07 November 2012
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane – Room 1061
Rockville, MD 20852
Docket No. FDA-2011-N-0090 "Unique Device Identification System"
Dear Dockets Manager:
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. Members are located in more than 80 countries.
AABB supports 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. In addition, our comments are in support of those submitted by ICCBBA. ISBT 128, the coding system managed by ICCBBA, encodes all information required by the proposed UDI regulation. ISBT 128 was designed to provide traceability between donor and recipient and to convey critical information about products of human origin. The use of ISBT 128 is widespread across the world. AABB comments to Docket No. FDA-2011-N-0090
Unique Device Identification System primarily address blood collection bags and human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated as devices.
AABB Standards for Blood Banks and Transfusion Services (28th edition) requires that labeling be in conformance with the most recent version of the US Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using the ISBT 128 coding system. For a number of years, bags used to collect blood (manual whole blood or by apheresis) in the US have been labeled with ISBT 128 bar codes and plain text identifying the manufacturer and the catalog number in one data structure (device identifier) and the lot number (production identifier) in the other. Software programs in US blood banks have been designed to capture information in this format. Collection bags with anticoagulant present are regulated as drugs while empty bags, such as those used for apheresis, are regulated as medical devices. Since both types of bags are used by the same staff within organizations, requirements, set forth in this rule, for labeling of the two types of bags should be consistent.
The proposed regulation 806.2 (m) indicates that an identifier should adequately identify a device through its distribution and use. It is not clear if the term "use" in this context includes a blood or apheresis bag after it has been filled with blood and has become a biologic. If "use" does include after the bag is filled with blood, then AABB, along with ICCBBA, recommends an exception to the requirement that the automatic identification and data capture (AIDC) UDI be visible throughout the use of the blood bag. We believe the current process in use at collection establishments adequately ensures traceability, supports the need for recall, and is less confusing to the end user of the blood. (Please refer to full description provided by ICCBBA and submitted separately to the docket).
AABB Standards for Cellular Therapy Product Services (5th edition) contains two requirements related to the use of ISBT 128 coding system. Standard 5.9.4 requires that "Product names and descriptions on product labels shall use the terms and definitions found in the Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions*" (*http://www.iccbba.org/uploads/27/29/27298935e0994ef2e3ad1eaa7cdb464e/Standard-Terminology-for-Blood-Cellular-Therapy-and-Tissue-Product-Descriptions-v4.16.pdf). Standard 188.8.131.52 states "The laboratory shall have a plan for implementation of ISBT 128 labeling."
ISBT 128 identification offers the best options for meeting the requirements to track HCT/Ps. The proposed UDI regulations are not ideal because they do not take into consideration the importance of the human donor of these products. Direct recall by donor identifier will be difficult or impossible using only the UDI set forth in the proposed rule, and the regulations as proposed cannot assure timely recall that may prevent transplant of a potentially unsafe HCT/P. AABB joins ICCBBA in recommending that the precedent set in
Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages, Final Guidance, March 2010, is also applicable to HCT/Ps regulated as devices. That is, ISBT 128 should be considered equivalent to UDI, and HCT/Ps regulated as medical devices that are labeled with ISBT 128 should be exempt from UDI requirements provided that, in addition to the donation identifier, all data elements required by UDI are present in both AIDC and simple text. These data elements are:
- The labeler;
- The specific version or model number (the product code and supplementary product information in ISBT 128);
- The serial number (the division code in ISBT 128); and
- The expiration date.
The donation identification number (DIN) should be added to the list of production identifiers considered under 801.45(b), in addition to the lot or batch number, serial number, manufacturing date or expiration date. In the case of products that originate with a human donor the ability to track and recall using the DIN is extremely important and is likely the only way to assure recall before a potentially unsafe HCT/P is transplanted.
Direct labeling of implantable HCT/P devices [801.50(a)(1)] would potentially be problematic as direct labeling on the tissue could impact the safety of the device. Containers would be labeled appropriately, but AABB recommends that an exception be granted to this requirement for direct labeling of the implantable HCT/P device. Information necessary to confirm a recall, or required for adverse event reporting, would be present in the recipient record and accompanying documents.
AABB agrees with the philosophy expressed in the proposed rule to set requirements that accomplish the necessary steps to enhance safety for patients without impeding the use of all available, or future technology that can meet the requirements.
Thank you for the opportunity to offer these comments. AABB looks forward to continuing to work with the Food and Drug Administration on patient safety initiatives. Questions concerning these comments may be directed to me at
M. Allene Carr-Greer
Director, Regulatory Affairs