Potential Disruption

Last Update: June 15 2021, 9:40 am EDT

Updates on Potential ChloraPrep Shortage

May 27, 2021

BD is committed to being transparent with its customers about potential supply chain disruptions. As part of that commitment, we are updating customers on a potential disruption to BD ChloraPrep™, based on legal proceedings in New Mexico involving a third-party sterilizer.

On May 26th, the Las Cruces District Court heard arguments regarding a potential preliminary injunction that could significantly limit or close a third-party sterilization facility. The judge expects to reconvene the proceeding in approximately one month at which time a ruling may be issued.

BD continues to prepare for a potential supply chain disruption, including putting BD ChloraPrep™ on allocation and identifying alternate sterilizers. However, there is not enough global sterilization capacity to offset all the lost capacity if the facility were to close, and a disruption would be unavoidable.

We recognize how important the BD ChloraPrep™ family of products is to healthcare providers across the United States. BD submitted an affidavit to the court describing the important role of BD ChloraPrep™ in the U.S. healthcare system, and the possible consequences for public health if the facility were to close for more than a few days. We have communicated the potential shortage and impact to the FDA.

May 25, 2021

BD is preparing for a potential supply disruption of BD ChloraPrep™. The possible disruption is related to potential challenges involving a third-party sterilizer that services many medical technology companies, including BD.
 
The New Mexico Attorney General is seeking to close an Ethylene Oxide (EtO) sterilization facility operated by Sterigenics in Santa Teresa, N.M. This is the main site at which BD ChloraPrep™ Applicators are EtO sterilized. The potential disruption could begin as early as June 2021. The Attorney General’s stated reason for closing the Sterigenics facility is concern regarding EtO emissions, and not quality or manufacturing concerns regarding BD or its products.
 
BD has already taken action to mitigate any potential supply disruption, including putting BD ChloraPrep™ on allocation and identifying alternate sterilizers. However, there is not enough global sterilization capacity to offset all the lost capacity and a disruption would be unavoidable. 
 
BD will continue to provide updates on the status of this situation on this page, and if there is a shutdown of the facility, we will provide more information on the impact to product supply on the Product Availability Update page.
 
We recognize how important the BD ChloraPrep™ family of products are to healthcare providers across the United States and have communicated the potential shortage and impact to the FDA.
If you would like to voice your concern about the impact on your facility with the FDA, please contact the Drug Shortage office at DRUGSHORTAGES@fda.hhs.gov.

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