Allograft safety initiative is granted a 1-year extension to achieve goals

Project advocates universal donor numbers and Web-based means of tracking allografts nationally.

After 3 years, the Transplantation Transmission Sentinel Network project, the initiative designed to decrease adverse events in tissue implantation, has reached the end of its funding but not the end of its mission, according to key project personnel who say there’s still work to be done to meet the initial program’s goals.

“We are currently in a sort of lull in the action,” said Michael Joyce, MD, staff surgeon at The Cleveland Clinic Department of Orthopedic Surgery and medical director of the clinic’s musculoskeletal tissue storage facility. Joyce acted as the project’s chairperson for the orthopedics community. “We still need to take further steps to implement all of our goals,” he said.

Better tracking and safety

Initiated in 2005, the Transplantation Transmission Sentinel Network (TTSN) was developed in response to the recognition of a need for better tracking of tissue and organ transplants, to enhance the safety of procedures which rely on the use of allografts. The initial effort was the collaboration of a number of agencies and medical societies, including the American Academy of Orthopaedic Surgeons, acting under the umbrella of the United Network for Organ Sharing (UNOS).

According to Matthew Kuehnert, MD, director of the Centers for Disease Control and Prevention’s Office of Blood, Organ, and other Tissue Safety, the objective of the initial proposal was to develop a network to detect and prevent disease transmission through improved communication among those in the organ, eye, and tissue health care facilities, as well as surgeons and public health authorities. After UNOS was awarded the contract, building of a development prototype was begun by focusing on a “task pyramid” of goals.

“Biovigilance”

“The cooperative agreement was slated to operate for 3 years, to end in 2008,” Kuehnert said. “However, UNOS has asked for, and been granted, a no-cost extension which will end in 2009.

“UNOS has designed TTSN as a working pilot to meet the goals set out by the cooperative agreement,” he added. “Now that a working system has been developed, the next step is to determine the requirements for a national effort, which will require input and resources from a variety of partners both inside and outside the government for such a system to be implemented.”

Kuehnert added that the area of patient safety area is being increasingly recognized as a priority worldwide and is advancing globally under a term called “biovigilance.”

Categorizing the initial efforts of the TTSN project as “worthy,” Joyce said the goals remain as viable and necessary now as they were when the need was defined at the project’s inception.

Universal donor number

“The basic question then and now is, how can we reduce the transfer of disease in this process?” he said. “We came up with several components. The first was the concept of the universal donor number, so that organs and tissues would be linked. If a recipient seroconverts for an infectious disease … sharing of information and knowing what happened to the organ recipient maybe we would prevent release of those musculoskeletal tissues.

“The second area we proposed was the development of a Web site, where these universal numbers could be stored and tracked,” Joyce said. “This would allow surgeons to type in an identifying number from the tissue packaging label and determine if tissues from the same donor had caused any adverse events, or whether or not the tissue had been recalled.”

The system would also allow surgeons and medical facilities to report adverse events, rather than reporting those events to the individual tissue banks and relying on them to report the incidents, he added.

“Some so-called adverse events occur only because the patient has to be rehospitalized for a time and are not of a serious nature,” Joyce said. “But there are subtle adverse events that we need to be keeping closer tabs on. The system we proposed would offer an easier way to report both subtle and major adverse events.”

Collaborative effort

For the TTSN goals to finally become a reality, Kuehnert said a collaborative effort between private and public bodies would likely be necessary.

“The rapid growth in the use of organs and tissues over the last several years reflects the tremendous advances in technology that have occurred, so that now patient safety efforts, like TTSN, are needed to catch up with the technology, to make these procedures as safe as they can possibly be,” he said. “For both organs and tissues, a TTSN-like system will not only yield important information but could also allow interventions that would prevent further transmission of disease through allografts, which would have a positive impact for physicians and could be of lifesaving benefit for patients when disease transmission is a risk.”

For more information:
Michael Joyce, MD, can be reached at The Cleveland Clinic Department of Orthopedic Surgery, 9500 Euclid Ave., Cleveland, OH 44195; 216-444-4282; e-mail: joycemich@aol.com. He has no direct financial interest in any of the products or companies mentioned in the article. Matthew Kuehnert, MD, can be reached at the Centers for Disease Control and Prevention, 1600 Clinton Road., Atlanta, GA, 30333; 404-639-6426; e-mail: mgk8@cdc.gov. He has no direct financial interest in any of the products or companies mentioned in the article.