AAMI is proud to recognize deserving individuals with AAMI Awards for their dedication and hard work on U.S. national and international standards development.
These award recipients exemplify how standards development is enriched by the collaboration and leadership of volunteer experts. With each document created by working groups consisting of dozens of volunteers from across the health industry, academia, and regulation, AAMI standards could not have obtained the global recognition they have achieved if it were not for many individuals’ outstanding commitment to improving patient safety.
Introducing the 2023 Standards Development Awardees:
Alan Hood, Ph.D., research toxicologist in the Division of Biology, Chemistry and Materials Science (DBCMS), Center for Devices and Radiological Health (CDRH)
Dr. Alan Hood serves as CDRH Primary Liaison to AAMI BE-WG 11 – the working group which determines the U.S. input for ISO technical matter related to “Allowable Limits for Leachable Substances” – and co-chairs that same group. He also serves as the convenor of ISO/TC 194/WG 11. Hood has been lauded by his colleagues for championing a major revision to the influential ISO/FDIS standard ISO 10993-17, Biological evaluation of medical devices–Part 17: Toxicological risk assessment of medical device constituents. After nearly six years of accounting for modern best practices and scientific consensus, the highly anticipated revision is expected to publish within 2023. Leveraging Hood’s expertise, the working group has expressed hope that their revisions will facilitate recognition of the international standard by the U.S. FDA.
Amy Jo Karren, microbiologist at W. L. Gore and Associates
After discovering a passion for improving health care through research, Amy Jo Karren has been contributing to her field for 30 years. A trained sterilization specialist and registered microbiologist, Karren has served on multiple working groups for Sterilization Standards and Biological Evaluation of Medical Devices technical committees for AAMI and ISO. She is celebrated for her work as the current convenor of ISO/TC 198/WG8, Microbiological Methods, as well as the co-chair for AAMI’s microbiological methods working group (ST-WG08). Karren was lauded by her colleagues as not only an expert in her field, but as a diplomatic and levelheaded liaison for the people and organizations she works with.
Debra R. Milamed, M.S., associate in anaesthesia, Harvard Medical School
Debra R. Milamed has been an active member of the U.S. TAG to ISO/TC121, Anaesthetic and respiratory equipment(AAMI AR), since 1989. In 2018, Milamed was appointed Committee Manager of ISO/TC121/SC4, Anaesthetic and respiratory equipment, vocabulary, and semantics, by ANSI. In this role she assured the publication of ISO 19223:2019 and ISO 4135:2022, two documents which establish a collection of common vocabulary and terms, as to avoid potentially disastrous mistakes in the development and labeling of medical devices. Notably, she was a key member of the AAMI COVID-19 Response Team, helping with the curation and development of publicly accessible emergency-use guidance during the world health crisis. A recognized leader for decades, Milamed is celebrated by her peers as a professional who has defined the shape of numerous standards projects.
James M. Anderson, M.D., Ph.D., Distinguished University Professor, Professor of Pathology, Biomedical Engineering, and Macromolecular Science, Case Western Reserve University
Dr. James Anderson has worked in the area of biomaterials, medical devices and prostheses for the past 40 years, with activities ranging from the clinical pathology evaluation of retrieved implants from humans to fundamental studies of cellular interactions with biomaterials. He is a founding member of the Society for Biomaterials, the Controlled Release Society, and AIMBE. He currently serves as convenor of ISO/TC 194/WG 1, which is responsible for the development of the international standard ISO 10993-1, Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process. He is lauded for his clinical and research activities, which have provided the foundation for revising this essential standard. In particular, he is celebrated as a mentor and voice of reason, leveraging his knowledge to find common ground between the working group’s many subject matter experts.
Paul Matsumura, senior director of research and technology, SunTech Medical
Once awed by the fantastical medical technologies featured in Star Trek, Matsumura now boast nearly 40 years of experience in the design of systems, hardware and software in several business areas including military and commercial telecom, industrial robotics and medical diagnostics. A Senior Member of the IEEE and a member of AAMI, he contributes to the development of ISO standards and other technical documents as a U.S. expert nominated by the respective U.S. technical advisory groups. He is currently serving as the Industry co-chair for AAMI’s Sphygmomanometer Committee (AAMI SP), establishing best practices for the development of blood pressure monitors, gauges and similar devices. Matsumura also serves as co-convenor for the ISO/TC 121/SC 3/JWG 7, which is responsible for developing standards applied by blood pressure device manufacturers in testing the accuracy of their products. Citing his expertise, calm leadership and respectful approach to complex deliberation, Matsumura’s peers have called him “the granite cornerstone” of the sphygmomanometer standards space.
