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Ballad Health responds to nationwide surgical supply recall, reschedules some elective surgical procedures

Friday, January 17, 2020

Ballad Health responds to nationwide surgical supply recall, reschedules some elective surgical procedures


Update: Read the latest on the surgical supply interruption.


Responding to an emerging potential shortage of certain sterile surgical supplies caused by an anticipated national recall by Cardinal Health, Ballad Health today took measures to preserve needed supplies by postponing certain elective surgical procedures.

Earlier this week, Cardinal Health, one of the nation’s leading providers of surgical supplies, asked hospitals nationwide to pull some of its surgical gowns and packaged surgical supplies because of possible sterility issues. Ballad Health immediately discontinued use of the potentially affected supplies in all its facilities.

“Our top priority is the safety and well-being of our patients,” said Ballad Health Chairman and CEO Alan Levine. “The information we have received from Cardinal Health at this point is very limited, and we do not currently have visibility on the duration of this issue. As a result, we are taking steps to preserve our supplies as much as possible to ensure high-acuity, emergent and urgent procedures can be performed without interruption. We feel obligated to take this step simply because Cardinal was unable to assure our supply chain would remain stable for these needed products. Once we have more definitive information from Cardinal, or alternative sources for the supplies can be secured, we may reevaluate this step. We have not made any decisions with respect to cases scheduled for after Tuesday, but we will communicate as soon as we have information.”

“This is clearly highly disruptive to our physicians, our patients and to our system,” added Levine. “Ballad Health certainly hopes Cardinal Health and the FDA can reach a safe conclusion for our patients.”

On Thursday, the FDA instructed hospitals nationwide not to use the company’s gowns or surgical supplies packaged with those gowns while it investigates the potential issue and conducts tests. Neither Cardinal Health nor the FDA has stated how long the interruption of surgical supplies might last or the results of tests.

Cardinal Health is one of the largest manufacturers of sterile medical supplies. It provides about half of the custom surgical packs in use at hospitals and outpatient surgical centers in the United States, and it makes up approximately 40% of Ballad Health’s surgical gowns and surgical packs.

“This surgical supply interruption greatly reduces the quantity of known-sterile surgical supplies currently available throughout the nation and at Ballad Health,” said Dr. Clay Runnels, chief physician executive at Ballad Health. “Taking that into consideration, our clinical leadership team came up with a course of action out of an abundance of caution to ensure patients requiring certain surgeries can receive them without disruption.”

Out of an abundance of caution, Ballad Health clinical leaders recommended the following steps, which were approved by Levine:

  • To ensure patient safety and preserve the limited quantity of known-sterile surgical packs, Ballad Health will suspend elective, non-emergency surgical procedures on Monday, Jan. 20 and Tuesday, Jan. 21.
  • Ballad Health will work with individual physicians to determine whether scheduled elective surgical procedures can be postponed or should proceed as scheduled.
  • Patients who have surgical procedures scheduled for Monday, Jan. 20 or Tuesday, Jan. 21, will be contacted to be notified whether their procedure will be cancelled or rescheduled.
  • No decision has been made related to any procedures scheduled after Tuesday, Jan. 21. Ballad Health is hopeful it will have more information from Cardinal Health, or alternative sources of the supplies secured.

As Ballad Health works to source supplies from other vendors and sources, the health system is also leveraging the supply of known-sterile surgical supplies from its entire system to ensure they will be available for patients who need them most.

“Ballad Health has been and will remain in close communication with Cardinal Health leadership to determine the best course of action to protect patient safety,” Levine said.

To read the FDA’s statement on the Cardinal Health surgical supplies quality issues, visit:

www.fda.gov/news-events/press-announcements/statement-quality-issues-certain-cardinal-health-surgical-gowns-and-packs.

Additional information about the nationwide surgical supply interruption can also be found here.

 

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