Allegheny Health Network cancels surgeries after gown recall

Several elective, non-emergency procedures were rescheduled at surgery centers throughout Allegheny Health Network on Thursday after the medical device manufacturer Cardinal Health recalled surgical gowns, a spokesman said.

The gowns, which are part of kits containing other surgical supplies, were immediately pulled from the shelves after a nationwide “voluntary recall” Cardinal Health related to concerns over whether the gowns are sterile, AHN spokesperson Dan Laurent said.

“We made sure to replace the gowns with sterile product, as well as other items in the packets,” Laurent said.

A spokesperson for Cardinal Health, based in Dublin, Ohio, said by email that “the safety of our products is a responsibility that we take very seriously.”

“Upon becoming aware of an issue related to the environmental conditions at a contract manufacturer, we initiated an investigation, placed a voluntary hold on product inventory, and are working with the U.S. Food and Drug Administration to quickly resolve this issue for our customers and the patients they serve,” the Cardinal Health spokesperson said.

Cardinal Health alerted customers about a potential quality issue affecting Level 3 surgical gowns — one of four levels of liquid barrier shielding that provide “moderate risk protection” — and procedural packs that contain those gowns on Jan. 11 and Jan. 15, according to a statement from the federal Food and Drug Administration, which oversees medical device recalls.

“At this time, we are concerned about possible contamination of the products and agree with the manufacturer’s recommendation about not using the affected lots of Level 3 surgical gowns or PreSource procedural packs,” a statement from the FDA said. “We understand the company is continuing to communicate directly with its customers about which specific products are directly impacted by the quality concern and will be issuing a recall soon.”

The FDA is not currently aware of any patients who have been harmed as a result of the issue, the statement said.

A recall has not yet been issued, FDA records show.

AHN purchases gowns from several vendors other than Cardinal Health, Laurent said. The gowns are worn by surgeons to create a sterile field between themselves and the patient.

AHN canceled about a dozen surgeries at surgery centers throughout the system Thursday and staffing levels were not affected, Laurent said. The system typically handles about 300 cases per day.

The system operates seven hospitals and five surgery centers in Western Pennsylvania. Its hospitals in Southwestern Pennsylvania include Allegheny Valley Hospital in Harrison, Allegheny General Hospital on Pittsburgh’s North Side, West Penn Hospital in Pittsburgh’s Bloomfield neighborhood, Forbes Hospital in Monroeville, Canonsburg Hospital and Jefferson Hospital in Jefferson Hills.

“Patient safety is the highest priority in surgical care, and it’s important that the surgical environment be completely sterile,” he said.

UPMC said it is no longer using the gowns and will wait for the FDA to provide further guidance.

“We have an adequate supply of gowns from an unaffected source, so patient care and medical procedures at UPMC are unaffected,” UPMC spokeswoman Allison Hydzik said in a statement Thursday.

ACMH Hospital in Armstrong County does not purchase surgical gowns from Cardinal Health and was not affected by the voluntary recall, spokesman Tim Lehner said in an email Friday.

Excela Health also does not purchase surgical gowns or procedure packs containing other surgical supplies from Cardinal Health but does purchase a variety other medical supplies from the company, said Robin Jennings, a spokesperson for the Excela Health system.