The FDA and Cardinal Health have issued a warning for some of its surgical gowns over concerns they may be contaminated. According to Cardinal, there was a recent 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.” As a result, the company conducted an investigation and decided to place “a voluntary hold on product inventory.” Unfortunately, the voluntary warning has led some hospitals and other healthcare facilities to cancel surgical procedures.

FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research; image by FDA, Public domain.

In a January 15 letter to customers, Cardinal said:“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. We recognize the criticality of our gowns and procedure packs to performing surgeries, and we apologize for the challenges this supply disruption will cause.”For now, customers who have the potentially contaminated surgical gowns should discontinue using them immediately. It's important to note, however, that not all Cardinal surgical gowns are affected in the warning. At the moment, only level 3 gowns are affected. According to the FDA, 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.”At the moment, Cardinal and FDA are working to determine what caused the quality issues that contaminated the gowns and what kind of risk, if any, the gowns may pose to patients and users. When commenting on the matter, Jeffrey E. Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said:“We also understand this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries. At this time, we are not aware of any patient harm because of this issue.”

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FDA Warns Against Use of Some Cardinal Surgical GownsCardinal Health has a surgical gowns contamination problem