No Serious Problems In US Human Tissue Recovery Industry Says FDA

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Main Category: Transplants / Organ Donations
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 13 Jun 2007 - 0:00 PDT

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The US Food and Drug Administration (FDA) reported this week that following an industrywide inspection it found no serious problems in the recovery of human tissue for transplantation, commonly referred to as the body parts industry.

The report was written by the FDA's Human Tissue Task Force (HTTF). The HTTF was set up in August 2006 to keep an eye on how well the industry follows the FDA's tissue regulations that were introduced in May 2005.

Providing human tissue for transplant is a growing and increasingly complex industry that recovers tendons, ligaments, bone, corneas, heart valves and other tissues from human cadavers, or from unwanted byproducts of surgical and other procedures (umbilical cord for instance). The tissue should be screened for diseases like HIV, hepatitis, and West Nile virus.

Although the risk of disease transmission is low, if it should happen the impact is potentially wide; up to 100 recipients could receive tissue from one donor, and approximately 1.5 million musculoskeletal tissue transplants are performed annually in the US said the FDA.

Investigators from the FDA' Office of Regulatory Affairs (ORA) carried out a "blitz" inspection of 153 major human tissue recovery companies between last October and March this year. They found some minor irregularities but none that would put transplant recipients at risk.

The blitz inspection followed last year's discovery that two companies were breaching regulations and were potentially putting recipients at risk. The FDA ordered they be closed down.

The HTTF's report makes several recommendations for tightening up compliance to the new regulations, help the agency better understand what is going on, and develop guides and plan future inspections.

Over 2,000 organizations active in the human tissue recovery industry are registered with the FDA, and the agency plans to inspect nearly 25 per cent of them in fiscal year 2007. The HTTF recommends the high risk ones be inspected every 2 years and the rest every 3 years.

Dr Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research (CBER) said that:

"The results, particularly of the blitz, show that FDA's new tissue regulations help keep human tissue safe."

"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," he explained.

Margaret O'K. Glavin, ORA Associate Commissioner said:

"The recommendations of the task force will help us provide greater assurance of tissue safety. 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."

The HTTF report also suggested that the FDA should:

• Sponsor and promote education on tissue processing and microbiology for the tissue industry, surgeons and academics.
• Explore public and private partnerships and develop best practice for reducing disease transmission risk.
• Enhance investigation, analysis and reporting of adverse reactions by the FDA's multidisciplinary Tissue Safety Team that was set up in 2004.
• Continue to develop guidance on the regulations. The FDA issued a guide September last year emphasizing who is responsible for various aspects of tissue safety in the supply chain, including contractors. The FDA will also issue a Current Good Tissue Practices guide.
• Look at ways to improve speed and reliability of tissue tracking all along the human tissue supply chain from donor to recipient.
• Learn more about the science of tissue safety, particularly the microbiology of the infectious diseases that can be transmitted via recovered human tissue.

Click here to see the full HTTF report.

Click here for more information on Human Tissue from the FDA's CBER web page.

Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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