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French Blood Institution Seeks Governmental Guidance

Following RFID pilots led by the organization that manages France's blood-donor centers, the French Agency for the Safety of Health Products is considering the creation of a protocol for the use of radio frequency identification on blood products in that country.
By Claire Swedberg
Dec 29, 2010Having completed two pilot projects testing an RFID solution for tracking blood products, the Etablissement Français du Sang (EFS), or French Blood Institution—which manages France's blood-donor centers—has submitted the results of those pilots to a French regulatory agency that will now determine a protocol based on the safety of RFID technology in the presence of blood products. If the agency issues such a protocol, blood banks throughout that nation will be permitted to track their products with radio frequency identification rather than bar-coded labels, thereby enabling them to store more information about the products, as well as automate some processes.

EFS, which has been examining RFID technology for the past 10 years, conducted two pilots—one in 2007 and 2008, involving red blood cells, and a second in 2009 and 2010, testing RFID to track plasma through laboratories and manufacturing sites, as well as to a hospital. In addition to supplying custom-designed tags and readers for this application, Biolog-ID (formerly known as Réseaumatique) provided the software that managed data from RFID reads and sent that information to the enterprise resource planning (ERP) systems used by the pilots' participants. The readers were designed to provide the reading and writing times required for the application, while the tags' form factor was modified to transmit in the presence of liquids, with an adhesive that would provide further RF insulation between the tag and the blood products.


The Biolog-ID Smart Fridge has drawers divided into 15 cells (each storing a single bag), with each cell equipped with a built-in RFID reader antenna to read a bag's RFID tag.
As a result of the pilots, says Gilles Folléa, EFS' manager throughout the projects and now the executive director of the European Blood Alliance, EFS submitted a request for approval in February 2010 from the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), the French governmental agency responsible for overseeing the safety of health products, asking that organization to put in place an approved protocol that would allow the blood industry to track products using RFID. The establishment of such a protocol, he cautions, may take a year or more. "Modifying regulations is very sensitive, and requires careful assessment," he explains. "It will take time, but it is very difficult to predict exactly how long."

The 2007-2008 pilot included attaching passive 13.56 MHz RFID tags, compliant with the ISO 15693 standard, to a total of 700 to 800 bags of red blood cells at the ETS-Pays de Loire blood center, in Nantes, after they have been separated from plasma. The pilot's objective, says François-Luc Monge, the commercial director of Biolog-ID's health division, was to test the hardware, ensuring that tags could be read on the blood bags, and to test the interface between the RFID tag reads and the blood transfusion center's back-end management system. The tags were encoded with a unique identifier, and as they were read, additional information was written to them. After a bag was filled with red blood cells, for example, a tag was attached to that bag, and a Biolog-ID desktop RFID interrogator read the tag's ID number, while at the same time encoding the tag with the identification number of the blood donation, as well as a product code and the blood type. The tags were read once more before leaving the blood center, immediately before being shipped to the participating hospital, Polyclinique du Parc.

When the hospital received a box packed with red blood-cell bags, the box was unpacked and the tags were read again with another Biolog-ID desktop reader, plugged into a PC. With each read, the interrogator transmitted the ID number and product information to the back-end ERP system, in which the bag's status would be updated to reflect its arrival at the hospital.

USER COMMENTS

S Brubaker 2010-12-30 12:03:03 PM
Verification at Point of Care Is it possible I missed something? I didn't see anything described where this system is helpful between time of issue of the product for use and subsequent time of use. Also, other labeling/coding systems match the transfusable unit's identification with the intended recipient's identification "at the bedside" (i.e., point of care). This did not appear to be described here, either.
Claire Swedberg 2011-01-04 09:28:41 AM
Senior Editor Although bed-side use of the RFID system was not part of the initial pilot, the Biolog-ID system is designed to allow reading of RFID tags on the blood bag at the bedside. In that case medical staff could use a PDA or hand-held reader to capture the ID number on the tag and link it to the patient. With that function, the software can track when a patient received the transfusion and the history of the blood used.

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