The Food and Drug Administration (FDA) of the United States has issued a statement on quality issues with certain Cardinal Health surgical gowns and packs.
On 11 January and again on 15 January 2020, 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. The manufacturer 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 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.
The FDA is working closely with the manufacturer 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, the FDA 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. The FDA understands the manufacturer 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.
The 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 the FDA is committed to taking what steps to mitigate any adverse patient impact. At this time, the FDA is not aware of any patient harm because of the 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. There are numerous FDA-cleared surgical gown alternatives on the market that provide Level 3 barrier protection. The FDA will continue to work with the manufacturer to keep the public informed about the impact on the supply of Level 3 surgical gowns and potential shortages. Customers with questions about whether their own inventory is affected should contact the manufacturer directly.
The FDA will continue to monitor this evolving situation and will continue to communicate with the public on this matter.
If you are in possession of the affected products, please contact your supplier for necessary actions.
For details, please refer to the following links:
Posted on 17 January 2020