Keypads could register numbers twice and lead to overdoses. A leading medical firm has quietly recalled hundreds of human tissue products destined for transplants around the nation that were supplied by a North Carolina body parts broker believed to have a tainted history.
The broker used an unsterile embalming room to carve up dozens of corpses to procure tissue, a Raleigh funeral home director said Tuesday. The U.S. Food and Drug Administration shut down the body broker on Friday, but refuses to say how many people may have received potentially risky tissue.
It is the second scandal in less than a year in the booming tissue transplant industry. Cadaver tissue is used in more than a million transplants each year in such routine operations as back surgery and knee repairs. While such donated tissue does tremendous good, it is also little regulated, a three-month Associated Press investigation found earlier this year.
Improperly processed or poorly tested tissue can lead to infections like hepatitis or AIDS or even death. Last year a scandal unfolded around Biomedical Tissue Services, a New Jersey company accused of using stolen bodies and of shipping nearly 20,000 potentially tainted body parts.
Federal authorities kept the North Carolina episode quiet until late on Friday
Federal authorities kept the North Carolina episode quiet until late last Friday, when the FDA shut down Donor Referral Services of Raleigh, N.C. The FDA said the company, run by Philip Guyett, had “serious deficiencies” in its processing, donor screening and record-keeping.
The government accused him of altering records to overlook such problems as cancer or drug use by the deceased donor.
But on July 6 the tissue provider, AlloSource of Centennial, Colo., began its own recall of about 300 Guyett-provided transplant parts that went to a company it had acquired, an AlloSource spokeswoman said Tuesday.
Guyett, 38, hung up on a reporter trying to reach him for comment on Friday.
The FDA won’t say how many potentially tainted body parts might have made it to hospitals for transplant. But two companies doing business with Guyett told The Associated Press Tuesday that they know of at least 60 bodies cut up and at least 300 body parts that were recalled. And those firms were not the only business associates that Guyett had, they said.
This is something of the same magnitude at least of what we saw with Biomedical Tissue
“This is something of the same magnitude at least of what we saw with Biomedical Tissue,” said former FDA top attorney and tissue safety expert Areta Kupchyk. “Many people could be affected. Even if it’s only 60 donors, that could affect hundreds of people.”
It’s still too early to tell how big the Guyett tissue scandal will be.
FDA spokeswoman Julie Zawisza would not comment on the recall or how many parts it involved.
“In specific instances where information has raised concerns about patient safety, FDA has worked with the firm that distributed the subject tissue to ensure that physicians are notified to inform patients and offer testing,” Zawisza said an e-mail to The Associated Press.
AlloSource began its own recall of tissue from 19 donor bodies provided by Guyett from 2002 to 2004, said Tipton Ford, chief of a company whose tissue transplant business was recently acquired by AlloSource.
But those parts from 19 bodies represent just a fraction of Guyett’s business. Larry Parker, president of Cremation Society of the Carolinas, a Raleigh funeral home, said Guyett paid him $1,000 for each of the roughly 60 donors the funeral home referred. Parker, who began seeking donor cadavers for Guyett in 2004, said he believed other funeral homes also dealt with Guyett.
Tissue must be procured and processed under sterile conditions to avoid spreading infection to recipients
“He did the recovery in our facility, in the embalming room. It is not a sterile facility. It was not built for tissue recovery,” said Parker, adding that he has been working with the FDA since the agency contacted him several weeks ago.
Tissue must be procured and processed under sterile conditions to avoid spreading infection to recipients. An industry group, the American Association of Tissue Banks, has highly detailed standards, but tissue banks are not required to belong, and Guyett and his company did not.
The body broker, Philip Guyett, appears to have a felony conviction from a previous tissue scandal in California.
A Philip Guyett with the same date of birth and other records that match the body broker in Raleigh pleaded no contest to a felony, embezzlement stemming from the willed body program he directed at an osteopathic college in Pomona, Calif., in the late 1990s, said Jane Robison, spokeswoman for the Los Angeles County District Attorney’s office.
In return, two other felony charges were dropped, she said. Guyett had been accused of selling a cadaver to another school and keeping the $1,100 payment. At that time, police raided a warehouse he used and found three freezers containing human heads and hearts.
He was fined and sentenced in April 2000, ordered to perform six months of community service and was given three years’ probation, Robison said.