Cardinal Health told its customers to stop using contaminated surgical gowns as the wholesale distribution giant orchestrates a recall with the Food and Drug Administration, according to a letter Cardinal sent to its customers Wednesday that Modern Healthcare exclusively obtained.
Certain lots of AAMI Level 3 surgical gowns, which include widely distributed non-sterile and single-sterile gowns, were contaminated due to "environmental conditions" at a contract manufacturer's facility, Dublin, Ohio-based Cardinal wrote. Some of the packs that contained the gowns were also contaminated.
The company said it will initiate a product recall. The first notice was sent Jan. 11, when Cardinal said it stopped distributing the gowns.
Cardinal "recognizes the criticality of our gowns and procedure packs to performing surgeries" and apologized for the disruption. It is contacting customers to coordinate alternatives, the company said.
"The safety of our products is a responsibility that we take very seriously," Cardinal said in a statement. "Upon becoming aware of an issue related to the environmental conditions at a contract manufacturer, we initiated an investigation, placed a voluntary hold on product inventory, and are working with the U.S. Food and Drug Administration to quickly resolve this issue for our customers and the patients they serve."
Cardinal did not clarify prior to deadline what the "environmental conditions" were, how many impacted gowns are in circulation, how long they have been in use and what the time line was for a recall.
The FDA is not aware of the any patient harm the contaminated gowns may have caused, Dr. Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.
"We also understand this issue may already be impacting patient care at health care facilities, such as the cancellation of non-elective surgeries," he said. "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 said it is working with Cardinal to source alternatives, of which there are many.
The Cleveland Clinic said it has pulled the products and is using alternatives. It will not cancel any surgeries, the health system noted.
Gowns are classified into four levels based on how well they protect individuals from microorganisms, fluids and other particulate matter. Level 4 is the most protective.
Level 3 gowns, which provide moderate risk protection according to the FDA, are used in a wide range of surgical procedures, such as open-heart surgery and knee replacements.
Cardinal, Medline and Owens & Minor control most of the market for acute medical-surgical products like gowns.