Macomb County man worried about infected human tissue
Capital News Service
LANSING – When a person has major surgery, the foremost thought is recovery, not an added risk of infectious diseases.
But Tom Atkins, of New Baltimore in Macomb County, has a cause for concern.
Atkins had surgery for a herniated disc on May 3, 2005, at St. Joseph Mercy Hospital in Clinton Township.
On Nov. 9, he received a letter from the hospital explaining that he may have not been notified about recalled human tissue that was placed inside his body. The letter went on to urge him to seek free consultation and testing immediately.
“I was very shocked,” said Atkins. “My first thought was that it was very silly. They couldn’t recall the bone that they put inside my body. Then I became very bothered that there was a risk of infection. It had never entered my mind before and I was very upset.”
The recalled tissue came from a company called BioMedical Tissue Services Ltd. of Ft. Lee, N.J.
The U.S. Food and Drug Administration first became aware of a problem with the company in October 2005. During inspection, the federal agency uncovered violations of the regulations governing donor screening and record-keeping practices.
The FDA found death certificates that didn’t match those obtained from the states where the deaths occurred. Important information such as cause, place and time of death and the identity of relatives was altered.
It also found several cases where blood samples didn’t come from the same donor as the tissue samples, so the results of the testing obtained from the blood sample may not have reflected the status of the donor.
The FDA ordered BioMedical to stop manufacturing and distributing the tissue on Jan. 31, 2006.
The investigation of the company is ongoing.
“There were concerns that donor eligibility requirements may not have been followed,” said Paul Richards, a public affairs specialist for the FDA.
“Ultimately, donors may not have been properly screened for certain infectious diseases. If the donors weren’t screened, then that certainly creates concern from the public health perspective in relation to the recipients of the saline tissue products,” he said.
Because of recent cases like Atkins’, the FDA formed a Human Tissue Task Force in August made up of senior officials to strengthen the agency’s risk-based system for regulating human cells and tissue.
“We want to take a look at the regulatory framework that is currently in place and ultimately determine what we can do different and, if appropriate, what additional proofing can be made to enhance that existing framework,” said Richards.
Atkins is awaiting infectious disease testing results before deciding whether to proceed with a lawsuit.
“I’ve talked with some attorneys about this,” he said. “But I have not taken any legal action yet. I’m waiting to get the testing back.”
Suzanne Schut, director of marketing and public relations for St. Joseph Mercy Hospital said that she knew nothing about any St. Joseph patients affected by the recall.
Atkins said hospital risk manager Denise Winiarski signed his letter. She was was unable to be reached for comment.
a nanovirus that sickened patrons at a Lansing-area Applebee’s restaurant.
The emergency action plan was produced by the Detroit Department of Health and Wellness Promotion, Macomb County Health Department, state Agriculture Department, Michigan Restaurant Association and the Oakland County Health Department.
“Creating the plan was a matter of making sure that we are all on a level playing field when it comes to dealing with emergencies,” said Gary White, division director of environmental health services for Macomb County.
“There was an inconsistency in parts of the state with the way people handled things. And that’s not saying that they were not effective, just that everybody does things a little bit differently,” he said.
All food establishments must comply with the plan under their operating licenses as soon as the documents are formally distributed, said White.
The action plan is available now in English, Spanish, Chinese and Arabic on the Agriculture Department’s Web site.
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