Failure of Surgical Gowns
Just as every patient trusts his or her surgeon, surgeons must be able to trust their equipment. What happens, though, when the surgeon’s equipment fails?
We are not discussing robotic devices or mechanical issues, but rather something significantly more dangerous: the timeless routine of gowning and gloving surgeons before surgery. While this is important to keep the surgeon sterile for the patient, it is also to protect the surgeon. A recent CBS 60 Minutes investigation, however, shows that many doctors may be at a greater risk.
This investigation concerns Halyard Health, a medical manufacturing company that, until 2014, had operated under Kimberly-Clark Corporation. When the Ebola virus outbreak in 2014 killed numerous health care workers properly protected by gowns, a deeper look into this company’s products was initiated. Most notably examined was a surgical gown called MICROCOOL with a rating of AAMI Level 4, which signifies that it does not allow body fluids like blood contaminated with HIV, Ebola, or hepatitis to penetrate its material. These gowns are used daily by a significant number of hospitals. These gowns, however, are vastly underperforming to a dangerous degree.
Bernard Vezeau, the global strategic marketing director for MICROCOOL and other products from 2012-2015, states that neither the FDA nor doctors or consumers were notified that their gowns were failing regulatory tests. In one major test of the gowns, a jaw-dropping 77% of the gowns failed the testing. Concerns were raised about “strike-through” which means blood and/or body fluid penetrates the gown. When these body fluids contain dangerous viruses, they can be transmitted to the surgeon. Other complaints include sleeves and ties becoming detached. Alternatively, Chris Lowery, the COO of Halyard Health, denies that their gowns are sub-standard despite testing that documents such failures.
At this time, Halyard Health has been served a subpoena by the United States Department of Justice investigation and a class-action suit was filed on June 28, 2016.
As a doctor in the surgical specialties, I always want to ensure that my patients, my associates, and I are protected to the highest level. I am eager to see how this case and investigation moves forward and will certainly take a second look before selecting the type of surgical gown to wear in the operating room on a daily basis.
Dr. Fiani is a neurosurgery resident with Desert Regional Medical Center’s Graduate Medical Education Program. He is a graduate of Michigan State University’s medical school.