Devices

FDA Ducks on Leaky Surgical Gowns 60 Minutes Report

Despite reported issuance of a Justice Department subpoena against the company, FDA 5/2 ducked when asked if it is investigating allegedly defective Halyard Health surgical gowns reported 5/1 by CBS 60 Minutes. Agency spokesperson Angela Stark trotted out FDA’s routine evasion in an email to FDA Webview: “As a matter of general policy, the FDA does not comment on potential or ongoing investigations, litigation or enforcement actions.”

Earlier, the agency had issued this statement on the 60 Minutes report: “The agency’s foremost concern is to protect the public health, including that of health care professionals who are doing life-saving and sometimes life-threatening work. Manufacturers of personal protective equipment (PPE) regulated by the FDA must establish and maintain procedures to make sure their products conform to specified requirements. We are committed to working with manufacturers, federal partners, patients and health care professionals to provide reasonable assurance of the safety and effectiveness of PPE. The FDA encourages users to report problems with or malfunctions of PPE, such as strike through and/or defects in material integrity identified during wear, to its MedWatch program.”

Presented by Anderson Cooper, the 60 Minutes report interviewed a former employee of Halyard Health, maker of Microcool personal protective surgical gowns used to protect hospital operating room personnel and patients against HIV, Ebola and other viruses and bacteria. According to Cooper’s report, the Microcool gowns leaked and sleeves fell off in normal use, and were the subject of litigation in a 2012 false advertising case in which a rival firm, Cardinal Health reported a 77% failure rate when they were tested for Cardinal by Intertek Laboratories. Cooper also interviewed a California attorney who is suing Kimberly Clark, former owner of Halyard, on behalf of hospitals, and Halyard COO Chris Lowery, who denied the allegations against the company.

The Intertek tests were “extreme outlier results, not seen before or since,” Lowery told Cooper. “We believe we were fully compliant with our requirements.” He said Halyard gets fewer than one complaint per million gowns sold, and for surgeons to be at risk from a leak, there would have to an open cut or tear in the kin in the immediate vicinity of the leak. In a statement issued to 60 Minutes after Cooper’s interview with Lowery, Halyard said it had installed new sealing machinery to improve the seams in its gown sleeves. Halyard also posted a statement on its Web site, in which it said it “forcefully rejects” the 60 Minutes allegations.

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