Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress

Background Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization proto...

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Veröffentlicht in:American journal of infection control 2015-12, Vol.43 (12), p.1336-1341
Hauptverfasser: Shaffer, Harry L., MS, Harnish, Delbert A., MS, McDonald, Michael, MS, Vernon, Reid A., BS, Heimbuch, Brian K., MS
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container_end_page 1341
container_issue 12
container_start_page 1336
container_title American journal of infection control
container_volume 43
creator Shaffer, Harry L., MS
Harnish, Delbert A., MS
McDonald, Michael, MS
Vernon, Reid A., BS
Heimbuch, Brian K., MS
description Background Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment poststerilization when challenged with aerosolized bacteria under dynamic environmental conditions. Methods Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used 
doi_str_mv 10.1016/j.ajic.2015.07.010
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This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment poststerilization when challenged with aerosolized bacteria under dynamic environmental conditions. Methods Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used &lt;5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization wrap were challenged with ∼102 colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 μm, while simultaneously experiencing air volume exchanges due to vacuum cycles–two 1-psi cycles, three 0.7-psi cycles, and three 0.4-psi cycles–to simulate air exchange events occurring during the sterilization, transportation, and storage of sterilized instrument trays in health care facilities. Results Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination rates of rigid containers increased significantly with increasing duration of use. Conclusions In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria.</description><identifier>ISSN: 0196-6553</identifier><identifier>EISSN: 1527-3296</identifier><identifier>DOI: 10.1016/j.ajic.2015.07.010</identifier><identifier>PMID: 26337855</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aerosols ; Bacteria ; Bacterial contamination ; Contamination ; Environmental conditions ; Fomites ; Infection Control ; Infectious Disease ; Microbial barrier ; Micrococcus luteus - isolation &amp; purification ; North America ; Packaging ; Product Packaging - methods ; Rigid container ; Sterility maintenance ; Sterilization ; Sterilization wrap ; Surgical Equipment - microbiology ; Surgical site infection ; Surgical tools</subject><ispartof>American journal of infection control, 2015-12, Vol.43 (12), p.1336-1341</ispartof><rights>2015</rights><rights>Copyright © 2015. Published by Elsevier Inc.</rights><rights>Copyright Mosby-Year Book, Inc. Dec 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-1a4453c69110b93fae9c1f0d6260e4964aad76e4796f0168e8f8931e71db5ae13</citedby><cites>FETCH-LOGICAL-c439t-1a4453c69110b93fae9c1f0d6260e4964aad76e4796f0168e8f8931e71db5ae13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajic.2015.07.010$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26337855$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shaffer, Harry L., MS</creatorcontrib><creatorcontrib>Harnish, Delbert A., MS</creatorcontrib><creatorcontrib>McDonald, Michael, MS</creatorcontrib><creatorcontrib>Vernon, Reid A., BS</creatorcontrib><creatorcontrib>Heimbuch, Brian K., MS</creatorcontrib><title>Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress</title><title>American journal of infection control</title><addtitle>Am J Infect Control</addtitle><description>Background Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment poststerilization when challenged with aerosolized bacteria under dynamic environmental conditions. Methods Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used &lt;5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization wrap were challenged with ∼102 colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 μm, while simultaneously experiencing air volume exchanges due to vacuum cycles–two 1-psi cycles, three 0.7-psi cycles, and three 0.4-psi cycles–to simulate air exchange events occurring during the sterilization, transportation, and storage of sterilized instrument trays in health care facilities. Results Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination rates of rigid containers increased significantly with increasing duration of use. Conclusions In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria.</description><subject>Aerosols</subject><subject>Bacteria</subject><subject>Bacterial contamination</subject><subject>Contamination</subject><subject>Environmental conditions</subject><subject>Fomites</subject><subject>Infection Control</subject><subject>Infectious Disease</subject><subject>Microbial barrier</subject><subject>Micrococcus luteus - isolation &amp; purification</subject><subject>North America</subject><subject>Packaging</subject><subject>Product Packaging - methods</subject><subject>Rigid container</subject><subject>Sterility maintenance</subject><subject>Sterilization</subject><subject>Sterilization wrap</subject><subject>Surgical Equipment - microbiology</subject><subject>Surgical site infection</subject><subject>Surgical tools</subject><issn>0196-6553</issn><issn>1527-3296</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ks-K1TAUxoMoznX0BVxIwI2b1qRpkkZEkPEvDLgYXYfc5HRIbdNrkl6pT-Bjm3pHhVm4Cpzz-z5yzncQekxJTQkVz4faDN7WDaG8JrImlNxBO8obWbFGibtoR6gSleCcnaEHKQ2EEMUEv4_OGsGY7DjfoZ9XGaIffV7xZHzIEEywgFNe3PoCv1mDmbzFcDTjYrKfA5770vwt-QEOR3_tHbZzyEUMMWETHP4ezeFQmj6kHJcJQsY5mjXhPONDhONW2Bu7uZixUNcRUnqI7vVmTPDo5j1HX969_Xzxobr89P7jxevLyrZM5YqatuXMCkUp2SvWG1CW9sSJRhBolWiNcVJAK5Xoy4466PpOMQqSuj03QNk5enbyPcT52wIp68knC-NoAsxL0lQWF9JJwQv69BY6zEsM5XeF4qQhUnRtoZoTZeOcUoReH6KfTFw1JXrLSQ96y0lvOWkidcmpiJ7cWC_7CdxfyZ9gCvDyBEDZxdFD1Ml6KNE4H8Fm7Wb_f_9Xt-R29MFbM36FFdK_OXRqNNFX26Vsh0I5KVMVg1-wfrsg</recordid><startdate>20151201</startdate><enddate>20151201</enddate><creator>Shaffer, Harry L., MS</creator><creator>Harnish, Delbert A., MS</creator><creator>McDonald, Michael, MS</creator><creator>Vernon, Reid A., BS</creator><creator>Heimbuch, Brian K., MS</creator><general>Elsevier Inc</general><general>Mosby-Year Book, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20151201</creationdate><title>Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress</title><author>Shaffer, Harry L., MS ; Harnish, Delbert A., MS ; McDonald, Michael, MS ; Vernon, Reid A., BS ; Heimbuch, Brian K., MS</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-1a4453c69110b93fae9c1f0d6260e4964aad76e4796f0168e8f8931e71db5ae13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aerosols</topic><topic>Bacteria</topic><topic>Bacterial contamination</topic><topic>Contamination</topic><topic>Environmental conditions</topic><topic>Fomites</topic><topic>Infection Control</topic><topic>Infectious Disease</topic><topic>Microbial barrier</topic><topic>Micrococcus luteus - isolation &amp; purification</topic><topic>North America</topic><topic>Packaging</topic><topic>Product Packaging - methods</topic><topic>Rigid container</topic><topic>Sterility maintenance</topic><topic>Sterilization</topic><topic>Sterilization wrap</topic><topic>Surgical Equipment - microbiology</topic><topic>Surgical site infection</topic><topic>Surgical tools</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shaffer, Harry L., MS</creatorcontrib><creatorcontrib>Harnish, Delbert A., MS</creatorcontrib><creatorcontrib>McDonald, Michael, MS</creatorcontrib><creatorcontrib>Vernon, Reid A., BS</creatorcontrib><creatorcontrib>Heimbuch, Brian K., MS</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of infection control</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shaffer, Harry L., MS</au><au>Harnish, Delbert A., MS</au><au>McDonald, Michael, MS</au><au>Vernon, Reid A., BS</au><au>Heimbuch, Brian K., MS</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress</atitle><jtitle>American journal of infection control</jtitle><addtitle>Am J Infect Control</addtitle><date>2015-12-01</date><risdate>2015</risdate><volume>43</volume><issue>12</issue><spage>1336</spage><epage>1341</epage><pages>1336-1341</pages><issn>0196-6553</issn><eissn>1527-3296</eissn><abstract>Background Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment poststerilization when challenged with aerosolized bacteria under dynamic environmental conditions. Methods Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used &lt;5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization wrap were challenged with ∼102 colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 μm, while simultaneously experiencing air volume exchanges due to vacuum cycles–two 1-psi cycles, three 0.7-psi cycles, and three 0.4-psi cycles–to simulate air exchange events occurring during the sterilization, transportation, and storage of sterilized instrument trays in health care facilities. Results Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination rates of rigid containers increased significantly with increasing duration of use. Conclusions In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26337855</pmid><doi>10.1016/j.ajic.2015.07.010</doi><tpages>6</tpages></addata></record>
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subjects Aerosols
Bacteria
Bacterial contamination
Contamination
Environmental conditions
Fomites
Infection Control
Infectious Disease
Microbial barrier
Micrococcus luteus - isolation & purification
North America
Packaging
Product Packaging - methods
Rigid container
Sterility maintenance
Sterilization
Sterilization wrap
Surgical Equipment - microbiology
Surgical site infection
Surgical tools
title Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress
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