Guidelines and Directions

The State of Florida and the Food and Drug Administration require RTI Surgical, Inc. to track all tissue(s) distributed. In accordance with The Joint Commission, FDA, and other agency requirements, it is the responsibility of the healthcare facility to maintain recipient records for the purpose of tracking human tissue implants. This record is NOT intended to be a substitute for the facility’s internal tracking system.

Each page must contain a clear and legible Patient ID, Tissue ID, or Serial Number sticker. In the case of copies, all reproduced pages must clearly display the identifier.

For procedures involving multiple tissue implants, the first Tissue ID/Serial Number must be verified on this screen. Additional Tissue IDs/Serial Numbers must be entered and verified on subsequent screens, with each requiring independent confirmation.