In a recent self-published study, 3M competitor Scott Augustine used data from a New York hospital to claim that the use of his conductive warming device resulted in fewer infections during joint surgeries than the use of the market-leading 3M™ Bair Hugger™ warming system.
But there is a critical flaw in Augustine’s study: the New York hospital has testified that it never used the Bair Hugger warming system.
The Clinical Chair of the Department of Anesthesiology at South Nassau Communities Hospital in New York testified in a sworn affidavit on Sept. 29, 2017, that his hospital actually was not part of any “study’’ and that he found “multiple errors’’ in Augustine’s paper, including the fact that the hospital didn’t use the Bair Hugger system.
South Nassau is one of three medical facilities cited by Augustine in a paper he paid to publish earlier this year in an Italian journal, Orthopedic Reviews.
The other two medical facilities also have provided information that significantly undermines the study’s credibility and Augustine’s claims. Ridgeview Medical Center of Minnesota stated that there is no data to support a direct correlation to Augustine’s device and the hospital’s reduced infection rates, contrary to Augustine’s claims. Ridgeview also publicly stated that it never authorized Augustine to use its data in any study. Like the data provided by South Nassau, the data provided by the other two facilities were selectively used in a way that flatly contradicted the stated protocol. The study creates the impression that there is a difference in infection rates and this is not supported by the totality of the data.
The latest revelations are yet another setback for plaintiffs’ attorneys in their campaign against 3M and the market-leading Bair Hugger system. A key expert used by plaintiffs’ lawyers has testified that he is relying on Augustine’s paper and its findings to support his beliefs.
In the South Nassau affidavit, the chairman of anesthesiology Jonathan Singer testified that Scott Augustine’s son Garrett asked for data in September 2014 on hip and knee replacement surgery at the hospital. Garrett Augustine was the sales representative for Augustine Temperature Management, maker of the HotDog warming blanket. Singer said he provided infection data on total hip surgeries from January 2013 to June 2014, but provided no data on knee surgeries. He said Garrett Augustine never asked if any changes were made to operating room practices or antibiotic use.
Among the multiple errors cited by Singer:
- Augustine wrote that “Only hospitals reporting that no other significant changes were made to their surgical and antibiotic prophylaxis protocols during the study qualified to be part of the study.’’ But Singer said “South Nassau Communities Hospital was not aware nor did we knowingly participate in any ‘study’; we did not seek IRB approval before releasing the data as to our knowledge we were not participating in a study; we were not asked about any variables in practice that occurred during the dates in question and as stated above, multiple protocols were changed during the timeframe when data was provided to Mr. Garrett Augustine.’’
- Singer noted that during the so-called study period, South Nassau Communities Hospital implemented multiple initiatives to decrease the rate of infection. They included:
- Standardizing cleansing of a patient’s skin before surgery
- Re-educating staff on proper draping practices
- Humidity control in the operating room
- Standardizing post-operative dress changes
- New wound-care instructions.
Singer was never informed that Augustine intended to use the data for a study. “At no time did Mr. Garrett Augustine inform me that he was going to use the data provided in any article or written publication nor did he ask my permission to do so.’’