Vermont Department of Health Update on Tissue Implant Investigation
DATE: March 20, 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.
In addition to the two hospitals identified on Friday as having received tissue that originated from Biomedical Tissue Services, Ltd, a tissue recovery supplier in New Jersey under investigation by federal prosecutors, the department has learned that one sample also went to Copley Hospital.
Copley is identifying and contacting the patient to offer screening. As a precautionary measure, the screening is recommended by the FDA for all patients impacted by this recall.
On Friday, the Health Department said in a press release that it was also obtaining information from distributors on any tissues that was used in an outpatient or dental setting. Based on that, the department has identified three oral surgery practices that received tissue. The 35 effected patients have been notified and are being referred for screening.
“Though risk of infection to these patients is low, Vermont hospitals and health care providers working closely with us in this investigation and taking immediate steps to notify any patients who have been impacted,” said Deputy Commissioner of Health Sharon Moffatt.
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,” she said.
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
- FDA Provides Information on Investigation into Human Tissue forTransplantation - October 26, 2005