Update on Transfusion Safety Management Systems

1. Update on Transfusion Safety Management Systems Blood Products Advisory Committee Meeting, March 9, 2006 Linda Weir, CSO, CBER/OBRR/DBA

2. Purpose • To provide FDA’s current considerations regarding the regulation of electronic systems for use in matching blood components to the intended recipients

3. What Are Transfusion Safety Management Systems? • An electronic system consisting of a barcode scanning device, specialized software, a portable printer (sometimes), and possibly other accessories • Intended specifically for use in matching blood components to the intended recipient • Used to scan the barcode on the blood product and the barcode on the patient arm band at the time of transfusion

4. What Are Transfusion Safety Management Systems? • They may be: • Stand-alone systems • Interfaced to an HIS/LIS • Interfaced to a BECS

5. What Are Transfusion Safety Management Systems? • They: • Are used for positive patient ID at the bedside • May be used when the specimen is collected from the patient for compatibility testing • Aid in the decision to transfuse or not • May be wired or wireless • May be used to record vital signs pre and post transfusion • May be used to record post-transfusion events

6. What Are Transfusion Safety Management Systems • May be used to track the blood product from the point of issue from the transfusion service, through subsequent refrigeration, to transfusion. • May record time out of refrigeration and warn the user if this time is outside of acceptable limits. • Track the date and time of transaction and the user ID of the person performing the transaction.

7. Transfusion Safety Management Systems Are Devices • Transfusion safety management systems have been determined to be medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act)[21 U.S.C. 321(h)] • This is because they are intended to prevent transfusion of blood to the wrong recipient thus preventing incompatible transfusions and associated hemolytic transfusion reactions, i.e. prevention of disease

8. Transfusion Safety Management Systems Are Also BECS • Transfusion Safety Management Systems are devices that further meet the definition of Blood Establishment Computer Software (BECS), • “…software designed to receive and store data used by blood establishments • which includes transfusion services per 21 CFR 607.3(c)) • during the manufacturing process • (which includes compatibility testing per 21 CFR 607.3(d) ), • from determining donor suitability through component processing, testing, and labeling to product release” • (From March 31, 1994 letter to manufacturers of blood establishment software: http://www.fda.gov/cber/bldmem/033194.txt

9. Transfusion Safety Management Systems Are Also BECS (cont’d) • Because FDA regulates compatibility testing under 21 CFR 606.151, software products used in transfusion services for compatibility testing are also considered to be BECS. • Transfusion service software products often contain other functionalities consistent with those of BECS, e.g., inventory control, label printing, etc. • These software products also usually store recipient data such as blood types, known antibodies, etc.

10. Message to Manufacturers of Transfusion Safety Management Systems • If you are manufacturing an electronic system intended for use in transfusion management submit a 510(k) if you have not already done so.

11. 21 CFR 801.4Meaning of Intended Uses • “…the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. ”

12. Wireless Technology • Manufacturers of medical devices using wireless technology must consider electromagnetic interference (EMI) and compatibility (EMC) caused by the device. • We request you provide the requirements as set forth in the recognized consensus standard AAMI/ANSI/ IEC 60601-1-2: 2001, Medical Electrical Equipment- Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.

13. Wireless Technology • The manufacturer of the equipment or system should provide a declaration of conformity to the standard or provide testing results as outlined in AAMI/ANSI/ IEC 60601-1-2: 2001 to the FDA in the 510(k) premarket notification

14. Message to Users of Transfusion Safety Management Systems • Know if the Transfusion Safety Management System you are considering is intended for use in transfusion management • If it is, know if the manufacturer has obtained clearance from CBER/FDA • If it is not, note that your validation burden may be higher

15. Cleared Systems • Care Fusion wBloodCare • Korcheck Technologies CareCheck Patient Identification System • Neoteric BloodTrack SafeTx • Neoteric BloodTrack Courier • http://www.fda.gov/cber/products/510ksoft.htm

16. Questions? • Linda Weir, BECS Expert linda.weir@fda.hhs.gov 301-827-6136

17. Acknowledgements • Sheryl Kochman, Chief, Devices Review Branch • Darcel Bigelow, CSO, Devices Review Branch • Faye Vigue, CSO, Devices Review Branch