BAIR HUGGER
Product
Bair Hugger Total Temperature Management System
Warm Touch
Mistral-Air
Drug Class
Medical device
Indication for Use
Used in surgical procedures and for prevention of hypothermia
Injuries
Peri-prosthetic joint infection leading to complications including irrigation & debridement, revision surgeries, and amputation
Severe, life threatening infection
About
Forced air warming (“FAW”) systems are blankets used during surgical procedures to keep the patient warm in hopes of reducing post-surgical complications.
Most operating rooms are kept clean by positive pressure air flow pushing all the contaminants to the floor. However, FAW systems produce heat, which creates a convection current and brings the unclean air up into the surgical field. With the increased use of FAW systems in operating rooms, the incidence of post-surgical infections has increased, notably peri-prosthetic joint infections during hip and knee device implant procedures, leading to revisions, two stage revision surgeries, and even amputations.
Litigation is pending in state court in Minnesota against 3M, the manufacturer of the Bair Hugger, and a Multi District Litigation (“MDL”) is anticipated to be formed in federal court.