Potential Disruption

Last Update: November 3, 2021
9:30 am EDT

Updates on Potential ChloraPrep Shortage

June 29, 2021

 

On June 29th, a District Court in New Mexico issued a preliminary injunction that prevents a third-party sterilizer from releasing “uncontrolled emissions” of ethylene oxide (EtO) from their facility. This sterilizer serves many medical technology companies, including BD, and is the primary site at which the BD ChloraPrep™ family of products are sterilized.

The injunction does not specify that the facility must close or stop production, and we do not currently believe it will result in an immediate impact to the supply of BD ChloraPrep™. 

In recent communications with the media and the court, the Attorney General has stated their objective is not to close the third-party facility and that they are “not requesting that there be an interruption of safe medical services.”

BD has taken early action to mitigate a potential disruption for several months, including putting BD ChloraPrep™ on allocation and identifying alternate sterilizers. However, as we have previously communicated, there is not enough global sterilization capacity to offset all the lost capacity if this facility does close or become limited, and a disruption would be unavoidable.

BD is committed to continued transparency about potential supply chain disruptions. We will provide updates as they are available and continue to update this page.

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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