In Raliegh, N.C., the Donor Referral Services harvested bone and tissue corpses without taking proper steps. They failed to follow reporting critera and now patients who had spinal surgery implants are upset that they may have received diseased tissue.
DRS donor bone fragments were used in orthopedic and neurosurgery procedures. The DRS bone tissue was used to stimulate new bone around a repaired joint or vertebrae. It is feared that the soft tissues were taken from cadavers without testing. These tissues have many uses. Donor tendons are used to repair torn ligaments, skin grafts are used to repair burns and pressure sores, and cadaver corneas are used for transplants. According to the FDA, the company listed some donors as younger than they were, listed more than one donor who died of cancer as cancer-free, and failed to identify a donor as an intravenous drug user.
This is the second time in the past year that concerns have been raised about the safety of bone and tissue products used in many corrective surgeries.
In the most recent case involving Donor Referral Services, a distributor in July began to recall tissue it had received from the Raleigh company. On Aug. 18, the FDA shut down Donor Referral Services, citing serious deficiencies in its processing, donor screening, and record-keeping. Local hospitals were alerted to the problem. The FDA needs to revisit and tighten their procedures in monitoring bone and tissue collection and processing. (News Story)
