Halyard Health Accused of Providing Defective Surgical Gowns. Halyard Health is accused of providing defective MICROCOOL surgical gowns to US health care workers during the recent Ebola crisis. Surgical gowns are used to protect health care workers from harmful pathogens; as such, they must be impenetrable to blood and other substances that can transmit disease. A whistleblower and former marketing director for the MICROCOOL brand told 60 Minutes that the gowns were defective, putting workers at risk.
MICROCOOL Gowns Subject of 60 Minutes Investigation
The whistleblower allegations were the subject of a 60 Minutes news investigation. Correspondent Anderson Cooper interviewed Bernard Vezeau, the former global strategic marketing director for the MICROCOOL brand. The 60 Minutes special, titled “Strike-through”, aired May 1, 2016.
“Strike-through” is when personal protective equipment fails, exposing workers to infectious bodily fluids. Protective gear has always been crucial to preventing the transmission of disease, but fears were particularly heightened during the deadly 2014 Ebola outbreak. According to 60 Minutes, more than 500 health care workers died of the disease.
Halyard sells about 13 million MICROCOOL surgical gowns worldwide each year, about a quarter of the market is in the United States. According to the 60 Minutes special, its label says it meets the AAMI Level 4, a rigorous industry standard indicating that it is impermeable to blood. However, Vezeau told Anderson Cooper that the gowns had an issue. “They would leak. When we pressure tested them, especially in the seams.” he said, according to a transcript of the interview.
Vezeau also said he was concerned about how the gowns were “aggressively being recommended”. He told Cooper “We put a full court press to drive MICROCOOL sales. We told hospitals to stock up on our MICROCOOL products. We told ’em to have at least 8 to 12 weeks of product on hand. And that’s when things became very difficult for me.” Vezeau was torn because “he knew the gowns were not consistently meeting industry standards.” 60 Minutes reports.
The whistleblower said that although the gowns failed to consistently meet standards for industry tests, the company did not notify customers or the FDA because it would cut into revenue.
The evidence for these failed tests is not based on Vezeau’s word alone. Legal experts showed 60 Minutes a report by an independent, certified laboratory that tested the sleeves of MICROCOOL gowns in December 2012. The report showed that 77 percent of tested gowns failed.
Health care professionals also told 60 Minutes that they had experienced the strike-through problem themselves. Surgeons at hospitals such as UF Health in Jacksonville, Florida said blood had soaked through their gowns repeatedly. Some even took pictures of their bloody arms and sent them to the company. Vezeau told Cooper that he received complaints from nurses and surgeons “on a very frequent basis” regarding strike-through, sleeves falling off and ties falling off. Below is an excerpt of the transcript:
Anderson Cooper: Were you at meetings where these problems were discussed?
Bernard Vezeau: Every time. We were the ones who were telling senior management the problems that we were having.
Anderson Cooper: And what was their response?
Bernard Vezeau: Well, it’s– I remember the response one time from the COO was, “Nobody really cares about this. Nobody really cares about surgical gowns.”
60 Minutes also interviewed Dr. Sherry Wren, a vice chair of surgery at Stanford University School of Medicine. She specializes in gastro-intestinal surgery and wears MICROCOOL gowns when performing procedures. “Dr. Wren told us she got blood on her arms and hands three times, while wearing three different MICROCOOL gowns and operating on another patient who also had Hepatitis C.” 60 Minutes reports:
Anderson Cooper: We’ve been told that as long as your skin is intact, you’re OK.
Dr. Sherry Wren: Actually with that case, I finished operating at 5:00 in the morning and I looked down at my hand and I realized I had eroded off a callus. So I had ripped my own skin in the OR.
Anderson Cooper: It does matter then to you that these gowns are impervious?
Dr. Sherry Wren: Yes. Of course it matters. Do I really want to have somebody else’s infected bodily fluids on my body? No, I do not.