{"id":143,"date":"2015-10-15T20:34:00","date_gmt":"2015-10-16T00:34:00","guid":{"rendered":"http:\/\/www.orthopaediclist.com\/blog\/?p=143"},"modified":"2016-09-05T06:23:18","modified_gmt":"2016-09-05T10:23:18","slug":"patient-warming-the-inside-story","status":"publish","type":"post","link":"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/","title":{"rendered":"Patient Warming: The Inside Story"},"content":{"rendered":"

by Scott D. Augustine MD, Augustine Temperature Management<\/span><\/p>\n

October 15, 2015<\/p>\n

\u00a0Almost 30 years ago, I invented a forced-air warming system for surgical patients and introduced it to the medical world.\u00a0 Now, I am proclaiming that forced-air warming, in certain circumstances, is a danger to patients.\u00a0 Given the irony, I thought some people might be interested in the full story.<\/i><\/p>\n

\u00a0I was a new anesthesia resident at the Naval Hospital in San Diego when I first encountered perioperative hypothermia. Nearly all patients were clinically hypothermic on admission to the recovery room in 1981, and no one thought twice about it.\u00a0 Despite using all available patient warming equipment (i.e. water mattresses, airway heaters, and fluid warmers) hypothermia was ubiquitous and considered an accepted part of surgery.<\/p>\n

I started asking postoperative patients and found that \u201cfreezing to death\u201d was the most memorable aspect of surgery.\u00a0 My interest was piqued.<\/p>\n

What was clear from the literature is that under anesthesia, general or conduction anesthesia, we all become poikilothermic.\u00a0 Just like the reptiles, we gain or lose heat depending on the environmental temperature.\u00a0 The challenge was obvious: how to produce a warm environment around a patient without requiring the whole room to be warm, as was the common practice in pediatric surgery.<\/p>\n

During my spare time as a resident, I started working on an inflatable air blanket that would wrap around the patient and circulate warm air. The first prototypes were very crude and made of plastic sheets that were heat-sealed together using a clothes iron. The first blower was a hairdryer. It took a lot of prototyping and refining, but by 1988 forced-air warming (FAW) was launched in recovery rooms across America.<\/p>\n

It was a good product that solved a need.\u00a0 The \u201cneed\u201d morphed from simply providing thermal comfort to avoiding the many recently documented negative physiological effects of hypothermia. \u00a0Hundreds of published studies demonstrated that mild hypothermia had an adverse effect on nearly everything that we studied: increased soft tissue wound infections, increased bleeding, increased adverse cardiac events, increased mortality, and increased hospital stays among other things.<\/p>\n

FAW changed surgical practice and measurably improved the outcomes of hundreds of millions of surgical patients over the past 25 years.<\/p>\n

I left Augustine Medical (renamed Arizant) at the end of 2002. Arizant was subsequently sold to a private equity firm and later to 3M. \u00a0After sitting out my two-year non-compete, I formed a product development company with no intention of getting back into patient warming. We were working on reliably producing a bubble of HEPA-clean air over a pillow for allergy and asthma reduction when we stumbled on the FAW waste heat rising phenomena.<\/p>\n

Forced-air systems produce 1000 watts of heat at 40 ft\/m3<\/sup>. Convective heat transfer is not particularly efficient, so only about 50 watts of the heated air gets transferred to the patient. We learned that there is a significant unintended consequence of that waste heat. The remaining 950 watts of waste hot air vents near the floor, heats the contaminated air resident near the floor, and then rises alongside the table into the sterile surgical field carrying contaminants with it.<\/p>\n

For 18 months we studied the rising waste heat from every angle.\u00a0 Bottom line–the waste heat rises 100% of the time, which is not surprising since it is a basic principle of physics.<\/p>\n

Even though I had been gone from the Company for six years, I was feeling terribly responsible for the unintended consequences of my invention.\u00a0 Digging into the research, we found that while soft tissue infections require contamination of over 1 million bacteria, the biofilm that can form on implanted material allows a single<\/i> airborne bacterium to cause a devastating periprosthetic joint infection. \u00a0Clearly implant patients, especially orthopedic implant patients, were the \u201cat-risk\u201d group.<\/p>\n

The fact that a problem turned up with forced air warming after 20 years on the market is certainly not unheard of in the medical device or pharmaceutical industries.\u00a0 For example, Cox-2 NSAIDs\u2014after many years on the market–now carry a \u201cblack box\u201d warning to not use if you have coronary artery disease.\u00a0 They are still very good drugs, just don\u2019t use them if you\u2019ve got heart problems.\u00a0 Similarly, I believe that forced-air warming should have a \u201cblack box\u201d warning: \u201cdo not use in implant surgery, especially orthopedic implant surgery.\u201d<\/p>\n

I became a doctor to help patients, not hurt them. I have the same motivation as an inventor, so I invented a safe alternative to FAW:\u00a0 air-free HotDog<\/a>\u00ae patient warming. It\u2019s the only warming system that can warm from above and below the patient simultaneously, which is far more effective than either above or below individually. HotDog\u00ae uses conductive fabric to deliver safe, even warmth\u2014no blowing air or water\u2014resulting is a uniquely versatile, more effective warming solution.<\/p>\n

Over the next short while, six independent studies were published corroborating our research showing that the rising waste forced air heat contaminates the sterile surgical field with contaminants from the floor.\u00a0 One study by Legg et al showed 2000 times more contaminating particles in the air above the surgical site with FAW than with HotDog\u00ae warming. \u00a0McGovern et al published their study showing that their deep joint infection rates dropped 74% (1437 patients, 2.5 years, p=0.028) when they discontinued FAW in orthopedics. They switched to HotDog\u00ae for safely maintaining normothermia.<\/p>\n

I let the manufacturer know about the problem with FAW, urging them to take action, offering business collaborations. \u00a0\u00a0Their response was massively negative. The more research that was published showing contamination and infection risk, the more adamant their denials.\u00a0 They have no credible research to refute the published waste heat studies\u2014zero studies<\/i>. With no research to promote, they instead decided to start a personal smear campaign against me and the HotDog\u00ae product, as if that could possibly solve their problem.<\/p>\n

A company can obfuscate, confuse and mislead for awhile, but eventually their customers and plaintiffs lawyers catch on.\u00a0 About two years ago, a law firm out of Houston filed two product liability lawsuits against that FAW manufacturer alleging that their clients\u2019 devastating knee infections were caused by the waste heat from FAW. By August 2015, a Google search of \u201cFAW infections\u201d revealed over 100 law firms advertising for injured joint implant patients.\u00a0 Many of these firms are also advertising on TV.\u00a0 These mass tort lawyers are well funded and seem to be very well organized.\u00a0 They have already filed for Multidistrict Litigation (MDL) certification in Federal Court. It is reasonable to assume that there could be tens of thousands of plaintiffs.<\/p>\n

We at ATM are just 3rd<\/sup> party bystanders watching the litigation show.\u00a0 While I feel terrible that my invention is causing catastrophic infections, I also feel that I\u2019ve done everything that I could reasonably do to warn both the FAW manufacturer and the medical community.\u00a0 FAW remains a useful tool, just not in ultra-clean surgeries like orthopedics. That is where air-free warming is the safer alternative.<\/p>\n

Dr. Augustine is a retired\u00a0Anesthesiologist and inventor of the HotDog\u00ae Warming System<\/a>.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

by Scott D. Augustine MD, Augustine Temperature Management October 15, 2015 \u00a0Almost 30 years ago, I invented a forced-air warming system for surgical patients and introduced it to the medical world.\u00a0 Now, I am proclaiming that forced-air warming, in certain circumstances, is a danger to patients.\u00a0 Given the irony, I thought some people might be […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17,4],"tags":[],"yoast_head":"\nPatient Warming: The Inside Story - OrthopaedicLIST.com Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Patient Warming: The Inside Story - OrthopaedicLIST.com Blog\" \/>\n<meta property=\"og:description\" content=\"by Scott D. Augustine MD, Augustine Temperature Management October 15, 2015 \u00a0Almost 30 years ago, I invented a forced-air warming system for surgical patients and introduced it to the medical world.\u00a0 Now, I am proclaiming that forced-air warming, in certain circumstances, is a danger to patients.\u00a0 Given the irony, I thought some people might be […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/\" \/>\n<meta property=\"og:site_name\" content=\"OrthopaedicLIST.com Blog\" \/>\n<meta property=\"article:published_time\" content=\"2015-10-16T00:34:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2016-09-05T10:23:18+00:00\" \/>\n<meta name=\"author\" content=\"James Hundley, MD\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"James Hundley, MD\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/\",\"url\":\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/\",\"name\":\"Patient Warming: The Inside Story - OrthopaedicLIST.com Blog\",\"isPartOf\":{\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/#website\"},\"datePublished\":\"2015-10-16T00:34:00+00:00\",\"dateModified\":\"2016-09-05T10:23:18+00:00\",\"author\":{\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/#\/schema\/person\/87a719b32f490b91a2f4a6a44d4d6752\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.orthopaediclist.com\/blog\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Patient Warming: The Inside Story\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/#website\",\"url\":\"https:\/\/www.orthopaediclist.com\/blog\/\",\"name\":\"OrthopaedicLIST.com Blog\",\"description\":\"News About Orthopaedic Surgery and Orthopaedic Products and Services\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.orthopaediclist.com\/blog\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/#\/schema\/person\/87a719b32f490b91a2f4a6a44d4d6752\",\"name\":\"James Hundley, MD\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.orthopaediclist.com\/blog\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/210425b5d38259409c4acb9bbb1e31bf?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/210425b5d38259409c4acb9bbb1e31bf?s=96&d=mm&r=g\",\"caption\":\"James Hundley, MD\"},\"description\":\"Dr. Hundley is a retired orthopaedic surgeon and the originator and co-founder of OrthopaedicLIST.com, a resource website for orthopaedic surgeons and related professionals.\",\"sameAs\":[\"http:\/\/www.orthopaediclist.com\"],\"url\":\"https:\/\/www.orthopaediclist.com\/blog\/author\/hundleysr\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Patient Warming: The Inside Story - OrthopaedicLIST.com Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orthopaediclist.com\/blog\/patient-warming-the-inside-story\/","og_locale":"en_US","og_type":"article","og_title":"Patient Warming: The Inside Story - OrthopaedicLIST.com Blog","og_description":"by Scott D. 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