{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,6,7]],"date-time":"2022-06-07T12:41:15Z","timestamp":1654605675571},"reference-count":11,"publisher":"Association for the Advancement of Medical Instrumentation (AAMI)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Fluid-warming systems are crucial in surgical and trauma settings because of their key role in preventing or treating hypothermia and enabling proper resuscitation of blood products that are stored cold. Recently, several manufacturers have issued warnings of the possibility of aluminum leaching from their fluid warmers and cautioned about the potential for aluminum toxicity in patients who underwent fluid resuscitation with these devices. Studies suggest that one of the main factors affecting aluminum leaching in this setting is the coating of the aluminum plate itself. Coating, often with a biocompatible material, appears to reduce aluminum leaching by 100- to 200-fold compared with an uncoated plate. Nonetheless, leaching with the coating is still at a level exceeding U.S. regulations. A few aluminum-free warming systems are available on the market, but these are not carried by all providers and some clinicians may be less familiar with their use. Medical device manufacturers will likely design future warming systems with less potential for aluminum blood contact. In the meantime, the risk of inadequate resuscitation, consequent to the proper fluid warmer no longer being available, is contrasted with the risk of potential toxicity. In the situation described here, the regulators deferred the ultimate decision of which fluid warmer to use in a given situation to the risk-benefit decision of the clinician.<\/jats:p>","DOI":"10.2345\/1943-5967-56.2.37","type":"journal-article","created":{"date-parts":[[2022,5,6]],"date-time":"2022-05-06T19:05:16Z","timestamp":1651863916000},"page":"37-40","source":"Crossref","is-referenced-by-count":0,"title":["Aluminum Leaching from Fluid Warmers: Regulatory Deferral to Clinicians' Decision"],"prefix":"10.2345","volume":"56","author":[{"given":"Marko","family":"Oydanich","sequence":"first","affiliation":[{"name":"Marko Oydanich, MS, is a medical student at Rutgers New Jersey Medical School in Newark, NJ. Email: mko36@gsbs.rutgers.edu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rotem","family":"Naftalovich","sequence":"additional","affiliation":[{"name":"Rotem Naftalovich, MD, MBA, is head of neurosurgical anesthesia at Rutgers New Jersey Medical School in Newark, NJ, and a Captain in the Medical Corps of the U.S. Army, Fort Sam Houston, TX. Email: naftalro@njms.rutgers.edu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick J.","family":"Discepola","sequence":"additional","affiliation":[{"name":"Patrick J. Discepola, MD, is the director of regional anesthesia at Rutgers New Jersey Medical School in Newark, NJ. Email: disceppj@njms.rutgers.edu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jim","family":"Doran","sequence":"additional","affiliation":[{"name":"Jim Doran, CRNA, is a clinical instructor at Rutgers New Jersey Medical School and the chief CRNA at University Hospital in Newark, NJ. Email: doranja@uhnj.org"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faraz A.","family":"Chaudhry","sequence":"additional","affiliation":[{"name":"Faraz Chaudhry, MD, is the director of clinical operations at Rutgers New Jersey Medical School in Newark, NJ. Email: chaudhfa@njms.rutgers.edu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel J.","family":"Eloy","sequence":"additional","affiliation":[{"name":"Jean Daniel Eloy, MD, is vice-chair for clinical research at Rutgers New Jersey Medical School in Newark, NJ. Email: eloyje@njms.rutgers.edu"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1193","published-online":{"date-parts":[[2022,5,6]]},"reference":[{"issue":"1","key":"2022060712252752000_i1943-5967-56-2-37-b1","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1186\/s12871-021-01378-7","article-title":"Aluminium release and fluid warming: provocational setting and devices at risk","volume":"21","author":"Perl","year":"2021","journal-title":"BMC Anesthesiol."},{"issue":"1","key":"2022060712252752000_i1943-5967-56-2-37-b2","doi-asserted-by":"crossref","first-page":"25","DOI":"10.2344\/0003-3006-57.1.25","article-title":"Thermoregulation: physiological and clinical considerations during sedation and general anesthesia","volume":"57","author":"D\u00edaz","year":"2010","journal-title":"Anesth Prog."},{"issue":"1","key":"2022060712252752000_i1943-5967-56-2-37-b3","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1186\/s12871-018-0565-x","article-title":"Breuer T. Heating capabilities of small fluid warming systems","volume":"18","author":"Zoremba","year":"2018","journal-title":"BMC Anesthesiol."},{"issue":"6","key":"2022060712252752000_i1943-5967-56-2-37-b4","doi-asserted-by":"crossref","first-page":"708","DOI":"10.1111\/anae.14601","article-title":"Aluminium release by coated and uncoated fluid-warming devices","volume":"74","author":"Perl","year":"2019","journal-title":"Anaesthesia."},{"key":"2022060712252752000_i1943-5967-56-2-37-b5","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1016\/B978-1-4377-0973-5.10016-7","article-title":"Intravenous therapy, fluid delivery systems for resuscitation, and cell salvage devices","volume-title":"The MGH Textbook of Anesthetic Equipment.","author":"Henke","year":"2011"},{"key":"2022060712252752000_i1943-5967-56-2-37-b6","unstructured":"Food and Drug Administration.\n          \n          Potential risk of aluminum leaching with use of certain fluid warmer devices: letter to health care providers.\n\t\t\t\t\twww.fda.gov\/medical-devices\/letters-health-care-providers\/potential-risk-aluminum-leaching-use-certain-fluid-warmer-devices-letter-health-care-providers. Accessed March 28, 2022."},{"issue":"11","key":"2022060712252752000_i1943-5967-56-2-37-b7","doi-asserted-by":"crossref","first-page":"1374","DOI":"10.1111\/anae.14697","article-title":"Characterisation of aluminium release by the enFlow fluid-warming system in crystalloids and blood products","volume":"74","author":"Taylor","year":"2019","journal-title":"Anaesthesia."},{"issue":"11","key":"2022060712252752000_i1943-5967-56-2-37-b8","doi-asserted-by":"crossref","first-page":"1354","DOI":"10.1111\/anae.14743","article-title":"Fluid warmers, aluminium and what the regulator did","volume":"74","author":"McGuire","year":"2019","journal-title":"Anaesthesia."},{"key":"2022060712252752000_i1943-5967-56-2-37-b9","unstructured":"Medicines and Healthcare products Regulatory Agency.\n          \n          enFlow IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA\/2019\/015).\n\t\t\t\t\twww.gov.uk\/drug-device-alerts\/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-mda-2019-015. Accessed March 28, 2022."},{"issue":"2","key":"2022060712252752000_i1943-5967-56-2-37-b10","first-page":"176","article-title":"Aluminum in large and small volume parenterals used in total parenteral nutrition: proposed rule","volume":"63","author":"Food and Drug Administration.","year":"1998","journal-title":"Fed Regist."},{"issue":"2","key":"2022060712252752000_i1943-5967-56-2-37-b11","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1016\/S0010-8545(02)00078-4","article-title":"Aluminum chelation principles and recent advances","volume":"228","author":"Yokel","year":"2002","journal-title":"Coordination Chemistry Reviews."}],"container-title":["Biomedical Instrumentation &amp; Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/meridian.allenpress.com\/bit\/article-pdf\/56\/2\/37\/3068759\/i1943-5967-56-2-37.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/meridian.allenpress.com\/bit\/article-pdf\/56\/2\/37\/3068759\/i1943-5967-56-2-37.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,6,7]],"date-time":"2022-06-07T12:26:12Z","timestamp":1654604772000},"score":1,"resource":{"primary":{"URL":"https:\/\/meridian.allenpress.com\/bit\/article\/56\/2\/37\/481648\/Aluminum-Leaching-from-Fluid-Warmers-Regulatory"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,1]]},"references-count":11,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,4,1]]}},"URL":"https:\/\/doi.org\/10.2345\/1943-5967-56.2.37","relation":{},"ISSN":["1943-5967","0899-8205"],"issn-type":[{"value":"1943-5967","type":"electronic"},{"value":"0899-8205","type":"print"}],"subject":[],"published":{"date-parts":[[2022,4,1]]}}}