FDA Warning: Potential Infections in Human Tissue Used During Surgery
The FDA recently updated a previous warning sent to healthcare professionals regarding human tissues recovered by BioMedical Tissue Services (BTS).
The tissue implanted in other patients included human skin, tendons and bone. BTS recovered this tissue from human donors who may not have met the FDA donor eligibility requirements and who may not have been properly screend for certain infectious diseases. As part of an ongoing investigation, the FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. In this report, the FDA strongly recommends that health care providers inform their patients who received tissue implants from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While the FDA believes the risks from these tissues are low because the tissues were routinely processed using methods to help reduce the risk of infectious disease, the actual infection risk is unknown.
You can read the complete FDA summary, including links to the Public Health Notification and previous advisories, at FDA MedWatch.