Adhering to standards

Infection Control Hotline

By Chuck Hughes, Gary Socola and Mariann Pierce

Sterilization standards developed by the Association for the Advancement of Medical Instrumentation (AAMI) are considered voluntary unless adopted by a regulatory authority, yet these standards are extremely influential. So how are AAMI standards developed? Chuck Hughes, who serves on numerous AAMI sterilization committees, and a couple of his colleagues respond to questions on this issue.

Source Notes

CHUCK HUGHES is the general manager and lead educator for SPSmedical Supply Corp., Rush, N.Y. Certified as a health education teacher, he serves on numerous AAMI sterilization committees and has worked for more than 25 years in the manufacturing industry in R&D, regulatory affairs, microbiology, marketing and sterilization training. In 2004, he was awarded “Educator of the Year” by the ASHSCP Inland Empire Chapter of California and received the “Award of Honor” in 2005 from IAHCSMM.

GARY SOCOLA is the vice president of scientific affairs for SPSmedical Supply Corp. He serves on numerous AAMI sterilization committees and supervises SPSmedical’s validation and testing services to medical device manufacturers. Gary has worked for more than 22 years in health care settings in areas of biomedical engineering, sterilization, R&D, quality assurance, regulatory affairs and validation testing.

MARIANN PIERCE is the director of marketing and sales for SPSmedical Supply Corp. She has a master’s degree in business and served on the 2007 ASHCSP educational committee. She travels the country speaking on sterilization topics, providing sales support to field representatives, and performing courtesy audits to hospitals and ambulatory surgery centers for compliance with sterilization standards.

Q: How are AAMI standards developed?

CHUCK HUGHES: AAMI standards are developed using technical committees, subcommittees or working groups composed of health care facilities, health care organizations, trade organizations, government agencies, medical device manufacturers, testing laboratories and consultants. Six basic steps are involved in developing an AAMI standard: 1) Identification of need: A 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: This 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.

Q: When are AAMI standards updated and what is the process?

GARY SOCOLA: Traditionally, AAMI standards are reviewed and updated at least once every five years; however, the new steam standard (ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care settings) is 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, multiyear 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 also is 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 Web site (www.aami.org), which also has instructions on how to submit comments for documents out for public review.

Q: What five standards did the new AAMI ST79 document consolidate?

MARIANN PIERCE: ANSI/AAMI ST79 was published in October 2006 and 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 tabletop 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 nonclinical 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 standards, users now have a single source for finding best practices. It eliminated redundancies and became much more user friendly. 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 [email protected].

Q: Why is adhering to standards important?

HUGHES: 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 health care setting.

According to the Centers for Disease Control and Prevention (CDC), HAIs are one of the top 10 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 percent were urinary-tract infections, 22 percent were surgical-site infections, 15 percent were pneumonia (lung infections) and 14 percent 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 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 housekeeping 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 staff training, with certification recommended for sterile processing personnel as a condition of employment, donning clean facility laundered attire at the hospital, 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 manufacture, distribute, purchase, use and/or reprocess medical devices have a legal and moral obligation to follow best practices for patient safety and document that they have done so.

As an educator who travels the world speaking (sometimes accused of preaching) on best practices, I firmly believe that adhering to standards improves patient care.

Q: What are some common noncompliance areas in health care facilities?

SOCOLA: As one of our many sterilization services, SPSmedical personnel provide both courtesy and fee-based, on-site sterilization audits to health care facilities. During these facility audits, some common noncompliance areas include:

Decontamination temperature not being maintained between 60 degrees and 65 degrees F for staff comfort and to limit microbial growth.
Improper ceiling tiles that facilitate dust accumulation and particulate shedding.
Floors and horizontal work surfaces not cleaned/disinfected at least daily.
Lack of hand washing by personnel upon reporting to work and throughout their shift.
Hair not being completely covered and reusable hats not laundered daily.
Noncertified sterile processing supervisors and technicians.
Inappropriate cleaners and cleaning implements in decontamination.
Dirty items cleaned on the clean side when bioburden is observed during inspection.
Items packaged inside paper/plastic pouches and then placed inside wrapped trays and/or rigid containers.
Improper steam sterilization parameters for complex medical devices.
Nonvalidated items processed in low-temperature processes, e.g., Sterrad.
Instrument sets that exceed 25 pounds causing both ergonomic and sterilization issues.
Placing sterilizer carts under air conditioner vents immediately after processing.
Not allowing processed items enough time to cool prior to distribution.
Wrapped trays stacked in sterile storage.
Sterile storage shelves closest to the floor not covered properly.
Infrequent cleaning of storage shelves and storage bins.
Nonexistent policy and procedures or those that aren’t up to date.
Continuing education (CE) of staff not documented and/or performed regularly.

Q: What can suppliers do to help hospitals adhere to standards?

HUGHES: I strongly believe that health care suppliers play a critical role in adhering to standards. First, when they visit facilities, they should be aware of sterilization best practices with regard 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 million 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.

Second, they should encourage CE by creating certification scholarships for the staff working in sterile processing. These scholarships can offset some or all of the costs associated with study materials, course fees and exam costs.

Third, suppliers can provide low-cost (or better yet, no-cost) CE programs to health care facilities that reinforce best practices as defined by AAMI standards.

This is a win-win situation, as knowledgeable health care workers will see the value in a supplier’s product much more readily.

About this column

This column presents answers and practical guidance to some of the most commonly asked questions of suppliers and educators in the infection control and sterile processing communities. To submit a question to the column, e-mail Bob Kehoe, executive editor, at [email protected].

This article first appeared in the March 2008 issue of Materials Management in Health Care.

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