science.
"There is no such thing
as impartiality when it
comes to who's doing the
study and who's doing
the funding," he says. He
also claims 3M doesn't
have any independent,
randomized controlled
trials or studies proving
their product is safe,
either.
"The onus isn't on us to show there are risks here," says Dr.
Augustine. "It's on them to show forced-air warming is safe."
Thus far, a few independent agencies have looked at the available
research and data, and have not found anything to discontinue the
Bair Hugger.
The FDA addressed the issue in a 2017 letter, writing: "After a thor-
ough review of available data, the FDA has been unable to identify a
consistently reported association between the use of forced air thermal
regulating systems and surgical site infection." The nonprofit ECRI
Institute, in Plymouth Meeting, Pa., reached a similar conclusion from its
2013 review of the medical literature, writing there is "insufficient evi-
dence to establish that the use of [forced-air warming] systems leads to
an increase in SSIs compared to other warming methods."
Dr. Augustine has his own take on the FDA and ECRI's reviews. He
says the groups aren't ready to make the link between contamination
of the sterile field and SSIs. "They're just being conservative," he says.
"If we're being asked, 'Does this cause infections?' They're saying,
'We're not sure.'"
A P R I L 2 0 1 9 • O U T PA T I E N T S U R G E R Y. N E T • 4 7
• HOT DOG VENDOR Scott Augustine, MD, says he's tried to sell his HotDog
warming system to 3M, suggesting "it would clean up their mess" to have an
air-free warming product for implant patients.
