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Wisconsin Blood-Tracking Study Moves to Phase 2
The study, conducted with HF, found that RF exposure caused neither a temperature increase in the blood, nor any cellular or protein degradation. From the onset, the group sought the guidance and advice of the U.S. Food and Drug Administration (FDA), which categorizes the system as a medical device, due to the group's intention to use the technology with blood destined for human transfusion. Section 510(k) of the Food, Drug and Cosmetic Act requires that medical devices be submitted to the FDA for a premarket approval.
"The FDA provided us with some good direction to help ensure what we did with RFID would be safe, and that we considered everything we should," Briggs states. This led to the initial tests on red blood cells and platelets. The group released the results to the FDA in spring 2008, and the agency reviewed those results. For the second phase, the FDA has requested a similar test for plasma before real products are used in a pilot, because it had not been part of the previous study of only red blood cells and platelets.
During Phase One, the UW RFID lab researchers also conducted feasibility tests to determine how well the tags could be read when attached to blood bags, and surrounded by the packing and storing materials typically used by blood centers.
The second phase includes building and then piloting the prototype. Although the location of that pilot has yet to be determined, Briggs says, the group has already decided at what points in the blood supply chain tags would be read, and which data would be stored on the tags, so that blood banks and hospitals could employ RFID technology to track the products from donor to recipient. Those permitted to read or write to the tag will be the tag manufacturer, the blood bag manufacturer, the blood center and the hospital transfusion service.
The HF ISO 15693 tags—the vendor for which has not yet been selected—will each come with a chip that has two separate sections allocated for data storage. The information stored on the tag must adhere to specifications outlined in a standard established by the International Society of Blood Transfusion (ISBT). The standard, known as ISBT Code 128, describes a system that uses Code 128 bar coding to identify and track the processing and use of human blood, tissue and cellular therapy products.
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"The FDA provided us with some good direction to help ensure what we did with RFID would be safe, and that we considered everything we should," Briggs states. This led to the initial tests on red blood cells and platelets. The group released the results to the FDA in spring 2008, and the agency reviewed those results. For the second phase, the FDA has requested a similar test for plasma before real products are used in a pilot, because it had not been part of the previous study of only red blood cells and platelets.
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| During the project's first phase, researchers used blood bags fitted with adhesive 13.56 MHz passive RFID tags. |
The second phase includes building and then piloting the prototype. Although the location of that pilot has yet to be determined, Briggs says, the group has already decided at what points in the blood supply chain tags would be read, and which data would be stored on the tags, so that blood banks and hospitals could employ RFID technology to track the products from donor to recipient. Those permitted to read or write to the tag will be the tag manufacturer, the blood bag manufacturer, the blood center and the hospital transfusion service.
The HF ISO 15693 tags—the vendor for which has not yet been selected—will each come with a chip that has two separate sections allocated for data storage. The information stored on the tag must adhere to specifications outlined in a standard established by the International Society of Blood Transfusion (ISBT). The standard, known as ISBT Code 128, describes a system that uses Code 128 bar coding to identify and track the processing and use of human blood, tissue and cellular therapy products.
