There is a saying within the standards developing community that when standards are done well and implemented correctly, they are practically unnoticeable to the general public. One of the primary purposes of standards is to remedy problems that can arise within a technical area due to multiple, fungible practices and lack of assurance of the effectiveness of those varying practices. In the case of practices related to healthcare technology and medical devices, patient safety is at stake when those practices are not effective.

Highly publicized cases of “superbugs” and antibiotic-resistant outbreaks of hospital-acquired infections linked to improper cleaning of medical devices have been hot topics in the news in recent years, as have the industry and public health alerts issued by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention regarding certain types of complex medical devices that have been associated with these infections. Healthcare facilities want to do the right thing to ensure patient safety, and healthcare product manufacturers do not want their products linked to deadly outbreaks. Standards for sterilization of healthcare products are essential tools for healthcare facilities, manufacturers, practitioners, and regulators for ensuring that sterilization practices are effective and align with best practices and guidance that are consistent with science and regulation.

The sterilization standards program is one of the largest areas of standards development within the purview of the Association for the Advancement of Medical Instrumentation (AAMI). AAMI's sterilization standards provide recommended practices across a variety of areas within sterilization of healthcare products, including various methods of sterilization(e.g., steam, chemical), applications of sterilization (e.g., industrial, healthcare facility based), types of sterilizer equipment, and sterilization processes for specific medical devices. AAMI also has published technical information reports (TIRs) that provide information on issues related to sterilization, such as water quality for reprocessing devices, cleaning processes, and guidance for the application of specific standards, to name a few. The Joint Commission, an accreditation and certification body for healthcare organizations, is very familiar with the AAMI standards that pertain to sterilization practices within healthcare facilities. Further, as an outcome of the Food and Drug Administration Modernization Act of 1997, the FDA recognizes most of AAMI's medical device standards, including standards pertaining to sterilization practices.

AAMI Standards Development: Advancing Healthcare Technology

The development of voluntary, consensus standards for medical instrumentation has been integral to AAMI's mission for more than 40 years. AAMI's leadership role in developing national and global standards pertaining to medical device technology serves to further the advancement of medical instrumentation and improve medical device safety. The standards, recommended practices, and technical information reports developed with AAMI's support are a collaborative, iterative effort to distill the collective expertise of the AAMI community and medical device field. This effort requires a balanced approach that includes the perspectives of the marketplace, current research and science, realities of the practical environment, and federal regulations, with the end goal of producing high-quality, relevant standards. These documents represent all areas of medical instrumentation and healthcare technology and are critical resources for the healthcare technology community, serving as frameworks for product development and guidance for processes or practices.

FDA recognizes most of AAMI's medical device standards, including standards pertaining to sterilization practices.

The expectation is that standards, once published, will be embraced, adopted, and broadly implemented. One way that AAMI is able to get a pulse on how widely particular standards are used or consulted is through the inquiries and feedback received from the medical device and sterilization community. The three standards pertaining to sterilization for which the AAMI Standards Department receives perhaps the greatest volume of feedback are ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST91, Flexible and semi-rigid endoscope processing in health care facilities; and ANSI/AAMI ST58 Chemical sterilization and high-level disinfection in health care facilities (Table 1).

Table 1.

Overview of three key sterilization standards: ANSI/AAMI ST79, ANSI/AAMI ST91, and ANSI/AAMI ST58

Overview of three key sterilization standards: ANSI/AAMI ST79, ANSI/AAMI ST91, and ANSI/AAMI ST58
Overview of three key sterilization standards: ANSI/AAMI ST79, ANSI/AAMI ST91, and ANSI/AAMI ST58

AAMI also is able to gain a sense of what needs exist for new guidance, more specific guidance, or more promotion of existing standards and TIRs based on the questions and requests for information received from sterilization professionals and others in the medical device field. Certain sterilization-related standards documents that are currently less prominent may eventually see an uptick in usage due to changes in industry or the marketplace, new regulations, or even environmental disasters. For example, disruptions to the water supply can pose considerable challenges for sterile processing departments, and at least a few facilities have sought guidance to address cleaning/disinfection and steam sterilization during recent occurrences of such situations.

Additional standards and TIRs that may tap into trends in information needs and “hot issues” within sterilization practices include:

  • AAMI TIR34:2014, Water for the reprocessing of medical devices

  • ANSI/AAMI ST67:2011, Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”

  • AAMI TIR12:2010, Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

To keep the content relevant and up to date, AAMI standards are reviewed at least every five years and can be revised more frequently, as needed, to keep pace with scientific research, technology, and the regulatory environment. The technical experts who are involved with developing and maintaining the standards keep a keen eye on emerging issues that might affect existing standards and TIRs and necessitate revisions. Ensuring that standards are based on current research is a key focus of AAMI's standards development efforts.

Within the sterilization standards program, AAMI is helping build and promote a community for sterilization research by making research presentations and poster sessions a part of the semiannual Sterilization Standards Weeks. The goal is to help inject scientific literature into conversations about standards development. AAMI's standards development activities also strive to be responsive to new trends or unmet needs within the medical device and healthcare technology fields, as well as being open to exploring new technologies to enhance the usability of standards through alternative delivery formats and dynamic content.

AAMI's standards development activities also strive to be responsive to new trends or unmet needs within the medical device and healthcare technology fields.

A handful of the sterilization standards are being revised or are likely to undergo revision in the near future. AAMI encourages anyone who would like to contribute to creating new standards or revising existing standards to review the AAMI standards work program posted on the AAMI website for areas that match your interest or those of your organization. AAMI standards staff also are happy to talk with you and help you determine which committees and standards would benefit from your particular expertise.

For more information, please visit www.aami.org/standards

About the Author

Amanda Benedict is a senior manager in the Standards Department at the Association for the Advancement of Medical Instrumentation in Arlington, VA. Email: abenedict@aami.org