Blood Bank Information Management System (BBIMS) v3.01
Device Facts
| Record ID | BK241069 |
|---|---|
| Device Name | Blood Bank Information Management System (BBIMS) v3.01 |
| Applicant | Carter BloodCare Bedford, TX |
| Product Code | MMH · Hematology |
| Decision Date | Jul 9, 2024 |
| Decision | SESE |
| Regulation | 21 CFR 864.9165 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Blood Bank Information Management System (BBIMS) v3.01 is a Blood Establishment Computer Software that is intended for use by trained healthcare professionals for the following blood manufacturing activities: - Provides a donor-administered or staff entered health history questionnaire - Transfers donor responses collected from the progressive web application to the system's network - Provides a staff entered physical assessment - Provides eligibility information regarding the suitability of a donor making a donation - Defers donors when they are prohibited from making a donation - Transfers donor information to Vista® Information System for donation optimization and receives procedure data information from Vista (when using certain automated blood collection systems) - Provides for maintenance and auditing of donor, donation and unit information - Provides for generation of donor notification letters - Provides for defining component preparation, modification and maintenance information - Provides for defining pooled products (e.g., platelets, cryoprecipitate) into single components - Transfers test orders and receives test results for all units processed, either through manual entry and/or donor sample testing software systems interfaces - Provides for labeling components based on Codabar and ISBT standards using HemaTrax® Unity Print Server to print 2x2, 4x2 and 4x4 labels - Provides for storing patient information during the manual crossmatch/consultation process - Provides for ordering products and storing information on inventories, orders, shipments, returns and imports
Device Story
BBIMS v3.01 is a blood establishment computer software system used by trained healthcare professionals in blood bank settings. It manages the end-to-end blood donation lifecycle: donor health history questionnaires (via web app), physical assessments, eligibility screening, and deferral tracking. The system integrates with Vista Information Systems for donation optimization and interfaces with laboratory systems for test order/result management. It supports component preparation, pooling, and labeling (Codabar/ISBT standards) via HemaTrax Unity Print Server. The system maintains audit trails for donor/unit records and manages inventory, shipping, and patient crossmatch data. By centralizing donor and unit information, it ensures regulatory compliance, accurate labeling, and efficient blood product management, ultimately supporting safe blood supply operations.
Clinical Evidence
Bench testing only. Verification and validation testing performed at unit, integration, and functional/system levels. Testing included program packages and risk control measures using established software development procedures to ensure safety-critical items and implementation hazards were addressed.
Technological Characteristics
Blood establishment computer software; supports Codabar and ISBT labeling standards; integrates with HemaTrax Unity Print Server; interfaces with Vista Information Systems and external laboratory testing systems; utilizes progressive web application for donor data collection; network-based architecture.
Indications for Use
Indicated for use by trained healthcare professionals to manage blood manufacturing activities, including donor health history, physical assessment, eligibility determination, donor deferral, component preparation, labeling, inventory management, and test result processing.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications ( *e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed. (3) Labeling must include: (i) Software limitations; (ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness; (iii) Revision history; and (iv) Hardware and peripheral specifications. (4) Traceability matrix must be performed. (5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements ( *e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
Predicate Devices
- Blood Bank Information Management System (BBIMS) v2.06.00 (BK180246)
