Regulation of Human Tissue Banks Hearing Before the Subcommittee On Regulation
Regulation of Human Tissue Banks Hearing Before the Subcommittee On Regulation
Business Opportunities United States Congress House Committee On Small
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Excellent clinical outcome of skin, bone and heart valves is clear within the literature. Due to our changing environment with the increase of transmissible diseases not only AIDS but more predominantly Hepatitis, regulation must be developed to protect the public safety. New types of tissue should be required to demonstrate not only their safety but their effectiveness. Preenactment status of tissues currently in use is a mandatory part of this legislation. The major thrust of this legislation... has always been patient safety and should continue along those noble lines. 139 Cost associated with implementation and onaoinq regulation Cost and regulations seem to go hand in hand. I personally believe that we can not associate cost with appropriate regulation. The cost to the public is too great if we do not appropriately regulate the tissue banking community. The Oregon Tissue Bank has felt the costs of regulating human heart valves under the Good Manufacturing Practices of dass III medical devices.
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