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Blood and Blood Components
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Cellular Therapies
Prescription Drug Marketing Act



Labeling requirements and bar code technology are playing an increasingly important role in the transfusion medicine and cellular therapy communities. Labels and bar codes — machine-readable representations of information — include critical information necessary to accurately identify, store, ship, track, and distribute blood and cellular therapy products. The technology has been shown to reduce facility operating costs while increasing the efficiency, traceability, accuracy, and safety of the products and the manufacturing processes.

There are two types of product labeling language approved for use by the Food and Drug Administration — Codabar and ISBT 128. The FDA's bar code rule does not specify which language should be used, only that machine-readable information must be available. Each label must have information that contains, at a minimum, a unique facility identifier, a lot number relating to the donor, a product code, and the ABO and Rh of the donor. The requirements are applicable to all blood and blood components, including autologous units collected within a hospital and to all aliquots, syringes and pools. AABB's Standards and Accreditation program requires facilities to comply with ISBT 128 labeling for blood and blood products. In addition, the international cellular therapy community has developed plans to use ISBT 128 bar code symbology as well.

Because labeling requirements and bar code scanning are considered to be an important step in reducing transfusion errors, AABB works with federal regulators to advance the use of this technology for positive identification of the patient and the product or component at the patient's bedside.

Recent Actions

AABB posted an analysis of the FDA final rule for the unique device identification system, which is expected to provide better tracking, inventory management and reporting of adverse events that may occur with a medical device.

The FDA’s Center for Biologics Evaluation and Research announced its approval of iTrace for Blood Centers, v 1.0.924.0 on June 7. According to an FDA press announcement, the iTrace for Blood Centers is the first device to use radio frequency identification, or RFID, technology in blood establishments to improve blood safety by helping to prevent the release of unsuitable components.

AABB submitted comments to Docket FDA-2011-0090, “Unique Device Identification System”, stating support for the use of standardized terminology, coding, and labeling for blood and blood components, cellular therapy products, and devices that assure patients receive the intended therapy. Such processes also enhance reporting of adverse events and other biovigilance activities. AABB also expressed support of ICCBBA’s comments that ISBT 128 will meet the requirements of a UDI as defined in the proposed rule.

FDA announced a review of the 2004 Bar Code Final Rule in the Federal Register on October 26, 2011. AABB responded by submitting comments on January 9, 2012, stating the fundamental goal of the requirements of the Bar Code Rule should be to assure essential information encoded by manufacturer(s) can be read and interpreted correctly by facilities receiving and using products in order to ensure the appropriate product is available for the patient. Manufacturers should not be limited to the amount of information that can be encoded simply because of a limited list of recognized technologies in the regulations. Specific questions from the Federal Register Notice were answered by AABB in the submitted comments.

FDA issues guidance on standardized numerical identification, or SNI, for prescription drug packages recommending that cellular and tissue products not using National Drug Code numbers, such as hematopoietic cells from peripheral and cord blood, use ISBT 128 or Codabar as the SNI.

AABB issues Association Bulletin #09-08 to inform members of its decision to keep conditional status open-ended but to impose additional requirements on those facilities that fail to comply with the ISBT 128 labeling standard.

AABB outlines the decision made by the board of directors along with input from the standards and accreditation program committees regarding facilities that have not implemented ISBT 128 by Nov. 1, and issues Association Bulletin #09-05 stating that facilities not compliant with the requirements for labeling of blood and blood products will be placed on conditional accreditation after that date.

AABB amends comments to FDA on SNIs and the NDC suggesting that the phrase "hematopoietic stem cells derived from peripheral" be expanded to include all cellular therapy products.

AABB submits comments to FDA on SNIs and the NDC fully supporting FDA's position that the use of ISBT 128 or Codabar labeling for blood and blood components and hematopoietic stem cells derived from peripheral and cord blood is equivalent to the SNI for product packaging.

AABB standard for implementation of ISBT 128 takes effect.

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