AEGiS-WSJ: Eye Banks' Rising Recalls Prompt Calls For More Rigorous Screening of Donors

Eye Banks' Rising Recalls Prompt Calls For More Rigorous Screening of Donors

Wall Street Journal - June 11, 2001
Jill Carroll, Staff Reporter of THE WALL STREET JOURNAL

WASHINGTON -- Eye banks are reporting more so-called recalls of transplanted corneas because donors tested positive for hepatitis or the virus that causes AIDS.

At the same time, the Food and Drug Administration has warned an eye bank about inadequate procedures for screening corpses for diseases.

The FDA said that while there were only a few cases of a cornea recipient contracting a disease before current screening procedures were adopted in the early 1980s, the risks warrant testing of donors for HIV and hepatitis. The agency said that no recipient has been infected with HIV from a cornea transplant even in instances where the donor had the virus.

Unlike a consumer-product recall, cornea recalls almost never result in removing the cornea. Rather, eye banks inform surgeons, who then have a choice of whether to inform patients. More than 45,000 corneal transplants -- considered one of the safest types of transplants -- are performed world-wide each year.

Late last month, the FDA sent a warning letter to Indiana Lion's Eye Bank Inc. in Indianapolis, for releasing corneas before ensuring that the donor was free of HIV or hepatitis. The eye bank said a technician didn't check the back of one corpse during the health exam because the person was too big to turn easily.

Although the blood tests came back negative, the agency said a thorough examination -- including the back -- is mandatory. In this case, the eye bank had to notify the surgeons who transplanted the corneas.

Eye banks contend that many of the growing number of cornea recalls are unnecessary. According to FDA data from enforcement reports, there were 31 recalls involving 119 donated corneas between 1998 and 2001. That was substantially higher than the three recalls involving about 35 corneas between 1995 and 1997.

Eye banks said the rise in recalls stems from a law that took effect in 1998 that increased the donor pool by requiring more hospitals to report deaths to transplant organizations.

For the eye banks, the problem is the way blood tests are performed on corpses. Separate tests are usually performed for donations of eyes, skin and bone. Often, blood work for donations of skin and bone is more extensive than the FDA currently requires, and comes in later than the blood tests performed by eye banks. If eye banks learn that those later tests show the donor may have had HIV, hepatitis or other diseases, the eye bank must send out recall notices.

Many surgeons believe the later tests are poor indicators of a donor's health and result in recalls that unnecessarily alarm patients with perfectly healthy corneas. For the past two years, however, the FDA has been studying whether to expand testing for a number of transplanted body parts, including corneas.

"We're always concerned anytime we have something like this happen," said Barbara Crow, chairman of the board of the Eye Bank Association of America, regarding the rise in cornea recalls. "There has been an increased number of unanticipated [blood-test results] that have been a problem for us."

To reduce the recalls, the eye-bank group wants all tissue harvesters to use one set of tests.

Write to Jill Carroll at jill.carroll@wsj.com1

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