番茄社区

Medical device company Becton Dickinson (BD) may be nearing the end of a shortage of plastic bottles used to contain blood culture media, a company official said Tuesday.

"Because of actions BD implemented beginning this spring to increase production and improve supply, with the support of our government and industry partners, we believe we have turned the corner," BD spokesperson Troy Kirkpatrick said in an email to 番茄社区. "Our outlook shows production levels reaching 100% of historic weekly demand volumes by the end of September for the U.S. market. By the end of the calendar year, we expect to produce 125% of historical weekly demand to enable distributors and customers in the U.S. to begin rebuilding inventory and safety stock."

The shortage began earlier this year, with BD that "For several months, we have seen reduced availability of plastic bottles from our supplier that has prevented us from manufacturing BD BACTEC media to meet full global demand." , "Most blood cultures in the United States are performed using continuous-monitoring blood culture systems; the BD continuous-monitoring blood culture system is used in about half of all U.S. laboratories and is only compatible with BD's BACTEC blood culture media bottles."

The FDA on July 10 to include the bottles. The agency recommended several actions affected providers could take to preserve the bottle supply, including:

• Performing blood culture collections when medically necessary, following clinical guidelines
• Prioritizing use for patients with clinical signs and symptoms of a bloodstream infection
• Performing routine disinfection of skin protocols prior to collection to minimize the risk of contamination of the blood culture
• Ensuring proper blood volume collection to avoid a need to recollect additional samples
• Utilizing safe blood collection and transfer devices to minimize the risk of damage to blood culture media bottles

In July, that "As an additional mitigation measure, we will be launching the BD BACTEC Lytic Anaerobic media in glass with availability beginning the first week of September. This product was previously discontinued in 2022 and is now being reintroduced as a short-term action that will improve overall product quantities."

Hospitals and labs are definitely feeling the pinch. "All laboratories that use BD BACTEC have been impacted by the shortage," Daniel Rhoads, MD, vice chair of the Microbiology Committee at the College of American Pathologists (CAP), said in an email to 番茄社区. "This shortage has led to delays in processing blood cultures, which are critical for diagnosing infections and other conditions. It has placed additional strain on lab resources and staff, highlighting the importance of a reliable supply chain for essential medical supplies."

To prevent future shortages, "Companies should consider and mitigate risk associated with manufacturing that could be impacted by a single point of failure, including manufacturing that is outsourced," Rhoads said. "Taking these steps is essential to safeguarding against disruptions that could impact product availability and patient care."

Hospitals that use the BD blood analyzer have been working on both short- and long-term plans to reduce the shortage's impact, according to Nancy Foster, vice president of quality and safety policy at the American Hospital Association (AHA). "In the short run, they are ramping up their efforts to be good stewards of their blood culture resources," she said in an email. "This includes efforts to reduce waste and unnecessary usage. If those efforts are insufficient, hospitals will have to prioritize patients to receive blood cultures." The AHA hosted member webinars recently featuring BD representatives who shared the latest mitigation strategies and committed to keeping AHA members informed, Foster said.

In the longer term, AHA "has been working with federal agencies and companies, such as BD, to create a much more resilient supply chain," said Foster. That may include manufacturers diversifying production sites and sources of raw materials, the federal government insisting that manufacturers have resiliency plans that specify how they'll handle a natural or man-made disaster or other supply disruption, and hospitals deciding to buy only from manufacturers that have resiliency plans.

The shortage also has garnered the attention of HHS higher-ups. On August 16, HHS Secretary Xavier Becerra saying the agency was "working closely with the manufacturer and other partners to accelerate rapid resolution of the shortage, including expediting any necessary review (e.g., for shelf-life extension), meeting with alternative suppliers, and communicating best practices and conservation strategies."

Last Friday, Becerra held a roundtable with BD and other stakeholders, including the AHA and CAP. One of the attendees was a representative from CMS; that agency has been talking with AHA "regarding the impact of the disruption on hospitals' ability to perform optimally on certain quality measures such as the Severe Sepsis and Septic Shock measure, and healthcare-associated infection measures, potentially affecting CMS Hospital Star Ratings and CMS' value-based programs," HHS . Becerra said that although resolving the shortage is the top priority right now, "finding solutions and increasing collaboration is the best path forward to avoiding similar shortages in the future."

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