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RTI Surgical® Collaborates with American Dental Association on Proposed Technical Report No. 1089, Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products

Wendy Crites Wacker, APR
Vice President, Global Communications
wwacker@rtix.com
386.418.8888

ALACHUA, Fla. (Oct. 5, 2016) – RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company providing surgeons with safe biologic, metal and synthetic implants, commends the recent work of the American Dental Association (ADA) to improve track and trace of tissue implants used in dental surgeries. The ADA has released a technical report that will help to improve tracking and tracing within this critical area of healthcare, and RTI Surgical is proud to have worked with the ADA on this important effort.

The proposed Technical Report (TR) 1089, Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), defines inventory management requirements in dental practices for HCT/Ps to ensure traceability from the donor to the recipient and the recipient to the donor. Its intent is also to facilitate reporting of potential adverse reactions to all parties involved in processing the HCT/P. The report may be purchased on the ADA website at http://ebusiness.ada.org/ProductCatalog under “Research and Standards.”

HCT/Ps are used in more than a million medical and dental procedures per year, including bone and gum grafting and repair, among many others. Most of these services are routinely performed in dental practices, hospitals, ambulatory surgery centers (ASC) and other medical facilities.

While requirements exist for tissue banks and many health care facilities to have validated processes in place to track and trace HCT/Ps, there is a lack of appropriate standardized identification standards and a mechanism by which to collect, store and share HCT/P data for public health, clinical and research purposes. Not only will this data be useful for public health, clinical and research purposes, it will also improve tissue banks’ efforts to connect donor families with recipients.

“RTI has been working diligently, both individually and with the tissue banking community, to enhance and extend the requirements for standardized tracking and tracing of these important tissue implants. Making these important connections enhances donation and tissue transplantation,” said Brian K. Hutchison, RTI president and CEO. “We anticipate TR 1089 will have far-reaching impact, given its applicability to other health care settings.”

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About the American Dental Association

The not-for-profit ADA is the nation's largest dental association, representing 159,000 dentist members. The premier source of oral health information, the ADA has advocated for the public's health and promoted the art and science of dentistry since 1859. The ADA's state-of-the-art research facilities develop and test dental products and materials that have advanced the practice of dentistry and made the patient experience more positive. The ADA Seal of Acceptance long has been a valuable and respected guide to consumer dental care products. The monthly The Journal of the American Dental Association (JADA) is the ADA's flagship publication and the best-read scientific journal in dentistry. For more information about the ADA, visit ADA.org. For more information on oral health, including prevention, care and treatment of dental disease, visit the ADA's consumer website MouthHealthy.org

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic-based implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.


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