SYMPOSIA PAPER Published: 23 November 2020
STP163020190156

Moving toward Meaningful Standards for Preclinical Performance Testing of Medical Devices and Combination Products with Antimicrobial Effects

Source

A significant portion of healthcare-associated infections (HAIs) are related to the use of medical devices, resulting in tens of thousands of deaths and billions of dollars in expense to the healthcare system in the United States alone each year. One area in need of further development is appropriate standard methods for preclinical performance testing of medical devices pertaining to antimicrobial effectiveness. The outcomes of this testing are most useful when they can be related to a clinical benefit to medical device users. In this paper, we discuss the challenges with current in vitro performance testing, as well as some possible pathways to the successful development of antimicrobial combination product standards.

Author Information

Wang, Hao
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, Silver Spring, MD, US
Garg, Aprajita
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health,Office of Product Evaluation and Quality, Office of Health Technology 6, Silver Spring, MD, US
Kazemzadeh-Narbat, Mehdi
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health,Office of Product Evaluation and Quality, Office of Health Technology 6, Silver Spring, MD, US
Urish, Kenneth, L.
Arthritis and Arthroplasty Design Group, The Bone and Joint Center, MageeWomens Hospital of the University of Pittsburgh Medical Center, Pittsburgh, PA, US Dept. of Orthopaedic Surgery, Dept. of Bioengineering, and Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, US Dept. of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA, US
Phillips, K., Scott
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, Silver Spring, MD, US
Price: $25.00
Contact Sales
Related
Reprints and Permissions
Reprints and copyright permissions can be requested through the
Copyright Clearance Center
Details
Pages: 17–25
DOI: 10.1520/STP163020190156
ISBN-EB: 978-0-8031-7707-9
ISBN-13: 978-0-8031-7706-2