The Bair Hugger, a system that controls the temperature of patients who have undergone surgery, have been linked to serious patient infections. Personal injury lawsuits have been filed nationwide. And a panel of judges known as the U.S. Judicial Panel on Multidistrict Litigation centralized federal Bair Hugger lawsuits before the U.S. District Court for the District of Minnesota.
One of the aims of centralization is to create a uniform and more efficient pretrial process. As the judges wrote Friday, "Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings ... and conserve the resources of the parties, their counsel, and the judiciary."
The Bair Hugger keeps the patient at an ideal temperature. An explanation of the system that the U.S. Food and Drug Administration received in 2002 reads as follows: "The temperature management unit delivers warmed or room-temperature air directly to a Bair Hugger blanket via a flexible hose, or it delivers room-temperature air to the Model 459 patient cooling set, which, when filled with common ice, cools the air before delivering it to a Bair Hugger blanket. Depending on the blanket model used, the blanket is placed around, over, or underneath the patient. Small perforations in the patient-side of the blanket disperse the air over the patient."
The common defendants in Bair Hugger lawsuits are 3M Company and Arizant Healthcare Inc., according to the panel, which summarized the litigation as follows.
"The actions share factual issues arising from allegations that plaintiffs developed serious infections during their orthopedic surgeries due to the introduction of contaminants into their open wounds as a result of the use of a Bair Hugger Forced Air Warming system (Bair FAW)," the judges wrote Friday. "Specifically, plaintiffs allege that the device is defective in at least two respects: (1) the device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site; and (2) the internal airflow paths of the device's blower can become contaminated with pathogens that can then be expelled into the operating room. The actions thus present common issues concerning the development, manufacture, testing, regulatory approval process, and marketing of the Bair FAW."
Researchers, not attorneys, have documented the infection risk. For instance, health care professionals in the U.K. rated the efficiency of the Bair Hugger's air filtration capacity.
"Forced-air warming devices are effective for the prevention of surgical hypothermia. However, these devices intake nonsterile floor-level air...," the study's authors wrote for the August 2013 edition of the American Association of Nurse Anesthetists Journal.
After studying several Bair Hugger blowers in hospital use, the researchers wrote, "Laboratory testing found the intake filter to be 63.8 percent efficient. Swabbing detected microorganisms within 100 percent of the forced-air warming blowers sampled, with isolates of coagulase-negative staphylococci, mold, and micrococci identified. Particle counting showed 96 percent of forced-air warming blowers to be emitting significant levels of internally generated airborne contaminants out of the hose end. These findings highlight the need for upgraded intake filtration, preferably high-efficiency particulate air filtration (99.97 percent efficient), on current-generation forced-air warming devices to reduce contamination buildup and emission risks."
Bair Hugger patients who were diagnosed with a post-operative infection may be entitled to compensation for their medical expenses and other losses. The experienced attorneys at Reich & Binstock, who have been representing clients in product liability cases since 1984, offer a free consultation. Reich & Binstock, which can be contacted at this link, operates in all 50 states.