{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T17:09:46Z","timestamp":1788628186949,"version":"build-2803163510"},"reference-count":18,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T00:00:00Z","timestamp":1721779200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2024,10,15]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Ethylene oxide (EO) sterilization is commonly employed for the sterilization of medical devices and has a very high market share. However, EO and its metabolite ethylene chlorohydrin (ECH) are toxic to humans. In compliance with the classification and residue limits of medical devices defined by ISO 10993\u20107, our study established two extraction methods for the testing of EO and ECH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The first method involves simulated\u2010use extraction using water as the extraction solvent. While the second, exhaustive extraction, directly extracts sample through headspace sampling analysis. Gas chromatography\u2013tandem mass spectrometry in multiple reaction monitoring mode was utilized, requiring only 16\u2009min. Then, the developed method was applied to assess 10 commercially available medical devices sterilized by EO.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In simulated\u2010use extraction, calibration curves were evaluated in the range of 1\u2013100 and 5\u2013500\u2009\u03bcg for EO and ECH, respectively (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009&gt;\u20090.999). Inter\u2010day recoveries ranged from 85.0% to 95.2% and from 94.8% to 102.4%. In exhaustive extraction, calibration curves spanned 0.5\u201350 and 2\u2013200\u2009\u03bcg for EO and ECH, respectively (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009&gt;\u20090.999). Inter\u2010day recoveries ranged from 101.6% to 102.1% for EO and from 98.1% to 102.2% for ECH. After analysis of the 10 commercially available medical devices, two cotton swabs were found to have ECH of 35.1 and 28.4\u00a0\u03bcg per device, and four medical devices were found to have EO with concentration below the limit of quantification. Meanwhile, we found that the EO internal standard (propylene oxide) recommended by ISO 10993\u20107 had interference problems with other similar substances and was not suitable as an internal standard for EO.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study offers a sensitive and straightforward analytical approach to EO and ECH residues in a variety of medical devices. In addition, the results show that the EO or ECH content of these types of medical devices in our study falls below the regulatory limits, therefore instilling confidence among consumers regarding their safe use.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.9869","type":"journal-article","created":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T01:09:32Z","timestamp":1721869772000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Development of the headspace gas chromatography\u2013tandem mass spectrometry method for ethylene oxide and ethylene chlorohydrin residue in medical devices"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9333-0441","authenticated-orcid":false,"given":"Yi Chun","family":"Chiang","sequence":"first","affiliation":[{"name":"Division of Research and Analysis, Taiwan Food and Drug Administration Ministry of Health and Welfare  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5956-6357","authenticated-orcid":false,"given":"Ming Chih","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Food Science National Taiwan Ocean University  Keelung Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuan Kai","family":"Yang","sequence":"additional","affiliation":[{"name":"Division of Research and Analysis, Taiwan Food and Drug Administration Ministry of Health and Welfare  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng Wei","family":"Wang","sequence":"additional","affiliation":[{"name":"Division of Research and Analysis, Taiwan Food and Drug Administration Ministry of Health and Welfare  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su Hsiang","family":"Tseng","sequence":"additional","affiliation":[{"name":"Division of Research and Analysis, Taiwan Food and Drug Administration Ministry of Health and Welfare  Taipei City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,24]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"World Health Organization (WHO).Environmental health criteria 55 \u2013 Ethylene oxide.1985. Accessed December 4 2023.https:\/\/wedocs.unep.org\/handle\/20.500.11822\/29329"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.4265\/bio.22.1"},{"key":"e_1_2_7_4_1","unstructured":"Gamma Industry Processing Alliance (GIPA) and International Irradiation Association (IIA).A comparison of gamma E\u2010beam X\u2010ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products.2017. Accessed December 4 2023.https:\/\/iiaglobal.com\/iia-publications\/"},{"key":"e_1_2_7_5_1","unstructured":"Agency for Toxic Substances and Disease Registry (ATSDR).Toxicological profile for ethylene oxide.2022. Accessed December 4 2023.https:\/\/wwwn.cdc.gov\/TSP\/ToxProfiles\/ToxProfiles.aspx?id=734&tid=133"},{"issue":"4","key":"e_1_2_7_6_1","first-page":"207","article-title":"Toxic effects of ethylene chlorohydrin","volume":"1","author":"Goldblatt MW","year":"1944","journal-title":"Brit J Industr Med"},{"key":"e_1_2_7_7_1","unstructured":"International Organization for Standardization (ISO).Sterilization of health\u2010care products \u2013 ethylene oxide \u2013 requirements for the development validation and routine control of a sterilization process for medical devices.2014. ISO 11135:2014. Accessed January 10 2023.https:\/\/www.iso.org\/standard\/56137.html"},{"key":"e_1_2_7_8_1","unstructured":"International Organization for Standardization (ISO).Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals.2008. ISO10993\u20107:2008. Accessed January 10 2023.https:\/\/www.iso.org\/standard\/34213.html"},{"key":"e_1_2_7_9_1","unstructured":"ZhangJQ ZhangYJ.Determination of ethylene oxide and ethylene chlorohydrin in medical devices using the Agilent 8890 GC and 7697A headspace sampler. Agilent Technologies Inc.2020; 5994\u20102183EN. Accessed January 20 2023.https:\/\/gcms.cz\/labrulez-bucket-strapi-h3hsga3\/application::paper.paper\/application-ethylene-oxide-in-medical-devices-8890-gc-5994-2183en-agilent.pdf"},{"key":"e_1_2_7_10_1","unstructured":"IwasaN.Analysis of residual ethylene oxide in medical devices by headspace gas chromatography (water extraction). Shimadzu Corporation.2021; 01\u201000140\u2010EN. Accessed January 20 2023.https:\/\/www.shimadzu.com\/an\/sites\/shimadzu.com.an\/files\/pim\/pim_document_file\/applications\/application_note\/14022\/an_01-00140-en.pdf"},{"key":"e_1_2_7_11_1","unstructured":"LeeD CojocariuC.A fast cost\u2010effective HS\u2010GC\u2010FID method for the analysis of ethylene oxide in surgical\u2010style face masks. Thermo Fisher Scientific.2020; 73790. Accessed January 20 2023.https:\/\/assets.thermofisher.com\/TFS-Assets\/CMD\/Application-Notes\/an-73790-hs-gc-ethylene-oxide-surgical-face-masks-an73790-en.pdf"},{"key":"e_1_2_7_12_1","unstructured":"IwasaN.Analysis of residual ethylene oxide in medical devices by gas chromatography. Shimadzu Corporation.2021; 01\u201000139\u2010EN. Accessed January 20 2023.https:\/\/www.shimadzu.com\/an\/sites\/shimadzu.com.an\/files\/pim\/pim_document_file\/applications\/application_note\/14021\/an_01-00139-en.pdf"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1590\/s1517\u2010707620230001.1334"},{"key":"e_1_2_7_14_1","unstructured":"DheerajH AnkushB DurveshS PrashantH SanketC AjitD JitendraK PratapR.Analysis of residual ethylene oxide in intraocular lenses using HS\u2010GCMS. Shimadzu Corporation.2013; PO\u2010CON1319E. Accessed January 25 2023.https:\/\/www.shimadzu.com\/an\/sites\/shimadzu.com.an\/files\/pim\/pim_document_file\/applications\/posters\/10168\/ipo213027_0.pdfAccessed January 25 2023."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2018.05.035"},{"key":"e_1_2_7_16_1","first-page":"1","article-title":"Solvent or thermal extraction of ethylene oxide from polymeric materials: medical device considerations","volume":"00","author":"Anne D","year":"2017","journal-title":"J Biomed Mater Res B"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.b.10036"},{"key":"e_1_2_7_18_1","unstructured":"European chemicals agency (ECHA).Methodology for recommending analytical methods to check compliance with REACH Annex XVII restrictions.2021. 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Accessed October 2 2023.https:\/\/food.ec.europa.eu\/document\/download\/b4412132-8c3e-4252-86df-c892e54730e8_en?filename=cs_vet-med-residues_guideline_eurl_validation-confirmatory.pdf"}],"container-title":["Rapid Communications in Mass Spectrometry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/rcm.9869","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T15:12:39Z","timestamp":1761491559000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/rcm.9869"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,24]]},"references-count":18,"journal-issue":{"issue":"19","published-print":{"date-parts":[[2024,10,15]]}},"alternative-id":["10.1002\/rcm.9869"],"URL":"https:\/\/doi.org\/10.1002\/rcm.9869","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1002\/RCM.9869\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/RCM.9869\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/RCM.9869\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/RCM.9869\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1002\/RCM.9869\/v2\/decision1","asserted-by":"object"}]},"ISSN":["0951-4198","1097-0231"],"issn-type":[{"value":"0951-4198","type":"print"},{"value":"1097-0231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,24]]},"assertion":[{"value":"2024-05-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e9869"}}