Safety of US tissue banks questioned

January 9, 2001

9th January, 2001

Department of Health and Human Services

WESTPORT, CT (Reuters Health) - Many US tissue banks have never been

inspected by federal authorities, leaving tissue recipients potentially

vulnerable to infection with HIV, hepatitis viruses and other pathogens,

according to a new government report. A second report advises that donors

should be better informed about the uses--and profits--made from donated

tissue.

" One in every five tissue banks has never been inspected, " experts at the

Department of Health and Human Services say in a report released Friday.

They note that when such inspections do occur, the US Food and Drug

Administration has found " serious deficiencies in tissue banks' screening

and testing practices. "

Americans are increasingly generous when it comes to tissue and organ

donations. According to the HHS, over 20,000 individuals donated cadaveric

tissue in 1999, representing an increase of over 6000 donors from 1994.

Those donations resulted in over 750,000 separate tissue transplants in

1999.

But the HHS Office of General Inspector notes that only two states, Florida

and New York, currently mandate regular safety inspections of tissue banks.

The FDA has no rules in place for regular re-inspection of tissue banks, and

even the exact " number and location of [the nation's] tissue banks are

unknown, " according to the HHS.

In those banks that were inspected, numerous serious oversights have come to

light. These include:

-- The " routine " storage of tissues for which no records are available to

clarify whether or not the donor was free of various infectious agents.

-- Lack of adequate controls aimed at preventing contamination of tissue

during handling and storage.

-- A test result indicating the presence of hepatitis C " even though others

who had handled the tissue had found negative test results. "

-- " Acceptance of foreign tissue with donor records not translated into

English and without documented medical/social histories. "

Based on these findings, the HHS is recommending that the FDA speed up

issuance of new rules governing the registration and inspection of all US

tissue banks, and " set a realistic, yet aggressive, date by which it would

complete an initial inspection of all tissue banks. "

In the second report, HHS officials say that donors and their families need

more information about how tissue and organs are used--and who profits from

them. They point out that while most donors and their families assume that

donated tissues will be used for " important medical needs, " tissues are

often viewed as a " commodity " and can be used for elective, non-emergency

procedures, including the use of skin for cosmetic surgeries.

" Processed tissue often is marketed and sold like any other medical

product, " the authors of the report note, with many groups involved

operating on a for-profit basis.

" Tissue banks could do a better job of providing basic information to

families, " HHS says, " either at the time they ask them to consent to

donation or in the days following that decision. " They advise that the

tissue banking industry should work together with government agencies,

hospitals, and nonprofit organizations to better inform donors as to the

realities of tissue donation.

January 9, 2001