Technical Bulletin – Labeling

Example of labeling excursion
Please remind your operating room staff: Do not provide any additional labeling on the tissue packaging other than the provided label. These can only be “labeled” as sterile if they have completed sterility testing under USP guidelines. The correct terminology is “aseptically packaged”.
Example of labeling excursion
Example of labeling excursion
In order for it to be labeled sterile it would need to be irradiated and then destructive testing done which would destroy the one unit of tissue packaged. Therefore we don’t use the term “sterile” with autografts. The proper terminology is aseptically packaged in an operating room environment.