Surgical gowns are worn for the purpose of protecting health care workers from dangerous pathogens, so they must be impermeable to blood or any substances that may transmit disease. Halyard Health sells approximately 13 million MICROCOOL surgical gowns worldwide every year, approximately one-quarter of the market is in the United States. Bernard Vezeau, former global strategic marketing director for MICROCOOL, told “60 Minutes” that workers had been put at risk by wearing gowns that were defective.
The term “strike-through” refers to personal protective equipment failure that may expose workers to blood-borne bacteria and viruses, such as hepatitis or HIV, or Ebola. According to the whistleblower allegations in the “60 Minutes” interview, the gowns had a serious issue. “They would leak. They would leak. When we pressure tested them, especially in the seams,’ he said.
According to the “60 Minutes” interview, the MICROCOOL surgical gown label says the gown meets the AAMI Level 4, a strict industry standard indicating that the gown is impenetrable to blood. Vezeau also expressed concern that the MICROCOOL gowns were being “aggressively recommended,” telling hospitals to stock up on MICROCOOL products to have at least 8 to 12 weeks of product on hand.
Vezeau also alleged that the gowns failed consistently to meet industry test standards and that Halyard Health did not notify the U.S. Food and Drug Administration (FDA) or customers of those results.
Legal experts showed “60 Minutes” a report that in December 2012, an independent certified laboratory tested the MICROCOOL gowns and reported that 77 percent of the tested gowns failed. Vezneau continued that complaints were received from nurses and surgeons “on a very frequent basis” regarding strike-through, sleeves falling off, and ties falling off.