{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T03:10:05Z","timestamp":1785381005807,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,12,11]],"date-time":"2017-12-11T00:00:00Z","timestamp":1512950400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Biomed Mater Res"],"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Ethylene oxide (EO) gas is commonly used to sterilize medical devices. Bioavailable residual EO, however, presents a significant toxicity risk to patients. Residual EO is assessed using international standards describing extraction conditions for different medical device applications. We examine a series of polymers and explore different extraction conditions to determine residual EO. Materials were sterilized with EO and exhaustively extracted in water, in one of three organic solvents, or in air using thermal desorption. The EO exhaustively extracted varies significantly and is dictated by two factors: the EO that permeates the material during sterilization; and the effectiveness of the extraction protocol in flushing residual EO from the material. Extracted EO is maximized by a close matches between Hildebrand solubility parameters \u03b4<jats:sub>polymer<\/jats:sub>, \u03b4<jats:sub>EO<\/jats:sub>, and \u03b4<jats:sub>solvent<\/jats:sub>. There remain complexities to resolve, however, because maximized EO uptake and detection are accompanied by great variability. These observations may inform protocols for material selection, sterilization, and EO extraction. \u00a9 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2455\u20132463, 2018.<\/jats:p>","DOI":"10.1002\/jbm.b.34052","type":"journal-article","created":{"date-parts":[[2017,12,11]],"date-time":"2017-12-11T07:12:37Z","timestamp":1512976357000},"page":"2455-2463","source":"Crossref","is-referenced-by-count":4,"title":["Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations"],"prefix":"10.1002","volume":"106","author":[{"given":"Anne D.","family":"Lucas","sequence":"first","affiliation":[{"name":"U.S. Food and Drug Administration, Center for Device and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, WO 64 Silver Spring Maryland 20903"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Forrey","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration, Center for Device and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, WO 64 Silver Spring Maryland 20903"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Saylor","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration, Center for Device and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, WO 64 Silver Spring Maryland 20903"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Vorvolakos","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration, Center for Device and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, 10903 New Hampshire Ave, WO 64 Silver Spring Maryland 20903"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,12,11]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"International Organization for Standardization. Sterilization of health\u2010care products \u2013 Ethylene oxide \u2013 Requirements for the development validation and routine control of a sterilization process for medical devices ANSI\/AAMI\/ISO 11135;2014."},{"key":"e_1_2_9_3_1","first-page":"91","article-title":"Comparison of health care\u2010based sterilization technologies: Safety, efficacy, and economics","volume":"1","author":"MacNeil JR","year":"1997","journal-title":"J Healthcare Safety Compliance Infect Control"},{"key":"e_1_2_9_4_1","first-page":"189","article-title":"Ethylene Oxide","author":"International Agency for Research on Cancer","year":"1985","journal-title":"IARC monograph on evaluation of carcinogenic risk of chemicals to humans"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/10408440008951121"},{"key":"e_1_2_9_6_1","volume-title":"Ethylene Oxide. 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