AAMI News September 2017

Spotlight on Standards: AAMI Standards Board Approves Seven Documents

During a June meeting in Austin, TX, the AAMI Standards Board approved five new or revised standards and two updated technical information reports (TIRs), clearing the way for their publication.

These guidance documents focus on an array of important topics, including the sterilization and reprocessing of medical devices, the safety and performance of in vitro diagnostics and high-frequency surgical equipment, the biological evaluation of devices, and systems used to forecast remaining battery service life in pacemakers.

STANDARDS
New Document ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Last revised in 2010, this comprehensive document covers all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides guidance to all healthcare personnel who use steam for sterilization. The material in the new version has been reorganized into topical groupings, making the content easier to reference and more user friendly. Other noteworthy changes include new guidance on heating, ventilation, and air conditioning systems as they relate to the well-being of sterile processing personnel, revised guidance on the placement of instruments, and increased flexibility for facilities to determine certain criteria.
New Document ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing
This new standard specifies the minimum requirements for a quality management system that can be used by healthcare organizations that process medical devices. It was developed to help healthcare professionals more effectively, efficiently, and consistently reprocess (clean, decontaminate, disinfect, and sterilize) reusable medical devices in order to prevent infections, pyrogenic reactions, or other adverse events.
New Document ANSI/AAMI/ISO 10993-16, Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
This revised standard specifies principles on toxicokinetic studies relevant to medical devices, including how they should be designed and performed, and is harmonized to ISO 10993-16:2010. This edition includes new materials, references to new relevant standards, and an updated bibliography.
New Document ANSI/AAMI/ISO 16142-2, Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
This revised standard identifies and describes the six general essential principles of safety and performance as they apply to in vitro diagnostic (IVD) devices. With the recent passage of new IVD regulations in Europe, this standard provides information that manufacturers may find useful for compliance.
New Document ANSI/AAMI/IEC 60601-2-2, Medical electrical equipment—Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
This revised standard sets the minimum safety requirements for high-frequency surgical equipment. It is a verbatim adoption of the international IEC 60601-2-2 standard.
TECHNICAL INFORMATION REPORTS
New Document AAMI TIR17, Compatibility of materials subject to sterilization
Originally published in 1997 and last revised in 2008, this report was developed to help manufacturers evaluate how sterilization affects their products and packaging. The new version has an expanded scope that includes additional sterilization methods, such as nitrogen dioxide, peracetic vapor, and liquid peracetic acid.
New Document AAMI TIR21, Systems used to forecast remaining pacemaker battery service life
This revised TIR describes the clinical expectations for the performance of systems that use “real-time” measurements telemetered by a pulse generator to forecast the remaining service life of batteries found in implantable cardiac pacemakers. The report discusses the input requirements from both the pulse generator and the clinician regarding usage history and the anticipated use profile, as well as the practical limitations of forecasting remaining pacemaker battery service life using this type of system.

All of these documents are or will soon be available for purchase through the AAMI Store, www.aami.org/store.

For a complete list of standards activity, including calls for comments and notices about meetings, please subscribe to Standards Monitor Online (free service), which is issued once a month. To subscribe, go to www.aami.org/standards/smo.html.