Bair Hugger Lawsuit - Surgical Infections
The lawsuit involving Bair Hugger states the manufacturer knew about the potential increased risks of joint infections linked with the use of its warming blanket machines during hip and knee replacement surgeries, but didn't redesign the machine to make it safer, and also did not warn healthcare providers of the infection risk. In fact, the lawsuit states the manufacturer attempted to hide and discredit any scientific research that found an increased risk of hip and knee infections with the use of the machines.
Why is the Bair Hugger Warming Blanket Utilized
The purpose of a warming blanket is to help maintain a patient's body temperature during surgery. Keeping the body at proper temperature has proven to reduce bleeding, speed up recovery time, and provide other benefits. For this reason, forced-air warming systems, fluid warming systems, intravenous fluid warming, and warming blankets often are used during surgery to help maintain a patient’s body temperature as close to normal as possible.
Surgical warming blankets, such as Bair Hugger, work like a forced-air heater, pushing warm air through a hose into a blanket covering a patient. The device releases warm air over a patient’s body, but also releases air under the surgical table. The air released under the table has the potential to cause germs and bacteria to spread throughout the room, landing on a patient's surgical site. This can cause an infection in the patient’s hip or knee, such as sepsis and Methicillin-resistant Staphylococcus aureus (MRSA). Unfortunately, these infections are very difficult to treat when they occur deep in a patient's joint.
Risks Associated with the Bair Hugger Warming Blanket
The most serious risk potentially caused by the use of the Bair Hugger surgical warming blanket is deep joint infections, especially in the hip and knee during replacement surgeries. Treatment for these infections include a combination of surgeries and antibiotic therapy. In severe cases, amputation, joint fusion, or removal and a two-stage revision surgery may be necessary. Patients who are not able to have a second surgery are usually treated with long-term antibiotics.
Some people are at a higher risk for developing infections after knee and hip replacement surgeries.
|Factors that Increase the Risk|
|Immune deficiencies (such as HIV, lymphoma)|
|Immunosuppressive treatments (such as chemotherapy or corticosteroids)|
|Peripheral vascular disease (poor circulation to the hands and feet)|
When a joint infection is suspected, early diagnosis and proper treatment increase the chances of a full recovery. If you have any symptoms of infection, you should immediately contact your medical provider and seek follow-up care.
|Key Signs and Symptoms of an Infection|
|Fevers, chills and night sweats|
|Increased pain or stiffness|
|Warmth and redness around the wound|
Infections are caused by bacteria. Although we have plenty of bacteria within our body, they are usually controlled by our immune system. However, because joint replacements are made of metal and plastic, it is difficult for our immune system to attack bacteria that make it to these implants. Additionally, the bacteria forming at the implant can create a film that acts like a shield which is resistant to antibiotics. Thus, patients with infected joint replacements often require surgery in order to cure the infection.
FDA and Scientific Studies Regarding Bair Hugger
Patient Warming Excess Heat: The Effects on Orthopedic Operating Room Ventilation PerformanceExcess heat from forced air warming resulted in the disruption of ventilation airflows over the surgical site, whereas conductive patient warming devices had no noticeable effect on ventilation airflows. These findings warrant future research into the effects of forced air warming excess heat on clinical outcomes during contamination-sensitive surgery. To read more, click International Anesthesia Research Society
Infection control hazards associated with the use of forced-air warming in operating theatresA review is presented of the published experimental and clinical research into the infection control hazards of using forced air-warming (FAW) in operating theatres to prevent inadvertent hypothermia. This evidence has been reviewed with emphasis on the use of ultra-clean ventilation, any interaction it has with different types of patient warming (and FAW in particular), and any related increased risk of surgical site infection (SSI). We conclude that FAW does contaminate ultra-clean air ventilation; however, there appears to be no definite link to an increased risk of SSI based on current research. Nevertheless, whereas this remains unproven, we recommend that surgeons should at least consider alternative patient-warming systems in areas where contamination of the operative field may be critical. Although this is not a systematic review of acceptable randomized controlled clinical trials, which do not exist, it does identify that there is a need for definitive research in this field. To read more, click The Journal of Hospital Infection
Forced-air patient warming blankets disrupt unidirectional airflow: This demonstrated that waste heat from the poorly insulated forced-air warming blanket increased the air temperature on the surgical side of the drape by > 5°C. This created convection currents that rose against the downward unidirectional airflow, causing turbulence over the patient. The convection currents increased the particle concentration 1000-fold (2 174 000 particles/m3 for forced-air warming vs 1000 particles/m3 for radiant warming and 2000 particles/m3 for the control) by drawing potentially contaminated particles from below the operating table into the surgical site. To read more, click The Journal of Bone and Joint Surgery
Do forced air patient-warming devices disrupt unidirectional downward airflow?: Patient warming significantly decreases the risk of surgical site infection. Recently there have been concerns that forced air warming may interfere with unidirectional airflow, potentially posing an increased risk of infection. Our null hypothesis was that forced air and radiant warming devices do not increase the temperature and the number of particles over the surgical site when compared with no warming device. A forced air warming device was compared with a radiant warming device and no warming device as a control. The temperature and number of particles were measured over the surgical site. The theatre was prepared as for a routine lower-limb arthroplasty operation, and the same volunteer was used throughout the study. Forced air warming resulted in a significant mean increase in the temperature (1.1°C vs 0.4°C, p < 0.0001) and number of particles (1038.2 vs 274.8, p = 0.0087) over the surgical site when compared with radiant warming, which raises concern as bacteria are known to require particles for transport. To read more, click The Journal of Bone and Joint Surgery
Forced-air warming and ultra-clean ventilation do not mix: an investigation of theatre ventilation, patient warming and joint replacement infection in orthopaedics: We investigated the capacity of patient warming devices to disrupt the ultra-clean airflow system. We compared the effects of two patient warming technologies, forced-air and conductive fabric, on operating theatre ventilation during simulated hip replacement and lumbar spinal procedures using a mannequin as a patient. Infection data were reviewed to determine whether joint infection rates were associated with the type of patient warming device that was used. Neutral-buoyancy detergent bubbles were released adjacent to the mannequin's head and at floor level to assess the movement of non-sterile air into the clean airflow over the surgical site. During simulated hip replacement, bubble counts over the surgical site were greater for forced-air than for conductive fabric warming when the anaesthesia/surgery drape was laid down (p = 0.010) and at half-height (p < 0.001). For lumbar surgery, forced-air warming generated convection currents that mobilised floor air into the surgical site area. Conductive fabric warming had no such effect. A significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio (3.8, p = 0.024), was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used. Air-free warming is, therefore, recommended over forced-air warming for orthopaedic procedures. To read more, click The Journal of Bone and Joint Surgery
Bair Hugger Recall Information
As of this time, there has not been a recall of the surgical warming blankets, including Bair Hugger, related to deep joint infections. However, even the inventor of one of the warming blankets, Dr. Scott Augustine, has stated his concern that the device is a danger to surgical patients because he believes the forced air can spread bacteria associated with infections. Additionally, research published in the Journal of Bone and Joint Surgery found that air circulated by a forced hot air warming blanket system contained 2,000 times more potentially contaminated particles when compared to air circulated by a similar device.
Bair Hugger Lawsuit NewsInventor of Surgical Warming Blanket Warns Medical Community and Public
When Dr. Scott Augustine realized his invention was causing more problems than it was solving, he began spreading the word to his colleagues in the medical community. Unfortunately, by the time he became aware of the dangers of the device, he no longer had control over its sales and distribution. The rights to Dr. Augustine’s invention now belong to corporate giant 3M – and they aren’t about to let go of their profitable product without a fight. To read more, click Drug Safety NewsSevere Knee and Hip Infections Occurring During Surgery Blamed on 3M Surgical Device
In at least 14 suits filed against 3M and Arizant in federal courts across the country, surgical patients have alleged that the introduction of warm air disrupts the normal air flow in the operating room, allowing bacteria to circulate and enter incisions, causing infections which require additional medical procedures, including premature replacement of their prosthetic devices and amputations. To read more, click The Ring of FireLawsuits turn up heat on 3M's Bair Hugger warming blankets
3M Co. is battling lawsuits from more than 50 orthopedic surgery patients who say the company's popular "Bair Hugger" warming blankets, used to keep people warm before surgery, circulated contaminants and caused debilitating deep-joint infections. To read more, click Minnesota Star Tribune