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http://www.freerepublic.com/forum/a39695df238ac.htm
Company mixes body parts

Excerpt:

INVESTIGATION: Act banned by national tissue bank group.

Florida company plans to mix bone from up to 100 cadavers in products it makes from donated human body parts, a practice banned by most of the nation’s tissue banks because of fears it can spread disease.

The new methods employed by Regeneration Technologies Inc. disregard safety standards adopted 12 years ago by the American Association of Tissue Banks in the wake of an outbreak of deaths in Japan. The methods fall outside the regulatory guidelines of the federal Food and Drug Administration.

The company says it has the technology to combine bone from up to 100 donors simultaneously, but is currently mixing body parts from three to five cadavers in a single batch. The products made from those batches are sold to doctors and hospitals.

“I think the public just assumes there are standards for distribution and handling of tissue,’’ said University of Pennsylvania bioethicist Arthur Caplan. “They’d be shocked to find out how much variation and discretion there is. It’s a bright red flag that has been waving for some time.’’

Caplan said the issue of mixing or pooling tissue points to holes in the regulations, an area he said the federal government needs to review.

The two-year-old firm - which gets bone from Orange County cadavers through a network of tissue bank suppliers - has set out to revolutionize the way body parts are handled. Regeneration Technologies is already the fastest growing maker of products from human parts and is about to sell its stock to the public. It said in federal filings that its “BioCleanse’’ methods are safe, efficient and reliable.

“With BioCleanse, the chance of disease transmission is virtually eliminated,’’ Richard Allen, the company’s chief financial officer said earlier this year. The company refused to answer more questions about the process, citing Securities and Exchange Commission rules about talking to the media right before an initial public offering.

The firm makes specialty pins, screws and dowels from human bone and reported to the SEC that its methods will speed up production at its Florida assembly lines.