ST. LOUIS -- Addressing long-held concerns about whether organ donors have adequate protections, the nation's transplant regulators acted late Monday to require that hospitals thoroughly inform living kidney donors of the risks they face, fully evaluate their medical and psychological suitability and then track their health for two years after donation.
Enactment of the policies by the United Network for Organ Sharing, which manages the transplant system under a federal contract, followed six years of halting development and debate.
Meeting at a St. Louis hotel, the group's board voted to establish uniform minimum standards for a field long regarded as a medical and ethical Wild West. The organ network, whose initial purpose was to oversee donation from people who had just died, has struggled at times to keep pace with rapid developments in donation from the living.
"There is no question that this is a major development in living donor protection," said University of Iowa nephrologist Christie P. Thomas, chairman of the network's living donor committee.
Yet some donor advocates complained that the measures did not go far enough and argued that the organ network, in its mission to encourage transplants, has a conflict of interest when it comes to safeguarding donors.
Three years ago, the network issued some of the same policies as voluntary guidelines, only to have the Department of Health and Human Services insist that they be made mandatory.
Although long-term data on the subject is scarce, few living kidney donors are thought to suffer lasting physical or psychological effects. Kidney donations, known as nephrectomies, are typically done laparoscopically these days through a series of small incisions. The typical patient may spend only a few nights in a hospital and feel largely recovered after several months.
Kidneys are by far the most transplanted organs, and there have been nearly as many living donors as deceased ones over the past decade. What data is available suggest that those with one kidney typically live as long as those with two, and that the risk of a donor dying during the procedure is roughly 3 in 10,000. But kidney transplants, like all surgery, can end in catastrophe.
In May at Montefiore Medical Center in New York City, a 41-year-old mother of three died when her aorta was accidentally cut during surgery to donate a kidney to her brother. In other recent isolated cases, patients have received donor kidneys infected with undetected HIV or hepatitis C.
Less clear are any longer-term effects on donors. Research conducted by the United Network for Organ Sharing shows that of roughly 70,000 people who donated kidneys between late 1999 and early 2011, 27 died within two years of medical causes that may -- or may not -- have been related to donation. For a small number of donors, their remaining kidney failed, and they required dialysis or a transplant.
The number of living donors -- 5,770 in 2011 -- has dropped 10 percent over the past two years, possibly because the struggling economy has made it difficult for prospective donors to take time off from work needed to recuperate. With the national kidney waiting list now stretching past 94,000 people, and thousands on the list dying each year, transplant officials have said they must improve confidence in the system, so more people will donate.
The average age of donors has been rising, posing additional medical risks. And new ethical questions have been raised by the emergence of paired kidney exchanges and transplant chains started by good Samaritans who give an organ to a stranger.
Under the policies approved this week, the organ network will require hospitals to collect medical data, including laboratory test results, on most living donors to study lasting effects. Results must be reported at six months, one year and two years.