs can compromise sterilization quality. Quality control guidelines addressed in this section concern:
• Mechanical equipment monitoring.
• Product identification and traceability.
• Sterilization processing monitoring devices.
• Routine load release.
• Routine sterilizer efficacy monitoring.
• Qualification testing.
• Periodic product quality assurance testing of routinely processed items and rigid sterilization container systems.
• Product recalls.

• Quality process improvement – Performance measures and process monitors are needed for continuous quality improvement (CQI) programs. CQI programs provide an effective means to improve sterilization process performance, and they should address decontamination, preparation and packaging, sterilization, quality control, sterile storage, and product distribution. Guidelines are presented relating to the quality process for decontamination, rigid sterilization container systems, and flash sterilization. As well, functional areas for product and process improvements and for implementing improvements in these areas are noted.

Conclusion

Unlike any other AAMI document, AAMI ST79 will be reviewed annually. The purpose of this continuous maintenance effort is to permit its standards and guidelines to evolve and be revised regularly rather than on a fixed multi-year amendment cycle.

AAMI has established a notification registry to enable update notices to be circulated. AAMI resources are a necessity for all Central Service Departments. They can be purchased from the AAMI at: AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA, 22201-4795, or online at: www.AAMI.org.

Endnotes

1. ANSI/AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. American National Standard ST79. Association for the Advancement of Medical Instrumentation. 2006.
   
2. OSHA blood-borne pathogen regulation. 29 CFR 1910.1030.