AUDIENCE: Patient, Health Professional, Risk Manager
ISSUE: The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
FDA also understands this issue may already be impacting patient care at health care 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 FDA is committed to taking what steps we can to mitigate any adverse patient impact. At this time, FDA is not aware of any patient harm because of this issue.
BACKGROUND: Surgical gowns are commonly used in health care facilities during surgical procedures and/or to provide moderate to high 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 health care personnel from transfer of microorganisms, body fluids, and particulate material.
RECOMMENDATION: Customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include the surgical gowns because the manufacturer cannot provide assurance the products are sterile. Customers with questions about whether their own inventory is affected should contact Cardinal Health directly.
Health care facilities may contact FDA at email@example.com with information about potential or actual supply issues.
[01-16-2020 - Press Announcement- FDA]