Patients fearful over suspect tissue

Triangle hospitals not affected so far

Revelations that a now-closed Raleigh company might have harvested bone and tissue from corpses that did not meet strict donor criteria have struck fear into patients who worry that they received diseased or tainted tissue.

"It's just creepy," said Debra Carlton of Holly Springs, who had spinal surgery that included a bone graft at Duke Hospital in April. "It's like something out of a Stephen King book."

Carlton, 44, felt sick with dread after she read news reports about the Food and Drug Administration's decision last week to close Donor Referral Services of Raleigh. According to the FDA, the company listed some donors as younger than they were and listed more than one donor who died of cancer as cancer-free.

The agency also said that Donor Referral Services failed to identify one donor as a user of intravenous drugs. Eligibility criteria followed by most organ and tissue recovery organizations would exclude such a person because of the risk of spreading diseases.

So far there is no evidence that bone and tissues collected by Donor Referral Services ended up at any Triangle hospitals, including Rex, WakeMed, UNC Hospitals or any of the Duke University Health System's three facilities. Spokespeople for Duke, Rex, and UNC said their suppliers have confirmed that they did not purchase tissues from Donor Referral Services.

WakeMed is checking with its vendors but has not heard back from all of them, said spokeswoman Debbie Laughery.

A research group at Duke's School of Medicine purchased one human brain from the company in April 2005 but did not continue as a client after that, said Chris DiFrancesco, a Duke spokesman.

Still, Carlton didn't relax until her surgeon assured her that only bone scraped from her own vertebrae had been used for her graft, which was needed to encourage new bone to form around the two 6-inch titanium rods now anchored to her vertebrae.

Donor bone fragments are frequently used in orthopedic and neurosurgery procedures to stimulate new bone around a repaired joint or vertebra. And soft tissues taken from cadavers have a wealth of 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 transplant.

It is the second time in the past 12 months that concerns have been raised about the safety of bone and tissue products used in many corrective surgeries. Earlier this year, a New Jersey company, Biomedical Tissue Services, was forced to close under suspicions that it harvested body parts from more than 1,000 corpses without obtaining consent from families and then failed to appropriately screen for disease and infection.

A swift response

Word of possible problems with the company's wares reached hospitals in October, when BTS began a voluntary recall of tissues it sold through many major medical supply vendors. Every hospital in the Triangle had purchased from someone on the list, prompting systemwide searches to find both suspect implants on shelves and patients who had already received them.

Hospitals used lot and serial numbers provided by their vendors to pull products made from BTS tissues from supply shelves. They also had staff comb through the medical records of patients who had surgeries using bone or tissue grafts to find those who had received implants made from BTS tissue.

Duke, which in 2005 began using software to monitor product alerts and recalls, learned of the recall about 6 p.m. the day it was issued. Health system staff tapped into the supply system and within hours located all affected products -- including some that would have been used in surgeries the next morning, said Dr. Michael Cuffe, the health system's vice chancellor for health affairs.

All together, Rex, WakeMed, UNC and Duke identified 56 patients who received BTS-collected tissues between early 2004 and September 2005. All of them were notified that they had received tissue that might be tainted and offered tests for HIV, syphilis and hepatitis A and C. None of the patients tested contracted a disease, according to the hospitals.

In the most recent case involving Donor Referral Services, a distributor in July began to recall tissue it had gotten 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. That was when local hospitals were alerted to the problem.