Surgical gown recall leaves medical centers scrambling


(CBS) – Surgeries across the country are being canceled because of a shortage of surgical gowns. The Food and Drug Administration is recalling millions of those gowns that doctors wear in the operating room because they may not be sterile. Dr. Jon Lapook reports without them doctors can’t do surgery.

When Cardinal Health recalled nine million of its surgical gowns amid concerns some might not be sterile, medical centers around the country began to scramble.

Alan Levine, CEO of Ballad Health in Tennessee, says they had to reschedule 200 surgeries.

“This is a big disruption,” Levine said. “We still don’t know if we’ve hit the worst of it or not. I mean, we’re being told four weeks at least.”

Thursday, the company admitted that a Chinese contractor supplying some of its gowns was using factories not registered with the FDA. The company has said these facilities “did not maintain proper environmental conditions.”

Problems included:

  • gowns exposed to contaminants, through open windows
  • failure to provide hand sanitation
  • operators eating in the production area

In 2018, Cardinal Health caught the same supplier using an unregistered factory. Back then, the company did testing and concluded there was no impact to its products. It did not tell the FDA. The gowns are often included in a package, along with surgical equipment.

All of the objects inside this surgical pack are supposed to be sterile, but that’s the problem. Because they can’t guarantee that the gown is sterile, it could have contaminated other objects here.

“There’s been an increasing concern about the reliability of the supply chain,” Levine said.

CBS asked the FDA if it conducted any inspections of the unregistered subcontractors uncovered by Cardinal Health. The FDA declined to answer.

Meanwhile, Cardinal Health says it’s no longer working with that Chinese contractor and is cooperating with the FDA.

SEE ALSO: Ballad Health postpones elective surgeries due to nationwide interruption of surgical supplies

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