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FDA to increase inspections to ensure safety of human transplant tissues

Infection Control Monitor, June 15, 2007

The U.S. Food and Drug Administration (FDA) concluded this week that there are no significant industry-wide problems in the recovery of human tissues used for transplantations.  However, the agency will increase inspections of the more than 2,000 active U.S. companies that recover human cells and tissues as recommended by its Human Tissue Task Force, an intra-agency group assembled last August to evaluate the effectiveness of the FDA's tissue regulations.

The FDA released the task force report on June 12. The FDA said it intends to conduct 484 inspections in fiscal year 2007, with the task force recommending the agency inspect all tissue establishments performing manufacturing steps considered to represent the highest potential risk for disease transmission every two years, and inspect all others every three years. Companies recover human tissues including tendons, ligaments, bone, and other musculoskeletal tissues.

The task force was formed after the FDA ordered two companies to cease manufacturing in 2006 after it found they were not following procedures intended to prevent infectious disease transmission. The task force recommended targeted inspections or a "blitz" of U.S. companies and investigators inspected 153 major human tissue recovery companies from October 2006 through March 2007. While inspectors found some deviations from the regulations, no major inaccuracies or deficiencies were found that put tissue recipients at risk, the FDA said in a press release.

The task force also recommended:

• Increased education and outreach
• Enhanced adverse reaction reporting and analysis
• Further regulations and guidance
• Further study of the science of tissue safety

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