Latest Updates about 3M™ Bair Hugger™ Therapy
Researchers failed in multiple efforts to prove Bair Hugger system spread bacteria
Competitor who engineered lawsuits couldn’t prove his own theory
Newly discovered documents and testimony reveal that medical researchers bankrolled by 3M competitor Scott Augustine tried and failed in efforts to show that the Bair Hugger warming system increased the amount of bacteria around an operating table.
The blockbuster evidence once again confirms what 3M and its legal team have been arguing: There is no proof that the Bair Hugger warming system increases the risk of bacterial infection at surgical sites. But there is ample research showing that forced-air warming reduces the risk of surgical site infections.
The revelations are just the latest in the litigation involving 3M’s market-leading patient warming system. That litigation was spawned by Augustine, who recently testified that he helped engineer the first personal injury lawsuits against the Bair Hugger warming device.
- “However, there is no suggestion from these results that turning on the Bair Hugger makes any difference to operative field particle counts under controlled conditions.’’
- “Settle plates, air sampling, wound sampling, and swabbing Bair Huggers showed there was only very low numbers of skin bacteria found within various areas of the operating theater during the operating procedure if correct procedures are carried out.’’
3M competitor Scott Augustine admits role in manufacturing lawsuits against Bair Hugger device
3M competitor Scott Augustine testified that he helped engineer the first personal injury lawsuits against the 3M Bair Hugger warming device.
Scott Augustine, CEO of Augustine Medical, testified in a sworn statement to a Minnesota federal court, that he hired Houston law firm Kennedy Hodges LLP in July 2009, more than three years before the first lawsuits were filed against 3M. Augustine acknowledged that he wanted to find ways to generate personal-injury lawsuits against 3M and the Bair Hugger system.
“The purposes of the representation were multiple,’’ Augustine said in the court affidavit. “First, we wanted to learn about product liability litigation – how cases were analyzed, what evidence was required, etc…Second, we wanted to understand why personal injury firms virtually never filed cases on behalf of patients injured by surgical infections. Finally, we wanted to educate Kennedy Hodges about the research regarding the risks of forced-air warming, receive analysis and reactions from them, and understand their concerns and objections, if any.’’
Compendium outlines huge body of science supporting 3M™ Bair Hugger™ patient warming system
Guess how many scientific studies prove that the 3M™ Bair Hugger™ Patient Warming System can cause surgical site infections? Zero. None. Nada.
Now, guess how many publications show proven benefits of patient warming? Dozens and dozens and dozens.
3M recently published an interactive compendium of scientific research conducted over the past 25+ years related to the Bair Hugger warming system. It includes more than 200 publication summaries – the vast majority of which relate to research involving the Bair Hugger system – that demonstrate the safety and effectiveness of patient warming products, including the Bair Hugger system.
Fact: Clinical research studies show a significant REDUCTION in surgical site infections with the use of Bair Hugger therapy compared to no warming.
Fact: Clinical research studies show that the Bair Hugger system DOES NOT increase bacteria at the surgical site or in the air.
The claims against the Bair Hugger system are based on a handful of studies trumpeted by a 3M competitor. Not one of those studies shows any proven link between the use of the Bair Hugger system and surgical site infections. In fact, the studies specifically say they do not prove a causal link.
If you have any doubts about the safety of the Bair Hugger system, take some time to read the accompanying press release about the compendium. You can download the research compendium on the Resources page here.
Scott Augustine Strikes Again with False Claims
- A 3M competitor once again is spreading inaccurate and malicious information about the market-leading 3M™ Bair Hugger™ patient warming system.
- Scott Augustine, maker of the HotDog warming blanket, has sent emails to medical providers stating that 3M is doing a “silent recall’’ by “quietly replacing Bair Hugger with an alternative device.’’ The emails are from Orthopedic Infection Advisory and StopSurgicalInfections.org, shell organizations supported by Augustine Temperature Management.
- That is absolutely false. 3M is not replacing the Bair Hugger warming system. This is another attempt by Augustine to spread confusion and concern in the medical community.
- Augustine, who pled guilty to Medicare fraud in 2004, has waged a decade-long campaign to malign the Bair Hugger warming system, a device he invented and then lost control of when he was ousted from his company during the criminal investigation.
- Augustine has a history of such behavior. In 1992, a federal court ordered Augustine to stop disparaging a competing product. In 2009, a German court ordered Augustine to stop making false claims. In 2012, the FDA ordered Augustine to stop making false statements.
- In a sworn statement, Augustine recently said that, in 2009, he contacted the Kennedy Hodges law firm to encourage them to pursue litigation against the Bair Hugger System. Kennedy Hodges filed the first two lawsuits against the Bair Hugger System.
- The FDA is aware of Augustine and his activity regarding the Bair Hugger system. In fact, in the first week of December 2016, the Food and Drug Administration’s Minneapolis District conducted an inspection at 3M regarding the Bair Hugger warming system. That inspection was triggered by a complaint from Augustine about 3M not complying with medical device adverse event reporting regulations. 3M has been very transparent with the agency regarding Bair Hugger system litigation and 3M’s medical device adverse event reporting process. After visiting 3M and reviewing its processes and the scientific evidence that the Bair Hugger System does not cause or contribute to infection, the FDA affirmed that 3M is in compliance with regulations and found no deficiencies.
- The Bair Hugger warming system has been used more than 200 million times during the past 30 years. It is safe and effective.
- Do not be alarmed or misguided by Scott Augustine and his campaign of lies.
Duke weighs in: Keep using forced-air warming devices
The Duke Infection Control Outreach Network has notified hospitals that it recommends they keep using forced-air warming devices (such as the 3M™ Bair Hugger™ warming system) during surgeries.
You can read DICON’s review here.
In the strongly worded missive, DICON said the warming devices are “the only devices proven to decrease the risk of developing a post-operative infection.’’ It noted that forced-air warming (FAW) devices have a 20-year track record of safety in more than 200 million patients.
DICON issued its memo as a result of the misinformation campaign being waged by Augustine Medical, maker of the HotDog warming blanket. The HotDog uses a different technology, called resistive polymer warming (RPW.)
- We continue to believe that it is reasonable and appropriate to use FAW warming devices to maintain normothermia as these devices are the only devices proven to decrease the risk of developing a post-operative infection.
- FAW warming devices have a >20-year track record of safety in >200 million surgical patients.
- FAW devices should be regularly undergo maintenance as outlined by manufacturer’s guidelines, see attached table for recommendations.
Lawsuit dismissed against 3M Bair Hugger device; case misstated facts
An Illinois judge has dismissed a lawsuit against 3M Company and its Bair Hugger surgical warming device.
Madison County Circuit Judge William A. Mudge on August 25 granted the request from Carol Wiltshire to dismiss her lawsuit.
She and her husband, Jeff Wiltshire, had sued 3M in November 2015, claiming an infection she contracted after knee surgery was the result of negligence on the part of 3M, St. Anthony’s Health Center in Alton, Ill., and her physician, Dr. Bruce Vest.
Wiltshire had a total knee replacement surgery on Nov. 11, 2013 at the hospital, according to the lawsuit filed by attorney John J. Hopkins. Wiltshire said she contracted an infection that necessitated multiple follow-up surgeries, and she blamed the Bair Hugger warming system for the infection.
The complaint wrongly claimed that the Bair Hugger device “was designed to circulate forced air around a patient’s surgical wound.’’ It also incorrectly claimed that the device circulated air “from the floor and other areas of contamination.’’
The Bair Hugger device is not designed to circulate forced air around a patient’s wound. It uses air forced through a warming blanket to keep patients warm; there is no air circulated around a wound. There is no evidence that the Bair Hugger system results in surgical site infections. In fact, clinical research studies indicate the use of patient warming actually reduces the risk of surgical site infection.
John P. Abraham, Ph. D., University of St. Thomas and Jennifer A. Wagner, Ph. D., Prism Environmental Health and Safety Solutions
The Bair Hugger Warming System provides a safe and effective way to maintain normal body temperature during surgery. When used properly the Bair Hugger Warming System lowers the risk of hypothermia and improves patient recovery and surgery outcomes (i.e. reduces risk of surgical site infection, blood loss and transfusion requirement, prolonged recovery, and fatal heart attack). A scientific research project was undertaken to assess whether the Bair Hugger System disturbed the clean-air flow in an operating room in the vicinity of a sterile surgical site. The investigation showed that the Bair Hugger Warming System did not disrupt the normal airflow patterns of an operating room, and did not move air from the floor to the surgical site in a simulated hip replacement procedure.
A trauma center at a Dallas hospital reduced average times that patients suffered lower body temperatures by using the 3M Bair Hugger warming system more frequently. This story details improvements at Parkland Memorial Hospital, which trained its trauma staff to use the warming system more frequently. Abnormal body temperature is an independent predictor of death in trauma. While patient warming systems are used widely in emergency rooms, they are not standard in most trauma centers. Said Dr. Frank Zhao: “There’s no reason that we shouldn’t recommend this be part of the rewarming protocol in every trauma center.’’
Of all the questions surrounding patient warming, the most burning is this: Do forced-air warmers circulate contaminants that can cause wound infections, as a spate of recent lawsuits alleges? Read on as we tackle this and other hot topics surrounding your quest to maintain normothermia.
1. Does forced-air warming cause SSIs?
Of the many proven benefits of maintaining normothermia, perhaps the greatest is that it staves off surgical wound infections. But what if the very act of forced-air warming causes SSIs?
You've no doubt heard the claims or seen the ads from law firms trolling for clients: Besides blowing hot air, forced-air warming units stir up the germs from the floor and cause them to go airborne. The jetstream of germs, the notion goes, rises alongside the table and settles over the surface of knee or hip implants in the sterile field. The germs can take root in the wounds and cause debilitating infections, especially in patients undergoing deep joint surgery. Not everyone is buying this (Bunch of) Hot Air Theory.
"Commercially driven junk science that has no basis in reality whatsoever," says an observer.
3M's lawyers say no reputable study has proven that forced-air warmers contaminate the air when they vent their waste heat. Just the opposite is true, they say. Decades of research and clinical experience show that using forced-air to maintain normal body temperature helps reduce the risk of infections and improves surgical outcomes.
"Forced air is highly effective, easy to use, inexpensive and remarkably safe," says anesthesiologist Daniel Sessler, MD, who has researched forced-air warming extensively as chair of the department of outcomes research at the Cleveland Clinic.
Continue reading here.
Top Class Actions has invited 3M to respond to recent coverage of lawsuits filed against 3M regarding its Bair Hugger Surgical Warming System.
3M believes strongly that none of these cases have merit and is eager to prove that in court. There is no valid evidence that anyone has ever contracted a surgical site infection from the Bair Hugger system. Likewise, there is no scientific study that has demonstrated a causal link between the use of Bair Hugger therapy and an increase in surgical site infections. The recent Proceedings of the International Consensus Meeting on Periprosthetic Joint Infections determined that “no studies have shown an increase in SSI related to the use of” forced-air warming devices such as Bair Hugger.
There is, however, ample evidence that Bair Hugger warming therapy helps patients. Many clinical and quality studies have shown that maintaining normal body temperature during surgery reduces the risk of surgical-site infections. Patient warming is a recommended practice by leading health care institutions and professional societies – and the Bair Hugger system is a safe, effective and efficient method of doing so.
Continue reading here.
The U.S. Food and Drug Administration issued a Warning Letter to 3M competitor Scott Augustine in 2012 for making claims about his company’s device that were not supported by data submitted to the FDA. The FDA said Augustine’s Hot Dog Warming System is “adulterated’’ and “misbranded’’ as a result of the claims made by Augustine.
From the FDA letter: “Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.’’
You can read the full letter here.
A five-member panel consolidated a group of lawsuits against 3M Company and the 3M Bair Hugger Warming System in to a Multi-District Litigation in the U.S. District Court for the District of Minnesota. In supporting the decision, 3M said it is “now convinced that consolidation of this litigation in an MDL in Minnesota will provide the fastest and most efficient means of vindicating their product. Although the formation of an MDL would still raise the spectre of intimidating medical providers into forgoing use of the Bair Hugger [system] and thus risking patient health, Defendants have concluded that that risk can best be managed through the quick and efficient disposal of these spurious claims, and that an MDL will best speed that resolution.’’
3M also told the court that “use of the Bair Hugger [system] does not increase contamination at the surgical site but actually [can] reduce the risk of surgical site infections’’ through normothermia maintenance….and that the company remains “confident that the facts and the scientific and medical evidence will completely exonerate the Bair Hugger [system].’’
Read the filing here.