The U.S. Centers for Disease Control and Prevention has issued a health advisory on a shortage of plastic Becton Dickinson and Co. Bactec blood culture media bottles, made by a singular supplier.
CDC said the shortage may disrupt patient care by delaying diagnosis or leading to the misdiagnosis of certain infectious diseases.
"Based on actions currently deployed at our supplier and the temporary sourcing of glass bottles … we expect to realize improvements in supply in September 2024," Chris Beddard, vice president at BD Life Sciences, said in a July 24 clinician call hosted by the Infectious Diseases Society of America. "We continue to produce and allocate weekly with the current plastic vial supply."
To help ease the shortage, BD said some specific lots of vials can be used for one month beyond the printed date on the bottles.
"The specific product lots and detail will be in a letter that we will post to our microsite and will be available via [customers'] BD account representative," Beddard said.
"In the interim, BD will continue to fill customer orders regularly and as supply is available," BD said in an update statement. "As this is a dynamic and evolving situation, we will provide another supply update by September 2024."
BD originally expected the shortage of the multilayer polycarbonate/nylon/polycarbonate bottles "to be temporary in nature," the statement said.
"After investigation and analysis, we determined the issues are more complex than the supplier originally communicated," it added. "Their manufacturing issues will limit BD's ability to supply BD Bactec blood culture vials to meet full global demand."
According to a report by STAT News, BD's bottles are supplied by one source in Indiana. BD told the publication that the design of the bottle's neck and associated intellectual property are "barriers to onboarding a secondary supplier."
"At this time, we are not aware of an issue with any other manufacturers," Carl Newman, deputy director of the Office of Supply Chain Resilience at the U.S. Food and Drug Administration, said during the call.
BD is collaborating with FDA to review potential options to resolve the issue "as quickly as possible," it said, adding that it "already implemented various mitigation measures," including working to improve production line efficiency and modifying manufacturing schedules with its supplier and reducing transit times with air shipments.
FDA is monitoring the situation and encourages laboratories and health care providers to notify officials of shortages, Newman added.
Most blood cultures in the U.S. are performed using continuous-monitoring blood culture systems, the July 23 CDC notice said.
"The BD continuous-monitoring blood culture system is used in about half of all U.S. laboratories and is only compatible with BD Bactec blood culture media bottles."
Health departments affected by the shortage should immediately assess their situation and develop plans to mitigate the potential effects on patient care, CDC said.
"Unnecessary and incorrect blood culture collection are not only detrimental to patient care but can contribute to or exacerbate shortages of blood culture media bottles," the advisory said. "Several studies have demonstrated that unnecessary blood cultures can be reduced without an increase in adverse events."
The studies can serve as a template for collaborative efforts and reduce the number of unnecessary blood cultures performed in health care facilities, it added. "CDC offers a quality tool to prevent blood culture contamination and improve diagnostic accuracy."
CDC suggests laboratories or facilities affected by the bottle shortage determine alternative options for blood cultures, such as working with a nearby facility or sending samples out to a laboratory not affected by the shortage.