Some Level 3 surgical gowns manufactured by Cardinal Health and the PreSource procedural packs that contain those gowns may be contaminated, Cardinal Health and the US Food and Drug Administration (FDA) warned Thursday, noting that use of the medical gear should be discontinued immediately. Both the company and the agency are working to determine the scope of the possible contamination, and Cardinal Health is expected to issue a recall soon.
The announcement could lead to interruptions in planned surgeries, according to a statement by Jeffrey E. Shuren MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH). The gowns also provide barrier protection.
Shuren said that “there are very real consequences that medical device supply chain disruptions can have on patients, and we’re committed to taking the steps we can to mitigate any adverse patient impact.”
According to the statement, Cardinal Health is cooperating in every way with the FDA and neither the agency nor the manufacturer have identified any patients who have been affected. Cardinal Health sent an alert to customers about the problems on January 11 and then again on January 15.
In addition, Cardinal Health customers who have questions can contact the company here. “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,” Shuren said.
Gowns are classified into 4 levels and “Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open-heart surgery and knee replacements,” Shuren said. “They are intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids, and particulate material.”
Cardinal Health is currently trying to pinpoint exactly which batches of products are affected.
The FDA is providing information about alternative FDA-approved Level 3 gowns on the market, and also encourages reports on shortages be submitted through this website.