It is estimated that nearly 500,000 Americans undergo hip joint replacement surgery on an annual basis. Similarly, it is estimated that 4 Million Americans have had knee-replacement. In the past five (5) years, hip joint lawsuits involving DePuy ASR and STRYKER REJUVENATE & ABG II have gained significant publicity because of lawsuits and related settlements.
Our office has been investigating these cases for years now in an effort to help victims. In this process, we have learned about other potential complications that may arise out of the surgical environment and the use of “forced air warming”.
What is Forced Air Warming?
Forced Air Warming (FAW) in the context of surgery involves the use of a system that blows heated air into an inflatable blanket to maintain a patient’s core body temperature.
The blanket may cover the patient or be placed under them to achieve this purpose. Marketing behind this technology promotes the use of these systems to keep a patient warm and aid in their recovery.
Who Manufactures Forced Air Warming Blankets?
The largest manufacturer of Forced Air Warming (FAW) systems is Arizant, Inc., which was bought by 3M in 2010. The BAIR HUGGER is arguably the industry leader in terms of this technology and has been promoting claimed benefits of use for years.
As a result, use of Forced Air Warming (FAW) using the BAIR HUGGER is pervasive in operating rooms around the United States. However, the pioneer and inventor behind the technology has been speaking out against his invention, as noted below, raising questions about patient safety.
This story explains how Dr. Scott D. Augustine, the inventor of the forced-air warming technology, began raising concerns and sounding the alarm over the use of his invention – the BAIR HUGGER. Given his status as the original pioneer, most would think that Dr. Augustine’s warnings should carry some weight. At a minimum, his claims should have raised serious questions within the medical community over safety and effectiveness given the source. The manufacturer denies the claims, but scientific studies raise questions about these denials.
The New York Times story reports that Dr. Augustine has acknowledged that forced air warming promotes the spread of bacteria associated with hospital-acquired infections. The manufacturer portrays his dissent as part of a long-running feud between him and other company personnel that pre-dates 3M’s $810 Million acquisition of the company.
Granted, there are often several sides to a story. In this case, patient safety and patients not knowing about being put at potential risks raise a number of concerns. Medical providers using the BAIR HUGGER may have been convinced they were doing their best for patient safety but unwittingly exposed them to increased risk of infections and complications.
A growing number of lawsuits, intended to shed light on the issues and the science critical of the BAIR HUGGER, have prompted our office to open an investigation into potential cases. In the past, joint infection lawsuits involving hip or knee raised questions about surgical technique, rather than the devices themselves and were not the focus of past investigations.
Forced Air Warming & Ultra Clean Ventilation Do Not Mix – Says Study
It is well known that heat rises, and that is a settled matter of physics. Operating rooms and the surgical environment are notoriously cold. A sterile environment is paramount to the successful outcome of any surgery, along with the skill and care of attending medical personnel.
The combination may, in fact, increase the risk for joint infections based upon developing scientific literature. In “Forced-Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of Theatre Ventilation, Patient Warming and Joint Replacement Infection In Orthopaedics“, authors McGovern, Albrecht, Nachtscheim, Partington, Carluke and Reed, highlight the possibility that there is, in fact, an increased risk of deep joint infection when forced air warming is used rather than alternative technology.
Granted, there are studies in support of the use of FAW and those against continued use. As a result, the debate over the safety and effectiveness of these medical devices is about to become even more vibrant and vetted outside of medical circles.
As lawsuits mount and discovery is undertaken to determine what has been known, or reported in the course of several decades of use, may help settle the issue once and for all. However, most patients are not likely to even know they were exposed to a potential risk. Only in retrospect will they now discover that their post-operative infection may have an explanation they and their medical providers were not warned of in obtaining consent.