June 12, 2007--The U.S. Food and Drug Administration (FDA) today released a report 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, an intra-agency group assembled in August 2006 to evaluate the effectiveness of FDA's tissue regulations. The Human Tissue Task Force recommended targeted inspections of U.S. companies that recover human tissues - including tendons, ligaments, bone, and other musculoskeletal tissues. One goal 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.
153 major human tissue recovery firms were inspected 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.
The task force report also made several recommendations on how to enhance FDA's tissue safety activities.
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
- Enhanced adverse reaction reporting and analysis
- Regulations and guidance
- Science of tissue safety
Source: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01650.html
