Violations Of Basic Norms - Causes Closure Of Tissue Bank In The United States

• The US Food and Drug Administration has ordered a company collecting human tissues to cease operations, citing "deficiencies" in its donor policies that may have exposed transplant patients to disease. According to an FDA Spokes person three patients who received donated tissue traced to BTS at the University of Chicago Hospitals were notified of the potential problem, but had not yet decided whether to be tested for disease.
  
  FDA cited not receiving consent from the donor, while alive or dead, or his or her family after expiry. Moreover the donor’s tissues were not screened properly making it ineligible for transplant. FDA and experts in the field said there was still an unknown risk.
  
  Five vendor companies that received tissues from Biomedical Tissues have recalled material not transplanted into patients.
  
  Hospitals are not taking chances and the notified dozens of patients about the risks from the transplanted tissues and offered screening for infectious diseases such as HIV/AIDS, hepatitis, and syphilis.
  
  Regulations have been tightened in recent years to prevent contamination as roughly 800,000 Americans receive Tissue transplantation a year. They receive donor organs and tissues ranging from heart valves to corneas to bones for spinal fusion surgery, and the last thing any one wants is an infectious tissue or organs.