Adhering to Standards
by Chuck Hughes
Sterilization standards developed by the Association for the Advancement of Medical Instrumentation (AAMI) are designed to reach a broad audience from medical device manufacturers to health care facilities. While compliance is considered voluntary (unless adopted by a regulatory authority), AAMI standards are extremely influential.
Standards should be adhered to in any profession because they reflect the values of that profession. In health care, adherence to sterilization standards is critical to ensure patient safety as one of our greatest threats is health care associated infections (HAIs). HAIs are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting. According to the Centers for Disease Control and Prevention (CDC), HAIs are one of the top ten leading causes of death in the United States each year affecting an estimated 1.7 million patients and causing 99,000 deaths. Of these reported infections; 32% were urinary tract infections, 22% were surgical site infections, 15% were pneumonia (lung infections) and 14% were bloodstream infections. The CDC believes these statistics will get worse as many of these preventable infections can no longer be treated with traditional antibiotics.
AAMI sterilization standards are developed using technical committees, subcommittees or working groups comprised of heath care facilities, health care organizations, trade organizations, government agencies, medical device manufacturers, testing laboratories and consultants. There are six basic steps in developing an AAMI standard: 1) Identification of Need – proposal is submitted regarding an issue and the level of interest is assessed in developing a document to address the issue. 2) Activation of a New Work Item - authorization is obtained from the AAMI Standards Board to charter a new technical committee or an existing committee to begin the new work. 3) Developing a Working Draft – a draft document is developed that reflects as many viewpoints and types of expertise as possible. Several working drafts are expected to be submitted and worked on during this step. 4) Reaching Consensus – committee ballot and public review is the next step and most important part of developing a standard. Committee members as well as individuals and organizations beyond the committee view the document and provide written comments. Upon consensus by the committee, the draft standard is submitted to the AAMI Standards Board for approval. 5) Approval – is granted after conducting a procedural review or audit of the previous steps in the process. Most documents are then submitted to the American National Standards Institute (ANSI) for approval. American National Standards may be used by the International Standards Organization (ISO) as the basis of international standards. 6) Review - each AAMI standard is considered a static document subject to periodic review to ensure content is still relevant. With each review, a standard may be reaffirmed without change, withdrawn or recommended for revision.
Traditionally, AAMI sterilization standards are reviewed and updated at least every five (5) years; however, the steam standard (ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care settings) is maintained under continuous maintenance procedures. Comments or proposals for revisions may be submitted to AAMI at any time. This comprehensive document consolidated five previous standards and revised them to reflect current best practices. The purpose of continuous maintenance is to permit standards and guidelines to evolve and be updated on a regular basis (as opposed to a fixed multi-year cycle). As such, proposals for revisions are sought from interested and knowledgeable parties; such as OR nurses, central service/sterile processing and infection control professionals. While participation from the medical industry is also vital, it is the clinical professional who can identify the important issues of safety and effectiveness that standards are intended to address. Clinical professionals are encouraged to join an AAMI technical committee by visiting the AAMI website (www.aami.org). The AAMI website also has instructions on how to submit comments for documents out for public review.
In 2006, AAMI consolidated the following documents: ANSI/AAMI ST46 - Steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST42 – Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical and dental facilities; ANSI/AAMI ST37 – Flash sterilization: Steam sterilization of patient care items for immediate use; ANSI/AAMI ST35 – Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings (with respect to steam sterilization only); and ANSI/AAMI ST33 – Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities.
By consolidating these five documents, users now can use AAMI ST79 as a single source for finding best practices. This eliminated redundancies and became much more user friendly.
AAMI standards stress that sterilization requires a systems approach and involves more than just the parameters set on the sterilization equipment used to process items. Adhering to standards involves facility design which emphasizes thorough house keeping of floors, walls, work surfaces and storage areas; special attention to air flow (negative pressure in decontamination, positive pressure in clean areas), and such things as keeping pass through windows and doors closed when not in use. Adhering to standards involves personnel training with certification recommended for sterile processing personnel as a condition of employment, donning clean - facility laundered attire at the facility, and frequent hand washing. Adhering to standards involves surgery preparing and transporting soiled items properly for decontamination; cleaning, disinfecting, inspection, assembly, packaging, sterilization and careful storage of processed items. Health care professionals who manufacturer, distribute, purchase, use and/or reprocess medical devices have a legal and moral obligation to comply with sterilization standards for patient safety and to document they have done so.
At a minimum, every CS department should purchase AAMI ST79 and update their reprocessing Policy & Procedures (P/P) referencing this comprehensive standard. Health care workers on all shifts should be in-serviced on the updated P/Ps and establish a routine schedule of continuing education (CE) days to reinforce these best practices. Supervisors should routinely observe staff for compliance with emphasis that sterilization requires a systems approach and is a patient safety issue. From a facility design standpoint, CS departments should assess the cleanliness of work stations, equipment and storage areas. They should meet with Environmental Services and Infection Control to discuss ways to maintain cleanliness and define areas of responsibility. CS departments should establish a career ladder program with pay increases for sterile processing staff that become certified. They should seek out low cost CE programs that allow sterile processing staff to stay up to date on best practices and to maintain certification. All health care departments should continually remind staff as to the importance of hand washing and keep sinks or waterless systems easily accessible. From a reprocessing point of view, it is important to emphasize that cleaning and decontamination are the first and most critical steps in reprocessing soiled items. The OR, CS and IC should get together and establish a zero tolerance policy when it comes to bioburden which starts with not allowing blood to dry on items after surgery. The use of enzymatic spray and/or a wet towel is recommended whenever there is a delay between surgery and decontamination. IC should routinely inspect the OR and CS departments for compliance with sterilization standards.
Health care suppliers also play a critical role in adhering to standards. When they visit facilities, they should be aware of sterilization best practices with regards to proper attire, hand washing, and authorized entry into restricted areas. Studies have shown that a person in street clothes can shed up to 10,000 particles per minute simply by walking. Therefore, before entering restricted areas, all staff and visitors should change into clean, hospital attire to limit contamination of these areas. Health care suppliers should encourage continuing education (CE) by creating scholarships for sterile processing technicians and managers who wish to get certified. These scholarships can offset some or all of the costs associated with study materials, course fees and exam costs. Lastly, health care suppliers should provide low-cost (or better yet, no-cost) continuing education (CE) programs directly to health care facilities that reinforce best practices as defined by AAMI standards. This is a win-win situation, as knowledgeable HCWs will see the value in a supplier’s product much more readily.
AAMI standards are adopted by ANSI as our American National Standard and are available for purchase in both text and CD-ROM format.
For more information, call (703) 525-4890, fax (703) 525-1067 or e-mail standards@aami.org.
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