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Chicago :FDA imposes Ban on Biomedical Tissue Services

by Medindia Content Team on February 5, 2006 at 4:12 PM
Chicago :FDA imposes Ban on Biomedical Tissue Services

Chicago : Friday turned out to be unlucky for Biomedical Tissue Services Ltd a company that is concerned with human tissues collection from cadavers. The Food and Drug Administration administered a ban after finding apparent flaws in the donor policies that might pose a threat to transplant patients, making them vulnerable to disease. Though, none of the patients have been diagnosed with any form of infectious disease, yet many hospitals informed patients about the risks from transplanted tissues , while offering an investigation for infectious diseases. The main violations enumerated by the FDA against the company, was mainly not seeking permission from the donor when he/she was alive or consent from the families. The screening of the donors for illnesses was also inappropriate, which means many of the tissues could be ineligible for a transplant, with the risk always lurking.

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According to FDA official, Margaret Glavin, close examination of practices at BTS, revealed significant anomalies in the manufacturing processes which would only magnify and pose a risk to public health. What was perhaps even more disconcerting, was the forging of death certificates by BTS with fictitious age and cause of death of 8 donors in the least, investigated and verified against official death certificates. According to the Chicago tribune, 10 Chicago-area hospitals have notified 62 patients about impending risks.

Subsequent to the ban imposed by the FDA, three patients who have undergone transplants with the tissue from BTS, were informed about the potential risk. Five recipient companies of biomedical tissues have ensured that the tissues are not transplanted into patients, soon after the FDA sought to investigate the matter in October. According to Kim McCullough of the Gift of Hope Organ and Tissue Donor Network., regulation has been extremely stringent in recent years to prevent any threat of contamination to transplant patients, ensuring they lead a normal life.

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