US steps up inspections of human tissue industry

June 13, 2007|Seth Borenstein and Marilynn Marchione, Associated Press

WASHINGTON -- Federal regulators say they have dramatically boosted inspections of companies that harvest cadaver body parts for transplant, acknowledging weaknesses in government oversight of the multibillion-dollar human tissue industry that last year was rocked by scandal.

The US Food and Drug Administration said the inspections turned up no serious problems. But an internal task force report urges agency officials to set up a method for tracking body parts from cadaver to transplant patient -- a system that currently doesn't go that far. The targeted companies remove bones, tendons, cartilage, heart valves, and other nonorgan parts from corpses. These tissues are used in roughly 1 million medical procedures in the United States each year, many of them for routine knee and back surgeries.

If improperly screened and processed, these tissues can cause serious viruses , including HIV or hepatitis in transplant recipients, or even death. Fears about the regulation of the industry arose after scandals involving two companies and the recall of thousands of tissues, many of which were already transplanted.

A three-month investigation by the Associated Press last year detailed many gaps in oversight by the FDA. The task force recommends steps to address some of those problems, but operators of accredited tissue banks and industry specialists say the report doesn't go far enough to clean up the problem.

The FDA says it is reviewing the recommendations, which include a tracking system that ends with the recipient of the transplanted tissue. The current tracking requirement ends with the doctor or hospital that does the transplant. As a result, it has been difficult to warn patients who may have received improperly processed cadaver parts. Also suggested by the task force is a need for the FDA to hire a microbiologist to answer questions about what sterilization or treatment processes are best.

Dr. Celia Witten, who oversees the FDA's cellular tissue and gene therapies office, said, "Today's report finds no significant industrywide problem in the recovery of human tissues."

Some in the industry disagree, and weaknesses came to light through recent scandals, the biggest involving Biomedical Tissue Services of New Jersey. Its operator faces trial along with a former New York funeral home director on charges that they stole bodies and unlawfully dissected them.