"Wave" of Bair Hugger Litigation?

A news article published in Clinical Quality & Infection Control, a publication of Becker’s ASC Review, stated:

“Recent studies published in medical journals questioning the safety of forced-air patient warming in orthopedic implant and other ultra-clean surgeries could mean a wave of new litigation.”

The studies, said the writer, show that forced-air blowers contain internally generated airborne contaminates and microorganisms that “could contaminate the surgical site….”

Infection Guidance: Air Turbulence in Operating Room Increases Risk of Orthopedic Infection

In its Guide to the Elimination of Orthopedic Surgical Site Infections, the Association of Professionals in Infection Control and Epidemiology (APIC) states, “If airflow is interrupted, rapid air turbulence can stir settled particles, enabling them to become airborne thus increasing the risk for wound contamination.” By applying recent research to APIC’s Guidance, StopSurgicalInfections.org found that forced-air warming systems violate APIC’s Guidance “by drawing potentially contaminated particles from below the operating table into the surgical site.”   

Minneapolis, MN July 25, 2013

According to the Association of Professionals in Infection Control (APIC), the maintenance of uninterrupted, downward airflow during orthopedic surgery is “vitally important.” Several recent articles published in top peer-reviewed medical journals, however, confirm that forced-air patient warming, such as 3M’s Bair Hugger, produces rising, turbulent convection currents that can mobilize floor-level contaminants.

The printing and distribution of APIC’s Guide was sponsored by 3M.  APIC, of course, neither endorses nor is affiliated with this press release.

“The APIC guidance,” says Dr. Scott Augustine, inventor of Bair Hugger, “ summarizes the reason that researchers have questioned the safety of forced-air patient warming (“FAW”) in orthopedic implant and other ultra-clean surgeries.  I believe the research is conclusive—the largest study involved a retrospective analysis of 1,437 hip or knee replacements. It showed a 74.6% decrease in deep joint infection when FAW was discontinued and replaced with air-free warming.”

New ECRI Guidance Expresses “Concern” About Forced-Air Warming in Implant Surgery

In the latest issue of Health Devices, ECRI Institute analyzed the safety of forced-air patient warming, concluding that thermal currents are “particularly worrisome” in implant surgery. Dr. Scott Augustine, inventor of both Bair Hugger and (air-free) HotDog patient warming and CEO of Augustine Temperature Management, comments.

Minneapolis, MN (PRWeb), April 17, 2013 -  After reviewing multiple published, peer-review articles addressing the consequences of the convection currents created by the waste heat produced by forced-air devices, ECRI stated:

• “The disruption of air-flow patterns is particularly worrisome in laminar-flow and ultraclean ORs, in which a wide variety of implant surgeries are performed.”
• “This is especially concerning during orthopedic surgeries because contamination of the surgical site may present a greater risk of developing a PJI, which is harder to treat and resolve than would be the case with SSIs in general.”

Video Evidence of the Vortex Caused by the Radiant Waste Heat from FAW Blankets

The video clip below is an excerpt from a nurse education course.  It shows the vortex-effect caused by the radiant waste heat from forced-air patient warming (FAW) blankets, similar to what was recently studied and published by orthopedic surgeons A.J. Legg and A.J.Hamer.

The Legg and Hamer study, published in the Bone & Joint Journal in March 2013, is different than the four previous studies examining the unintended consequence of FAW.  Studies by Belani, Dasari, McGovern and a previous study by Legg all showed the mass effect of waste heat forming thermals under the drapes and rising from the floor to the surgical field.  The latest study is unique because it shows that the radiant heat travels through the drapes, interacts with the downward flow of air from the ceiling ventilation, and forms vortices that suck contaminated air from the floor.  Legg and Hamer discovered 2,000x more contaminant particles at the surgical site when FAW was used than when air-free HotDog patient warming was used.

This is especially concerning in orthopedic surgery, where airborne contaminants can cause devastating deep-joint infections.

As you’re watching the short video clip, notice the tight-spinning vortex captured by orthopedic surgeons in Northumbria, UK, towards the end.

Study: Contamination Increased 2000x With Bair Hugger Warming

Minneapolis, MN: March 14, 2013— The use of Bair Hugger forced-air warmers during surgery creates convection currents that capture particles below the surgical table, lifting them into the sterile surgical field, according to research recently published by orthopedic surgeons. The waste heat radiating through the surgical drape induced the formation of tornado-like vortexes of rapidly spinning air near the surgical site. The vortexes sucked contaminated air from the operating room floor and deposited it over the surgical wound. 

2,000 times more contaminant particles were found in the air over the wound with Bair Hugger warming than with air-free HotDog conductive warming. With HotDog patient warming, only 1,000 particles per cubic meter of air were present. With Bair Hugger warming, the particle count was 2,174,000 per cubic meter, an increase of 217,300% 

Concerned by convection currents produced by hot-air warming devices, orthopedic surgeons A.J. Legg and A.J. Hamer from Northern General Hospital in Sheffield, United Kingdom, compared the torso-style disposable blankets of 3M’s Bair Hugger system with the reusable, air-free HotDog conductive warming system. The surgeons released particles below the surgical table and then measured how many were transported to the surgical site. Neither surgeon has any financial relationship with either of the products studied. 

The study was published in the February issue of The Bone and Joint Journal and entitled “Forced-air patient warming blankets disrupt unidirectional airflow.” 

Dr. Scott Augustine, inventor of both products studied, stated, “Such a massive increase in airborne contamination is obviously a safety issue in contamination-sensitive surgeries. In joint replacement surgery, for example, a single airborne bacterium can cause a deep joint infection.” 

Periprosethetic joint infections are often catastrophic: immense pain and suffering, permanent disability and an enormous cost to the hospital. 

“Every joint infection is a disaster—both for the patient and the system,” said Dr. Augustine. “The process is horrific: ex-plant the joint, prolonged hospitalization, 6-8 weeks of IV antibiotics and then—assuming no amputation—re-implant the joint. The average cost is around $100,000.” More than 12,000 of these infections occur each year in the US, a rate that some see as a significant public health problem.