Cardinal Health customers may contact their sales representative to obtain lot numbers for surgical gowns and procedure packs affected by a quality issue at a contract manufacturing facility, the company has said. Currently, Cardinal is unable to offer sterility assurance for those gowns and surgical packs and recently placed a hold on certain AAMI Level 3 surgical gowns and Presource procedure packs containing the gowns while it works with the Food and Drug Administration to resolve the issue. Cardinal said customers should not use the products, which the company plans to recall because it cannot provide sterility assurances due to the potential for cross-contamination. The issue seems to affect about 25%-30% of the company’s AAMI Level 3 gowns. In addition, it is unclear when the potential contamination of these gowns and packs began, but AHA expects Cardinal to provide further information soon.
“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,” said Jeffrey Shuren M.D., director of FDA’s Center for Devices and Radiological Health. “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. We also understand this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries. There are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking steps we can to mitigate any adverse patient impact. At this time, we are not aware of any patient harm because of this issue.”
FDA said it was engaged in activities to mitigate supply chain disruption that would negatively impact clinical care operations, including identifying alternative Level 3 gowns.
“There are numerous FDA-cleared surgical gown alternatives on the market that provide Level 3 barrier protection,” Shuren said. “We will continue to work with Cardinal Health to keep the public informed about the impact on the supply of Level 3 surgical gowns and potential shortages.”
Health care providers and others may notify FDA about potential or actual supply issues by emailing email@example.com.
The AHA is in communication with FDA, other federal agencies and Cardinal Health as they work to resolve the issue and will share details with members as they become available.