Surgeons warned patients who recently received tissue grafts at local hospitals to get tested for communicable diseases because their implants may not have been previously screened.
Staff at two Evanston Northwestern Healthcare hospitals called the 22 at-risk patients last week and urged them to take HIV, Hepatitis C and syphilis tests. The system includes Evanston, Highland Park and Glenbrook hospitals. Most of the patients received their grafts between 2004 and 2005, spokesman Art Massa said.
The questionable tissue originates from a New York funeral home, where directors allegedly harvested body parts for Biomedical Tissue Services, a human-tissue recovery firm in Fort Lee, N.J. New York state authorities are investigating whether Biomedical sent unscreened tissue to companies that sell the parts to hospitals.
“When we get the parts, we have no way in our hospitals to test this again,” Massa said.
The Federal Food and Drug Administration ordered Biomedical to cease its manufacturing operations Friday after an investigation “uncovered serious violations of the regulations governing donor screening and record keeping,” according to a press release. The company voluntarily recalled its unused human tissue last October.
Grafts replace damaged tissue and come from areas of the body such as bones, tendons and veins. When recovered, stored and treated properly, tissue and bone grafts are effectively used in bypass surgeries and spinal fusions. Massa said the at-risk patients have so far shown no signs of contamination.
“Of all the 22 patients, not one has reported a medical problem,” he said.
The doctors suggest testing as a precaution, Massa said. The tissue samples used at Evanston Hospital and across the country may not have been screened using proper medical standards.
The mishap is a rarity in the tissue donation field, where the screening process can take up to six months, said Kim McCullough, a spokeswoman for organ and tissue donation organization Gift of Hope.
“We’ve never heard of this kind of thing happening,” she said. “This entire story points to the need for an informed consent for tissue donation. It’s very sad that there are patients that might be harmed by this.”
Medical staff at Evanston Hospital plan to send letters calling for at-risk patients to be tested for any health problems that arise from the grafts. The patients can go to any of the three hospitals in Evanston Northwestern Healthcare system to receive free testing.
“The focus now is on the patient and bringing them peace of mind,” Massa said.
Reach Vincent Bradshaw at [email protected].
