Top 10 things OR nurses should know about the AAMI standards

AORN Journal, Oct, 2005

The Association for the Advancement of Medical Instrumentation's (AAMI's) standards and guidance documents for medical equipment reach a broad audience: from the manufacturers who design and produce medical devices in state-of-the-art factories, to the fast-paced clinical engineering departments where biomedical engineers repair and service equipment, and into the tension-filled ORs where the devices are put into use by OR nurses. In a perfect world, every OR nurse would have intrinsic knowledge of the AAMI standards that might affect his or her daily work, but in this high-pressure field it is understandable that someone might choose a few hours of sleep over studying up on the latest guidance for selecting surgical gowns. For the many OR nurses juggling hectic work schedules, family responsibilities, continuing education requirements, and so much more, we offer the top 10 things every OR nurse should know about the AAMI standards.

10. THE AAMI STANDARDS, RECOMMENDED PRACTICES, AND TECHNICAL INFORMATION REPORTS ARE DIFFERENT ANIMALS. The term AAMI standards actually covers several different kinds of technical documents, each with a specific purpose and readership and development procedure.

An AAMI medical device standard contains labeling, safety, and performance requirements for a particular medical device, as well as test methods that can be used to verify that the requirements are met. While device users may find a medical device standard of value as a reference for device evaluation, a device standard is directed primarily to the manufacturer, and it is the manufacturer who chooses whether to comply with it. The AAMI has promulgated dozens of device standards. Examples of AAMI medical device standards pertaining to sterilization are American National Standards Institute (ANSI)/AAMI ST55 (ie, Table-top steam sterilizers); ANSI/AAMI ST21 (ie, Sterilization of healthcare products--Biological indicators--Part 2: Biological indicators for ethylene oxide sterilization); and ANSI/AAMI PB70 (ie, Liquid barrier performance and classification of protective apparel and drapes).

An AAMI recommended practice provides guidelines for the use, care, evaluation, or processing of medical devices, including sterilization practices in hospitals, as well as industrial sterilization practices. Operating room nurses are probably most familiar with AAMI's large body of work in the area of sterilization in health care facilities. Among these recommended practices are ANSI/AAMI ST46 (ie, Steam sterilization and sterility assurance in healthcare facilities); ANSI/AAMI ST37 (ie, Flash sterilization: Steam sterilization of patient care items for immediate use); and ANSI/AAMI ST35 (ie, Safe handling and biological decontamination of medical devices in healthcare facilities and in nonclinical settings).

An American National Standard is an AAMI device standard or recommended practice that has been approved by the ANSI as having been developed and promulgated in accordance with ANSI requirements for consensus and due process, including being subject to public review. Virtually all AAMI standards and recommended practices become American National Standards.

An AAMI technical information report (TIR) is a review of technical issues relevant to technology or health care practice and a statement of expert opinion released by a technical committee. A TIR can be anything from a literature review to a guidance document. A TIR does not contain "requirements" and does not go through the same formal development and approval process as a standard or recommended practice. An AAMI TIR may be directed primarily to device manufacturers (eg, TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for device manufacturers) or health care personnel (eg, TIR11 Selection of surgical gowns and drapes in healthcare facilities).

9. THE AAMI STANDARDS ARE VOLUNTARY. Compliance with AAMI standards and recommended practices is strictly voluntary, unless they are adopted by a regulatory authority, in which case it is the regulatory authority's responsibility to enforce compliance. Device manufacturers are not obliged to comply with a standard unless they claim to do so in their labeling. Health care professionals are not obliged to comply with a recommended practice unless it becomes an accreditation or regulatory requirement (eg, the state of New Jersey requires compliance with AAMI's recommended practice on flash sterilization).

8. ALL INTERESTED PARTIES PARTICIPATE IN A TECHNICAL COMMITTEE. The AAMI technical committees are composed of representatives of the medical device industry, representatives of health care organizations and health care facilities, government representatives, academic scientists, and individual experts.

7. THE AAMI STANDARDS ARE DEVELOPED BY CONSENSUS. What is consensus? In the AAMI's standards-development program, consensus is substantial agreement among interested parties. Substantial agreement is hard to define precisely. It is considerably more than a majority of the committee members and requires agreement within each interest category represented on the committee, as well as between the various interests. Unanimous agreement is not required to claim consensus, but it is often achieved.