The public health crisis created by medical malpractice and the improper and illegal harvesting of human tissue continues to grow. U.S. health officials ordered yet another human tissue collection company to shut down on Friday, saying lapses in screening and record keeping put recipients of the donated body parts at risk of infection.
Donor Referral Services of Raleigh, North Carolina, and its owner, Philip Guyett, must immediately stop recovery and shipment of cells and tissues from human donors, the Food and Drug Administration said in a letter to the company.
FDA inspectors found the company did not follow procedures meant to make sure body parts from cadavers are free from infectious diseases such as HIV or hepatitis. In part, the company failed to review relevant medical records to check for risk factors for infectious disease, the FDA said.
The problems were "so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health,"
The regulations require that establishments process HCT/Ps in a way that does not cause contamination or cross-contamination and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P. … All tissue products initially recovered from human donors by DRS have been recalled. The agency will continue to investigate DRS' activities, monitor the recalls to account for all distributed tissue and work cooperatively with tissue processors and appropriate federal, state and local authorities. FDA will take further actions as needed.
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