Over 4,000 patients reportedly contracted serious infections after using 3M’s warm air blower blanket post-operation that has allegedly deposited infectious bacteria into their incisions.
Most of the patients reportedly underwent joint surgery and used the blanket to keep warm during the procedure. The deep-joint infections have reportedly caused septic arthritis in some cases. The inflammation of a joint through infection can be very painful and cause swelling, requiring treatment with anti-biotics.
The Bair Hugger is a single-use blanket that gets inflated with hot air to keep a patient warm before and during surgery. The Minnesota-based multinational company behind the product maintains that the product is safe for use and has been used in over 200 million procedures since 1987. According to StarTirbune online news, 3M are disputing the claims, saying that none of the claimants have, “definitive physical proof”, that the surgical warming device, “moved a specific bacterium into their wound”.
Of course it would be incredibly difficult for an individual claim to prove their claim, so the patients are relying on expert testimonies as well as computers to calculate algorithms that they feel will show that the Bair Hugger can cause infections by moving around bacteria or particles with bacteria into the wounds during surgery.
The claimants are hoping to rely on scientific studies and experts who have reportedly found that the Bair Hugger’s inner workings harbour bacteria and, “disrupt the normal downward airflow inside an operating room that keeps bacteria-carrying particles on the floor and away from the surgical site”, says StarTribune.
Lawyers for 3M have rejected the simulation, citing that there is, “no case where a medical mass tort has been decided based on a computer simulation.” However, in a world where computer calculations based on algorithms are becoming increasingly common and widespread, this method may not be as unreasonable as it may sound. The court carefully considered what kind of evidence will be allowed in the trial that is due to start soon.
One of the lawyers representing the claimants asserts that the simulation is more than appropriate to see where the small particles go when the Bair Hugger is switched on in the operating room. The computational fluid dynamic (CFD) model is often used, “to test all manner of engineering issues, from airplane design and nuclear weapons, to weather patterns… because it is so well-established and reliable”, says Genevieve Zimmerman.
Surgical infections are one of the most common problems in hospitals and regulators are keen to reduce the number of infections as much as possible. Warming patients up before and during surgery is believed to reduce infection as surgical incisions makes the patients lose heat very quickly, and in the process, can slow down healing and get in the way of the body’s infection prevention mechanisms. Is it ironic that the Bair Hugger – designed to warm up the patient’s body and prevent infections – may be the very thing actively causing infections by moving bacteria-laden particles into the cuts?
That is if the case is proven…
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