{"ID":78184,"post_author":"9208550","post_date":"2018-12-17 16:46:25","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"Introduction to Medical Devices (Volume 1)","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2018-12-17 16:46:25","post_modified_gmt":"2018-12-17 21:46:25","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=78184","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"FD633C54-E350-42B2-AE99-5B1FF5DDCDBA","title":"Introduction to Medical Devices (Volume 1)","subtitle":"","cover_theme":"nico_10","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_10&subtitle=&editor=John+Jones&title=Introduction+to+Medical+Devices+%28Volume+1%29&title_image=https%3A%2F%2Fupload.wikimedia.org%2Fwikipedia%2Fcommons%2Fb%2Fbf%2FStetoskop.jpg&publisher=Laboratory+Informatics+Institute","editor":"John Jones","publisher":"Laboratory Informatics Institute","author_id":"2","image_url":"","items":{"509a78b4fc5d0046b2bae625b2c376a6_type":"article","509a78b4fc5d0046b2bae625b2c376a6_title":"Staphylococcus epidermidis","509a78b4fc5d0046b2bae625b2c376a6_url":"https:\/\/www.limswiki.org\/index.php\/Staphylococcus_epidermidis","509a78b4fc5d0046b2bae625b2c376a6_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tStaphylococcus epidermidis\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t\n\n\n\n\nStaphylococcus epidermidis\n\n\n\n\n\nScanning electron image of S. epidermidis.\n\n\n\n\n\n\n\nScientific classification\n\n\n\n\n\n\n\nDomain:\n\nBacteria\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nPhylum:\n\nFirmicutes\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nClass:\n\nBacilli\n\n\n\n\n\n\n\n\n\n\n\nOrder:\n\nBacillales\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nFamily:\n\nStaphylococcaceae\n\n\n\n\n\n\n\n\n\n\n\n\n\nGenus:\n\nStaphylococcus\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nSpecies:\n\nS. epidermidis\n\n\n\n\n\n\n\n\n\nBinomial name\n\n\nStaphylococcus epidermidis \r\n(Winslow & Winslow 1908)\r\nEvans 1916\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nSynonyms\n\n\n\nStaphylococcus albus Rosenbach 1884\n\n\n\n\nStaphylococcus epidermidis is a Gram-positive bacterium, and one of over 40 species belonging to the genus Staphylococcus.[1] It is part of the normal human flora, typically the skin flora, and less commonly the mucosal flora.[2] It is a facultative anaerobic bacteria. Although S. epidermidis is not usually pathogenic, patients with compromised immune systems are at risk of developing infection. These infections are generally hospital-acquired.[3] S. epidermidis is a particular concern for people with catheters or other surgical implants because it is known to form biofilms that grow on these devices.[4] Being part of the normal skin flora, S. epidermidis is a frequent contaminant of specimens sent to the diagnostic laboratory.[5]\n\n Staphylococcus epidermidis biofilm on titanium substrate\nContents \n\n1 Etymology \n2 Discovery \n3 Cellular morphology and biochemistry \n4 Virulence and antibiotic resistance \n5 Disease \n6 Identification \n7 See also \n8 Notes and references \n9 External links \n\n\nEtymology \n'Staphylococcus' - bunch of grape-like berries, 'epidermidis' - of the epidermis [6]\n\nDiscovery \nFriedrich Julius Rosenbach distinguished S. epidermidis from S. aureus in 1884, initially naming S. epidermidis as S. albus.[7] He chose aureus and albus since the bacteria formed yellow and white colonies, respectively.\n\nCellular morphology and biochemistry \n Staphylococcus epidermidis, 1000 magnification under bright field microscopy\nS. epidermidis is a very hardy microorganism, consisting of nonmotile, Gram-positive cocci, arranged in grape-like clusters. It forms white, raised, cohesive colonies about 1\u20132 mm in diameter after overnight incubation, and is not hemolytic on blood agar.[4] It is a catalase-positive,[8] coagulase-negative, facultative anaerobe that can grow by aerobic respiration or by fermentation. Some strains may not ferment.[9]\nBiochemical tests indicate this microorganism also carries out a weakly positive reaction to the nitrate reductase test. It is positive for urease production, is oxidase negative, and can use glucose, sucrose, and lactose to form acid products. In the presence of lactose, it will also produce gas. S. epidermidis does not possess the gelatinase enzyme, so it cannot hydrolyze gelatin.[citation needed ] It is sensitive to novobiocin, providing an important test to distinguish it from Staphylococcus saprophyticus, which is coagulase-negative, as well, but novobiocin-resistant.[3]\nSimilar to those of S. aureus, the cell walls of S. epidermidis have a transferrin-binding protein that helps the organism obtain iron from transferrin. The tetramers of a surface exposed protein, glyceraldehyde-3-phosphate dehydrogenase, are believed to bind to transferrin and remove its iron. Subsequent steps include iron being transferred to surface lipoproteins, then to transport proteins which carry the iron into the cell.[4]\n\nVirulence and antibiotic resistance \nThe ability to form biofilms on plastic devices is a major virulence factor for S. epidermidis. One probable cause is surface proteins that bind blood and extracellular matrix proteins.\nIt produces an extracellular material known as polysaccharide intercellular adhesin (PIA), which is made up of sulfated polysaccharides. It allows other bacteria to bind to the already existing biofilm, creating a multilayer biofilm.\nSuch biofilms decrease the metabolic activity of bacteria within them. This decreased metabolism, in combination with impaired diffusion of antibiotics, makes it difficult for antibiotics to effectively clear this type of infection.[4]\nS. epidermidis strains are often resistant to antibiotics, including rifamycin, fluoroquinolones, gentamicin, tetracycline, clindamycin, and sulfonamides.[10] Methicillin resistance is particularly widespread, with 75-90% of hospital isolates resistance to methicilin.[10] Resistant organisms are most commonly found in the intestine, but organisms living freely on the skin can also become resistant due to routine exposure to antibiotics secreted in sweat.\n\nDisease \n Staphylococcus epidermidis stained by safranin.(x1000)\nAs mentioned above, S. epidermidis causes biofilms to grow on plastic devices placed within the body.[11] This occurs most commonly on intravenous catheters and on medical prostheses.[12]\nInfection can also occur in dialysis patients or anyone with an implanted plastic device that may have been contaminated.\nIt also causes endocarditis, most often in patients with defective heart valves. In some other cases, sepsis can occur in hospital patients.[citation needed ]\nAntibiotics are largely ineffective in clearing biofilms. The most common treatment for these infections is to remove or replace the infected implant, though in all cases, prevention is ideal. The drug of choice is often vancomycin, to which rifampin or an aminoglycoside can be added.[citation needed ] Hand washing has been shown to reduce the spread of infection.\nPreliminary research also indicates S. epidermidis is universally found inside affected acne vulgaris pores, where Propionibacterium acnes is normally the sole resident.[13]\n\nIdentification \nThe normal practice of detecting S. epidermidis is by using appearance of colonies on selective media, bacterial morphology by light microscopy, catalase and slide coagulase testing. On the Baird-Parker agar with egg yolk supplement, colonies appear small and black. Increasingly, techniques such as quantitative PCR are being employed for the rapid detection and identification of Staphylococcus strains.[14][15] Normally, sensitivity to desferrioxamine can also be used to distinguish it from most other staphylococci, except in the case of Staphylococcus hominis, which is also sensitive.[16] In this case, the production of acid from trehalose by S. hominis can be used to tell the two species apart.\n\nSee also \nBiofilms\nMicrobiology\nStaphylococcus\nNotes and references \n\n\n^ Schleifer, K. H.; Kloos, W. E. (1975). \"Isolation and Characterization of Staphylococci from Human Skin I. Amended Descriptions of Staphylococcus epidermidis and Staphylococcus saprophyticus and Descriptions of Three New Species Staphylococcus cohnii, Staphylococcus haemolyticus, and Staphylococcus xylosus\". International Journal of Systematic Bacteriology. 25 (1): 50\u201361. doi:10.1099\/00207713-25-1-50. ISSN 0020-7713. \n\n^ Fey, P. D.; Olson, M. E. (2010). \"Current concepts in biofilm formation of Staphylococcus epidermidis\". Future Microbiology. 5 (6): 917\u2013933. doi:10.2217\/fmb.10.56. PMC 2903046 . \n\n^ a b Levinson, W. (2010). Review of Medical Microbiology and Immunology (11th ed.). pp. 94\u201399. \n\n^ a b c d Salyers, Abigail A. & Whitt, Dixie D. (2002). Bacterial Pathogenesis: A Molecular Approach, 2nd ed. Washington, D.C.: ASM Press. ISBN 1-55581-171-X. \n\n^ Queck SY & Otto M (2008). \"Staphylococcus epidermidis and other Coagulase-Negative Staphylococci\". Staphylococcus: Molecular Genetics. Caister Academic Press. ISBN 978-1-904455-29-5. \n\n^ http:\/\/www.vetbact.org\/vetbact\/?artid=205 \n\n^ Friedrich Julius Rosenbach at Who Named It? \n\n^ \"Todar's Online Textbook of Bacteriology: Staphylococcus aureus and Staphylococcal Disease\". Kenneth Todar, PhD. Retrieved Dec 7, 2013 . \n\n^ \"Bacteria Genomes - STAPHYLOCOCCUS EPIDERMIDIS\". Karyn's Genomes. EMBL-EBI. Retrieved December 23, 2011 . \n\n^ a b Otto M (August 2010). \"Staphylococcus epidermidis - the \"accidental\" pathogen\". Nature Reviews Microbiology. 7 (8): 555\u2013567. doi:10.1038\/nrmicro2182. PMC 2807625 . \n\n^ Otto M (2009), \"Staphylococcus epidermidis \u2014 the 'accidental' pathogen\", Nature Reviews Microbiology, 7 (8): 555\u2013567, doi:10.1038\/nrmicro2182, PMC 2807625 , PMID 19609257 \n\n^ Hedin G (1993), \"Staphylococcus epidermidis \u2014 hospital epidemiology and the detection of methicillin resistance\", Scandinavian Journal of Infectious Diseases Supplementum, Oslo Norway: Scandinavian University Press, 90: 1\u201359, PMID 8303217 \n\n^ Bek-Thomson, M.; et al. (2008). \"Acne is Not Associated with Yet-Uncultured Bacteria\". Journal of Clinical Microbiology. 46 (10): 3355\u20133360. doi:10.1128\/JCM.00799-08. PMC 2566126 . PMID 18716234. \n\n^ Francois P & Schrenzel J (2008). \"Rapid Diagnosis and Typing of Staphylococcus aureus\". Staphylococcus: Molecular Genetics. Caister Academic Press. ISBN 978-1-904455-29-5. \n\n^ Mackay IM (editor). (2007). Real-Time PCR in Microbiology: From Diagnosis to Characterization. Caister Academic Press. ISBN 978-1-904455-18-9. \n\n^ Antunes, Ana L\u00facia Souza; Secchi, Carina; Reiter, Keli Cristine; Perez, Leandro Reus Rodrigues; Freitas, Ana L\u00facia Peixoto De; D'azevedo, Pedro Alves (2008-01-01). \"Feasible identification of Staphylococcus epidermidis using desferrioxamine and fosfomycin disks\". APMIS. 116 (1): 16\u201320. doi:10.1111\/j.1600-0463.2008.00796.x. ISSN 1600-0463. \n\n\nExternal links \nType strain of Staphylococcus epidermidis at BacDive - the Bacterial Diversity Metadatabase\nTeruaki Nakatsuji et al.: A commensal strain of Staphylococcus epidermidis protects against skin neoplasia, in: Science Advances; 28th of Feb., 2018; Vol. 4, No. 2, DOI:10.1126\/sciadv.aao4502\nvte\nFirmicutes (low-G+C) Infectious diseases\nBacterial diseases: G+\nprimarily A00\u2013A79, 001\u2013041, 080\u2013109\nBacilliLactobacillales\r\n(Cat-)Streptococcus\u03b1optochin susceptible\nS. pneumoniae\nPneumococcal infection\noptochin resistant\nViridans streptococci: S. mitis\nS. mutans\nS. oralis\nS. sanguinis\nS. sobrinus\nmilleri group\n\u03b2A\nbacitracin susceptible: S. pyogenes\nGroup A streptococcal infection\nStreptococcal pharyngitis\nScarlet fever\nErysipelas\nRheumatic fever\nB\nbacitracin resistant, CAMP test+: S. agalactiae\nGroup B streptococcal infection\nungrouped\nStreptococcus iniae\nCutaneous Streptococcus iniae infection\n\u03b3\nD\nBEA+: Streptococcus bovis\nEnterococcus\nBEA+: Enterococcus faecalis\nUrinary tract infection\nEnterococcus faecium\nBacillales\r\n(Cat+)StaphylococcusCg+\nS. aureus\nStaphylococcal scalded skin syndrome\nToxic shock syndrome\nMRSA\nCg-\nnovobiocin susceptible\nS. epidermidis\nnovobiocin resistant\nS. saprophyticus\nBacillus\nBacillus anthracis\nAnthrax\nBacillus cereus\nFood poisoning\nListeria\nListeria monocytogenes\nListeriosis\nClostridiaClostridium (spore-forming)motile:\nClostridium difficile\nPseudomembranous colitis\nClostridium botulinum\nBotulism\nClostridium tetani\nTetanus\nnonmotile:\nClostridium perfringens\nGas gangrene\nClostridial necrotizing enteritis\nPeptostreptococcus (non-spore forming)\nPeptostreptococcus magnus\nMollicutesMycoplasmataceae\nUreaplasma urealyticum\nUreaplasma infection\nMycoplasma genitalium\nMycoplasma pneumoniae\nMycoplasma pneumonia\nAnaeroplasmatales\nErysipelothrix rhusiopathiae\nErysipeloid\n\n Biology portal \nTaxon identifiers\nWikidata: Q131915 \nWikispecies: Staphylococcus epidermidis \nBacDive: 14529 \nEoL: 975953 \nEPPO: STAPEP \nGBIF: 3227655 \niNaturalist: 356566 \nIRMNG: 10540350 \nITIS: 377 \nNCBI: 1282 \nNZOR: a3dfb255-a960-44df-bbef-6642126dd86a \n\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of the Wikipedia article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Staphylococcus_epidermidis\">https:\/\/www.limswiki.org\/index.php\/Staphylococcus_epidermidis<\/a>\n\t\t\t\t\tCategory: Science termsHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal 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id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\"><i>Staphylococcus epidermidis<\/i><\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><p class=\"mw-empty-elt\">\n<\/p>\n\n<p><i><b>Staphylococcus epidermidis<\/b><\/i> is a <a href=\"https:\/\/en.wikipedia.org\/wiki\/Gram-positive\" class=\"mw-redirect\" title=\"Gram-positive\" rel=\"external_link\" target=\"_blank\">Gram-positive<\/a> bacterium, and one of over 40 species belonging to the genus <i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Staphylococcus\" title=\"Staphylococcus\" rel=\"external_link\" target=\"_blank\">Staphylococcus<\/a><\/i>.<sup id=\"rdp-ebb-cite_ref-SchleiferKloos1975_1-0\" class=\"reference\"><a href=\"#cite_note-SchleiferKloos1975-1\" rel=\"external_link\">[1]<\/a><\/sup> It is part of the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Human_flora\" class=\"mw-redirect\" title=\"Human flora\" rel=\"external_link\" target=\"_blank\">normal human flora<\/a>, typically the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Skin_flora\" title=\"Skin flora\" rel=\"external_link\" target=\"_blank\">skin flora<\/a>, and less commonly the mucosal flora.<sup id=\"rdp-ebb-cite_ref-FeyOlson2010_2-0\" class=\"reference\"><a href=\"#cite_note-FeyOlson2010-2\" rel=\"external_link\">[2]<\/a><\/sup> It is a facultative anaerobic bacteria. Although <i>S. epidermidis<\/i> is not usually pathogenic, patients with compromised <a href=\"https:\/\/en.wikipedia.org\/wiki\/Immune_system\" title=\"Immune system\" rel=\"external_link\" target=\"_blank\">immune systems<\/a> are at risk of developing infection. These infections are generally <a href=\"https:\/\/en.wikipedia.org\/wiki\/Hospital-acquired_infection\" title=\"Hospital-acquired infection\" rel=\"external_link\" target=\"_blank\">hospital-acquired<\/a>.<sup id=\"rdp-ebb-cite_ref-Levinson,_W._2010_94\u201399_3-0\" class=\"reference\"><a href=\"#cite_note-Levinson,_W._2010_94\u201399-3\" rel=\"external_link\">[3]<\/a><\/sup> <i>S. epidermidis<\/i> is a particular concern for people with <a href=\"https:\/\/en.wikipedia.org\/wiki\/Catheters\" class=\"mw-redirect\" title=\"Catheters\" rel=\"external_link\" target=\"_blank\">catheters<\/a> or other surgical implants because it is known to form <a href=\"https:\/\/en.wikipedia.org\/wiki\/Biofilms\" class=\"mw-redirect\" title=\"Biofilms\" rel=\"external_link\" target=\"_blank\">biofilms<\/a> that grow on these devices.<sup id=\"rdp-ebb-cite_ref-Salyers_4-0\" class=\"reference\"><a href=\"#cite_note-Salyers-4\" rel=\"external_link\">[4]<\/a><\/sup> Being part of the normal skin flora, <i>S. epidermidis<\/i> is a frequent contaminant of specimens sent to the diagnostic laboratory.<sup id=\"rdp-ebb-cite_ref-Queck_5-0\" class=\"reference\"><a href=\"#cite_note-Queck-5\" rel=\"external_link\">[5]<\/a><\/sup>\n<\/p>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:222px;\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif\" class=\"image\" rel=\"external_link\" target=\"_blank\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/b\/be\/Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif\/lossy-page1-220px-Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif.jpg\" width=\"220\" height=\"165\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif\" class=\"internal\" title=\"Enlarge\" rel=\"external_link\" target=\"_blank\"><\/a><\/div>Staphylococcus epidermidis biofilm on titanium substrate<\/div><\/div><\/div>\n\n<h2><span class=\"mw-headline\" id=\"Etymology\">Etymology<\/span><\/h2>\n<p>'Staphylococcus' - bunch of grape-like berries, 'epidermidis' - of the epidermis <sup id=\"rdp-ebb-cite_ref-6\" class=\"reference\"><a href=\"#cite_note-6\" rel=\"external_link\">[6]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Discovery\">Discovery<\/span><\/h2>\n<p><a href=\"https:\/\/en.wikipedia.org\/wiki\/Friedrich_Julius_Rosenbach\" title=\"Friedrich Julius Rosenbach\" rel=\"external_link\" target=\"_blank\">Friedrich Julius Rosenbach<\/a> distinguished <i>S. epidermidis<\/i> from <i>S. aureus<\/i> in 1884, initially naming <i>S. epidermidis<\/i> as <i>S. albus<\/i>.<sup id=\"rdp-ebb-cite_ref-7\" class=\"reference\"><a href=\"#cite_note-7\" rel=\"external_link\">[7]<\/a><\/sup> He chose <i>aureus<\/i> and <i>albus<\/i> since the bacteria formed yellow and white colonies, respectively.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Cellular_morphology_and_biochemistry\">Cellular morphology and biochemistry<\/span><\/h2>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:222px;\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Staphylococcus_epidermids.jpg\" class=\"image\" rel=\"external_link\" target=\"_blank\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/95\/Staphylococcus_epidermids.jpg\/220px-Staphylococcus_epidermids.jpg\" width=\"220\" height=\"162\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Staphylococcus_epidermids.jpg\" class=\"internal\" title=\"Enlarge\" rel=\"external_link\" target=\"_blank\"><\/a><\/div><i>Staphylococcus epidermidis<\/i>, 1000 magnification under bright field microscopy<\/div><\/div><\/div>\n<p><i>S. epidermidis<\/i> is a very hardy microorganism, consisting of nonmotile, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Gram-positive\" class=\"mw-redirect\" title=\"Gram-positive\" rel=\"external_link\" target=\"_blank\">Gram-positive<\/a> cocci, arranged in grape-like clusters. It forms white, raised, cohesive colonies about 1\u20132 mm in diameter after overnight incubation, and is not <a href=\"https:\/\/en.wikipedia.org\/wiki\/Hemolytic\" class=\"mw-redirect\" title=\"Hemolytic\" rel=\"external_link\" target=\"_blank\">hemolytic<\/a> on blood agar.<sup id=\"rdp-ebb-cite_ref-Salyers_4-1\" class=\"reference\"><a href=\"#cite_note-Salyers-4\" rel=\"external_link\">[4]<\/a><\/sup> It is a <a href=\"https:\/\/en.wikipedia.org\/wiki\/Catalase\" title=\"Catalase\" rel=\"external_link\" target=\"_blank\">catalase<\/a>-positive,<sup id=\"rdp-ebb-cite_ref-Todar_8-0\" class=\"reference\"><a href=\"#cite_note-Todar-8\" rel=\"external_link\">[8]<\/a><\/sup> <a href=\"https:\/\/en.wikipedia.org\/wiki\/Coagulase\" title=\"Coagulase\" rel=\"external_link\" target=\"_blank\">coagulase<\/a>-negative, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Facultative_anaerobe\" class=\"mw-redirect\" title=\"Facultative anaerobe\" rel=\"external_link\" target=\"_blank\">facultative anaerobe<\/a> that can grow by <a href=\"https:\/\/en.wikipedia.org\/wiki\/Aerobic_respiration\" class=\"mw-redirect\" title=\"Aerobic respiration\" rel=\"external_link\" target=\"_blank\">aerobic respiration<\/a> or by <a href=\"https:\/\/en.wikipedia.org\/wiki\/Fermentation_(biochemistry)\" class=\"mw-redirect\" title=\"Fermentation (biochemistry)\" rel=\"external_link\" target=\"_blank\">fermentation<\/a>. Some strains may not ferment.<sup id=\"rdp-ebb-cite_ref-9\" class=\"reference\"><a href=\"#cite_note-9\" rel=\"external_link\">[9]<\/a><\/sup>\n<\/p><p>Biochemical tests indicate this microorganism also carries out a weakly positive reaction to the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Nitrate_reductase_test\" title=\"Nitrate reductase test\" rel=\"external_link\" target=\"_blank\">nitrate reductase test<\/a>. It is positive for <a href=\"https:\/\/en.wikipedia.org\/wiki\/Urease\" title=\"Urease\" rel=\"external_link\" target=\"_blank\">urease<\/a> production, is oxidase negative, and can use glucose, sucrose, and lactose to form acid products. In the presence of lactose, it will also produce gas. <i>S. epidermidis<\/i> does not possess the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Gelatinase\" title=\"Gelatinase\" rel=\"external_link\" target=\"_blank\">gelatinase<\/a> enzyme, so it cannot hydrolyze gelatin.<sup class=\"noprint Inline-Template Template-Fact\" style=\"white-space:nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Citation_needed\" title=\"Wikipedia:Citation needed\" rel=\"external_link\" target=\"_blank\"><span title=\"This claim needs references to reliable sources. (November 2013)\">citation needed<\/span><\/a><\/i>]<\/sup> It is sensitive to <a href=\"https:\/\/en.wikipedia.org\/wiki\/Novobiocin\" title=\"Novobiocin\" rel=\"external_link\" target=\"_blank\">novobiocin<\/a>, providing an important test to distinguish it from <i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Staphylococcus_saprophyticus\" title=\"Staphylococcus saprophyticus\" rel=\"external_link\" target=\"_blank\">Staphylococcus saprophyticus<\/a><\/i>, which is coagulase-negative, as well, but novobiocin-resistant.<sup id=\"rdp-ebb-cite_ref-Levinson,_W._2010_94\u201399_3-1\" class=\"reference\"><a href=\"#cite_note-Levinson,_W._2010_94\u201399-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Similar to those of <i>S. aureus<\/i>, the cell walls of <i>S. epidermidis<\/i> have a transferrin-binding protein that helps the organism obtain iron from <a href=\"https:\/\/en.wikipedia.org\/wiki\/Transferrin\" title=\"Transferrin\" rel=\"external_link\" target=\"_blank\">transferrin<\/a>. The tetramers of a surface exposed protein, glyceraldehyde-3-phosphate dehydrogenase, are believed to bind to transferrin and remove its iron. Subsequent steps include iron being transferred to surface lipoproteins, then to transport proteins which carry the iron into the cell.<sup id=\"rdp-ebb-cite_ref-Salyers_4-2\" class=\"reference\"><a href=\"#cite_note-Salyers-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Virulence_and_antibiotic_resistance\">Virulence and antibiotic resistance<\/span><\/h2>\n<p>The ability to form <a href=\"https:\/\/en.wikipedia.org\/wiki\/Biofilm\" title=\"Biofilm\" rel=\"external_link\" target=\"_blank\">biofilms<\/a> on plastic devices is a major virulence factor for <i>S. epidermidis<\/i>. One probable cause is surface proteins that bind blood and extracellular matrix proteins.\nIt produces an extracellular material known as polysaccharide intercellular adhesin (PIA), which is made up of sulfated <a href=\"https:\/\/en.wikipedia.org\/wiki\/Polysaccharide\" title=\"Polysaccharide\" rel=\"external_link\" target=\"_blank\">polysaccharides<\/a>. It allows other bacteria to bind to the already existing biofilm, creating a multilayer biofilm.\nSuch biofilms decrease the metabolic activity of bacteria within them. This decreased metabolism, in combination with impaired diffusion of antibiotics, makes it difficult for antibiotics to effectively clear this type of infection.<sup id=\"rdp-ebb-cite_ref-Salyers_4-3\" class=\"reference\"><a href=\"#cite_note-Salyers-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<i>S. epidermidis<\/i> strains are often resistant to antibiotics, including <a href=\"https:\/\/en.wikipedia.org\/wiki\/Rifamycin\" title=\"Rifamycin\" rel=\"external_link\" target=\"_blank\">rifamycin<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Fluoroquinolones\" class=\"mw-redirect\" title=\"Fluoroquinolones\" rel=\"external_link\" target=\"_blank\">fluoroquinolones<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Gentamicin\" title=\"Gentamicin\" rel=\"external_link\" target=\"_blank\">gentamicin<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Tetracycline\" title=\"Tetracycline\" rel=\"external_link\" target=\"_blank\">tetracycline<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Clindamycin\" title=\"Clindamycin\" rel=\"external_link\" target=\"_blank\">clindamycin<\/a>, and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Sulfonamide\" title=\"Sulfonamide\" rel=\"external_link\" target=\"_blank\">sulfonamides<\/a>.<sup id=\"rdp-ebb-cite_ref-Otto_10-0\" class=\"reference\"><a href=\"#cite_note-Otto-10\" rel=\"external_link\">[10]<\/a><\/sup> <a href=\"https:\/\/en.wikipedia.org\/wiki\/Methicillin\" title=\"Methicillin\" rel=\"external_link\" target=\"_blank\">Methicillin<\/a> resistance is particularly widespread, with 75-90% of hospital isolates resistance to methicilin.<sup id=\"rdp-ebb-cite_ref-Otto_10-1\" class=\"reference\"><a href=\"#cite_note-Otto-10\" rel=\"external_link\">[10]<\/a><\/sup> Resistant organisms are most commonly found in the intestine, but organisms living freely on the skin can also become resistant due to routine exposure to antibiotics secreted in sweat.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Disease\">Disease<\/span><\/h2>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:222px;\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Stained_Staphylococcus_epidermidis.jpg\" class=\"image\" rel=\"external_link\" target=\"_blank\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/30\/Stained_Staphylococcus_epidermidis.jpg\/220px-Stained_Staphylococcus_epidermidis.jpg\" width=\"220\" height=\"220\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/en.wikipedia.org\/wiki\/File:Stained_Staphylococcus_epidermidis.jpg\" class=\"internal\" title=\"Enlarge\" rel=\"external_link\" target=\"_blank\"><\/a><\/div><i>Staphylococcus epidermidis<\/i> stained by safranin.(x1000)<\/div><\/div><\/div>\n<p>As mentioned above, <i>S. epidermidis<\/i> causes biofilms to grow on plastic devices placed within the body.<sup id=\"rdp-ebb-cite_ref-11\" class=\"reference\"><a href=\"#cite_note-11\" rel=\"external_link\">[11]<\/a><\/sup> This occurs most commonly on intravenous <a href=\"https:\/\/en.wikipedia.org\/wiki\/Catheter\" title=\"Catheter\" rel=\"external_link\" target=\"_blank\">catheters<\/a> and on medical <a href=\"https:\/\/en.wikipedia.org\/wiki\/Prostheses\" class=\"mw-redirect\" title=\"Prostheses\" rel=\"external_link\" target=\"_blank\">prostheses<\/a>.<sup id=\"rdp-ebb-cite_ref-12\" class=\"reference\"><a href=\"#cite_note-12\" rel=\"external_link\">[12]<\/a><\/sup>\nInfection can also occur in dialysis patients or anyone with an implanted plastic device that may have been contaminated.\nIt also causes <a href=\"https:\/\/en.wikipedia.org\/wiki\/Endocarditis\" title=\"Endocarditis\" rel=\"external_link\" target=\"_blank\">endocarditis<\/a>, most often in patients with defective heart valves. In some other cases, sepsis can occur in hospital patients.<sup class=\"noprint Inline-Template Template-Fact\" style=\"white-space:nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Citation_needed\" title=\"Wikipedia:Citation needed\" rel=\"external_link\" target=\"_blank\"><span title=\"This claim needs references to reliable sources. (November 2013)\">citation needed<\/span><\/a><\/i>]<\/sup>\n<\/p><p>Antibiotics are largely ineffective in clearing biofilms. The most common treatment for these infections is to remove or replace the infected implant, though in all cases, prevention is ideal. The drug of choice is often <a href=\"https:\/\/en.wikipedia.org\/wiki\/Vancomycin\" title=\"Vancomycin\" rel=\"external_link\" target=\"_blank\">vancomycin<\/a>, to which <a href=\"https:\/\/en.wikipedia.org\/wiki\/Rifampin\" class=\"mw-redirect\" title=\"Rifampin\" rel=\"external_link\" target=\"_blank\">rifampin<\/a> or an <a href=\"https:\/\/en.wikipedia.org\/wiki\/Aminoglycoside\" title=\"Aminoglycoside\" rel=\"external_link\" target=\"_blank\">aminoglycoside<\/a> can be added.<sup class=\"noprint Inline-Template Template-Fact\" style=\"white-space:nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Citation_needed\" title=\"Wikipedia:Citation needed\" rel=\"external_link\" target=\"_blank\"><span title=\"This claim needs references to reliable sources. (July 2011)\">citation needed<\/span><\/a><\/i>]<\/sup> Hand washing has been shown to reduce the spread of infection.\n<\/p><p>Preliminary research also indicates <i>S. epidermidis<\/i> is universally found inside affected <a href=\"https:\/\/en.wikipedia.org\/wiki\/Acne_vulgaris\" class=\"mw-redirect\" title=\"Acne vulgaris\" rel=\"external_link\" target=\"_blank\">acne vulgaris<\/a> pores, where <i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Propionibacterium_acnes\" class=\"mw-redirect\" title=\"Propionibacterium acnes\" rel=\"external_link\" target=\"_blank\">Propionibacterium acnes<\/a><\/i> is normally the sole resident.<sup id=\"rdp-ebb-cite_ref-13\" class=\"reference\"><a href=\"#cite_note-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Identification\">Identification<\/span><\/h2>\n<p>The normal practice of detecting <i>S. epidermidis<\/i> is by using appearance of colonies on selective media, bacterial morphology by light microscopy, catalase and slide coagulase testing. On the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Baird-Parker_agar\" title=\"Baird-Parker agar\" rel=\"external_link\" target=\"_blank\">Baird-Parker agar<\/a> with <a href=\"https:\/\/en.wikipedia.org\/wiki\/Egg_yolk\" class=\"mw-redirect\" title=\"Egg yolk\" rel=\"external_link\" target=\"_blank\">egg yolk<\/a> supplement, colonies appear small and black. Increasingly, techniques such as <a href=\"https:\/\/en.wikipedia.org\/wiki\/Quantitative_PCR\" class=\"mw-redirect\" title=\"Quantitative PCR\" rel=\"external_link\" target=\"_blank\">quantitative PCR<\/a> are being employed for the rapid detection and identification of <i>Staphylococcus<\/i> strains.<sup id=\"rdp-ebb-cite_ref-FrancoisP_14-0\" class=\"reference\"><a href=\"#cite_note-FrancoisP-14\" rel=\"external_link\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Mackay_15-0\" class=\"reference\"><a href=\"#cite_note-Mackay-15\" rel=\"external_link\">[15]<\/a><\/sup> Normally, sensitivity to <a href=\"https:\/\/en.wikipedia.org\/wiki\/Desferrioxamine\" class=\"mw-redirect\" title=\"Desferrioxamine\" rel=\"external_link\" target=\"_blank\">desferrioxamine<\/a> can also be used to distinguish it from most other staphylococci, except in the case of <i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Staphylococcus_hominis\" title=\"Staphylococcus hominis\" rel=\"external_link\" target=\"_blank\">Staphylococcus hominis<\/a><\/i>, which is also sensitive.<sup id=\"rdp-ebb-cite_ref-16\" class=\"reference\"><a href=\"#cite_note-16\" rel=\"external_link\">[16]<\/a><\/sup> In this case, the production of acid from <a href=\"https:\/\/en.wikipedia.org\/wiki\/Trehalose\" title=\"Trehalose\" rel=\"external_link\" target=\"_blank\">trehalose<\/a> by <i>S. hominis<\/i> can be used to tell the two species apart.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Biofilms\" class=\"mw-redirect\" title=\"Biofilms\" rel=\"external_link\" target=\"_blank\">Biofilms<\/a><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Microbiology\" title=\"Microbiology\" rel=\"external_link\" target=\"_blank\">Microbiology<\/a><\/li>\n<li><i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Staphylococcus\" title=\"Staphylococcus\" rel=\"external_link\" target=\"_blank\">Staphylococcus<\/a><\/i><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Notes_and_references\">Notes and references<\/span><\/h2>\n<div class=\"reflist columns references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-SchleiferKloos1975-1\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-SchleiferKloos1975_1-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Schleifer, K. H.; Kloos, W. E. (1975). \"Isolation and Characterization of Staphylococci from Human Skin I. Amended Descriptions of Staphylococcus epidermidis and Staphylococcus saprophyticus and Descriptions of Three New Species Staphylococcus cohnii, Staphylococcus haemolyticus, and Staphylococcus xylosus\". <i>International Journal of Systematic Bacteriology<\/i>. <b>25<\/b> (1): 50\u201361. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1099%2F00207713-25-1-50\" target=\"_blank\">10.1099\/00207713-25-1-50<\/a>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" title=\"International Standard Serial Number\" rel=\"external_link\" target=\"_blank\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/issn\/0020-7713\" target=\"_blank\">0020-7713<\/a>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=International+Journal+of+Systematic+Bacteriology&rft.atitle=Isolation+and+Characterization+of+Staphylococci+from+Human+Skin+I.+Amended+Descriptions+of+Staphylococcus+epidermidis+and+Staphylococcus+saprophyticus+and+Descriptions+of+Three+New+Species+Staphylococcus+cohnii%2C+Staphylococcus+haemolyticus%2C+and+Staphylococcus+xylosus&rft.volume=25&rft.issue=1&rft.pages=50-61&rft.date=1975&rft_id=info%3Adoi%2F10.1099%2F00207713-25-1-50&rft.issn=0020-7713&rft.aulast=Schleifer&rft.aufirst=K.+H.&rft.au=Kloos%2C+W.+E.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FeyOlson2010-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-FeyOlson2010_2-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Fey, P. D.; Olson, M. E. (2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2903046\" target=\"_blank\">\"Current concepts in biofilm formation of Staphylococcus epidermidis\"<\/a>. <i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Future_Microbiology\" title=\"Future Microbiology\" rel=\"external_link\" target=\"_blank\">Future Microbiology<\/a><\/i>. <b>5<\/b> (6): 917\u2013933. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.2217%2Ffmb.10.56\" target=\"_blank\">10.2217\/fmb.10.56<\/a>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" title=\"PubMed Central\" rel=\"external_link\" target=\"_blank\">PMC<\/a> <span class=\"cs1-lock-free\" title=\"Freely accessible\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2903046\" target=\"_blank\">2903046<\/a><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Future+Microbiology&rft.atitle=Current+concepts+in+biofilm+formation+of+Staphylococcus+epidermidis&rft.volume=5&rft.issue=6&rft.pages=917-933&rft.date=2010&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2903046&rft_id=info%3Adoi%2F10.2217%2Ffmb.10.56&rft.aulast=Fey&rft.aufirst=P.+D.&rft.au=Olson%2C+M.+E.&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2903046&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Levinson,_W._2010_94\u201399-3\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-Levinson,_W._2010_94\u201399_3-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Levinson,_W._2010_94\u201399_3-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation book\">Levinson, W. (2010). <i>Review of Medical Microbiology and Immunology<\/i> (11th ed.). pp. 94\u201399.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Review+of+Medical+Microbiology+and+Immunology&rft.pages=94-99&rft.edition=11th&rft.date=2010&rft.au=Levinson%2C+W.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Salyers-4\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-Salyers_4-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Salyers_4-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Salyers_4-2\" rel=\"external_link\"><sup><i><b>c<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Salyers_4-3\" rel=\"external_link\"><sup><i><b>d<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation book\">Salyers, Abigail A. & Whitt, Dixie D. (2002). <i>Bacterial Pathogenesis: A Molecular Approach, 2nd ed<\/i>. Washington, D.C.: ASM Press. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" title=\"International Standard Book Number\" rel=\"external_link\" target=\"_blank\">ISBN<\/a> 1-55581-171-X.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Bacterial+Pathogenesis%3A+A+Molecular+Approach%2C+2nd+ed.&rft.place=Washington%2C+D.C.&rft.pub=ASM+Press&rft.date=2002&rft.isbn=1-55581-171-X&rft.au=Salyers%2C+Abigail+A.&rft.au=Whitt%2C+Dixie+D.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Queck-5\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-Queck_5-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation book\">Queck SY & Otto M (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.horizonpress.com\/staph\" target=\"_blank\">\"Staphylococcus epidermidis and other Coagulase-Negative Staphylococci\"<\/a>. <i>Staphylococcus: Molecular Genetics<\/i>. Caister Academic Press. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" title=\"International Standard Book Number\" rel=\"external_link\" target=\"_blank\">ISBN<\/a> 978-1-904455-29-5.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.atitle=Staphylococcus+epidermidis+and+other+Coagulase-Negative+Staphylococci&rft.btitle=Staphylococcus%3A+Molecular+Genetics&rft.pub=Caister+Academic+Press&rft.date=2008&rft.isbn=978-1-904455-29-5&rft.aulast=Queck&rft.aufirst=SY&rft.au=Otto%2C+M&rft_id=http%3A%2F%2Fwww.horizonpress.com%2Fstaph&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-6\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-6\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.vetbact.org\/vetbact\/?artid=205\" target=\"_blank\">http:\/\/www.vetbact.org\/vetbact\/?artid=205<\/a><\/span>\n<\/li>\n<li id=\"cite_note-7\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-7\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><i><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.whonamedit.com\/doctor.cfm\/1203.html\" target=\"_blank\">Friedrich Julius Rosenbach<\/a><\/i> at <a href=\"https:\/\/en.wikipedia.org\/wiki\/Who_Named_It%3F\" class=\"mw-redirect\" title=\"Who Named It?\" rel=\"external_link\" target=\"_blank\">Who Named It?<\/a><\/span>\n<\/li>\n<li id=\"cite_note-Todar-8\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-Todar_8-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/textbookofbacteriology.net\/staph.html\" target=\"_blank\">\"Todar's Online Textbook of Bacteriology: Staphylococcus aureus and Staphylococcal Disease\"<\/a>. Kenneth Todar, PhD<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">Dec 7,<\/span> 2013<\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Todar%27s+Online+Textbook+of+Bacteriology%3A+Staphylococcus+aureus+and+Staphylococcal+Disease&rft.pub=Kenneth+Todar%2C+PhD&rft_id=http%3A%2F%2Ftextbookofbacteriology.net%2Fstaph.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-9\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-9\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ebi.ac.uk\/2can\/genomes\/bacteria\/Staphylococcus_epidermidis.html\" target=\"_blank\">\"Bacteria Genomes - STAPHYLOCOCCUS EPIDERMIDIS\"<\/a>. <i>Karyn's Genomes<\/i>. EMBL-EBI<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">December 23,<\/span> 2011<\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Karyn%27s+Genomes.&rft.atitle=Bacteria+Genomes+-+STAPHYLOCOCCUS+EPIDERMIDIS&rft_id=http%3A%2F%2Fwww.ebi.ac.uk%2F2can%2Fgenomes%2Fbacteria%2FStaphylococcus_epidermidis.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Otto-10\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-Otto_10-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Otto_10-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Otto M (August 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2807625\" target=\"_blank\">\"<i>Staphylococcus epidermidis<\/i> - the \"accidental\" pathogen\"<\/a>. <i>Nature Reviews Microbiology<\/i>. <b>7<\/b> (8): 555\u2013567. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1038%2Fnrmicro2182\" target=\"_blank\">10.1038\/nrmicro2182<\/a>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" title=\"PubMed Central\" rel=\"external_link\" target=\"_blank\">PMC<\/a> <span class=\"cs1-lock-free\" title=\"Freely accessible\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2807625\" target=\"_blank\">2807625<\/a><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Nature+Reviews+Microbiology&rft.atitle=Staphylococcus+epidermidis+-+the+%22accidental%22+pathogen&rft.volume=7&rft.issue=8&rft.pages=555-567&rft.date=2010-08&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2807625&rft_id=info%3Adoi%2F10.1038%2Fnrmicro2182&rft.au=Otto+M&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2807625&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-11\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-11\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite id=\"rdp-ebb-CITEREFOtto_M2009\" class=\"citation\">Otto M (2009), \"Staphylococcus epidermidis \u2014 the 'accidental' pathogen\", <i>Nature Reviews Microbiology<\/i>, <b>7<\/b> (8): 555\u2013567, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1038%2Fnrmicro2182\" target=\"_blank\">10.1038\/nrmicro2182<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" title=\"PubMed Central\" rel=\"external_link\" target=\"_blank\">PMC<\/a> <span class=\"cs1-lock-free\" title=\"Freely accessible\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2807625\" target=\"_blank\">2807625<\/a><\/span>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" class=\"mw-redirect\" title=\"PubMed Identifier\" rel=\"external_link\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19609257\" target=\"_blank\">19609257<\/a><\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Nature+Reviews+Microbiology&rft.atitle=Staphylococcus+epidermidis+%E2%80%94+the+%27accidental%27+pathogen&rft.volume=7&rft.issue=8&rft.pages=555-567&rft.date=2009&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2807625&rft_id=info%3Apmid%2F19609257&rft_id=info%3Adoi%2F10.1038%2Fnrmicro2182&rft.au=Otto+M&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-12\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-12\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite id=\"rdp-ebb-CITEREFHedin_G1993\" class=\"citation\">Hedin G (1993), \"Staphylococcus epidermidis \u2014 hospital epidemiology and the detection of methicillin resistance\", <i>Scandinavian Journal of Infectious Diseases Supplementum<\/i>, Oslo Norway: Scandinavian University Press, <b>90<\/b>: 1\u201359, <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" class=\"mw-redirect\" title=\"PubMed Identifier\" rel=\"external_link\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/8303217\" target=\"_blank\">8303217<\/a><\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Scandinavian+Journal+of+Infectious+Diseases+Supplementum&rft.atitle=Staphylococcus+epidermidis+%E2%80%94+hospital+epidemiology+and+the+detection+of+methicillin+resistance&rft.volume=90&rft.pages=1-59&rft.date=1993&rft_id=info%3Apmid%2F8303217&rft.au=Hedin+G&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-13\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-13\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Bek-Thomson, M.; et al. (2008). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2566126\" target=\"_blank\">\"Acne is Not Associated with Yet-Uncultured Bacteria\"<\/a>. <i>Journal of Clinical Microbiology<\/i>. <b>46<\/b> (10): 3355\u20133360. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1128%2FJCM.00799-08\" target=\"_blank\">10.1128\/JCM.00799-08<\/a>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" title=\"PubMed Central\" rel=\"external_link\" target=\"_blank\">PMC<\/a> <span class=\"cs1-lock-free\" title=\"Freely accessible\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2566126\" target=\"_blank\">2566126<\/a><\/span>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" class=\"mw-redirect\" title=\"PubMed Identifier\" rel=\"external_link\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18716234\" target=\"_blank\">18716234<\/a>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Journal+of+Clinical+Microbiology&rft.atitle=Acne+is+Not+Associated+with+Yet-Uncultured+Bacteria&rft.volume=46&rft.issue=10&rft.pages=3355-3360&rft.date=2008&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2566126&rft_id=info%3Apmid%2F18716234&rft_id=info%3Adoi%2F10.1128%2FJCM.00799-08&rft.au=Bek-Thomson%2C+M.&rft_id=%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2566126&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-FrancoisP-14\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-FrancoisP_14-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation book\">Francois P & Schrenzel J (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.horizonpress.com\/staph\" target=\"_blank\">\"Rapid Diagnosis and Typing of Staphylococcus aureus\"<\/a>. <i>Staphylococcus: Molecular Genetics<\/i>. Caister Academic Press. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" title=\"International Standard Book Number\" rel=\"external_link\" target=\"_blank\">ISBN<\/a> 978-1-904455-29-5.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.atitle=Rapid+Diagnosis+and+Typing+of+Staphylococcus+aureus&rft.btitle=Staphylococcus%3A+Molecular+Genetics&rft.pub=Caister+Academic+Press&rft.date=2008&rft.isbn=978-1-904455-29-5&rft.aulast=Francois&rft.aufirst=P&rft.au=Schrenzel%2C+J&rft_id=http%3A%2F%2Fwww.horizonpress.com%2Fstaph&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Mackay-15\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-Mackay_15-0\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation book\">Mackay IM (editor). (2007). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.horizonpress.com\/rtmic\" target=\"_blank\"><i>Real-Time PCR in Microbiology: From Diagnosis to Characterization<\/i><\/a>. Caister Academic Press. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" title=\"International Standard Book Number\" rel=\"external_link\" target=\"_blank\">ISBN<\/a> 978-1-904455-18-9.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Real-Time+PCR+in+Microbiology%3A+From+Diagnosis+to+Characterization&rft.pub=Caister+Academic+Press&rft.date=2007&rft.isbn=978-1-904455-18-9&rft.au=Mackay+IM+%28editor%29.&rft_id=http%3A%2F%2Fwww.horizonpress.com%2Frtmic&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-16\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-16\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Antunes, Ana L\u00facia Souza; Secchi, Carina; Reiter, Keli Cristine; Perez, Leandro Reus Rodrigues; Freitas, Ana L\u00facia Peixoto De; D'azevedo, Pedro Alves (2008-01-01). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1600-0463.2008.00796.x\/abstract\" target=\"_blank\">\"Feasible identification of Staphylococcus epidermidis using desferrioxamine and fosfomycin disks\"<\/a>. <i>APMIS<\/i>. <b>116<\/b> (1): 16\u201320. <a href=\"https:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" title=\"Digital object identifier\" rel=\"external_link\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1111%2Fj.1600-0463.2008.00796.x\" target=\"_blank\">10.1111\/j.1600-0463.2008.00796.x<\/a>. <a href=\"https:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" title=\"International Standard Serial Number\" rel=\"external_link\" target=\"_blank\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.worldcat.org\/issn\/1600-0463\" target=\"_blank\">1600-0463<\/a>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=APMIS&rft.atitle=Feasible+identification+of+Staphylococcus+epidermidis+using+desferrioxamine+and+fosfomycin+disks&rft.volume=116&rft.issue=1&rft.pages=16-20&rft.date=2008-01-01&rft_id=info%3Adoi%2F10.1111%2Fj.1600-0463.2008.00796.x&rft.issn=1600-0463&rft.aulast=Antunes&rft.aufirst=Ana+L%C3%BAcia+Souza&rft.au=Secchi%2C+Carina&rft.au=Reiter%2C+Keli+Cristine&rft.au=Perez%2C+Leandro+Reus+Rodrigues&rft.au=Freitas%2C+Ana+L%C3%BAcia+Peixoto+De&rft.au=D%27azevedo%2C+Pedro+Alves&rft_id=http%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1111%2Fj.1600-0463.2008.00796.x%2Fabstract&rfr_id=info%3Asid%2Fen.wikipedia.org%3AStaphylococcus+epidermidis\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<\/ol><\/div>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/bacdive.dsmz.de\/index.php?search=14529&submit=Search\" target=\"_blank\">Type strain of <i>Staphylococcus epidermidis<\/i> at Bac<i>Dive<\/i> - the Bacterial Diversity Metadatabase<\/a><\/li>\n<li>Teruaki Nakatsuji et al.: <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/advances.sciencemag.org\/content\/4\/2\/eaao4502\" target=\"_blank\">A commensal strain of Staphylococcus epidermidis protects against skin neoplasia<\/a>, in: Science Advances; 28th of Feb., 2018; Vol. 4, No. 2, <a href=\"https:\/\/doi.org\/10.1126\/sciadv.aao4502\" class=\"extiw\" title=\"doi:10.1126\/sciadv.aao4502\" rel=\"external_link\" target=\"_blank\">DOI:10.1126\/sciadv.aao4502<\/a><\/li><\/ul>\n\n\n\n<p><!-- \nNewPP limit report\nParsed by mw1325\nCached time: 20181216234105\nCache expiry: 1900800\nDynamic content: false\nCPU time usage: 0.556 seconds\nReal time usage: 0.684 seconds\nPreprocessor visited node count: 4512\/1000000\nPreprocessor generated node count: 0\/1500000\nPost\u2010expand include size: 131979\/2097152 bytes\nTemplate argument size: 4268\/2097152 bytes\nHighest expansion depth: 24\/40\nExpensive parser function count: 14\/500\nUnstrip recursion depth: 1\/20\nUnstrip post\u2010expand size: 41981\/5000000 bytes\nNumber of Wikibase entities loaded: 13\/400\nLua time usage: 0.297\/10.000 seconds\nLua memory usage: 5.64 MB\/50 MB\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 570.947 1 -total\n<\/p>\n<pre>35.03% 199.981 1 Template:Reflist\n27.33% 156.051 1 Template:Taxobox\n25.24% 144.119 1 Template:Taxobox\/core\n20.88% 119.232 5 Template:Cite_journal\n20.16% 115.115 11 Template:Navbox\n12.89% 73.620 1 Template:Taxonbar\n12.61% 71.976 14 Template:Delink\n11.46% 65.443 11 Template:Taxobox_colour\n 9.75% 55.648 1 Template:Gram-positive_bacterial_diseases\n<\/pre>\n<p>-->\n<\/p><p><!-- Saved in parser cache with key enwiki:pcache:idhash:2648919-1!canonical and timestamp 20181216234104 and revision id 873445757\n<\/p>\n<pre>-->\n<\/pre>\n<\/div>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>This article is a direct transclusion of <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/en.wikipedia.org\/wiki\/Staphylococcus_epidermidis\" target=\"_blank\">the Wikipedia article<\/a> and therefore may not meet the same editing standards as LIMSwiki.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181217214715\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.043 seconds\nReal time usage: 0.243 seconds\nPreprocessor visited node count: 25\/1000000\nPreprocessor generated node count: 139\/1000000\nPost\u2010expand include size: 127\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 5\/40\nExpensive parser function count: 0\/100\nLua time usage: 0.020\/7.000 seconds\nLua virtual size: 8.2 MB\/50 MB\nLua estimated memory usage: 0 bytes\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 230.591 1 - -total\n 64.63% 149.024 1 - wikipedia:Staphylococcus_epidermidis\n 34.98% 80.668 1 - Template:Italic_title\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:8433-0!*!*!*!*!*!* and timestamp 20181217214715 and revision id 24675\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Staphylococcus_epidermidis\">https:\/\/www.limswiki.org\/index.php\/Staphylococcus_epidermidis<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","509a78b4fc5d0046b2bae625b2c376a6_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/e\/e0\/Staphylococcus_epidermidis_01.png\/440px-Staphylococcus_epidermidis_01.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/b\/be\/Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif\/lossy-page1-440px-Staphylococcus_epidermidis_biofilm_on_titanium_substrate.tif.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/95\/Staphylococcus_epidermids.jpg\/440px-Staphylococcus_epidermids.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/30\/Stained_Staphylococcus_epidermidis.jpg\/440px-Stained_Staphylococcus_epidermidis.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/2\/2d\/Issoria_lathonia.jpg\/48px-Issoria_lathonia.jpg"],"509a78b4fc5d0046b2bae625b2c376a6_timestamp":1545083235,"c9e7e589abaded1dc205bee7420521de_type":"article","c9e7e589abaded1dc205bee7420521de_title":"Single-use medical device reprocessing","c9e7e589abaded1dc205bee7420521de_url":"https:\/\/www.limswiki.org\/index.php\/Single-use_medical_device_reprocessing","c9e7e589abaded1dc205bee7420521de_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tSingle-use medical device reprocessing\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThis article is an orphan, as no other articles link to it. Please introduce links to this page from related articles ; try the Find link tool for suggestions. (July 2014)\nSingle-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use.[1] Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled \u201cSingle Use Device\u201d (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing.[2] Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified third-party vendor.[3] The U.S. revenue for reprocessed devices (not SUDs) is estimated to be around $400 million annually.[4]\n\nContents \n\n1 History of reprocessing in the United States \n\n1.1 The Single Use Label \n\n\n2 Commonly reprocessed SUDs \n3 U.S. regulations for reprocessed SUDs \n4 Safety and efficacy of reprocessed SUDs \n5 Benefits of reprocessing \n\n5.1 Economic \n5.2 Environmental \n\n\n6 Physician and Clinical Statements in Support \n7 List of Known Regulated Third-Party SUD Reprocessing Vendors \n8 International Regulation of \u201cSingle-Use\u201d Medical Device Reprocessing \n\n8.1 European Union \n8.2 Africa and the Middle East \n\n8.2.1 Israel \n\n\n8.3 Asia\/Japan \n8.4 Australia \n8.5 Canada \n\n8.5.1 British Columbia \n8.5.2 Manitoba \n8.5.3 Alberta \n8.5.4 Northwest Territories \n8.5.5 Ontario \n8.5.6 Saskatchewan \n\n\n\n\n9 References \n\n\nHistory of reprocessing in the United States \nThe practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s.[5] After a thorough review by the U.S. FDA in 1999 and 2000,[5] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market,[6] under the condition that third-party reprocessors would be treated as the manufacturer and would meet the same criteria as the original equipment manufacturers (OEMs) of the medical device.[6] Following the implementation of FDA regulation, the U.S. Congress codified these standards and other requirements in the Medical Device User Fee Act of 2002.[7]\n\nThe Single Use Label \nOriginal equipment manufacturers undergo a thorough analysis to determine whether a device should be single-use or reusable. Factors in determining to label a device single-use include but are not limited to possible infection\/sterility concerns and the risk of reduced efficacy. Depending on the device and its design, failure to completely clean a single-use device could lead to cross patient infection or there is the risk that the chemicals used to clean the device will themselves pose a risk to patients by being absorbed, for example, by the plastic from which the device is made and then subsequently leaching out into a patient's body. There can also be the risk of deterioration of the device when exposed to cleaning or sterilization processes which could lead to device malfunction. When a manufacturer designs and develops a product, it determines the materials used and how the device is labeled.[8] In the U.S., to market a device as \u201creusable\u201d, a manufacturer must provide increased data requirements and invest the resources necessary to demonstrate to FDA that the product can be safely reprocessed at the hospital level.[9] Unlike reusable devices, single-use devices are not sold with instructions on how they can be properly cleaned and sterilized nor have they been validated or tested for exposure to cleaning or sterilization processes, including chemical exposure and heat.\n\nCommonly reprocessed SUDs \nCommonly reprocessed medical devices include lower-risk, U.S. FDA Class I non-invasive devices such as sequential compression sleeves, tourniquet cuffs, and pulse oximeter sensors, to medium-risk, FDA Class II minimally invasive surgical devices including Ear, Nose and Throat microdebriders and cautery electrodes, laparoscopic graspers, scissors, forceps, scalpels, orthopedic blades, bits, burs, external fixation clamps, bolts and components, and electrophysiological cardiac catheters.[10] To date, the FDA has not approved for reprocessing any Class III, or higher risk, SUDs.\n\nU.S. regulations for reprocessed SUDs \nThe Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and Medical Device User Fee Stabilization Act of 2005 were signed into law on October 26, 2002, and August 1, 2005, respectively. All medical devices including reprocessed devices are subject to premarket review by the U.S. FDA, unless the agency has, by regulation, declared the device to be exempt from premarket requirements.[1] Unless exempt, the lower risk \u201cClass I\u201d and \u201cClass II\u201d devices, whether \u201coriginal\u201d or reprocessed, are required to have cleared premarket notification submissions (\u201c510(k)s\u201d).[11] With regard to premarket review, reprocessors are subject to more stringent regulation by FDA than are OEMs[12] because MDUFMA, require FDA to withdraw premarket notification exemptions for a significant number of previously exempt reprocessed devices, although \u201coriginal\u201d devices remain exempt from premarket review.[13]\nReprocessors must also validate the cleaning and sterilization methods they seek to use in the reprocessing of a SUD, and include in their 510(k) submissions \u201cvalidation data [...] regarding cleaning, sterilization, and functional performance\u201d to show that the reprocessed device \u201cwill remain substantially equivalent [...] after the maximum number of times the device is reprocessed as intended\u201d.[14] Both OEMs and reprocessors are subject to establishment registration and medical device listing; medical device reporting; medical device tracking; reports of corrections and removals, the quality system regulation (\u201cQSR\u201d); and labeling requirements.[6]\n\nSafety and efficacy of reprocessed SUDs \nFDA and the independent U.S. Government Accountability Office (GAO) have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs. A 2008 GAO report found that of the over 320,000 adverse events filed with FDA between 2000 and 2006, only 65 adverse events \u201cactually involved or were suspected to involve a reprocessed SUD and that the reprocessed SUD was one of several possible causal factors in the adverse event. In reviewing these 65 reports, FDA found that the types of adverse events reported to be associated with the use of reprocessed SUDs were the same types of events that were reported for new devices\u201d.[15] The 2008 GAO report concluded: \u201cAfter reviewing the available evidence \u2013 including FDA\u2019s process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA\u2019s consultations with hospital representatives \u2013 we found no reason to question FDA\u2019s analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs\".[15] In a separate letter from FDA to Congressman Tom Davis and Harry Waxman dated January 23, 2006, FDA indicated that a total of 65,325 reports have been filed between 2003 and 2006 for the malfunction or injury associated with the first use of devices labeled for \u201csingle use.\u201d The same search produced 176 cases of apparent malfunction or injury associated with reprocessed devices. Upon analysis of the latter reports, FDA determined that these adverse events were not related to the reprocessing of the \u201csingle use\u201d device.[16]\n\nBenefits of reprocessing \nEconomic \nFDA-regulated reprocessed devices cost between 40%-60% of an original device.[17] Currently, reprocessors estimate that a typical 200-bed hospital, if taking advantage of a reprocessor\u2019s full product line, can save between $600,000 and $1 million a year and divert between 5,000 and 15,000 pounds of waste from landfills.[18] According to a study by The Commonwealth Fund with funding from the Robert Wood Johnson Foundation and Health Care Without Harm in November 2012, they estimated that from hospitals implementing a reprocessing program, cost savings over five years was about $57 per procedure, and that if hospitals nationwide adopted an SUD reprocessing intervention, cost savings would be $540 million annually, or $2.7 billion over five years.[19]\n\nEnvironmental \nRegulated medical waste (RMW), or \u201cred bag waste,\u201d is a waste expenditure that typically costs hospitals 6 to 10 times more to dispose of than regular solid waste.[17] Among the inventory of devices reprocessed annually, ninety-five percent (95%) are recycled at the end of their life cycle rather than sent to landfills.[20] A variety of otherwise reprocessable raw materials that end up in a hospital\u2019s RMW include stainless steel, aluminum, titanium, gold, polycarbonate and polyurethane. Reprocessing has allowed some hospitals to divert over 8,000 pounds of RMW from landfills each year, while larger systems can divert more than 50,000 pounds.[21]\n\nPhysician and Clinical Statements in Support \nAmerican College of Cardiology (ACC) (1999)[22]\nAssociation for Healthcare Resource and Materials Management (AHRMM) Reprocessing Advisory [23]\nAmerican Hospital Association (AHA) (2000) [24]\nAmerican Medical Association (AMA), Report of the Council on Scientific Affairs (I-00) (2000) [25]\nAmerican Nursing Association (ANA), (2010)[26]\nAssociation of periOperative Registered Nurses (AORN), Environmental Responsibility (2006)[27]\nPractice Greenhealth [28]\nThe Mayo Clinic (with AAOS and AHA), August 2, 2001 [29]\nList of Known Regulated Third-Party SUD Reprocessing Vendors \n\n\nRegulated Vendor\nLocation\n\n\nHygia Health Services[30]\nBirmingham, AL\n\n\nMedline ReNewal[31]\nRedmond, OR\n\n\nNEScientific[32]\nWaterbury, CT\n\n\nReNu Medical[33]\nEverett, WA\n\n\nSterilMed, Inc[34]\nMaple Grove, MN\n\n\nSteriPro Canada, Inc[35]\nToronto, Canada\n\n\nStryker Sustainability Solutions[36]\nLakeland, FL\n\n\nSureTek Medical[37]\nGreenville, SC\n\n\nVanguard (International)[38]\nBerlin, Germany\n\n\nThe Association of Medical Device Reprocessors (AMDR),[39] based in Washington, D.C., is the global trade association consisting of members of the regulated, commercial single-use medical device reprocessing and remanufacturing industry. AMDR was founded in 1997 and the commercial single-use medical device reprocessors in the association now serve a majority of U.S. hospitals, including all the country\u2019s Honor Roll hospitals, as ranked by U.S. News & World Report.\"[40]\n\n International Regulation of \u201cSingle-Use\u201d Medical Device Reprocessing \nThe reprocessing of SUDs is commonplace worldwide. Even in developed nations, including those that have reprocessing prohibitions in place, hospitals routinely reuse SUDs in an unregulated manner. In many cases (particularly in Africa and Asia), uncontrolled reuse of such devices is relatively common, if not the norm.[41]\n\nEuropean Union \nCurrently, the European Union (EU) does not have a single policy regarding the reprocessing of SUDs. However, it is in the process of revising its Medical Device Directive. In 1993, at the issuance of the last Medical Device Directive, the issue of medical device reprocessing was identified as in need of additional clarification and the European Commission was instructed to submit a report on the issue by 2010.[42] In August, 2010, the Commission released its report,[43] highlighting the risks of unregulated reprocessing. Ultimately, the European Commission released its proposal[44] and the European Parliament approved its draft[45] (9 October 2013). Both legislative versions propose to regulate reprocessing as manufacturing. The European Council is now set to approve its own version of the legislation. Ultimately, both the Council and Parliament will have to agree, meeting in Trialogue with the European Commission, on the final version of the legislation. It is hoped the final agreement on the regulation will completed in 2015.\nUntil then, regulation of reprocessing activities is left to the individual Member States. Since 2001, Germany has had in place a regulatory framework that does not distinguish between the reprocessing of \u201creusable\u201d and so-called \u201csingle-use\u201d medical devices. The guidelines, therefore, allow for SUD reprocessing if conformance with certain standards is achieved. The German Medical Devices Law and the Medical Devices Operator Ordinance regulate the reprocessing of medical devices and in doing so refer to the mutual recommendation by the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) for the reprocessing of medical devices.[46] As a result, the RKI\u2019s requirements must be observed.\nInstitutions, which want to reprocess single-use medical devices, must adopt and implement a quality management system according to DIN EN ISO 13485:2007. Compliance with the quality management requirements is monitored annually by \u201cNotified Bodies\u201d that have been accredited by the Central Authority of the L\u00e4nder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).\nOther Member States, such as the United Kingdom, Spain and France,[47] discourage or prohibit SUD reprocessing. The majority of Member States in Europe do not have any national regulations regarding reprocessing.[48]\n\nAfrica and the Middle East \nThe lack of resources, including medical devices and distribution channels, \u201cnecessitates the reuse of single-use devices\u201d in much of Africa.[41] This includes the reuse of syringes and needles that have not been sterilized, and even rubber gloves. In the Middle East, available data indicates that reuse of SUDs is common throughout Arab countries (particularly for cardiac catheters), despite the absence of a regulatory framework. Reprocessing in both Africa and the Middle East is done at the user-facility level.[41]\n\nIsrael \nIsrael does not have regulations in place specific to the reprocessing of SUDs, but as a general matter, medical devices must be registered with the Ministry of Health (MOH) before they can be sold in the country. If a product is approved by the U.S. FDA, it will generally be registered by the MOH with no further testing requirements and, therefore, may be lawfully marketed in the country. Consistent with this policy, FDA-cleared reprocessed devices have been registered with MOH and are actively imported into the country.[49]\n\n Asia\/Japan \nThe reuse of SUDs in much of Asia is common, particularly for injection needles.[41] For the most part, there are no national regulations governing reuse of SUDs and, thus, third-party reprocessors do not offer their services in Asia. Rather, most reuse in Asia is conducted in an unregulated-manner at the user-facility level. Reprocessing is not currently regulated in Japan, but, available data indicates that the reuse of SUDs is relatively common. A 2003 survey found that 80 to 90 percent of hospitals reused SUDs.[41]\n\nAustralia \nAustralia enacted regulations regarding the reprocessing (\u201cremanufacturing\u201d in Australia) of SUDs in 2003.[50] Similar to the U.S., in Australia, all reprocessors (third-party, hospital, and OEM) must conform to medical device manufacturer requirements as regulated by the Therapeutic Goods Administration (TGA). Prior to implementation of these requirements, hospital reprocessing of SUDs was common.\n\nCanada \nHealth Canada does not currently regulate reprocessed single-use devices or the third-party companies that are reprocessing these devices for Canadian hospitals. Whether or not to reprocess a single-use device is determined by the territorial and provincial health ministries as well as hospital boards.[51] A number of provinces have adopted similar positions that allow for the reprocessing of SUDs if the third party reprocessor is regulated by the FDA.\n\nBritish Columbia \nBritish Columbia issued a policy to its health authorities stating that by January 1, 2008, all health authorities must have eliminated the reprocessing and reuse of critical contact SUDs, unless they have been reprocessed by a licensed third-party reprocessor that is certified by a national regulatory authority such as Health Canada or the U.S. Food and Drug Administration.[51] The policy was revised in 2011 with additional information that sharps (e.g. scalpel blades, drill bits, saw blades, shavers) and needles shall be single-use and shall not be reprocessed.\n\nManitoba \nManitoba does not permit hospitals to reuse SUDs in-house, but does permit hospitals to contract with an FDA regulated vendor, among other requirements.[52]\n\nAlberta \nAlberta Health Services issued a policy in 2012 prohibiting the reuse and reprocessing of both critical and semi-critical single-use medical devices.[53]\n\nNorthwest Territories \nSince 2005, the Northwest Territories have prohibited reprocessing. Specifically, the Northwest Territories Department of Health and Social Services revised its Hospital and Health Care Facility Standards Regulations to require that \u201ca disposable device intended to be used on a patient during a single procedure shall not be used on a patient for more than one procedure and shall not be used on another patient.\" [51]\n\nOntario \nIn 2006, the Ontario Ministry of Health and Long Term Care endorsed a guidance document developed by its Provincial Infectious Diseases Advisory Committee (PIDAC) advising that critical and semi-critical SUDs must not be reprocessed and reused, unless the reprocessing is done by a licensed reprocessor.[51]\n\nSaskatchewan \nIn 2013, The Saskatchewan Ministry of Health affirmed a policy outlining requirements for hospitals that reprocess SUDs. Consistent with the policies of other provinces, Saskatchewan requires, among other things, that hospitals outsource to an FDA regulated vendor.[54]\n\nReferences \n\n\n^ a b \"Reprocessing of Single-Use Devices\". Fda.gov. 2006-09-26. Retrieved 2013-10-24 . \n\n^ \"A Winning Approach | AMH Magazine - Preventing Infection in Medical Treatment\". AMH Magazine. Retrieved 2013-10-24 . \n\n^ Landro, Laura (2008-03-19). \"Hospitals Reuse Medical Devices To Lower Costs - WSJ.com\". Online.wsj.com. Retrieved 2013-10-24 . \n\n^ Rodak, Sabrina (2013-06-14). \"Reprocessing Saves Up to $20k Per OR Annually\". Beckersasc.com. Retrieved 2013-10-24 . \n\n^ a b \"Reuse of Medical Devices Labeled for Single-use\". Fda.gov. Retrieved 2013-10-24 . \n\n^ a b c \"Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals\". Fda.gov. Retrieved 2013-10-24 . \n\n^ \"MDUFMA Frequently Asked Questions\". Fda.gov. Retrieved 2013-10-24 . \n\n^ Office, U. S. Government Accountability (2008-03-03). \"Reprocessed Single Use Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk\" (GAO-08\u2013147). GAO-08-147: Published: Jan 31, 2008. Publicly Released: Mar 3, 2008. \n\n^ \"Draft Guidance for Industry and FDA Staff - Processing\/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling\". Fda.gov. Retrieved 2013-10-24 . \n\n^ \"List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing (Attachment 1)\". Fda.gov. Retrieved 2013-10-24 . \n\n^ \"List 2 - Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Now Require the Submission of Validation\". Fda.gov. Retrieved 2013-10-24 . \n\n^ Testimony of Dr. Daniel Schultz, Director, CDRH, FDA (September 26, 2006) (\"Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the agency that exceeded the requirements for the original manufacturers (OEMs)\" http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/ReprocessingofSingle-UseDevices\/ucm121067.htm \n\n^ \"Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices\". Fda.gov. Retrieved 2013-10-24 . \n\n^ \"68 Fed. Reg. 23139\" (PDF) . April 30, 2003. citing 21 U.S.C. \u00a7 360(o) (emphasis added). For a full description of the validation data reprocessors must submit on a premarket basis, including more particular guidance on cleaning, functional testing, and sterilization data requirements, see Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Medical Devices (Sept. 25, 2006), at 15 \n\n^ a b U.S. Government Accountability Office, GAO-08-147, Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk (January 2008), at 1 http:\/\/www.gao.gov\/new.items\/d08147.pdf; See also, GAO\u2019s 2000 report: \n\n^ \"Letter from FDA to Congressman Tom Davis and Harry Waxman dated January 23, 2006\" (PDF) . Fda.gov. Retrieved 2013-10-24 . \n\n^ a b Sheehan, Kaeleigh. \"Reprocess and Reuse\". Greenhealth Magazine. Retrieved 2013-10-24 . \n\n^ \"Remanufactured Goods: An Overview\" (PDF) . Usitc.gov. Retrieved 2014-03-07 . \n\n^ SuSan Kaplan, Blair Sadler, Kevin little, Calvin Franz, and Peter OrrisS \"Can Sustainable Hospitals Help Bend the Health Care Cost Curve?\". The Commonwealth Fund. Retrieved 2013-10-24 . \n\n^ \"AMDR Statement\" (PDF) . Usitc.gov. Retrieved 2014-03-07 . \n\n^ \"Healthier Hospitals Initiative 2012 Milestone Report\" (PDF) . Healthierhosptials.org. Retrieved 2014-03-07 . \n\n^ \"Letter from American College of Cardiology to Senator Richard Durbin in support of reprocessing\" (PDF) . 1999. \n\n^ \"Reprocessing Advisory\". ahrmm.org. Retrieved 2014-03-30 . \n\n^ \"Letter from American Hospital Association to Senator Thad Cochran in support of reprocessing\" (PDF) . 1999. \n\n^ \"2000 Interim Meeting of the American Medical Association, Reports of the Council on Scientific Affairs\" (PDF) . \n\n^ \"American Nursing Association 2010 House of Delegates Resolution: Safety and Effectiveness of Reprocessed Single Use Devices in Healthcare\" (PDF) . 2010. \n\n^ (PDF) http:\/\/amdr.org\/documents\/APICsingleusedevicepositionChangesIncluded-Final8_31_07-r.pdf. Missing or empty |title= (help) \n\n^ \"Frequently Asked Questions | Practice Greenhealth\". practicegreenhealth.org. Retrieved 2014-03-30 . \n\n^ \"Letter from Mayo Clinic to Secretary Tommy Thompson, Department of Health and Human Services\" (PDF) . 2001. \n\n^ http:\/\/www.hygia.net\/ Official Website \n\n^ http:\/\/www.medlinerenewal.com\/ Official Website \n\n^ http:\/\/www.mdreprocess.com\/ Official Website \n\n^ http:\/\/renumedical.com\/ Official Website \n\n^ http:\/\/www.sterilmed.com\/ Official Website \n\n^ http:\/\/www.steriprocanada.com\/ Official Website \n\n^ http:\/\/sustainability.stryker.com\/ Official Website \n\n^ http:\/\/suretekmedical.com\/ Official Website \n\n^ http:\/\/www.vanguard-healthcare.com\/ Official Website \n\n^ \"Home\". AMDR home page. Retrieved 14 May 2018 . \n\n^ \"AMDR members are serving all of U.S. News & World Report's \"honor roll\" hospitals\". AMDR Top Hopsitals. 2017-09-19. Retrieved 14 May 2018 . \n\n^ a b c d e Popp, Walter; Rasslan, Ossama; Unahalekhaka, Akeau; Brenner, Pola; Fischnaller, Edith; Fathy, Maha; Goldman, Carol; Gillespie, Elizabeth (July 2010). \"What is the use? An international look at reuse of single-use medical devices\". International Journal of Hygiene and Environmental Health. 213 (4): 302\u2013307. doi:10.1016\/j.ijheh.2010.04.003. PMID 20471316. \n\n^ \"Council Directive 93\/42\/EEC (14 June 1993), Article 12a, OJ L 169, 12.7.1993, p. 1.\" \n\n^ \"Report from the Commission to the European Parliament and the Council: Report on the Issue of the Reprocessing of Medical Devices in the European Union, in Accordance with Article 12a of Directive 93\/42\/EEC, European Commission (27 August 2010).\" \n\n^ \"European Commission, Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, on medical devices, and amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 (26 September 2012).\" \n\n^ \"European Parliament, Report on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 (COM(2012)0542 \u2013 C7-0318\/2012 \u2013 2012\/0266(COD)), Committee on the Environment, Public Health and Food Safety (9 October 2013).\" \n\n^ \"Hygienic Requirements for Processing of Medical Devices: Recommendation by the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and the Federal German Institute for Medical Drugs and Medical Products (BfArM) Concerning the \"Hygienic Requirements for Processing of Medical Devices,\" Robert Koch Institute: Recommendation (2001).\" \n\n^ Commission Report, supra note 2, at 6. See also, Circulaire DGS\/DH n 51 (December 29, 1994) Relative a l\u2019utilisation des dispositifs medicaux steriles a usage unique dans les etblissements de sant\u00e9 publics et prives (France), Ministerio de sanidad y consume, Royal Decree 414.1996 Sec. 5, (July 9, 1999) (Spain) and MHRA Device Bulletin: DB 2006(04) Single-Use Medical Devices: Implications and Consequences of Reuse (UK).\" \n\n^ Commission Report, supra note 2, at 6. See also, European Association of Medical Device Reprocessors.\" \n\n^ \"Medical Device Regulatory Requirements for Israel,\", U.S. International Trade Administration (May 2, 2005) http:\/\/www.ita.doc.gov\/td\/health\/israelregs.html \n\n^ \"Statement by the TGA on regulations for sterilisation of single use devices,\" Australian Government, Therapeutic Goods Administration (July 21, 2003) http:\/\/www.tga.gov.au\/archive\/media-2003-sud-030721.htm \n\n^ a b c d CADTH Report \"Issue Analysis Summary: The Reuse of Single-Use Medical Devices,\" Health Canada; Therapeutic Products Directorate (April 28, 2005) http:\/\/www.hc-sc.gc.ca\/dhp-mps\/alt_formats\/hpfb-dgpsa\/pdf\/md-im\/saprmd_ias_gcsrmm_raq_2005-06-09-eng.pdf. See also, \"Reprocessing Single-Use Medical Devices: An Update of the Clinical Evidence and An Environmental Scan of Policies in Canada,\" Canadian Agency for Drugs and Technologies in Health (June 23, 2010) http:\/\/www.cadth.ca\/media\/pdf\/ES8_Reprocessing_SUDs_e.pdf \n\n^ Manitoba Deputy Health Minister\u2019s Office (March 21, 2013) \n\n^ Alberta Health Services. Single Use Medical Devices Policy. May 1, 2012 http:\/\/www.albertahealthservices.ca\/6444.asp \n\n^ Saskatchewan Health, Deputy Minister\u2019s Office (June 27, 2013) \n\n\n\n\n\n<\/pre>\n\nNotes \nThis article is a direct transclusion of article and therefore may not meet the same editing standards as LIMSwiki.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Single-use_medical_device_reprocessing\">https:\/\/www.limswiki.org\/index.php\/Single-use_medical_device_reprocessing<\/a>\n\t\t\t\t\tCategories: Healthcare termsRegulation of medical devicesHidden category: Articles transcluded from other wikis\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 8 April 2016, at 21:17.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 1,328 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","c9e7e589abaded1dc205bee7420521de_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Single-use_medical_device_reprocessing skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Single-use medical device reprocessing<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n<p><b>Single-use medical device reprocessing<\/b> is the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Disinfection\" class=\"mw-redirect\" title=\"Disinfection\" rel=\"external_link\" target=\"_blank\">disinfection<\/a>, cleaning, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Remanufacturing\" title=\"Remanufacturing\" rel=\"external_link\" target=\"_blank\">remanufacturing<\/a>, testing, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Packaging_and_labeling\" title=\"Packaging and labeling\" rel=\"external_link\" target=\"_blank\">packaging and labeling<\/a>, and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Sterilization_(microbiology)\" title=\"Sterilization (microbiology)\" rel=\"external_link\" target=\"_blank\">sterilization<\/a> among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), <a href=\"https:\/\/en.wikipedia.org\/wiki\/Medical_device\" title=\"Medical device\" rel=\"external_link\" target=\"_blank\">medical device<\/a> to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Food_and_Drug_Administration\" class=\"mw-redirect\" title=\"U.S. Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">U.S. Food and Drug Administration<\/a> (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use.<sup id=\"rdp-ebb-cite_ref-fda_a_1-0\" class=\"reference\"><a href=\"#cite_note-fda_a-1\" rel=\"external_link\">[1]<\/a><\/sup> Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled \u201cSingle Use Device\u201d (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing.<sup id=\"rdp-ebb-cite_ref-2\" class=\"reference\"><a href=\"#cite_note-2\" rel=\"external_link\">[2]<\/a><\/sup> Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified third-party <a href=\"https:\/\/en.wikipedia.org\/wiki\/Vendor\" title=\"Vendor\" rel=\"external_link\" target=\"_blank\">vendor<\/a>.<sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\" rel=\"external_link\">[3]<\/a><\/sup> The U.S. revenue for reprocessed devices (not SUDs) is estimated to be around $400 million annually.<sup id=\"rdp-ebb-cite_ref-4\" class=\"reference\"><a href=\"#cite_note-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p>\n\n<h2><span class=\"mw-headline\" id=\"History_of_reprocessing_in_the_United_States\">History of reprocessing in the United States<\/span><\/h2>\n<p>The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s.<sup id=\"rdp-ebb-cite_ref-fda_5-0\" class=\"reference\"><a href=\"#cite_note-fda-5\" rel=\"external_link\">[5]<\/a><\/sup> After a thorough review by the U.S. FDA in 1999 and 2000,<sup id=\"rdp-ebb-cite_ref-fda_5-1\" class=\"reference\"><a href=\"#cite_note-fda-5\" rel=\"external_link\">[5]<\/a><\/sup> the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market,<sup id=\"rdp-ebb-cite_ref-Fda.gov_6-0\" class=\"reference\"><a href=\"#cite_note-Fda.gov-6\" rel=\"external_link\">[6]<\/a><\/sup> under the condition that third-party reprocessors would be treated as the manufacturer and would meet the same criteria as the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Original_equipment_manufacturers\" class=\"mw-redirect\" title=\"Original equipment manufacturers\" rel=\"external_link\" target=\"_blank\">original equipment manufacturers<\/a> (OEMs) of the medical device.<sup id=\"rdp-ebb-cite_ref-Fda.gov_6-1\" class=\"reference\"><a href=\"#cite_note-Fda.gov-6\" rel=\"external_link\">[6]<\/a><\/sup> Following the implementation of FDA regulation, the <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Congress\" class=\"mw-redirect\" title=\"U.S. Congress\" rel=\"external_link\" target=\"_blank\">U.S. Congress<\/a> codified these standards and other requirements in the Medical Device User Fee Act of 2002.<sup id=\"rdp-ebb-cite_ref-7\" class=\"reference\"><a href=\"#cite_note-7\" rel=\"external_link\">[7]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"The_Single_Use_Label\">The Single Use Label<\/span><\/h3>\n<p>Original equipment manufacturers undergo a thorough analysis to determine whether a device should be single-use or reusable. Factors in determining to label a device single-use include but are not limited to possible infection\/sterility concerns and the risk of reduced efficacy. Depending on the device and its design, failure to completely clean a single-use device could lead to cross patient infection or there is the risk that the chemicals used to clean the device will themselves pose a risk to patients by being absorbed, for example, by the plastic from which the device is made and then subsequently leaching out into a patient's body. There can also be the risk of deterioration of the device when exposed to cleaning or sterilization processes which could lead to device malfunction. When a manufacturer designs and develops a product, it determines the materials used and how the device is labeled.<sup id=\"rdp-ebb-cite_ref-8\" class=\"reference\"><a href=\"#cite_note-8\" rel=\"external_link\">[8]<\/a><\/sup> In the U.S., to market a device as \u201c<a href=\"https:\/\/en.wikipedia.org\/wiki\/Reuse\" title=\"Reuse\" rel=\"external_link\" target=\"_blank\">reusable<\/a>\u201d, a manufacturer must provide increased data requirements and invest the resources necessary to demonstrate to FDA that the product can be safely reprocessed at the hospital level.<sup id=\"rdp-ebb-cite_ref-9\" class=\"reference\"><a href=\"#cite_note-9\" rel=\"external_link\">[9]<\/a><\/sup> Unlike reusable devices, single-use devices are not sold with instructions on how they can be properly cleaned and sterilized nor have they been validated or tested for exposure to cleaning or sterilization processes, including chemical exposure and heat.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Commonly_reprocessed_SUDs\">Commonly reprocessed SUDs<\/span><\/h2>\n<p>Commonly reprocessed medical devices include lower-risk, U.S. FDA Class I non-invasive devices such as sequential compression sleeves, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Tourniquet\" title=\"Tourniquet\" rel=\"external_link\" target=\"_blank\">tourniquet<\/a> cuffs, and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Pulse_oximeter\" class=\"mw-redirect\" title=\"Pulse oximeter\" rel=\"external_link\" target=\"_blank\">pulse oximeter<\/a> sensors, to medium-risk, FDA Class II minimally invasive surgical devices including Ear, Nose and Throat microdebriders and cautery electrodes, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Laparoscopic\" class=\"mw-redirect\" title=\"Laparoscopic\" rel=\"external_link\" target=\"_blank\">laparoscopic<\/a> graspers, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Scissors\" title=\"Scissors\" rel=\"external_link\" target=\"_blank\">scissors<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Forceps\" title=\"Forceps\" rel=\"external_link\" target=\"_blank\">forceps<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Scalpels\" class=\"mw-redirect\" title=\"Scalpels\" rel=\"external_link\" target=\"_blank\">scalpels<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Orthopedic\" class=\"mw-redirect\" title=\"Orthopedic\" rel=\"external_link\" target=\"_blank\">orthopedic<\/a> blades, bits, burs, <a href=\"https:\/\/en.wikipedia.org\/wiki\/External_fixation\" title=\"External fixation\" rel=\"external_link\" target=\"_blank\">external fixation<\/a> clamps, bolts and components, and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Electrophysiological\" class=\"mw-redirect\" title=\"Electrophysiological\" rel=\"external_link\" target=\"_blank\">electrophysiological<\/a> cardiac <a href=\"https:\/\/en.wikipedia.org\/wiki\/Catheters\" class=\"mw-redirect\" title=\"Catheters\" rel=\"external_link\" target=\"_blank\">catheters<\/a>.<sup id=\"rdp-ebb-cite_ref-10\" class=\"reference\"><a href=\"#cite_note-10\" rel=\"external_link\">[10]<\/a><\/sup> To date, the FDA has not approved for reprocessing any Class III, or higher risk, SUDs.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"U.S._regulations_for_reprocessed_SUDs\">U.S. regulations for reprocessed SUDs<\/span><\/h2>\n<p>The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and Medical Device User Fee Stabilization Act of 2005 were signed into law on October 26, 2002, and August 1, 2005, respectively. All medical devices including reprocessed devices are subject to premarket review by the U.S. FDA, unless the agency has, by regulation, declared the device to be exempt from premarket requirements.<sup id=\"rdp-ebb-cite_ref-fda_a_1-1\" class=\"reference\"><a href=\"#cite_note-fda_a-1\" rel=\"external_link\">[1]<\/a><\/sup> Unless exempt, the lower risk \u201cClass I\u201d and \u201cClass II\u201d devices, whether \u201coriginal\u201d or reprocessed, are required to have cleared premarket notification submissions (\u201c510(k)s\u201d).<sup id=\"rdp-ebb-cite_ref-11\" class=\"reference\"><a href=\"#cite_note-11\" rel=\"external_link\">[11]<\/a><\/sup> With regard to premarket review, reprocessors are subject to more stringent regulation by FDA than are OEMs<sup id=\"rdp-ebb-cite_ref-12\" class=\"reference\"><a href=\"#cite_note-12\" rel=\"external_link\">[12]<\/a><\/sup> because MDUFMA, require FDA to withdraw premarket notification exemptions for a significant number of previously exempt reprocessed devices, although \u201coriginal\u201d devices remain exempt from premarket review.<sup id=\"rdp-ebb-cite_ref-13\" class=\"reference\"><a href=\"#cite_note-13\" rel=\"external_link\">[13]<\/a><\/sup>\nReprocessors must also validate the cleaning and sterilization methods they seek to use in the reprocessing of a SUD, and include in their 510(k) submissions \u201cvalidation data [...] regarding cleaning, sterilization, and functional performance\u201d to show that the reprocessed device \u201cwill remain substantially equivalent [...] after the maximum number of times the device is reprocessed as intended\u201d.<sup id=\"rdp-ebb-cite_ref-14\" class=\"reference\"><a href=\"#cite_note-14\" rel=\"external_link\">[14]<\/a><\/sup> Both OEMs and reprocessors are subject to establishment registration and medical device listing; medical device reporting; medical device tracking; reports of corrections and removals, the quality system regulation (\u201cQSR\u201d); and labeling requirements.<sup id=\"rdp-ebb-cite_ref-Fda.gov_6-2\" class=\"reference\"><a href=\"#cite_note-Fda.gov-6\" rel=\"external_link\">[6]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Safety_and_efficacy_of_reprocessed_SUDs\">Safety and efficacy of reprocessed SUDs<\/span><\/h2>\n<p>FDA and the independent <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Government_Accountability_Office\" class=\"mw-redirect\" title=\"U.S. Government Accountability Office\" rel=\"external_link\" target=\"_blank\">U.S. Government Accountability Office<\/a> (GAO) have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs. A 2008 GAO report found that of the over 320,000 adverse events filed with FDA between 2000 and 2006, only 65 adverse events \u201cactually involved or were suspected to involve a reprocessed SUD and that the reprocessed SUD was one of several possible causal factors in the adverse event. In reviewing these 65 reports, FDA found that the types of adverse events reported to be associated with the use of reprocessed SUDs were the same types of events that were reported for new devices\u201d.<sup id=\"rdp-ebb-cite_ref-GAO_a_15-0\" class=\"reference\"><a href=\"#cite_note-GAO_a-15\" rel=\"external_link\">[15]<\/a><\/sup> The 2008 GAO report concluded: \u201cAfter reviewing the available evidence \u2013 including FDA\u2019s process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA\u2019s consultations with hospital representatives \u2013 we found no reason to question FDA\u2019s analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs\".<sup id=\"rdp-ebb-cite_ref-GAO_a_15-1\" class=\"reference\"><a href=\"#cite_note-GAO_a-15\" rel=\"external_link\">[15]<\/a><\/sup> In a separate letter from FDA to Congressman Tom Davis and Harry Waxman dated January 23, 2006, FDA indicated that a total of 65,325 reports have been filed between 2003 and 2006 for the malfunction or injury associated with the first use of devices labeled for \u201csingle use.\u201d The same search produced 176 cases of apparent malfunction or injury associated with reprocessed devices. Upon analysis of the latter reports, FDA determined that these adverse events were not related to the reprocessing of the \u201csingle use\u201d device.<sup id=\"rdp-ebb-cite_ref-16\" class=\"reference\"><a href=\"#cite_note-16\" rel=\"external_link\">[16]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Benefits_of_reprocessing\">Benefits of reprocessing<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"Economic\">Economic<\/span><\/h3>\n<p>FDA-regulated reprocessed devices cost between 40%-60% of an original device.<sup id=\"rdp-ebb-cite_ref-greenhealthmagazine_17-0\" class=\"reference\"><a href=\"#cite_note-greenhealthmagazine-17\" rel=\"external_link\">[17]<\/a><\/sup> Currently, reprocessors estimate that a typical 200-bed hospital, if taking advantage of a reprocessor\u2019s full product line, can save between $600,000 and $1 million a year and divert between 5,000 and 15,000 pounds of waste from landfills.<sup id=\"rdp-ebb-cite_ref-18\" class=\"reference\"><a href=\"#cite_note-18\" rel=\"external_link\">[18]<\/a><\/sup> According to a study by <a href=\"https:\/\/en.wikipedia.org\/wiki\/The_Commonwealth_Fund\" class=\"mw-redirect\" title=\"The Commonwealth Fund\" rel=\"external_link\" target=\"_blank\">The Commonwealth Fund<\/a> with funding from the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Robert_Wood_Johnson_Foundation\" title=\"Robert Wood Johnson Foundation\" rel=\"external_link\" target=\"_blank\">Robert Wood Johnson Foundation<\/a> and Health Care Without Harm in November 2012, they estimated that from hospitals implementing a reprocessing program, cost savings over five years was about $57 per procedure, and that if hospitals nationwide adopted an SUD reprocessing intervention, cost savings would be $540 million annually, or $2.7 billion over five years.<sup id=\"rdp-ebb-cite_ref-19\" class=\"reference\"><a href=\"#cite_note-19\" rel=\"external_link\">[19]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Environmental\">Environmental<\/span><\/h3>\n<p>Regulated medical waste (RMW), or \u201cred bag waste,\u201d is a waste expenditure that typically costs hospitals 6 to 10 times more to dispose of than regular solid waste.<sup id=\"rdp-ebb-cite_ref-greenhealthmagazine_17-1\" class=\"reference\"><a href=\"#cite_note-greenhealthmagazine-17\" rel=\"external_link\">[17]<\/a><\/sup> Among the inventory of devices reprocessed annually, ninety-five percent (95%) are <a href=\"https:\/\/en.wikipedia.org\/wiki\/Recycled\" class=\"mw-redirect\" title=\"Recycled\" rel=\"external_link\" target=\"_blank\">recycled<\/a> at the end of their <a href=\"https:\/\/en.wikipedia.org\/wiki\/Product_life_cycle\" class=\"mw-redirect\" title=\"Product life cycle\" rel=\"external_link\" target=\"_blank\">life cycle<\/a> rather than sent to <a href=\"https:\/\/en.wikipedia.org\/wiki\/Landfills\" class=\"mw-redirect\" title=\"Landfills\" rel=\"external_link\" target=\"_blank\">landfills<\/a>.<sup id=\"rdp-ebb-cite_ref-20\" class=\"reference\"><a href=\"#cite_note-20\" rel=\"external_link\">[20]<\/a><\/sup> A variety of otherwise reprocessable <a href=\"https:\/\/en.wikipedia.org\/wiki\/Raw_materials\" class=\"mw-redirect\" title=\"Raw materials\" rel=\"external_link\" target=\"_blank\">raw materials<\/a> that end up in a hospital\u2019s RMW include <a href=\"https:\/\/en.wikipedia.org\/wiki\/Stainless_steel\" title=\"Stainless steel\" rel=\"external_link\" target=\"_blank\">stainless steel<\/a>, aluminum, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Titanium\" title=\"Titanium\" rel=\"external_link\" target=\"_blank\">titanium<\/a>, gold, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Polycarbonate\" title=\"Polycarbonate\" rel=\"external_link\" target=\"_blank\">polycarbonate<\/a> and <a href=\"https:\/\/en.wikipedia.org\/wiki\/Polyurethane\" title=\"Polyurethane\" rel=\"external_link\" target=\"_blank\">polyurethane<\/a>. Reprocessing has allowed some hospitals to divert over 8,000 pounds of RMW from landfills each year, while larger systems can divert more than 50,000 pounds.<sup id=\"rdp-ebb-cite_ref-21\" class=\"reference\"><a href=\"#cite_note-21\" rel=\"external_link\">[21]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Physician_and_Clinical_Statements_in_Support\">Physician and Clinical Statements in Support<\/span><\/h2>\n<ul><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/American_College_of_Cardiology\" title=\"American College of Cardiology\" rel=\"external_link\" target=\"_blank\">American College of Cardiology<\/a> (ACC) (1999)<sup id=\"rdp-ebb-cite_ref-22\" class=\"reference\"><a href=\"#cite_note-22\" rel=\"external_link\">[22]<\/a><\/sup><\/li>\n<li>Association for Healthcare Resource and Materials Management (AHRMM) Reprocessing Advisory <sup id=\"rdp-ebb-cite_ref-ahrmm_23-0\" class=\"reference\"><a href=\"#cite_note-ahrmm-23\" rel=\"external_link\">[23]<\/a><\/sup><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/American_Hospital_Association\" title=\"American Hospital Association\" rel=\"external_link\" target=\"_blank\">American Hospital Association<\/a> (AHA) (2000) <sup id=\"rdp-ebb-cite_ref-24\" class=\"reference\"><a href=\"#cite_note-24\" rel=\"external_link\">[24]<\/a><\/sup><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/American_Medical_Association\" title=\"American Medical Association\" rel=\"external_link\" target=\"_blank\">American Medical Association<\/a> (AMA), Report of the Council on Scientific Affairs (I-00) (2000) <sup id=\"rdp-ebb-cite_ref-25\" class=\"reference\"><a href=\"#cite_note-25\" rel=\"external_link\">[25]<\/a><\/sup><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/American_Nursing_Association\" class=\"mw-redirect\" title=\"American Nursing Association\" rel=\"external_link\" target=\"_blank\">American Nursing Association<\/a> (ANA), (2010)<sup id=\"rdp-ebb-cite_ref-26\" class=\"reference\"><a href=\"#cite_note-26\" rel=\"external_link\">[26]<\/a><\/sup><\/li>\n<li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Association_of_periOperative_Registered_Nurses\" title=\"Association of periOperative Registered Nurses\" rel=\"external_link\" target=\"_blank\">Association of periOperative Registered Nurses<\/a> (AORN), <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ascquality.org\/Library\/singleusedevicereprocessingtoolkit\/AORN%20Guidance%20Statement%20on%20Reuse%20of%20Single%20Use%20Devices%202006.pdf\" target=\"_blank\">Environmental Responsibility (2006)<\/a><sup id=\"rdp-ebb-cite_ref-27\" class=\"reference\"><a href=\"#cite_note-27\" rel=\"external_link\">[27]<\/a><\/sup><\/li>\n<li>Practice Greenhealth <sup id=\"rdp-ebb-cite_ref-practicegreenhealth_28-0\" class=\"reference\"><a href=\"#cite_note-practicegreenhealth-28\" rel=\"external_link\">[28]<\/a><\/sup><\/li>\n<li>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Mayo_Clinic\" title=\"Mayo Clinic\" rel=\"external_link\" target=\"_blank\">Mayo Clinic<\/a> (with AAOS and AHA), August 2, 2001 <sup id=\"rdp-ebb-cite_ref-29\" class=\"reference\"><a href=\"#cite_note-29\" rel=\"external_link\">[29]<\/a><\/sup><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"List_of_Known_Regulated_Third-Party_SUD_Reprocessing_Vendors\">List of Known Regulated Third-Party SUD Reprocessing Vendors<\/span><\/h2>\n<table class=\"wikitable\" style=\"\">\n<tbody><tr>\n<th>Regulated Vendor<\/th>\n<th>Location\n<\/th><\/tr>\n<tr>\n<td>Hygia Health Services<sup id=\"rdp-ebb-cite_ref-30\" class=\"reference\"><a href=\"#cite_note-30\" rel=\"external_link\">[30]<\/a><\/sup><\/td>\n<td>Birmingham, AL\n<\/td><\/tr>\n<tr>\n<td>Medline ReNewal<sup id=\"rdp-ebb-cite_ref-31\" class=\"reference\"><a href=\"#cite_note-31\" rel=\"external_link\">[31]<\/a><\/sup><\/td>\n<td>Redmond, OR\n<\/td><\/tr>\n<tr>\n<td>NEScientific<sup id=\"rdp-ebb-cite_ref-32\" class=\"reference\"><a href=\"#cite_note-32\" rel=\"external_link\">[32]<\/a><\/sup><\/td>\n<td>Waterbury, CT\n<\/td><\/tr>\n<tr>\n<td>ReNu Medical<sup id=\"rdp-ebb-cite_ref-33\" class=\"reference\"><a href=\"#cite_note-33\" rel=\"external_link\">[33]<\/a><\/sup><\/td>\n<td>Everett, WA\n<\/td><\/tr>\n<tr>\n<td>SterilMed, Inc<sup id=\"rdp-ebb-cite_ref-34\" class=\"reference\"><a href=\"#cite_note-34\" rel=\"external_link\">[34]<\/a><\/sup><\/td>\n<td>Maple Grove, MN\n<\/td><\/tr>\n<tr>\n<td>SteriPro Canada, Inc<sup id=\"rdp-ebb-cite_ref-35\" class=\"reference\"><a href=\"#cite_note-35\" rel=\"external_link\">[35]<\/a><\/sup><\/td>\n<td>Toronto, Canada\n<\/td><\/tr>\n<tr>\n<td>Stryker Sustainability Solutions<sup id=\"rdp-ebb-cite_ref-36\" class=\"reference\"><a href=\"#cite_note-36\" rel=\"external_link\">[36]<\/a><\/sup><\/td>\n<td>Lakeland, FL\n<\/td><\/tr>\n<tr>\n<td>SureTek Medical<sup id=\"rdp-ebb-cite_ref-37\" class=\"reference\"><a href=\"#cite_note-37\" rel=\"external_link\">[37]<\/a><\/sup><\/td>\n<td>Greenville, SC\n<\/td><\/tr>\n<tr>\n<td>Vanguard (International)<sup id=\"rdp-ebb-cite_ref-38\" class=\"reference\"><a href=\"#cite_note-38\" rel=\"external_link\">[38]<\/a><\/sup><\/td>\n<td>Berlin, Germany\n<\/td><\/tr>\n<\/tbody><\/table>\n<p>The Association of Medical Device Reprocessors (AMDR),<sup id=\"rdp-ebb-cite_ref-39\" class=\"reference\"><a href=\"#cite_note-39\" rel=\"external_link\">[39]<\/a><\/sup> based in Washington, D.C., is the global <a href=\"https:\/\/en.wikipedia.org\/wiki\/Trade_association\" title=\"Trade association\" rel=\"external_link\" target=\"_blank\">trade association<\/a> consisting of members of the regulated, commercial single-use medical device reprocessing and remanufacturing industry. AMDR was founded in 1997 and the commercial single-use medical device reprocessors in the association now serve a majority of U.S. hospitals, including all the country\u2019s Honor Roll hospitals, as ranked by <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._News_%26_World_Report\" title=\"U.S. News & World Report\" rel=\"external_link\" target=\"_blank\">U.S. News & World Report<\/a>.\"<sup id=\"rdp-ebb-cite_ref-40\" class=\"reference\"><a href=\"#cite_note-40\" rel=\"external_link\">[40]<\/a><\/sup>\n<\/p>\n<h2><span id=\"rdp-ebb-International_Regulation_of_.E2.80.9CSingle-Use.E2.80.9D_Medical_Device_Reprocessing\"><\/span><span class=\"mw-headline\" id=\"International_Regulation_of_\u201cSingle-Use\u201d_Medical_Device_Reprocessing\">International Regulation of \u201cSingle-Use\u201d Medical Device Reprocessing<\/span><\/h2>\n<p>The reprocessing of SUDs is commonplace worldwide. Even in developed nations, including those that have reprocessing prohibitions in place, hospitals routinely reuse SUDs in an unregulated manner. In many cases (particularly in Africa and Asia), uncontrolled reuse of such devices is relatively common, if not the norm.<sup id=\"rdp-ebb-cite_ref-Journal_a_41-0\" class=\"reference\"><a href=\"#cite_note-Journal_a-41\" rel=\"external_link\">[41]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"European_Union\">European Union<\/span><\/h3>\n<p>Currently, the European Union (EU) does not have a single policy regarding the reprocessing of SUDs. However, it is in the process of revising its Medical Device Directive. In 1993, at the issuance of the last Medical Device Directive, the issue of medical device reprocessing was identified as in need of additional clarification and the European Commission was instructed to submit a report on the issue by 2010.<sup id=\"rdp-ebb-cite_ref-42\" class=\"reference\"><a href=\"#cite_note-42\" rel=\"external_link\">[42]<\/a><\/sup> In August, 2010, the Commission released its report,<sup id=\"rdp-ebb-cite_ref-43\" class=\"reference\"><a href=\"#cite_note-43\" rel=\"external_link\">[43]<\/a><\/sup> highlighting the risks of unregulated reprocessing. Ultimately, the European Commission released its proposal<sup id=\"rdp-ebb-cite_ref-44\" class=\"reference\"><a href=\"#cite_note-44\" rel=\"external_link\">[44]<\/a><\/sup> and the European Parliament approved its draft<sup id=\"rdp-ebb-cite_ref-45\" class=\"reference\"><a href=\"#cite_note-45\" rel=\"external_link\">[45]<\/a><\/sup> (9 October 2013). Both legislative versions propose to regulate reprocessing as manufacturing. The European Council is now set to approve its own version of the legislation. Ultimately, both the Council and Parliament will have to agree, meeting in Trialogue with the European Commission, on the final version of the legislation. It is hoped the final agreement on the regulation will completed in 2015.\n<\/p><p>Until then, regulation of reprocessing activities is left to the individual Member States. Since 2001, Germany has had in place a regulatory framework that does not distinguish between the reprocessing of \u201creusable\u201d and so-called \u201csingle-use\u201d medical devices. The guidelines, therefore, allow for SUD reprocessing if conformance with certain standards is achieved. The German Medical Devices Law and the Medical Devices Operator Ordinance regulate the reprocessing of medical devices and in doing so refer to the mutual recommendation by the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) for the reprocessing of medical devices.<sup id=\"rdp-ebb-cite_ref-46\" class=\"reference\"><a href=\"#cite_note-46\" rel=\"external_link\">[46]<\/a><\/sup> As a result, the RKI\u2019s requirements must be observed.\n<\/p><p>Institutions, which want to reprocess single-use medical devices, must adopt and implement a quality management system according to DIN EN ISO 13485:2007. Compliance with the quality management requirements is monitored annually by \u201cNotified Bodies\u201d that have been accredited by the Central Authority of the L\u00e4nder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).\n<\/p><p>Other Member States, such as the United Kingdom, Spain and France,<sup id=\"rdp-ebb-cite_ref-47\" class=\"reference\"><a href=\"#cite_note-47\" rel=\"external_link\">[47]<\/a><\/sup> discourage or prohibit SUD reprocessing. The majority of Member States in Europe do not have any national regulations regarding reprocessing.<sup id=\"rdp-ebb-cite_ref-48\" class=\"reference\"><a href=\"#cite_note-48\" rel=\"external_link\">[48]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Africa_and_the_Middle_East\">Africa and the Middle East<\/span><\/h3>\n<p>The lack of resources, including medical devices and distribution channels, \u201cnecessitates the reuse of single-use devices\u201d in much of Africa.<sup id=\"rdp-ebb-cite_ref-Journal_a_41-1\" class=\"reference\"><a href=\"#cite_note-Journal_a-41\" rel=\"external_link\">[41]<\/a><\/sup> This includes the reuse of syringes and needles that have not been sterilized, and even rubber gloves. In the Middle East, available data indicates that reuse of SUDs is common throughout Arab countries (particularly for cardiac catheters), despite the absence of a regulatory framework. Reprocessing in both Africa and the Middle East is done at the user-facility level.<sup id=\"rdp-ebb-cite_ref-Journal_a_41-2\" class=\"reference\"><a href=\"#cite_note-Journal_a-41\" rel=\"external_link\">[41]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Israel\">Israel<\/span><\/h4>\n<p>Israel does not have regulations in place specific to the reprocessing of SUDs, but as a general matter, medical devices must be registered with the Ministry of Health (MOH) before they can be sold in the country. If a product is approved by the U.S. FDA, it will generally be registered by the MOH with no further testing requirements and, therefore, may be lawfully marketed in the country. Consistent with this policy, FDA-cleared reprocessed devices have been registered with MOH and are actively imported into the country.<sup id=\"rdp-ebb-cite_ref-49\" class=\"reference\"><a href=\"#cite_note-49\" rel=\"external_link\">[49]<\/a><\/sup>\n<\/p>\n<h3><span id=\"rdp-ebb-Asia.2FJapan\"><\/span><span class=\"mw-headline\" id=\"Asia\/Japan\">Asia\/Japan<\/span><\/h3>\n<p>The reuse of SUDs in much of Asia is common, particularly for injection needles.<sup id=\"rdp-ebb-cite_ref-Journal_a_41-3\" class=\"reference\"><a href=\"#cite_note-Journal_a-41\" rel=\"external_link\">[41]<\/a><\/sup> For the most part, there are no national regulations governing reuse of SUDs and, thus, third-party reprocessors do not offer their services in Asia. Rather, most reuse in Asia is conducted in an unregulated-manner at the user-facility level. Reprocessing is not currently regulated in Japan, but, available data indicates that the reuse of SUDs is relatively common. A 2003 survey found that 80 to 90 percent of hospitals reused SUDs.<sup id=\"rdp-ebb-cite_ref-Journal_a_41-4\" class=\"reference\"><a href=\"#cite_note-Journal_a-41\" rel=\"external_link\">[41]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Australia\">Australia<\/span><\/h3>\n<p>Australia enacted regulations regarding the reprocessing (\u201cremanufacturing\u201d in Australia) of SUDs in 2003.<sup id=\"rdp-ebb-cite_ref-50\" class=\"reference\"><a href=\"#cite_note-50\" rel=\"external_link\">[50]<\/a><\/sup> Similar to the U.S., in Australia, all reprocessors (third-party, hospital, and OEM) must conform to medical device manufacturer requirements as regulated by the Therapeutic Goods Administration (TGA). Prior to implementation of these requirements, hospital reprocessing of SUDs was common.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Canada\">Canada<\/span><\/h3>\n<p><a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_Canada\" title=\"Health Canada\" rel=\"external_link\" target=\"_blank\">Health Canada<\/a> does not currently regulate reprocessed single-use devices or the third-party companies that are reprocessing these devices for Canadian hospitals. Whether or not to reprocess a single-use device is determined by the territorial and provincial health ministries as well as hospital boards.<sup id=\"rdp-ebb-cite_ref-CADTH_a_51-0\" class=\"reference\"><a href=\"#cite_note-CADTH_a-51\" rel=\"external_link\">[51]<\/a><\/sup> A number of provinces have adopted similar positions that allow for the reprocessing of SUDs if the third party reprocessor is regulated by the FDA.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"British_Columbia\">British Columbia<\/span><\/h4>\n<p><a href=\"https:\/\/en.wikipedia.org\/wiki\/British_Columbia\" title=\"British Columbia\" rel=\"external_link\" target=\"_blank\">British Columbia<\/a> issued a policy to its health authorities stating that by January 1, 2008, all health authorities must have eliminated the reprocessing and reuse of critical contact SUDs, unless they have been reprocessed by a licensed third-party reprocessor that is certified by a national regulatory authority such as <a href=\"https:\/\/en.wikipedia.org\/wiki\/Health_Canada\" title=\"Health Canada\" rel=\"external_link\" target=\"_blank\">Health Canada<\/a> or the <a href=\"https:\/\/en.wikipedia.org\/wiki\/U.S._Food_and_Drug_Administration\" class=\"mw-redirect\" title=\"U.S. Food and Drug Administration\" rel=\"external_link\" target=\"_blank\">U.S. Food and Drug Administration<\/a>.<sup id=\"rdp-ebb-cite_ref-CADTH_a_51-1\" class=\"reference\"><a href=\"#cite_note-CADTH_a-51\" rel=\"external_link\">[51]<\/a><\/sup> The policy was revised in 2011 with additional information that sharps (e.g. scalpel blades, drill bits, saw blades, shavers) and needles shall be single-use and shall not be reprocessed.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Manitoba\">Manitoba<\/span><\/h4>\n<p><a href=\"https:\/\/en.wikipedia.org\/wiki\/Manitoba\" title=\"Manitoba\" rel=\"external_link\" target=\"_blank\">Manitoba<\/a> does not permit hospitals to reuse SUDs in-house, but does permit hospitals to contract with an FDA regulated vendor, among other requirements.<sup id=\"rdp-ebb-cite_ref-52\" class=\"reference\"><a href=\"#cite_note-52\" rel=\"external_link\">[52]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Alberta\">Alberta<\/span><\/h4>\n<p>Alberta Health Services issued a policy in 2012 prohibiting the reuse and reprocessing of both critical and semi-critical single-use medical devices.<sup id=\"rdp-ebb-cite_ref-53\" class=\"reference\"><a href=\"#cite_note-53\" rel=\"external_link\">[53]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Northwest_Territories\">Northwest Territories<\/span><\/h4>\n<p>Since 2005, the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Northwest_Territories\" title=\"Northwest Territories\" rel=\"external_link\" target=\"_blank\">Northwest Territories<\/a> have prohibited reprocessing. Specifically, the Northwest Territories Department of Health and Social Services revised its Hospital and Health Care Facility Standards Regulations to require that \u201ca disposable device intended to be used on a patient during a single procedure shall not be used on a patient for more than one procedure and shall not be used on another patient.\" <sup id=\"rdp-ebb-cite_ref-CADTH_a_51-2\" class=\"reference\"><a href=\"#cite_note-CADTH_a-51\" rel=\"external_link\">[51]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Ontario\">Ontario<\/span><\/h4>\n<p>In 2006, the Ontario Ministry of Health and Long Term Care endorsed a guidance document developed by its Provincial Infectious Diseases Advisory Committee (PIDAC) advising that critical and semi-critical SUDs must not be reprocessed and reused, unless the reprocessing is done by a licensed reprocessor.<sup id=\"rdp-ebb-cite_ref-CADTH_a_51-3\" class=\"reference\"><a href=\"#cite_note-CADTH_a-51\" rel=\"external_link\">[51]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Saskatchewan\">Saskatchewan<\/span><\/h4>\n<p>In 2013, The Saskatchewan Ministry of Health affirmed a policy outlining requirements for hospitals that reprocess SUDs. Consistent with the policies of other provinces, Saskatchewan requires, among other things, that hospitals outsource to an FDA regulated vendor.<sup id=\"rdp-ebb-cite_ref-54\" class=\"reference\"><a href=\"#cite_note-54\" rel=\"external_link\">[54]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist columns references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-fda_a-1\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-fda_a_1-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-fda_a_1-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/ReprocessingofSingle-UseDevices\/\" target=\"_blank\">\"Reprocessing of Single-Use Devices\"<\/a>. Fda.gov. 2006-09-26<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Reprocessing+of+Single-Use+Devices&rft.pub=Fda.gov&rft.date=2006-09-26&rft_id=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FReprocessingofSingle-UseDevices%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><\/span>\n<\/li>\n<li id=\"cite_note-2\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-2\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.amhmagazine.com\/article.php?article_id=818\" target=\"_blank\">\"A Winning Approach | AMH Magazine - Preventing Infection in Medical Treatment\"<\/a>. 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Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=A+Winning+Approach+%26%23124%3B+AMH+Magazine+-+Preventing+Infection+in+Medical+Treatment&rft.pub=AMH+Magazine&rft_id=http%3A%2F%2Fwww.amhmagazine.com%2Farticle.php%3Farticle_id%3D818&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-3\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\">Landro, Laura (2008-03-19). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wsj.com\/articles\/SB120588469924246975\" target=\"_blank\">\"Hospitals Reuse Medical Devices To Lower Costs - WSJ.com\"<\/a>. 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Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Reprocessing+Saves+Up+to+%2420k+Per+OR+Annually&rft.pub=Beckersasc.com&rft.date=2013-06-14&rft.aulast=Rodak&rft.aufirst=Sabrina&rft_id=http%3A%2F%2Fwww.beckersasc.com%2Fasc-supply-chain-materials-management%2Freprocessing-saves-up-to-20k-per-or-annually.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-fda-5\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-fda_5-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-fda_5-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/NewsEvents\/Testimony\/ucm114926.htm\" target=\"_blank\">\"Reuse of Medical Devices Labeled for Single-use\"<\/a>. 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Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Reuse+of+Medical+Devices+Labeled+for+Single-use&rft.pub=Fda.gov&rft_id=http%3A%2F%2Fwww.fda.gov%2FNewsEvents%2FTestimony%2Fucm114926.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-Fda.gov-6\"><span class=\"mw-cite-backlink\">^ <a href=\"#cite_ref-Fda.gov_6-0\" rel=\"external_link\"><sup><i><b>a<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Fda.gov_6-1\" rel=\"external_link\"><sup><i><b>b<\/b><\/i><\/sup><\/a> <a href=\"#cite_ref-Fda.gov_6-2\" rel=\"external_link\"><sup><i><b>c<\/b><\/i><\/sup><\/a><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm107164.htm\" target=\"_blank\">\"Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals\"<\/a>. Fda.gov<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Enforcement+Priorities+for+Single-Use+Devices+Reprocessed+by+Third+Parties+and+Hospitals&rft.pub=Fda.gov&rft_id=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FGuidanceDocuments%2Fucm107164.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-7\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-7\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"#19\">\"MDUFMA Frequently Asked Questions\"<\/a>. Fda.gov<span class=\"reference-accessdate\">. Retrieved <span class=\"nowrap\">2013-10-24<\/span><\/span>.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=MDUFMA+Frequently+Asked+Questions&rft.pub=Fda.gov&rft_id=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FOverview%2FMedicalDeviceUserFeeandModernizationActMDUFMA%2Fucm109208.htm%2319&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-8\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-8\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation journal\">Office, U. S. Government Accountability (2008-03-03). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gao.gov\/products\/GAO-08-147\" target=\"_blank\">\"Reprocessed Single Use Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk\"<\/a> (GAO-08\u2013147). GAO-08-147: Published: Jan 31, 2008. Publicly Released: Mar 3, 2008.<\/cite><span title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Reprocessed+Single+Use+Devices%3A+FDA+Oversight+Has+Increased%2C+and+Available+Information+Does+Not+Indicate+That+Use+Presents+an+Elevated+Health+Risk&rft.issue=GAO-08%E2%80%93147&rft.date=2008-03-03&rft.aulast=Office&rft.aufirst=U.+S.+Government+Accountability&rft_id=http%3A%2F%2Fwww.gao.gov%2Fproducts%2FGAO-08-147&rfr_id=info%3Asid%2Fen.wikipedia.org%3ASingle+Use+Medical+Device+Reprocessing\" class=\"Z3988\"><\/span><link rel=\"mw-deduplicated-inline-style\" href=\"mw-data:TemplateStyles:r861714446\"\/><\/span>\n<\/li>\n<li id=\"cite_note-9\"><span class=\"mw-cite-backlink\"><b><a href=\"#cite_ref-9\" rel=\"external_link\">^<\/a><\/b><\/span> <span class=\"reference-text\"><cite class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm252999.htm\" target=\"_blank\">\"Draft Guidance for Industry and FDA Staff - Processing\/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling\"<\/a>. Fda.
