The tracking requirement
ends with the doctor
or hospital doing
the transplant
(click to enlarge)
Does the FDA Have the Backbone to Stop Body Part Harvesting?
June 13, 2007
Federal regulators say that they have drastically improved inspections of companies that are known to harvest cadaver body parts for transplant, after a scandal last year that led to the recall of thousands of surgically transferred tissues.
The Food and Drug Administration said that the inspections did not have any substantial problems, but the regulators strongly suggest the creation of a system for tracking the body parts from cadaver to transplant patient. Unfortunately, the current system falls short of working.
These companies remove bones, cartilage, heart valves, tendons, and other non-organ parts from corpses used in one million medical procedures in the United States each year. If the tissues are not screened and processed correctly, they can cause serious infections or even death in patients.
Because of the government's failure to adequately supervise the tissue industry, a three-month investigation by the Associated Press that took place last year was needed to reveal what the FDA missed. The FDA will now review the tracking requirement, but they cannot guarantee its legality, making it difficult to warn recipients of infectious body parts.
"They have the legal authority, they just need the backbone to do it," said former FDA attorney Areta Kupchyk, an expert in the tissue industry and one of many anxious critics.