bioMérieux announces U.S. FDA 510(k) Clearance for New Plastic BacT/ALERT® Culture Bottles dedicated to the Blood Bank IndustrySeptember 01, 2003
Marcy l'Etoile, France - 1er septembre 2003. bioMérieux® announces U.S. FDA-CBER(*) 510(k) clearance of new, innovative plastic BacT/ALERT BPA and BacT/ALERT BPN culture bottles for microbial quality control testing of leucocyte-reduced apheresis platelets (LRAPs).
Blood bank laboratories are committed to ensuring the safest possible environment for their patients and employees. One of the ways of doing so is by converting glass products to plastic wherever possible. The new break-resistant plastic BacT/ALERT bottles will significantly impact the world of blood culture testing, by reducing the risks of accidental injury among laboratory staff. The upcoming commercialisation of this innovative product is the most recent example of bioMérieux’s mission to deliver products that stay ahead of laboratories’ needs.
The plastic BacT/ALERT BPA and BacT/ALERT BPN culture bottles are dedicated for use by the blood bank industry on BacT/ALERT Microbial Detection Systems for platelet testing. BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms and BacT/ALERT BPN culture bottles support the growth of anaerobic and facultative anaerobic microorganisms. Through extensive, external clinical trials, the plastic bottles have demonstrated equivalent performance to the currently marketed glass BacT/ALERT SA and BacT/ALERT SN culture bottles, while greatly improving safety.
The multi-layer plastic used to produce these bottles does not alter the system’s detection performance; furthermore, the plastic bottles are 30 % lighter than the glass bottles currently used on the BacT/ALERT system, resulting in easier handling and more cost effective disposal. The bottles do not contain heavy metals and can be disposed safely, without polluting the environment.
bioMérieux has incorporated an additional internal 100% quality control inspection of each individual culture bottle following a retention period to ensure strict sterility measures are maintained. The introduction of this new blood bank specific product will also allow bioMérieux to improve tracking of the field performance of bacterial contamination testing of blood products.
In the beginning of 2004, bioMérieux anticipates launching an innovative, software package: BacT/Notify™. The software package will enable the blood bank laboratory to broadcast positive results to remote distribution locations. More important, the software enables an authorised person in a remote location (e.g. a hospital) to have access to the latest available BacT/ALERT result of the product being tested. This unique feature will unite the functions of sampling and quality control testing of LRAPs to delivery of the latest available result, virtually at the bedside.
Automation in the field of blood culture plays a significant role in improving laboratory workflows and patient care through continuous monitoring and rapid results. The automated BacT/ALERT system provides the blood bank industry with a reliable state-of-the-art technology for the detection of bacterial contamination of blood products. The system demonstrates sensitivity and specificity for quality control testing of platelet products, detecting bacterial cell concentrations as low as 4 CFU/ml with detection times generally shorter than 24 hours(**).
Through continuous innovation, the BacT/ALERT product range offers high-performance technology and easy-to-use design to blood bank laboratories, large or small, worldwide. bioMérieux is the world leader in the automated blood culture market and is committed to a long-term partnership with the blood bank industry to further improve patient care by increasing the bacterial safety of blood products.
(*) United States Food and Drug Administration Center for Biologics Evaluation and Research (see http://www.fda.gov/cber/whatsnew.htm).
(**) Brecher ME., Heath DG., Hay SN., Rothenberg SJ., Stutzman LC., Evaluation of a new generation of culture bottle using an automated bacterial culture system for detecting nine common contaminating organisms found in platelet components. Transfusion 2002;42:774-779.