AAMI recently announced that deserving individuals and teams have received AAMI Awards for their work in standards development.
“These award recipients exemplify how standards development is enriched by the collaboration and leadership of volunteer experts,” said Amanda Benedict, vice president of standards, AAMI. “AAMI standards could not have obtained the global recognition they have achieved if it were not for these volunteer developers’ outstanding commitment to improving patient safety.”
Standards Developer Award
This award recognizes major contributions to the development or revision of a specific AAMI or international standard. This year’s recipients are:
Carolyn Braithwaite-Nelson has served in AAMI standards development for more than 20 years, participating in AAMI sterilization standards technical committees. Serving as co-chair for Working Group 8, she was instrumental in the revision of AAMI ST72:2019, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing. During the development of ISO 11737-3 (DIS) – bacterial endotoxin testing, she was hailed as a “voice of manufacturers,” ensuring equal representation during the international standards writing process.
Mary Ann Drosnock served as the co-chair of AAMI’s Working Group 84 from its inception, leading the first effort to create ANSI/AAMI ST91:2015, a first-of-its-kind document outlining best practices for the sterile processing of endoscopes. Seven years later, that document has been extensively updated for staff and patient safety. To wrap up this essential work during a global pandemic was a test of her leadership and “a demonstration in what a co-chair and a standards developer should embody,” added Nancy Chobin, president of Sterile Processing University.
Susan Klacik is a long-time AAMI member and standards development volunteer, having previously co-chaired two sterile processing working groups before becoming the current co-chair of Working Group 40 for steam sterilization hospital practices. In this capacity, Klacik led the effort to amend AAMI’s premiere Sterilization Standards document, ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. And her work is not done yet! Klacik is now leading the early development of a first-of-its-kind document to addresses the safe transport of medical devices to and from external locations.
AAMI Technical Committee Award
This is awarded to up to two AAMI technical committees to recognize their outstanding efforts for the greater health technology field. Attention is paid to the results and expected impact of the committees’ hard work, especially in the case of field-defining standards or other guidance. This year, AAMI has recognized Working Group 84, which designed the newly published standards document ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities. Importantly, the document is the product of seven years of deliberation and research conducted by the working group and reflects the consensus of industry, clinicians, and sterilization professionals from around the world.
“The revision of the standard represents a complete overhaul to the 2015 version and incorporated innumerable changes in general information, annexes, recommendations and requirements,” explained Drosnock, former co-chair of the group and director of clinical affairs for Healthmark Industries. “Ultimately, this will lead to improved patient outcomes and reduced instances of infections related to endoscopes because of the additional steps that will have to be taken for conformance with the standard.”
Additionally, AAMI has recognized Working Group 2, which saw the development and advancement of three important documents for the radiation sterilization field.
After two years of development, AAMI TIR 76, Sterilization of health care products – Radiation-Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-S was issued alongside a new web-based electronic calculation tool to assist the industry in establishing appropriate radiation dosage.
AAMI/CDV-2 TIR104, Guidance on transferring health care products between radiation sterilization sites or modalities, is a new document that also published earlier this year, 2022.
“This is a document that will be instrumental to the industry to provide much needed guidance for the transfer of dose between radiation source types,” said Elaine Daniell of Edan-SA Consulting, co-chair of the group.
Finally, a popular international standard providing guidance on radiation sterilization process control was adopted as ANSI/AAMI/ISO/TS 11137-4 by the working group to publish later this year, 2022.
“This document was fundamental in getting international agreement with controlling and monitoring of the radiation sterilization process for standardization across geographies,” Daniell explained.
