From Donor to Recipient

Bar code-generating software allows a tissue-processing firm to trace its every move.


RTI�s allografts for spinal, sports medicine, cardiovascular, and general orthopedic surgeries are labeled and scanned for traceability. Photos 
courtesy RTI and The Danby Group.

For Regeneration Technologies Inc. (RTI; Alachua, FL), product tracking is critical. The firm processes donated human tissue to create allografts and prepares them for implantation into human recipients. According to its literature, RTI is one of the leading providers of tissue-based innovations for the repair and natural healing of human bone and other tissues. It is among the largest processors of precision-tooled allografts. 

According to Nancy Walsh, RTI's manager of marketing communications, tissue traceability from donor to recipient is crucial. At the same time, however, patient privacy must be protected. So RTI opted to use linear bar codes to encode unique serial numbers for each tissue. Tied to database records maintained by RTI, these codes can be used to quickly recall tissue history and processing should there be a need for it. 

During processing, a bar coded label accompanies the tissue through each step as a unique identifier. This label remains with the tissue, straight through the firm's BioCleanse tissue sterilization step, until packaging. Whenever an RTI employee handles the tissue, he or she scans the bar code to record every processing step. For final packaging, the tissue is placed in a sterile pouch; that pouch is then placed into a second pouch. A third pouch, which RTI's packaging engineer Randy Althouse calls a dust cover, holds both the double-pouched tissue and related paperwork. An outer label with the tissue's final identification number is then placed on the package.

For RTI's bone paste product, the pouch is inserted into a folding carton designed to withstand extremely cold temperatures. Several different labels including tamper-evident labels and color-coded product identification labels are placed upon the high-gloss printed folding carton. 

To achieve traceability, RTI started by using preprinted labels with bar codes. To make the process cost-
effective and validatable, RTI decided to print its own codes and labels. 

To do so, RTI began using DataGard software from The Danby Group (Norcross, GA). The software generates sequential bar codes, of which Danby guarantees there will be no duplication. The Danby Group also provides folding cartons and labels. One of the software's most important features, says Althouse, is its ability to be validated. 

According to Fred Lovelady of The Danby Group, DataGard software enables users to produce 100% validatable labels. The user can command the system to print by beginning number or by total number of labels in a batch. Bad serial numbers or bar codes that do not meet specifications are automatically eliminated from the database and logged as unusable. Electronic files are automatically produced that contain all data necessary to document 21 CFR Part 11 validation.

Labeling equipment was provided by The Danby Group. The DataGard System consists of Zebra Technologies' Model 90 XiIII printers, Microscan's 850 fixed-mount scanners, and software from The Danby Group. 

RTI recently moved into a new building and integrated its labeling equipment into a new processing area. "The use of the software has not changed with the move, but the equipment and the software have all made the transition seamlessly," Althouse explains. 

RTI's facility in Alabama, which processes cardiac tissue, including heart valves and vessels, is currently implementing a similar system and validating DataGard to manage labeling operations. 

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