BD Blood Culture Bottles Face Shortage; bioMérieux Poised to Benefit
BD
Medical Device R&D Manufacturer, Distributor
Source: 360Dx
Reprint: IVD Tool Man
New York — The U.S. Food and Drug Administration sent a letter on Wednesday,RaiseAlert: Shortage of Becton Dickinson Blood Culture Bottles for Medical Service Providers。
FDA States That the Shortage of BD Bactec Bottles, Due to Supplier Issues, Is Expected to Impact Patient Diagnosis and Management as Well as Antimicrobial Stewardship Efforts.
In the letter, the agency advised laboratories to perform blood cultures only when medically necessary, in order to preserve the supply for high-risk patients.
Especially,FDA Recommends Prioritizing the Use of Blood Culture Bottles for Patients with Clinical Signs and Symptoms of Bloodstream Infections, disinfect the skin before collection to avoid contamination, collect an appropriate volume of blood, and use transport equipment to minimize the risk of bottle damage.
The agency said it would continue to monitor the situation.
BD Diagnostic Solutions President Nikos Pavlidis said in a statement that the company understands the critical role of blood culture testing in diagnosing and treating infections.
Pavlidis said, "While we are able to meet the majority of global demand, we are taking all possible measures to address this critical issue." He added, "BD Bactec blood culture bottles are being manually allocated so that we can best mitigate the impact on patient care."
Pavlidis said that the company also provides manufacturing expertise to suppliers, uses air transport, adjusts its rapid production schedule, and collaborates with the FDA to review all potential options to reduce supply delays.
BD said in the statement,The company's previous glass bottle supplier will also resume production.，To help fill intermittent supply gaps.
BD recommends that customers prioritize blood culture according to the guidelines of the Infectious Diseases Society of America and the World Health Organization.
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