On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain these gowns, according to a statement from Dr. Jeffrey E. Shuren MD, JD with the DRH Offices’ Office of the Center Director posted on the U.S. Food and Drug Administration (FDA) website. Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile. The FDA is working to assess the cause and full impact of these concerns.
Surgical gowns are commonly used in healthcare facilities during surgical procedures and/or to provide moderate-to-high risk barrier protection. Gowns are classified into four levels of barrier protection based on their liquid barrier performance. 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. They are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
The FDA is working closely with Cardinal Health to understand and address the quality issues with these products, including the potential risks to users and patients, which specific product lots are impacted, and the potential impact on the supply chain. 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. 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 healthcare 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.
The FDA is engaged in activities to mitigate supply chain disruption that would negatively impact clinical care operations, including identifying alternative Level 3 gowns. 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.
