Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device
Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical prod...
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creator | Li, Donghui Bisel, Tucker T. Cooley, Scott K. Murphy, Mark K. Spencer, Mychal P. Hasan, Md Kamrul Fifield, Leonard S. Pharr, Matt Staack, David Huang, Min Pillai, Suresh D. Nichols, Larry Parker, Rodney Gustin, Erick |
description | Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical product, comprised of eight distinct polymer materials, were directly compared for three radiation technologies – cobalt-60 gamma, E-beam, and X-ray – at four dose levels (15, 25, 50, and 70 kGy). The objective was to determine how radiation effects (deleterious or beneficial) are influenced by source and dose level, with the specific goal of determining whether E-beam radiation and/or X-ray radiation could be viable alternatives to gamma radiation for device sterilization. The specific product considered is a single-use medical device for orthopedic surgery, the Stryker Instruments MixeVac III bone cement mixer, which is currently sterilized using gamma radiation from cobalt-60 sources. Following ASTM International standards and input from the manufacturer, we characterized the effects of the three radiation sources on product functionality as well as on the mechanical and optical properties of the constituent polymers. Results indicate that although measurable differences in properties between the standard gamma irradiated materials and the alternative E-beam and X-ray irradiated materials were observed, those differences were small. Statistically significant differences were noted in the case of yellowness index for polyvinyl chloride, high-density polyethylene, and polycarbonate, and in the case of tensile elongation at break for high impact polystyrene and polyvinyl chloride. In general, the results of this study support the viability of E-beam and X-ray radiation as alternative options to cobalt-60 gamma radiation for sterilization of Stryker single-use universal bone cement mixer medical devices.
•Stryker MixeVac-III® (ME3) comprises 8 common polymers and is current sterilized using cobalt-60 gamma irradiation.•ME3 devices were irradiated to 15, 25, 50, and 70 kGy using gamma, E-beam, and X-ray to directly compare radiation effects.•Effects of dose and radiation source on product functionality and polymer mechanical and visual properties were determined.•Increased yellowing was noted in certain electron beam irradiated polymers at higher doses.•Results support viability of electron beam and X-ray options for sterilization of Stryker MixeVac-III® bone cement m |
doi_str_mv | 10.1016/j.radphyschem.2024.111971 |
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•Stryker MixeVac-III® (ME3) comprises 8 common polymers and is current sterilized using cobalt-60 gamma irradiation.•ME3 devices were irradiated to 15, 25, 50, and 70 kGy using gamma, E-beam, and X-ray to directly compare radiation effects.•Effects of dose and radiation source on product functionality and polymer mechanical and visual properties were determined.•Increased yellowing was noted in certain electron beam irradiated polymers at higher doses.•Results support viability of electron beam and X-ray options for sterilization of Stryker MixeVac-III® bone cement mixers.</description><identifier>ISSN: 0969-806X</identifier><identifier>EISSN: 1879-0895</identifier><identifier>DOI: 10.1016/j.radphyschem.2024.111971</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>E-Beam ; Gamma ; INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND TECHNOLOGY ; Medical devices ; medical devices, radiation effects, polymers, sterilization, irradiation, E-Beam, X-ray, gamma, Team Nablo ; Polymers ; Radiation effects ; Sterilization ; X-ray</subject><ispartof>Radiation physics and chemistry (Oxford, England : 1993), 2024-10, Vol.223, p.111971, Article 111971</ispartof><rights>2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c222t-57cb511d738571287d3367f4404d492b0504ca5552a9c19f9f62a104dea2f58b3</cites><orcidid>0000-0002-7432-5356 ; 0000-0002-2589-0658 ; 0000000225890658 ; 0000000274325356</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.radphyschem.2024.111971$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.osti.gov/biblio/2396284$$D View this record in Osti.gov$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Donghui</creatorcontrib><creatorcontrib>Bisel, Tucker T.</creatorcontrib><creatorcontrib>Cooley, Scott K.</creatorcontrib><creatorcontrib>Murphy, Mark K.</creatorcontrib><creatorcontrib>Spencer, Mychal P.</creatorcontrib><creatorcontrib>Hasan, Md Kamrul</creatorcontrib><creatorcontrib>Fifield, Leonard S.</creatorcontrib><creatorcontrib>Pharr, Matt</creatorcontrib><creatorcontrib>Staack, David</creatorcontrib><creatorcontrib>Huang, Min</creatorcontrib><creatorcontrib>Pillai, Suresh D.</creatorcontrib><creatorcontrib>Nichols, Larry</creatorcontrib><creatorcontrib>Parker, Rodney</creatorcontrib><creatorcontrib>Gustin, Erick</creatorcontrib><creatorcontrib>Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)</creatorcontrib><title>Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device</title><title>Radiation physics and chemistry (Oxford, England : 1993)</title><description>Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical product, comprised of eight distinct polymer materials, were directly compared for three radiation technologies – cobalt-60 gamma, E-beam, and X-ray – at four dose levels (15, 25, 50, and 70 kGy). The objective was to determine how radiation effects (deleterious or beneficial) are influenced by source and dose level, with the specific goal of determining whether E-beam radiation and/or X-ray radiation could be viable alternatives to gamma radiation for device sterilization. The specific product considered is a single-use medical device for orthopedic surgery, the Stryker Instruments MixeVac III bone cement mixer, which is currently sterilized using gamma radiation from cobalt-60 sources. Following ASTM International standards and input from the manufacturer, we characterized the effects of the three radiation sources on product functionality as well as on the mechanical and optical properties of the constituent polymers. Results indicate that although measurable differences in properties between the standard gamma irradiated materials and the alternative E-beam and X-ray irradiated materials were observed, those differences were small. Statistically significant differences were noted in the case of yellowness index for polyvinyl chloride, high-density polyethylene, and polycarbonate, and in the case of tensile elongation at break for high impact polystyrene and polyvinyl chloride. In general, the results of this study support the viability of E-beam and X-ray radiation as alternative options to cobalt-60 gamma radiation for sterilization of Stryker single-use universal bone cement mixer medical devices.
•Stryker MixeVac-III® (ME3) comprises 8 common polymers and is current sterilized using cobalt-60 gamma irradiation.•ME3 devices were irradiated to 15, 25, 50, and 70 kGy using gamma, E-beam, and X-ray to directly compare radiation effects.•Effects of dose and radiation source on product functionality and polymer mechanical and visual properties were determined.•Increased yellowing was noted in certain electron beam irradiated polymers at higher doses.•Results support viability of electron beam and X-ray options for sterilization of Stryker MixeVac-III® bone cement mixers.</description><subject>E-Beam</subject><subject>Gamma</subject><subject>INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND TECHNOLOGY</subject><subject>Medical devices</subject><subject>medical devices, radiation effects, polymers, sterilization, irradiation, E-Beam, X-ray, gamma, Team Nablo</subject><subject>Polymers</subject><subject>Radiation effects</subject><subject>Sterilization</subject><subject>X-ray</subject><issn>0969-806X</issn><issn>1879-0895</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNqNUE1LxDAQDaLguvofoudtTdKmbY6yrB-w4EVhbyFNJzZL0y5JXdybP92UevAoDAzMm3lv3kPolpKUElrc71OvmkN7CroFlzLC8pRSKkp6hha0KkVCKsHP0YKIQiQVKXaX6CqEPSGkrHi2QN8bY0CPAQ8Gfyjn1ApDFwd-6HENyq2w6hu8S7w6YeujllWjjVissQV86FQYrcZ6cIehh34mUvizt0fwQXW4jmOswUUMO_sFHjtorI5IA0er4RpdGNUFuPntS_T-uHlbPyfb16eX9cM20YyxMeGlrjmlTZlVvKSsKpssK0qT5yRvcsFqwkmuFeecKaGpMMIUTNEIgmKGV3W2RHcz7xAflkHbEXSrh76PZiXLRMGqPC6JeUn7IQQPRh68dcqfJCVyylvu5Z-85ZS3nPOOt-v5FqKLowU_iUCvo1s_aTSD_QfLD9GWj_4</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Li, Donghui</creator><creator>Bisel, Tucker T.</creator><creator>Cooley, Scott K.</creator><creator>Murphy, Mark K.</creator><creator>Spencer, Mychal P.</creator><creator>Hasan, Md Kamrul</creator><creator>Fifield, Leonard S.</creator><creator>Pharr, Matt</creator><creator>Staack, David</creator><creator>Huang, Min</creator><creator>Pillai, Suresh D.</creator><creator>Nichols, Larry</creator><creator>Parker, Rodney</creator><creator>Gustin, Erick</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>OTOTI</scope><orcidid>https://orcid.org/0000-0002-7432-5356</orcidid><orcidid>https://orcid.org/0000-0002-2589-0658</orcidid><orcidid>https://orcid.org/0000000225890658</orcidid><orcidid>https://orcid.org/0000000274325356</orcidid></search><sort><creationdate>20241001</creationdate><title>Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device</title><author>Li, Donghui ; Bisel, Tucker T. ; Cooley, Scott K. ; Murphy, Mark K. ; Spencer, Mychal P. ; Hasan, Md Kamrul ; Fifield, Leonard S. ; Pharr, Matt ; Staack, David ; Huang, Min ; Pillai, Suresh D. ; Nichols, Larry ; Parker, Rodney ; Gustin, Erick</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c222t-57cb511d738571287d3367f4404d492b0504ca5552a9c19f9f62a104dea2f58b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>E-Beam</topic><topic>Gamma</topic><topic>INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND TECHNOLOGY</topic><topic>Medical devices</topic><topic>medical devices, radiation effects, polymers, sterilization, irradiation, E-Beam, X-ray, gamma, Team Nablo</topic><topic>Polymers</topic><topic>Radiation effects</topic><topic>Sterilization</topic><topic>X-ray</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Donghui</creatorcontrib><creatorcontrib>Bisel, Tucker T.</creatorcontrib><creatorcontrib>Cooley, Scott K.</creatorcontrib><creatorcontrib>Murphy, Mark K.</creatorcontrib><creatorcontrib>Spencer, Mychal P.</creatorcontrib><creatorcontrib>Hasan, Md Kamrul</creatorcontrib><creatorcontrib>Fifield, Leonard S.</creatorcontrib><creatorcontrib>Pharr, Matt</creatorcontrib><creatorcontrib>Staack, David</creatorcontrib><creatorcontrib>Huang, Min</creatorcontrib><creatorcontrib>Pillai, Suresh D.</creatorcontrib><creatorcontrib>Nichols, Larry</creatorcontrib><creatorcontrib>Parker, Rodney</creatorcontrib><creatorcontrib>Gustin, Erick</creatorcontrib><creatorcontrib>Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>CrossRef</collection><collection>OSTI.GOV</collection><jtitle>Radiation physics and chemistry (Oxford, England : 1993)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Donghui</au><au>Bisel, Tucker T.</au><au>Cooley, Scott K.</au><au>Murphy, Mark K.</au><au>Spencer, Mychal P.</au><au>Hasan, Md Kamrul</au><au>Fifield, Leonard S.</au><au>Pharr, Matt</au><au>Staack, David</au><au>Huang, Min</au><au>Pillai, Suresh D.</au><au>Nichols, Larry</au><au>Parker, Rodney</au><au>Gustin, Erick</au><aucorp>Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device</atitle><jtitle>Radiation physics and chemistry (Oxford, England : 1993)</jtitle><date>2024-10-01</date><risdate>2024</risdate><volume>223</volume><spage>111971</spage><pages>111971-</pages><artnum>111971</artnum><issn>0969-806X</issn><eissn>1879-0895</eissn><abstract>Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical product, comprised of eight distinct polymer materials, were directly compared for three radiation technologies – cobalt-60 gamma, E-beam, and X-ray – at four dose levels (15, 25, 50, and 70 kGy). The objective was to determine how radiation effects (deleterious or beneficial) are influenced by source and dose level, with the specific goal of determining whether E-beam radiation and/or X-ray radiation could be viable alternatives to gamma radiation for device sterilization. The specific product considered is a single-use medical device for orthopedic surgery, the Stryker Instruments MixeVac III bone cement mixer, which is currently sterilized using gamma radiation from cobalt-60 sources. Following ASTM International standards and input from the manufacturer, we characterized the effects of the three radiation sources on product functionality as well as on the mechanical and optical properties of the constituent polymers. Results indicate that although measurable differences in properties between the standard gamma irradiated materials and the alternative E-beam and X-ray irradiated materials were observed, those differences were small. Statistically significant differences were noted in the case of yellowness index for polyvinyl chloride, high-density polyethylene, and polycarbonate, and in the case of tensile elongation at break for high impact polystyrene and polyvinyl chloride. In general, the results of this study support the viability of E-beam and X-ray radiation as alternative options to cobalt-60 gamma radiation for sterilization of Stryker single-use universal bone cement mixer medical devices.
•Stryker MixeVac-III® (ME3) comprises 8 common polymers and is current sterilized using cobalt-60 gamma irradiation.•ME3 devices were irradiated to 15, 25, 50, and 70 kGy using gamma, E-beam, and X-ray to directly compare radiation effects.•Effects of dose and radiation source on product functionality and polymer mechanical and visual properties were determined.•Increased yellowing was noted in certain electron beam irradiated polymers at higher doses.•Results support viability of electron beam and X-ray options for sterilization of Stryker MixeVac-III® bone cement mixers.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><doi>10.1016/j.radphyschem.2024.111971</doi><orcidid>https://orcid.org/0000-0002-7432-5356</orcidid><orcidid>https://orcid.org/0000-0002-2589-0658</orcidid><orcidid>https://orcid.org/0000000225890658</orcidid><orcidid>https://orcid.org/0000000274325356</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | E-Beam Gamma INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND TECHNOLOGY Medical devices medical devices, radiation effects, polymers, sterilization, irradiation, E-Beam, X-ray, gamma, Team Nablo Polymers Radiation effects Sterilization X-ray |
title | Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device |
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