Reported in Star Tribune, a medical device used to keep patients warm during surgery is the focus point of a federal trial currently taking place in Minneapolis.
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The Bair Hugger warming system, developed by medical device maker 3M is alleged to have caused serious joint infections for thousands of patients after surgery. Yesterday (15 May), a lawyer for plaintiff Louis Gareis, argued that the device was defectively designed and caused an infection, which occurred after he underwent hip replacement surgery in 2010.
The Bair Hugger device is used to control a patient’s body temperature during surgery. According to 3M, keeping patients at an optimal body temperature during surgery is thought to reduce the risk of infection, bleeding, heart attack following surgery, the length of hospital stay, and improve overall surgical outcomes.
The trial, which is expected to last around three weeks, is being touted as a ‘bellwether’ trial, as it may affect thousands of other cases that have been brought against 3M in recent years. A bellwether trial is used to help determine the results of similar cases in the future.
Around 4,000 patients have sued 3M in relation to the Bair Hugger device, all of which have been consolidated into the federal court in Minneapolis.
During the opening day of the trial, Gareis’ lawyer Genevieve Zimmerman presented computer modelling animations showing how the device could theoretically move particles from beneath an operating table and into the opening of a surgical wound. Zimmerman argued that the operating room where Gareis’ surgery took place could not have anticipated the change to airflow disruption, allegedly caused by the Bair Hugger device.
The plaintiff’s defence is based on allegations form the inventor of the device, Dr Scott Augustine, who claims he warned 3M about the risks of infection before the company bought the device. The theory is that the Bair Hugger device causes heat to rise and carry microscopic particles from the floor and into the space directly above a patient’s open wound.
Attorney Jerry Blackwell for 3M argued there is no evidence showing that the Bair Hugger device contaminates wound sites. Blackwell stated that the plaintiff’s computer models didn’t look at protective measures such as surgical gowns, drapes and taped skin, and also that they didn’t recognise other sources of air flow such as the door to the operating room being opened. He also told jurors to understand that patients’ skin carries bacteria which can cause infections.
Last year, the FDA issued a reminder to healthcare providers stating that thermoregulation devices have been “demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients”.
After receiving reports that some healthcare providers were avoiding the use of thermoregulation during surgery, the FDA reviewed data and did not find an association between the use of such devices and surgical site infections.
The Bair Hugger device is used in 80% of US hospitals and 3M state that there are no verified cases of infection caused by the device.
In its ‘Truth About Bair Hugger’ campaign, 3M state that “numerous studies show that the Bair Hugger patient warming system helps patients. There is no conclusive evidence that the Bair Hugger system’s forced-air warming causes infections.”