Press Release: IT Synergistics Releases New FDA-Compliant Bacterial Detection Process

BECS Software Update Includes Support for Bacterial Risk Control Strategies and “Find A Typed Unit” Antigen Search

Recently, the Food and Drug Administration (FDA) provided new bacterial detection testing guidelines for the blood collection industry. IT Synergistics has updated its blood establishment computer system (BECS) software to be fully compliant with the new recommendations for culture and rapid testing that are scheduled to go into effect for blood centers by early second quarter 2021.

Bacterial detection testing is the process of identifying any bacteria that is growing in the blood bag. Without stringent bacterial detection processes in place, the likelihood of infection from blood transfusion increases due to undetected harmful organisms. The new FDA recommendations aim to further improve the safety of platelet products and increase their availability. For instance, by applying a multi-step bacterial risk control strategy, blood centers will be able to store platelet products up to seven days (extended from the current limit of five days) – this increases the number of products available for patient use.

bexWISE Process has been updated to include highly configurable single-step and multi-step bacterial risk strategies that, when applied, allow for culture-based testing (including cataloging of culture samples and results), adequate culture incubation, and rapid test results. FDA-approved culture-based or rapid detection devices are compatible with the software. Through bexWISE Process, bacterial detection can be performed on apheresis platelet products, pooled platelet (both pre-storage and post-storage) products, and single units of whole blood derived (WBD) platelets.

“We’re pleased to make this very important enhancement to our bacterial detection process. Our customers are eager to implement these changes and realize the benefits of an extended platelet inventory,” said Tim Bryant, Managing Director of IT Synergistics.

This new software version also includes support for Versiti’s “Find A Typed Unit” antigen search application, which is offered in conjunction with Blood Centers of America (BCA). BCA member blood centers that want to participate in the program can provide a list of products with specific antigen negative results currently in their inventory. The gathered data will be exported through the use of bexWISE InterLink, where it will then be uploaded and made available within the Find A Typed Unit application.

bexWISE Software Release 33 (v2.0.33.00) was released November 2020.

About IT Synergistics

IT Synergistics (ITSy) is a customer driven, 510 (k) approved blood establishment computer system (BECS) vendor. Based upon an ongoing review of member blood centers’ strategic plans and initiatives, ITSy’s customers identify, prioritize, and recommend strategic additions to ITSy’s overall portfolio. IT Synergistics is committed to meeting blood centers’ software needs.

Contact:  Tim Bryant, Managing Director,

All company and product names mentioned herein are the property of their respective owners.

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