Donor Screening

At Restoreflow Allografts, we work personally with selected independently federally-registered tissue bank recovery partners to ensure tissue viability and enhance patient safety.

In order to minimize the risk of transmitted diseases and infection through allograft transplantation, Tissue Banks must adhere to strict donor guidelines, including all regulatory requirements provided by the Food and Drug Administration (FDA), now including nucleic acid testing (NAT)and the American Association of Tissue Banks (AATB). While these regulatory criteria establish a strong foundation to prevent disease transmission and infection, Registered Tissue Banks may implement additional operational and recovery protocol based on their own processing methods and tissue availability to even further reduce the risks of transmitted diseases and infection and to increase the viability of recovered tissue.

At Restoreflow, we work closely with all our recovery partners to implement our own strict protocol that focus on using the safest tissue recovery techniques and sterile equipment to ensure the viability of every allograft, and to minimize any bioburden contamination. Before any tissue is recovered from a donor, all Registered Tissue Banks must receive the appropriate donor consent forms and conduct a full comprehensive Donor Screening Process in accordance with AATB standards, FDA Regulations, and Restoreflow protocol where donors are screened/tested for various high risk behaviors and potential transmittable diseases.

These federally-mandated Donor Screening Processes include: a complete physical examination and review of all donor medical records, an interview with the family and next-of-kin, full disclosure of the medical examiner/coroner’s report including the autopsy report (when available), and any laboratory, radiology, and pathology reports are examined to rule out any possibility of diseases such as HIV, hepatitis B, hepatitis C, and syphilis. If any of these tests return positive, the donor tissue will not be accepted for use.

To provide an additional layer of safety and reduction of disease transmission, we utilize an advanced technology known as the ISBT 128 Donor Coding/Labeling system, providing enhanced identification, information transference, and labeling of all our donated tissue.