Surgical Site Infection Risk With Forced Air Warming Blankets Not Established By Evidence, FDA States
While a growing number of hip infection lawsuits and knee infection lawsuits continue to be filed over problems with the 3M Bair Hugger, alleging that use of the warming blanket during joint replacement surgery caused contaminants to enter the surgical wound, federal regulators have told doctors they see no reason to avoid using forced-air warming systems.
The 3M Bair Hugger is designed to help control body temperature during orthopedic surgery, involving the use of warmed air that is forced into an inflatable blanket placed over the body. However, in recent years, concerns have emerged about the risk that the system may disrupt the operating room air flow, causing bacteria from the floor to rise up and cause deep-tissue infections.
There are currently hundreds of product liability lawsuits filed against 3M company and its Arizant subsidiary, alleging that the manufacturers provided false and misleading safety information for consumers and the medical community, and failed to make design changes that could have made the warming blankets safer.
Amid increasing concerns within the medical community, a “Dear Health Care Provider” letter was sent by the FDA’s Center for Devices and Radiological Health on August 30, indicating that the FDA is unable to verify that a forced air warming blanket infection risk exists.
“The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g. following joint replacement surgery),” the letter states. “After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”
The statement is unlikely to have a major impact on the pending Bair Hugger surgical site infection lawsuits, which are expected to start going to trial early next year.
Given the similar questions of fact and law presented in the cases, the U.S. Judicial Panel on Multidistict Litigation (JPML) previously established coordinated pretrial proceedings for the federal litigation, centralizing cases brought nationwide before U.S. District Judge Joan Ericksen in the District of Minnesota to reduce duplicative discovery into common issues that will arise in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
The first in a series of “bellwether” trials are scheduled to begin on February 8, 2018, which is designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.