FDA orders firm to stop tissue recovery
- From: indigoace@xxxxxxxxxxxxxxxx (Indigo Ace)
- Date: Sat, 04 Feb 2006 17:38:01 GMT
From the Chicago Tribune--
FDA orders firm to stop tissue recovery
By Jeremy Manier
Tribune staff reporter
Published February 4, 2006
Federal officials Friday ordered a New Jersey firm linked to a
national tissue looting scandal to stop recovering and distributing
tissue, citing numerous violations that included unsanitary recovery
practices and phony death records that changed donors' ages and causes
of death.
Tissue from Biomedical Tissue Services was used in at least 10
hospitals and 62 patients in the Chicago area, in addition to many
other centers around the country.
The findings, released Friday by the U.S. Food and Drug Administration
after an investigation that began in October, show that Biomedical's
records contained inauthentic death certificates that reported the
wrong age or cause of death for at least eight donors. In some cases
the paperwork concealed infections or other conditions that might have
disqualified the donors.
Biomedical also failed to refrigerate some tissue donors within 12
hours of death to reduce the chance of disease transmission, as
recommended by federal guidelines, the report states. In one case the
company waited nearly two days to refrigerate the corpse, according to
the FDA report.
FDA associate commissioner Margaret Glavin said in a statement that
the investigation of Biomedical "revealed serious and widespread
deficiencies in their manufacturing practices that provide the agency
reason to believe that allowing the firm to manufacture would present
a danger to public health by increasing the risk of communicable
disease transmission."
The report did not address allegations that Biomedical obtained tissue
from corpses without obtaining appropriate consent. FDA spokesman
Stephen King said that the agency's investigation is ongoing and that
he cannot comment on the allegation of tissue looting.
Attorney Mario Gallucci, who represents Biomedical Chief Executive
Officer Michael Mastromarino, said that he has requested a hearing
with the agency to contest the allegations in the report. Until now,
he said, his client had continued to recover tissue from corpses and
ship it to processors.
Examples of wrongdoing in the FDA report included one donor who was
listed in the Biomedical death certificate as a 63-year-old who died
of a heart attack. The donor was 69 and died of multi-organ failure
related to liver disease, the report states. Another 63-year-old
listed as a heart attack victim was 79 and died from pneumonia.
The report lists two cases in which Biomedical waited too long to
refrigerate donors or recover organs. Gallucci responded that FDA
inspectors had cleared Mastromarino's operation in the past and were
acting now because news reports have created an air of controversy.
"I think it's a little disingenuous on their part," Gallucci said. He
said Biomedical followed all relevant regulations. He blamed any
problems on errors by funeral home directors Mastromarino worked with.
King, the FDA spokesman, said the case marks the first time the FDA
has ordered a tissue recovery company to stop operating, under new
agency regulations completed in May.
----------
jmanier;@tribune.com
Copyright © 2006, Chicago Tribune
http://www.chicagotribune.com/news/specials/chi-0602040125feb04,1,3984859.story?coll=chi-news-hed
--
Anne
indigoace at goodsol period com
http://www.goodsol.com/cats/
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