FDA May Increase Cornea Donor Screening After Some Donations Discovered to be HIV-Positive

The FDA has requested that eye tissue banks recall more transplanted corneas following reports that some donors had tested positive for HIV or hepatitis, the Wall Street Journal reports. Cornea "recalls" are unlike other consumer product recalls in that they "almost never result in removing the cornea." Instead, eye banks are required to inform transplant surgeons of a donor's HIV-positive status, and the surgeons then have the option to inform patients. Cornea recalls have increased in recent years, with 31 recalls involving 119 donated corneas prompted between 1998 and 2001, "substantially higher" than recalls occurring in the previous three years.

Reasons for Concern
To date, there have been no cases of cornea recipients contracting HIV from an HIV-positive donor, and before current screening practices were implemented, "only a few" cornea recipients contracted diseases from donors, the "risks warrant testing of donors for HIV and hepatitis," the Journal reports. Different blood tests are performed for donations of eye tissue, skin and bone, and tests on skin and bone tissue typical are more extensive and take longer than the tests for eye tissue. As a result, corneal tissue may be implanted before it is known whether the donor had HIV. For instances in which the tests on skin and bone later reveal the donor may have had HIV, hepatitis or other diseases, the eye bank is then prompted to send out recall notices. However, some eye banks say the recalls are "unnecessary, and "[m]any" surgeons feel the later tests for skin and bone are "poor indicators" of a donor's health status and "result in recalls that unnecessarily alarm patients with perfectly healthy corneas." The FDA is now studying whether to expand testing for a number of donor tissues, including corneas, while the Eye Bank Association of America wants the FDA to require all tissue harvesters to use the same set of tests for all tissues to reduce the number of recalls. Barbara Crow, chair of the Eye Bank Association, said, "We're always concerned anytime we have something like this happen. There has been an increased number of unanticipated (blood test results) that have been a problem for us" (Carroll, Wall Street Journal, 6/11).