Vermont Department of Health Following FDA Guidance on Tissue Implant Investigation
DATE: March 17, 2006
Contact: Communication Office
BURLINGTON, VT – The Vermont Department of Health continues to investigate the Federal Drug Administration’s national recall of tissue donor samples distributed to Vermont health care providers. The recalled samples were not properly screened for communicable disease.
Two Vermont hospitals, Fletcher Allen Health Care and Northwestern Medical Center, received tissue that originated from Biomedical Tissue Services, Ltd, a tissue recovery supplier in New Jersey under investigation by federal prosecutors.
No adverse reactions to donor tissue have been reported. Northwest Medical Center has contacted all patients who received tissue from their hospital and offered screening.
FAHC is contacting patients who received tissue from this company and will be offering screenings.
Testing is recommended by the FDA for all patients impacted as a precautionary measure.
“Though risk of infection to these patients is low, Vermont hospitals and health care providers are acting quickly and professionally in the best interest of their patients to identify anyone who might have been impacted,” said Vermont Health Department Deputy Commissioner Sharon Moffatt, RN, MSN. “The FDA has recommended that health care providers inform their patients of this potential risk and offer to provide access to appropriate infectious disease testing.
“We will stay in close contact with the FDA and follow their investigation,” Moffatt said. “We are working in close cooperation with health care providers and hospitals to make sure that anyone who may have received the tissue gets the necessary information and screening.”
Federal prosecutors allege that Biomedical Services, Inc. inadequately screened donors for communicable disease agents and diseases. The risk of infection is low because before being implanted, the tissue routinely receives additional processing using methods that help reduce the risk of infectious disease.
Donor testing guidelines issued by the FDA involves testing samples of the donor’s blood to minimize the risk of communicable disease transmission. Donors are tested for HIV, hepatitis B virus, hepatitis C virus and syphilis. A donor is only eligible if the results of donor screening and donor testing indicates no communicable diseases or communicable disease risks.
FDA requires tissue establishments to investigate any adverse reaction involving a communicable disease when there is a reasonable possibility that the transplanted tissue distributed by them caused the reaction.
The Vermont Department of Health is also obtaining information on any transplants that may have taken place in the outpatient or dental setting. As more information is available, the Health Department will provide updates and post information on its website, Healthvermont.gov.
- FDA Update of Information about BioMedical Tissue Services - March 2, 2006