title: Bacterial endotoxin detection in hyaluronic acid-based medical devices.
abstract: A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured by kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The method was applied to two different ophthalmic viscosurgical devices (OVDs) and one dermal filler, and may easily be adapted to use with up to 3% HA solutions and other HA-based medical devices. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. J Biomed Mater Res Part B: Appl Biomater, 2016. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1210-1215, 2017.
authors.affiliation: Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, 20993.
authors.forename: Larissa F
authors.initials: LF
authors.lastname: Baeva
authors.affiliation: Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, 20993.
authors.forename: Srilekha
authors.initials: S
authors.lastname: Sarkar Das
authors.affiliation: Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, 20993.
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Hitchins
mesh_terms: D000818:Animals; D002417:Cattle; D004866:Equipment Contamination; D004864:Equipment and Supplies; D006801:Humans; D006820:Hyaluronic Acid / Q000737:chemistry*; D008070:Lipopolysaccharides / Q000032:analysis*; D013508:Ophthalmologic Surgical Procedures / Q000295:instrumentation*
chemical_list: D008070:Lipopolysaccharides; C433788:lipopolysaccharide, E. coli O26-B6; D006820:Hyaluronic Acid
keywords: bacterial endotoxin; biomaterials; hyaluronic acid; hyaluronidase; medical devices; viscosity