The FDA is recommending against the use of certain Cardinal Health surgical gowns because of potential contamination, and resulting supply-chain problems may already be causing the cancellation of some surgical procedures.
Cardinal said it recently learned of “an issue related to the environmental conditions with a contract manufacturer in China” that makes some level 3 surgical gowns, including gowns in PreSource procedural packs. Cardinal started an investigation, placed a voluntary hold on product inventory, and contacted the FDA.
“At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination,” Cardinal told customers in a January 15 letter. “We recognize the criticality of our gowns and procedure packs to performing surgeries, and we apologize for the challenges this supply disruption will cause.”
Both Cardinal and the FDA say customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these gowns.
Surgical gowns are classified into four levels of protection based on their liquid barrier performance, the FDA says. Level 3 gowns provide moderate protection and are used in a wide range of procedures, such as open-heart surgery and knee replacements. They protect both the patient and health care personnel from transfer of microorganisms, body fluids, and particulate material.
The FDA says it is working with Cardinal to understand and address the quality issues with these products, including the potential risks to users and patients. While a recall is expected, specific product lots have not been disclosed publicly.
“We also understand this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries,” said Jeffrey E. Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “At this time, we are not aware of any patient harm because of this issue.” While the agency is concerned about potential gown shortages, numerous FDA-cleared surgical gown alternatives on the market provide level 3 barrier protection, the agency said.