Cardinal Health announced late yesterday that it has terminated its relationship with Siyang Holymed in Suqian, China, an FDA-authorized supplier that shifted production of the OEM's surgical gowns to non-approved sites without the proper controlled environments. Unable to ensure the sterility of the gowns produced under those conditions, Cardinal Health has recalled or initiated a corrective action on 2.9 million procedure packs containing the affected gowns.
The issue first came to light in mid-January, when Cardinal Health alerted customers to potential quality issues affecting some of its surgical gowns and PreSource procedural packs containing the gowns. An FDA statement noted on Jan. 16 that “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.” Yesterday, Cardinal Health publicly revealed the cause.
In its press release, Cardinal Health said that it severed ties with Siyang Holymed after learning that it had shifted production of the gowns to an unapproved site in December 2019. It’s not the first time, however, that the supplier has played fast and loose with the medical device OEM based in Dublin, OH.
In spring 2018, Cardinal Health learned that Siyang Holymed had outsourced some of its production to a non-registered, non-qualified facility. At the time, Cardinal Health conducted a quality review supported by laboratory testing and concluded there was no impact to its products. Based on the results of the quality review, the company determined a field action was not necessary, and therefore did not coordinate any such action with the FDA, said Cardinal Health.
This time around, Cardinal Health is conducting two voluntary field actions in coordination with FDA involving select Presource Procedure Packs containing gowns that were part of last week's recall of AAMI Level 3 surgical gowns. (This class of gown is intended for use in procedures with a moderate risk of exposure.) These procedure packs, also known as kits, were placed on voluntary hold at the time of the gown recall, said Cardinal Health.
Cardinal Health has initiated the following actions involving 2.9 million procedure packs manufactured between September 2018 and January 2020 that contain affected gowns:
- A voluntary correction of 374,794 procedure packs with components separated from the affected gown by inner, sealed packaging or other packs within the sterilization pouch. These packs can be "over-labeled," allowing the components within inner, sealed packages to be used after the gown is discarded. All other components including the gowns are to be removed and discarded. Approximately 62,976 of these packs remain in Cardinal Health inventory.
- A voluntary recall of 2,518,653 procedure packs containing gowns with components that are not separated from the affected gown by inner, sealed packaging. Those procedure packs should not be used and must be returned. Approximately 357,127 of these packs remain in Cardinal Health inventory.
Customers will receive detailed instructions for handling the affected procedure packs on or about Monday, February 3.
Cardinal Health also said that it is taking the following actions to address supply shortages:
- Increasing production of similar and replacement products;
- offering more protective AAMI Level 4 gowns [designed for procedures with a high risk of exposure] to help bridge the supply gap;
- working to identify alternatives, including in many cases working with industry partners who offer comparable products; and
- mobilizing employees from all parts of the company to work directly with healthcare providers to replace gowns and procedure packs.
Moving forward, Cardinal Health said that it is engaging third-party experts to conduct a comprehensive review of quality assurance processes and business practices.
"I apologize to patients and our customers," said Mike Kaufmann, CEO of Cardinal Health. "We understand the gravity of this situation and the disruptions to the healthcare system that will impact patient care. We are fully committed to making this right, and we are doing everything we can to ensure it never happens again."
Image: iQoncept/Adobe Stock