Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -16

Accepted - Volume 7

Comment Record
Commentor Ms. Suzanne Butch Date/Time 2003-04-04 17:46:00
Organization University of Michigan
Category Health Professional

Comments for FDA General
1. General Comments I am a Clinical Laboratory Scientist who has been working in blood banking for over 30 years. Over that time I have seen the growing need to improve existing process controls. The failure of the largest blood collecting organizations in the US to adopt a more secure and useable blood labeling standard requires regulatory action. Requiring machine readable information on blood components without specifying a single standard does little to assist in increasing patient safety. In order for software manufacturers to develop software to detect and prevent errors, there needs to be an expected set of data with a finite structure. Bedside verification of blood compatibility requires that both the vendor of the transfusion service software and the vendor of the bedside verification system be able to read and process information. With the current proposal, a facility could decide to make up its own standards for producing machine readable labels. This would likely defeat the purpose of having machine readable information. ISBT 128 represents a great step forward. ISBT 128 is more than a bar code standard as it provides a data structure that can be used with other technology such as two dimensional bar codes and RFID chips. Thus, adoption of this data structure will not limit advancement. Failure to require ISBT 128 as the single standard structure for use in the US at this time will further delay conversion to the more secure bar coding standard. It will hinder development of software that can use the error prevention options built into the standard such as data identifiers and internal check digits. Failure to adopt ISBT 128 will ensure that we continue to have a fragmented approach to blood labeling. Without designating a specific standard structure for the machine readable information, we will continue to have multiple codes in use and no incentive for equipment and software manufacturers to improve their existing process controls. Relabeling of units will continue to be the way of making the systems compatible making traceability more susceptible to error. By specifying a single data structure such as ISBT 128, manufacturers of information systems will be able to develop robust systems for identifying patients, specimens and blood components from the time of specimen collection to transfusion. Without a single data structure standard, multiple competing but incompatible systems will be developed. In response to your question about the use of bar coded blood components in hospitals, simply having a machine readable label on a blood bag does not mean the hospital transfusion service will actually use the bar codes on the label. The vast majority of hospital transfusion services currently use blood components that have machine readable labels. However, a significant number do not utilize the existing technology. These facilities will not be likely to change their processes regardless of the machine readable standard chosen. In response to your question about requiring UCC/EAN standards for blood and blood components, changing to a new standard will take years to develop the data structures, change blood bank transfusion software to accommodate the new data structures and implement at both donor centers and transfusion centers. This will set the industry standardization effort back by years. Therefore, I urge you to require blood and blood components to be labeled using the machine readable ISBT 128 data structures. Today it will be bar codes. Tomorrow with two dimensional bar codes, RFID chips or with some yet to be determined method.

EC -16