{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T18:24:01Z","timestamp":1785435841058,"version":"3.56.0"},"reference-count":31,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2021,3,29]],"date-time":"2021-03-29T00:00:00Z","timestamp":1616976000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Biomed Mater Res"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study evaluated the performance of a new O<jats:sub>3<\/jats:sub>\/H<jats:sub>2<\/jats:sub>O<jats:sub>2<\/jats:sub> mixed gas sterilization instrument for killing microorganisms and inactivating bacterial endotoxin at low temperatures. Sterility assurance level was achieved by an over 6\u2010log reduction of <jats:italic>Geobacillus stearothermophilus<\/jats:italic> ATCC 12980, and the decimal reduction value was 0.77\u2009min in sterilization mode. A reduction of over 3 logs in Limulus amebocyte lysate coagulation activity of purified endotoxin from <jats:italic>Escherichia coli<\/jats:italic> was observed after treatment in endotoxin\u2010inactivation mode. The same inactivation ability was observed when treating dried bacterial cells. Biomaterials made of polymer or metal did not exhibit cytotoxicity after gas exposure at O<jats:sub>3<\/jats:sub> concentrations below 200\u2009ppm. As the results of human cell\u2010based pyrogen testing, significant amounts of endotoxin that were over the limit for medical devices contacting cerebrospinal fluid (2.15\u2009EU\/device) were detected on scissors washed with a washer\u2010disinfector and sterilized with ethylene oxide or autoclaving. In contrast, endotoxin decreased to 0.29\u2009\u00b1\u20090.05\u2009EU\/device after O<jats:sub>3<\/jats:sub>\/H<jats:sub>2<\/jats:sub>O<jats:sub>2<\/jats:sub> mixed gas sterilization in endotoxin\u2010inactivation mode. Compared to conventional gas sterilization methods, O<jats:sub>3<\/jats:sub>\/H<jats:sub>2<\/jats:sub>O<jats:sub>2<\/jats:sub> mixed gas has high sterilization ability and a strong capacity to inactivate endotoxin. It is expected that this sterilization technology will improve the safety of reusable medical devices and utensils for regenerative medicine.<\/jats:p>","DOI":"10.1002\/jbm.b.34840","type":"journal-article","created":{"date-parts":[[2021,3,30]],"date-time":"2021-03-30T05:55:50Z","timestamp":1617083750000},"page":"1807-1816","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Performance evaluation of bactericidal effect and endotoxin inactivation by low\u2010temperature ozone\/hydrogen peroxide mixed gas exposure"],"prefix":"10.1002","volume":"109","author":[{"given":"Yusuke","family":"Nomura","sequence":"first","affiliation":[{"name":"Division of Medical Devices National Institute of Health Sciences  Kawasaki\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junji","family":"Yamamura","sequence":"additional","affiliation":[{"name":"Environment and Cleran Group, Strategy Development Department Industrial Systems and General\u2010Purpose Machinery Business Area, IHI Corporation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chie","family":"Fukui","sequence":"additional","affiliation":[{"name":"Division of Medical Devices National Institute of Health Sciences  Kawasaki\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideo","family":"Fujimaki","sequence":"additional","affiliation":[{"name":"Research Department Public Welfare Institute of Scientific Research Foundation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuyuki","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Environment and Cleran Group, Strategy Development Department Industrial Systems and General\u2010Purpose Machinery Business Area, IHI Corporation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken\u2010ichi","family":"Matsuo","sequence":"additional","affiliation":[{"name":"Environment and Cleran Group, Strategy Development Department Industrial Systems and General\u2010Purpose Machinery Business Area, IHI Corporation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Kuromatsu","sequence":"additional","affiliation":[{"name":"Environment and Cleran Group, Strategy Development Department Industrial Systems and General\u2010Purpose Machinery Business Area, IHI Corporation  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Kikuchi","sequence":"additional","affiliation":[{"name":"Division of Microbiology National Institute of Health Sciences  Kawasaki\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuji","family":"Haishima","sequence":"additional","affiliation":[{"name":"Division of Medical Devices National Institute of Health Sciences  Kawasaki\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,29]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"A compendium of processes materials test methods and acceptance criteria for cleaning reusable medical devices. Technical information report. AMMI TIR30: 2011\/(R)2016."},{"key":"e_1_2_9_3_1","unstructured":"DGKH DGSV AKI.Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices (5thed. 2017) Zentral Sterilisation suppl2017."},{"key":"e_1_2_9_4_1","unstructured":"Guideline for evaluation and assessment of medical instrument cleanliness. Japanese Society of Medical Instrumentation 2012."},{"key":"e_1_2_9_5_1","first-page":"402","article-title":"Gram\u2010negative bacterial endotoxin and the pathogenesis of fever","volume":"19","author":"Snell ES","year":"1975","journal-title":"Prog Drug Res"},{"issue":"3","key":"e_1_2_9_6_1","first-page":"R512","article-title":"Role of hypothalamic interleukin\u20106 and tumor necrosis factor\u2010alpha in LPS fever in rat","volume":"265","author":"Klir JJ","year":"1993","journal-title":"Am J Physiol"},{"issue":"4","key":"e_1_2_9_7_1","first-page":"R693","article-title":"Endotoxin shock: thermoregulatory mechanisms","volume":"270","author":"Romanovsky AA","year":"1996","journal-title":"Am J Physiol"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cyto.2008.01.006"},{"key":"e_1_2_9_9_1","unstructured":"Pyrogen and endotoxins testing: Questions and answers. Guidance document. FDA 2012."},{"key":"e_1_2_9_10_1","first-page":"126","article-title":"Inactivation of dry endotoxin by several sterilization methods","volume":"2","author":"Hosobuchi K","year":"1999","journal-title":"Bull Tokyo Metrop Ind Technol Res Inst"},{"key":"e_1_2_9_11_1","first-page":"83","volume-title":"Methods in Carbohydrate Chemistry","author":"Westphal O","year":"1965"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/1097-4636(20010605)55:3<424::AID-JBM1032>3.0.CO;2-S"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2006.11.016"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/1753425907088243"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.2320\/matertrans.43.3155"},{"key":"e_1_2_9_16_1","unstructured":"Statement from FDA commissioner Scot Gottlieb M.D. on steps the agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contact sterilization facility. FDA statement March 26 2019https:\/\/www.fda.gov\/news\u2010events\/press\u2010announcements\/statement\u2010fda\u2010commissioner\u2010scott\u2010gottlieb\u2010md\u2010steps\u2010agency\u2010taking\u2010prevent\u2010potential\u2010medical\u2010device"},{"key":"e_1_2_9_17_1","unstructured":"ISO 14937:2009(2009):Sterilization of health care products \u2010 general requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices. Geneva: International Organization for StandardizationAvailable fromhttps:\/\/www.iso.org\/standard\/44954.html"},{"key":"e_1_2_9_18_1","unstructured":"ISO 11138\u20101:2006(2006):Sterilization of health care products. Biological indicators \u2010part 1: general requirements. Geneva: International Organization for Standardization. Available fromhttps:\/\/www.iso.org\/standard\/33956.html"},{"key":"e_1_2_9_19_1","unstructured":"ISO 11737\u20102:2019(2009):Sterilization of health care products \u2010 microbiological methods \u2010 part 2: tests of sterility performed in the definition validation and maintenance of a sterilization process. Geneva: International Organization for StandardizationAvailable fromhttps:\/\/www.iso.org\/standard\/70801.html"},{"key":"e_1_2_9_20_1","first-page":"5","volume-title":"Endotoxin from pathophysiology to therapeutic approaches","author":"Rietschel ETBL","year":"1990"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-06-028704"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1634\/stemcells.2006-0189"},{"key":"e_1_2_9_23_1","first-page":"828","article-title":"The effect of lipopolysaccharide on the expression and activity of toll\u2010like receptor 4 in mesenchymal stem cells","volume":"28","author":"Shi L","year":"2007","journal-title":"Zhonghua Xue Ye Xue Za Zhi"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cellbi.2009.03.006"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0149876"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.a.34558"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(16)58164-3"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reth.2017.08.004"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reth.2018.01.002"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijheh.2006.05.001"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.4265\/bio.12.131"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.4265\/bio.21.1"}],"container-title":["Journal of Biomedical Materials Research Part B: Applied Biomaterials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jbm.b.34840","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jbm.b.34840","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jbm.b.34840","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T15:08:56Z","timestamp":1693321736000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jbm.b.34840"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,29]]},"references-count":31,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2021,11]]}},"alternative-id":["10.1002\/jbm.b.34840"],"URL":"https:\/\/doi.org\/10.1002\/jbm.b.34840","archive":["Portico"],"relation":{},"ISSN":["1552-4973","1552-4981"],"issn-type":[{"value":"1552-4973","type":"print"},{"value":"1552-4981","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,29]]},"assertion":[{"value":"2020-09-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}