FDA report sees no major problems with human tissue.

FDA released a report June 12 that concludes there are no significant industry-wide problems in the recovery of human tissues used for transplantation.

The report was issued by FDA's Human Tissue Task Force (HTTF), an intra-agency group assembled in August 2006 to evaluate the effectiveness of FDA's tissue regulations.

The HTTF recommended targeted inspections or a "blitz" of U.S. companies that recover human tissues--including tendons, ligaments, bone and other musculoskeletal tissues. One goal of the blitz was to look for more widespread problems in tissue recovery after FDA ordered two companies to cease manufacturing in 2006. FDA had found that these companies were not following procedures intended to prevent infectious disease transmission.

Investigators from FDA's Office of Regulatory Affairs (ORA) inspected 153 major human tissue recovery firms from October 2006 through March 2007. While some deviations from the regulations were identified, no major inaccuracies or deficiencies were found that could put tissue recipients at risk.

Based on data from the blitz, HTTF reported that nearly all recovery firms were in substantial compliance with FDA's comprehensive risk-based tissue regulations that went into effect in May 2005.

The task force report also made several recommendations on how to enhance FDA's tissue safety activities. FDA will use the information to better understand and oversee industry practices and to develop or revise guidance documents, regulations and future inspection strategies.

"The results, particularly of the blitz, show that FDA's new tissue regulations help keep human tissue safe," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "The work of the HTTF and FDA has provided valuable information about tissue recovery firms, our status on tissue safety, and important additional steps that should be taken to enhance the safeguards already in place."

The overall risk of disease transmission through tissue transplantation is believed to be very low, according to Goodman. While 1.5 million musculoskeletal tissue transplants are performed annually, reports of disease transmission are rare.

However, any instance of disease transmission can be serious, and up to 100 recipients may receive tissue from a single donor. In addition, the industry is growing in size, scope and complexity, further underscoring the need for strong process control by manufacturers and effective federal oversight.

"The recommendations of the task force will help us provide greater assurance of tissue safety," said ORA Associate Commissioner Margaret O'K. Glavin. "The collaboration between CBER and the Office of Regulatory Affairs through the HTTF is a model that served us particularly well and will be continued."

There are more than 2,000 active cell and tissue establishments registered with FDA. In fiscal year 2007, FDA intends to conduct 484 inspections. The task force recommends that all tissue establishments performing manufacturing steps considered to represent the highest potential risk for disease transmission be inspected every two years. It recommends that all others be inspected every three years. Other task force recommendations include:

Increased Education and Outreach: FDA will sponsor a workshop on tissue processing and microbiology for industry, implanting surgeons and academia to explore public and private partnerships and to develop and share best practices for reducing the risk of disease transmission.

Enhanced Adverse Reaction Reporting and Analysis: FDA received expert advice that is being used to refine the activities of FDA's multidisciplinary Tissue Safety Team, formed in 2004 to investigate adverse reaction reports and other tissue safety issues. CBER has further strengthened its communications and collaboration with the Centers for Disease Control and Prevention, FDA's principal federal partner in tissue safety surveillance and adverse reaction investigations. FDA also intends to expand its use of voluntary adverse reaction reporting.

Regulations and Guidance: FDA issued a guidance document in September 2006 to emphasize responsibilities for ensuring tissue safety between establishments and their contractors. FDA will issue guidance on Current Good Tissue Practices that will encourage tissue manufacturers to achieve best practices that can further reduce the risk of infection transmission.

To enhance investigative and compliance activities, FDA is considering options to improve the speed and reliability of tissue tracking from donor to recipient.

Science of Tissue Safety: Much still needs to be learned about microorganisms that could affect tissue safety. FDA will initiate a tissue microbiology program in collaboration with other partners, to work on opportunities for reducing risk through detection, prevention and best practices in manufacturing.

For more information, see CBER's Human Tissue Web Page at http://www.fda.gov/cber/tiss.htm