Whistleblower Accuses Halyard Health of Selling Defective Surgical Gowns During Ebola Crisis

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Halyard Health is accused of providing defective surgical gowns to health care workers during the recent Ebola crisis. Surgical gowns are crucial to protecting health care workers from harmful pathogens and they must be impenetrable to blood and other substances that can transmit disease.

A whistleblower and former marketing director for the MICROCOOL surgical gown brand told 60 Minutes that the gowns were defective, putting workers at risk.Anderson Cooper, 60 Minutes correspondent, interviewed whistleblower Bernard Vezeau about the allegations. Vezeau is former global strategic marketing director for the MICROCOOL brand. The 60 Minutes investigation aired on May 1, 2016.

The program was titled “Strike-through,” the term that used when personal protective equipment fails, exposing workers to infectious bodily fluids. Protective gear is crucial to preventing the transmission of disease. Fears of disease transmission were heightened during the deadly 2014 Ebola outbreak. More than 500 health care workers died of the disease, 60 Minutes reports.

Halyard sells about 13 million MICROCOOL surgical gowns worldwide each year, about a quarter of them in the United States. The MICROCOOL gown label says the gown meets the AAMI Level 4, a rigorous industry standard indicating that the gown is impermeable to blood. But Vezeau told Anderson Cooper that the gowns “would leak. . . especially in the seams,” according to a transcript of the interview.

Vezeau said that although the MICROCOOL gowns consistently failed to meet industry testing standards, Halyard Health did not notify customers or the Food and Drug Administration (FDA) because that would have cut into revenue

The evidence for the failed tests comes not just from Vezeau but also from an independent, certified laboratory that tested the sleeves of MICROCOOL gowns in December 2012 showed that 77 percent of the tested gowns failed.

Health care professionals at hospitals such as UF Health in Jacksonville told 60 Minutes that they had experienced strike-through problems themselves. Some of the Florida surgeons took pictures of their bloody arms after the patient’s blood had penetrated the sleeves and sent them to Halyard Health. Vezeau told Cooper that he received strike-through complaints from nurses and surgeons “on a very frequent basis,” but Halyard’s COO told him, “Nobody really cares about surgical gowns.”

Dr. Sherry Wren, a vice chair of surgery at Stanford University School of Medicine told 60 Minutes that she got blood on her arms three times, while wearing three different MICROCOOL gowns. Anderson Cooper asked her if the impermeability of the surgical gowns she wears is important to her. Dr. Wren said, “Do I really want to have somebody else’s infected bodily fluids on my body? No, I do not.”