I’d like to report a discrepancy between the FDA’s stance with regards to the safety of the 3M™ Bair Hugger™ Forced-Air patient warming system and what is reported by one of their competitors. As a physician, I have an obligation to bring this to the attention of the public.

Recently, the FDA chose to support Forced-Air patient warming systems as safe and not responsible for an increase in Surgical Site Infections (SSIs). When used properly this is most likely the case. A competitor in the patient warming arena is Augustine Temperature Management™ with their HotDog™ Patient Warming system. Their website includes a 2011 study in an attempt to back-up the findings of a 74% reduction in Joint Sepsis Rates for Total Hip and Knee Arthroplasty with Discontinuing Forced-Air Warming and use of Non-Forced-Air Patient Warming Systems.

Where are these infections coming from if the FDA takes the position that the Bair Hugger™ forced-air warming system is safe? 

There are currently over 4000 patient lawsuits against 3M’s Bair Hugger™ from all 50 states.

The origin as I see it, is from what I learned from many of the nurses visiting the OPERATIONHEATJAC booth at this year’s AORN meeting in Boston. Their anesthesia providers were borrowing the hose from the patient’s Bair Hugger™ and using it under their scrubs or warm-up jackets or surgical gowns in an effort to keep comfortable in the freezing cold OR. This was also made apparent to me at the ASA meeting 10/21/17 – 10/23/17 in Boston.

This practice in my opinion can blow squamous skin cells covered in bacteria throughout the OR and is most likely the cause of the SSis. We recently learned of one hospital communicating a new policy, forbidding the use of the Bair Hugger™ by anesthesia personnel to keep themselves warm!

The Solution:

Hospitals and/or Anesthesia Departments will need to make the purchase of the  Operationheatjac TROs or Operationheatjac BTR the Transformer sets as included with the Operationheatjac BTR+ , for their anesthesia providers and perioperative nurses in an effort to provide for them a harmless system for them to keep comfortable.

The Cost:

A mere pittance when compared to the cost of treating a SSI, and with performance-based reimbursement, having additional surgeries and/or a re-do is $$$ out the window. In addition, a good defense from potential litigation is provided.

Worried about who will launder and care for these garments?

A recent publication In the Journal of the American College of Surgeons found surgical attire irrelevant as an (Infection Control Practice), ICP. Therefore, the laundering and care of the Operationheatjac products can be left to the wearers.

Multi-Institution Analysis of Infection Control Practices Identifies the Subset Associated with Best Surgical Site Infection Performance: A Texas Alliance for Surgical Quality Collaborative Project
Catherine H Davis, MD, MPH, Lillian S Kao, MD, MS, FACS, Jason B Fleming, MD, FACS, Thomas A Aloia, MD, FACS, for the Texas Alliance for Surgical Quality Collaborative

Operating Room Attire:

There was more variability within the category of OR attire. All hospitals reported surgeons frequently wearing scrubs outside of the OR (on inpatient wards or in the office) (17 hospitals, 76% to 100%; 3 hospitals, 51% to 75%). Median rates of representative other attire practices were reported as follows: 25% to 50% of surgeons and 51% to 75% of anesthesia personnel wearing personal cloth hats, 51% to 75% of anesthesia personnel wearing personal jackets, 26% to 50% of surgeons bringing uncovered bags into the OR, 26% to 50% of surgeons wearing shoe covers, and 51% to 75% of OR personnel covering their forearms. No correlation was identified between SSI rates and attire practices (all p > 0.1).

Their Conclusions:

Although well-intended, a large number of recommended (Infection Control Practices) ICPs have failed to improve outcomes. This analysis suggests that the subset of ICPs that focus on perioperative patient skin and wound hygiene and transparent display of SSI data, not OR attire issues, correlates with SSI performance. Focusing on implementation of these evidence- based ICPs may improve SSI rates at lower-performing hospitals.

Found the Smoking Gun by Googling – “Anesthesia Providers Borrowing the Bair Hugger Hose!”

With “Warmest” Regards,

Mark

Mark Silverberg, DDS, MD
Anesthesiologist & Managing Member
OPERATIONHEATJAC, LLC
mark@operationheatjac.com