The show reported that the gowns, which are recommended by the Centers for Disease Control and have AAMI Level 4 standards of impermeability to prevent transmission, had faulty seams and regularly leaked.
Former Halyard Health Microcool global strategic marketing director Bernard Vezeau, told 60 Minutes that when the Microcool gowns were pressure tested, they would leak, especially at the seams.
Vezeau said things became difficult for him at the company as the gowns were being recommended for use in handling Ebola and “aggressively marketed” during the outbreak.
“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 told 60 Minutes.
But the Microcool gowns were not consistently meeting industry standards, Vezeau said. And neither customers or the FDA were being notified of the failures.
“Because Kimberly-Clark knew that if they – they told customers, it would cost us a lot of business,” Vezeau told 60 Minutes.
The Alpharetta, Ga.-based company said that the report presented no new information, and that its Microcool gowns have “an exceptional record of safety and efficacy,” according to a press release.
The gowns were at the center of a dispute between Cardinal Health and previously Kimberly-Clark owned Halyard Health back in 2012, 60 Minutes reported. Cardinal health urged for the testing of the Microcool gowns and reported a 77% rate of failure, according to the report.
Vezeau said outside of failing inspections, he also received reports from nurses and surgeons of strike-through, ties falling off and sleeves falling off the gowns. He said he reported the issues to the senior management but the complaints weren’t being heard.
“I remember the response one time from the COO was, ‘Nobody really cares about this. Nobody really cares about surgical gowns’,” Vezeau said.
Halyard Health COO Chris Lowery said the accusation was untrue, and that the company wasn’t receiving the complaints Vezeau is reporting.
“Yes. We get less than 1 complaint for every million gowns sold. And even more so is we’ve never received even 1 report of a health care professional contracting an infection as a result of a flaw in our product,” COO Lowery said.
The company said it has sold more than 58 million Microcool gowns “without a single complaint of personal injury” due to failures in barrier protection, and that there have been no reports of infections due to barrier failure from any health organization or journal in respect to any surgical gowns, not just its own.
Halyard health said it has received “overwhelmingly favorable” feedback from doctors and nurses, and said it delivered Microcool gowns to 60 Minutes to test and engaged with them because it “strongly believes in the efficacy and safety of Microcool gowns and strongly disagrees with the allegations raised in the litigation,” according to a press release.
The post Halyard battles ’60 Minutes’ story on faulty Ebola gowns appeared first on MassDevice.
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