FDA Issues Regulations Governing Tissue Banks After Years of Delay

[Guest guest]

CDC HIV/STD/TB Prevention News Update

Friday, November 19, 2004

" FDA Issues Regulations Governing Tissue Banks After Years of Delay "

Associated Press (11.19.04):: Meckler

On Thursday, the Food and Drug Administration issued new safety

standards for tissue banks that process donated skin, ligaments and bones

for transplant. The regulations, which will take effect in May, aim to

prevent infection and disease in an industry that has gone unregulated

during a period of explosive growth. So far this year, doctors have

performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for

the industry. In January, FDA required all tissue banks to register with the

agency and allow regular inspections. In May, FDA said tissue donors, like

blood donors, must be screened for diseases including HIV, hepatitis B and

C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow

disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need

for regulations, with investigators reporting widespread problems: operators

running multiple tests on recovered tissue in hope a second test would find

the material healthy when the first did not; mishandling cadavers after

removing bone and skin; and tissue banks pooling donors' material despite

the medical risk of one person's tissue contaminating another's.

" This rule is a major step toward ensuring that tissue contaminated

with life-threatening diseases is not transplanted into unsuspecting

patients, " Sen. (R-Maine), the panel's chairperson, said in a

statement.

[Guest guest]

CDC HIV/STD/TB Prevention News Update

Friday, November 19, 2004

" FDA Issues Regulations Governing Tissue Banks After Years of Delay "

Associated Press (11.19.04):: Meckler

On Thursday, the Food and Drug Administration issued new safety

standards for tissue banks that process donated skin, ligaments and bones

for transplant. The regulations, which will take effect in May, aim to

prevent infection and disease in an industry that has gone unregulated

during a period of explosive growth. So far this year, doctors have

performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for

the industry. In January, FDA required all tissue banks to register with the

agency and allow regular inspections. In May, FDA said tissue donors, like

blood donors, must be screened for diseases including HIV, hepatitis B and

C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow

disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need

for regulations, with investigators reporting widespread problems: operators

running multiple tests on recovered tissue in hope a second test would find

the material healthy when the first did not; mishandling cadavers after

removing bone and skin; and tissue banks pooling donors' material despite

the medical risk of one person's tissue contaminating another's.

" This rule is a major step toward ensuring that tissue contaminated

with life-threatening diseases is not transplanted into unsuspecting

patients, " Sen. (R-Maine), the panel's chairperson, said in a

statement.

[Guest guest]

CDC HIV/STD/TB Prevention News Update

Friday, November 19, 2004

" FDA Issues Regulations Governing Tissue Banks After Years of Delay "

Associated Press (11.19.04):: Meckler

On Thursday, the Food and Drug Administration issued new safety

standards for tissue banks that process donated skin, ligaments and bones

for transplant. The regulations, which will take effect in May, aim to

prevent infection and disease in an industry that has gone unregulated

during a period of explosive growth. So far this year, doctors have

performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for

the industry. In January, FDA required all tissue banks to register with the

agency and allow regular inspections. In May, FDA said tissue donors, like

blood donors, must be screened for diseases including HIV, hepatitis B and

C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow

disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need

for regulations, with investigators reporting widespread problems: operators

running multiple tests on recovered tissue in hope a second test would find

the material healthy when the first did not; mishandling cadavers after

removing bone and skin; and tissue banks pooling donors' material despite

the medical risk of one person's tissue contaminating another's.

" This rule is a major step toward ensuring that tissue contaminated

with life-threatening diseases is not transplanted into unsuspecting

patients, " Sen. (R-Maine), the panel's chairperson, said in a

statement.

[Guest guest]

CDC HIV/STD/TB Prevention News Update

Friday, November 19, 2004

" FDA Issues Regulations Governing Tissue Banks After Years of Delay "

Associated Press (11.19.04):: Meckler

On Thursday, the Food and Drug Administration issued new safety

standards for tissue banks that process donated skin, ligaments and bones

for transplant. The regulations, which will take effect in May, aim to

prevent infection and disease in an industry that has gone unregulated

during a period of explosive growth. So far this year, doctors have

performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for

the industry. In January, FDA required all tissue banks to register with the

agency and allow regular inspections. In May, FDA said tissue donors, like

blood donors, must be screened for diseases including HIV, hepatitis B and

C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow

disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need

for regulations, with investigators reporting widespread problems: operators

running multiple tests on recovered tissue in hope a second test would find

the material healthy when the first did not; mishandling cadavers after

removing bone and skin; and tissue banks pooling donors' material despite

the medical risk of one person's tissue contaminating another's.

" This rule is a major step toward ensuring that tissue contaminated

with life-threatening diseases is not transplanted into unsuspecting

patients, " Sen. (R-Maine), the panel's chairperson, said in a

statement.