Caroselli, Beachler & Coleman, L.L.C.

Bair Hugger Forced Air Warming Devices Linked to Infections

There has been considerable debate in the medical and biotechnology communities about patient safety and whether forced-air warming systems can disrupt operating room airflow resulting in airborne contaminants that can lead to surgical infections. Until recently, little was known about patient safety and the risk of infection during when using Forced Air Warming devices. Patients undergoing prosthetic and deep joint surgery (hip replacement, knee replacement, etc.) must maintain an ideal core body temperature during the surgery. And while patient warming devices and equipment are critical to preventing mild hypothermia during hip, knee, or joint replacement surgery, Forced Air Warming Devices are suspected of increasing infection risk to those patients.

New research suggests that there are potentially significant product liability issues are associated with 3M's Bair Hugger forced-air patient warming system as the system has been linked to surgical infections in U.S. hospitals. The most dramatic research directly linking Bair was performed by P.D. McGovern et al. According to an online abstract published on The Bone and Joint Journal (http://www.bjj.boneandjoint.org.uk/content/93-B/11/1537.abstract) titled "Forced-air warming and ultra-clean ventilation do not mix - An investigation of theatre ventilation, patient warming and joint replacement infection in orthopedics, Drs. McGovern and Reed, orthopedic surgeons in the Northumbria Healthcare NHS Trust in the UK, reported a dramatic 74% decrease in PJIs when they discontinued using Bair Hugger warming during total joint replacement surgery. They switched to HotDog air-free warming, maintaining their new low infection rate. This research shows that Bair Hugger FAW was linked to a 3.8 times increase in deep joint infections (Forced-air warming and surgical site infections, ECRI Institute. health Devices 2013;42-4:122-125).

Prosthetic and deep joint surgery patients are at risk of infection during their operation where 3M Bair Hugger forced-air patient warming systems are used. Now, a Texas patient is suing 3M for a Bair Hugger injury that occurred during surgery. According to TwinCities.com (Pioneer Press) http://www.twincities.com/health/ci_22894244/texas-patient-suing-3m-bair-hugger-injury , a civil lawsuit was filed in Texas by Mr. Tommy Walton. Mr. Walton, 70-years old, was a hip replacement patient who sustained an infection during his surgery and alleges that 3M's Bair Hugger product (manufactured by a 3M subsidiary) was the cause of the infection. Mr. Walton had the hip replacement surgery in March of 2011 and claims he needed 15 additional surgeries. One of those surgeries included the removal of the artificial hip. Mr. Walton's lawsuit, filed in state court in Houston, claims the Bair Hugger picked up germs under the surgical table and rose with the heat and was then recirculated into the hip replacement device used by doctors. Mr. Walton is seeking $1 million in damages.

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Caroselli, Beachler & Coleman, L.L.C.
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Pittsburgh, PA 15222

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