Nationwide Interruption of Sterile Surgical Supplies

Background

• Cardinal Health is a large and respected manufacturer of sterile medical supplies.
• Nationally, Cardinal Health provides about half of the custom surgical packs in use at hospitals and outpatient surgical centers.
• Surgical packs include sterile surgical gowns and other items used by physicians during surgical procedures.
• Cardinal Health announced potential sterility issues with some of its surgical procedure packs.
  • Cardinal Health instructed hospitals nationwide not to use some surgical packs while it investigated these potential sterility issues.
  • Ballad Health responded immediately and pulled these items from use in all its facilities.
• The Food and Drug Administration and Cardinal Health further instructed all health care providers to discontinue use of the company’s surgical supply packs in preparation for a national recall.
  • The FDA and Cardinal Health have instructed health care providers nationwide not to use these products while they conduct testing to determine any extent to which these products might not be sterile.
• Neither Cardinal Health nor the FDA have announced the results of testing or how long the national interruption of surgical packs might last.
• Ballad Health has been in communication with Cardinal Health leadership to determine the best course of action to protect patient safety.
• This surgical supply interruption greatly reduces the quantity of known-sterile surgical supplies currently available throughout the nation and at Ballad Health facilities.

Ballad Health actions

• The announcement from Cardinal Health and the FDA requires Ballad Health to immediately discontinue the use of any potentially impacted Cardinal Health surgical supplies.
• Out of an abundance of caution, Ballad Health has decided in consultation with clinical leadership to take the following steps:
  • To ensure patient safety and to preserve the limited quantity of known-sterile surgical packs, Ballad Health will suspend elective, non-emergency surgical procedures on Monday, January 20 and Tuesday, January 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, January 20 or Tuesday, January 21, will be contacted to be notified whether their procedure will be cancelled or rescheduled.
• The Cardinal Health announcement represents a national shortage of a commonly used and necessary surgical supply item.
• Ballad Health is working to source these supplies from other vendors and sources.
• Because the extent and duration of this nationwide shortage is not yet known, Ballad Health is leveraging the supply of known-sterile surgical supplies from its entire system to ensure they will be available for patients who need them most.
• For additional information regarding this issue, please visit:​
  • https://www.cardinalhealth.com/en/cmp/ext/corp/cardinal-health-surgical-gown-issue.html
  • https://www.fda.gov/news-events/press-announcements/statement-quality-issues-certain-cardinal-health-surgical-gowns-and-packs

Questions?

If you are a Ballad Health patient and have questions regarding rescheduling an outpatient or non-emergent surgical case, please call (423) 302-3050 for assistance.