Surgical Gowns May Not Be Sterile, Increasing Risk of Infection or Other Complications

Federal health officials are working with the manufacturer of certain surgical gowns to recall procedural packs that may not be sterile, and may pose an increased risk of infection and potentially life threatening surgical complications among patients.

The U.S. Food and Drug Administration (FDA) issued a Cardinal Health Surgical Gown warning on January 16, alerting hospitals and surgical centers that certain Level 3 surgical gowns and prepackaged procedural kits could be contaminated with bacteria, increasing the risk of infection to patients.

The surgical gowns are intended to be worn to protect both the patient and health care personnel during procedures, to prevent the transfer of microorganisms, body fluids, and particulate material. The products are classified into four levels of barrier protection, based on their liquid barrier performance.

The warning involves Cardinal Health Level 3 surgical gowns, which are designed to provide moderate risk protection in a wide range of surgical procedures, including open heart and knee replacement surgeries, according to the FDA.

On January 11, and again on January 15, Cardinal Health, in conjunction with the FDA, warned healthcare facilities to immediately stop using all Level 3 surgical gowns, and all PreSource procedural packs that include surgical gowns, due to the manufacturer’s inability to ensure the products are sterile.

Cardinal Health issued a warning letter to its customers indicating there were quality control issues identified at one or more of its manufacturing facilities which jeopardized their ability to provide sterility assurances. According to the letter, the Level 3 gowns and kits could have been subject to cross-contamination during the manufacturing and packaging processes.

At this time, the FDA is working with Cardinal Health to identify the specific product lots that are impacted by the potential cross-contamination, as well as assessing the scope of potential contamination risk to the rest of the company’s supply chain.

Cardinal Health announced it will continue to work with the FDA to determine which products require a recall. However, all hospitals and customers who have received Level 3 surgical gowns and kits should stop using them immediately to prevent the potential spread of infection and patient injury or death.

Cardinal Health also issued an apology to hospital facilities and to patients for the disruption the pending recall has caused, as many facilities across the country using Cardinal Health procedural packs have had to cancel and delay surgeries to protect patients.

The Pittsburgh-based healthcare system, Allegheny Health Network announced they have been forced to cancel at least a dozen surgeries across the multi-hospital network since the January 11 Cardinal Health warning.

Customers with questions about whether their own inventory is affected should contact Cardinal Health directly at 800-964-5227. The FDA has also encouraged hospitals to contact them regarding any issues arising from the shortage or sterility of impacted Cardinal Health surgical gowns and kits at deviceshortages@fda.hhs.gov.