This article is more than 5 years old. Information may no longer be current.
CDC reports on investigation of post-tissue recall infectious disease testing
Officials urged patients who received the recalled tissue to get tested for four infectious diseases.
The Centers for Disease Control and Prevention has recommended that every patient who received human tissues recovered by Biomedical Tissue Services Ltd. undergo testing for HIV, the hepatitis B and C viruses, and syphilis.
From June 2002 to October 2005, Biomedical Tissue Services (BTS), Fort Lee, N.J., recovered and distributed to five U.S. tissue processors human allograft tissue from donors whose eligibility to donate tissue was uncertain, officials said. BTS and all five tissue processors voluntarily recalled the tissue in question last fall, although some of it had already been implanted in an unknown number of patients in the United States and other countries.
The reason for the recall stemmed from the fact that some tissue came from “human donors who may not have met FDA eligibility requirements and who may not have been properly screened for certain infectious diseases,� an earlier FDA press release said. According to media reports, a BTS official and others have since been charged with and pleaded not guilty to body stealing, unlawful dissection and forgery.
In January, FDA ordered BTS to cease manufacturing and retain all human cells, tissue, and cellular and tissue-based products (HCT/Ps).
Testing detailed
Based on its investigation, officials at the Centers for Disease Control and Prevention (CDC) said in Morbidity and Mortality Weekly Report (MMWR) that the protocol for testing patients who received the recalled tissue will vary depending on how much time elapsed from when the patient received the questionable allograft tissue and the time of the recall.
The need for testing became more urgent after FDA officials determined in March that some blood samples used to screen BTS donors for diseases did not correspond to the individuals whose tissue had been donated. At that time, the FDA and CDC urged anyone who received BTS tissue during the time period in question and had it implanted for more than six months undergo several tests, including HIV antibody, antibody to hepatitis B core antigen and antibody to hepatitis C virus tests.
For patients with BTS allografts in place less than six months, CDC officials said similar tests should be performed and repeated at six months postop. Negative test results would likely indicate a very low risk that any diseases contracted came from the BTS tissue.
According to the MMWR, health professionals who are unsure whether their patient(s) received BTS tissue should contact the tissue distributor or the health care facility that provided it. Although some lawsuits have been filed in this case related to possible exposure to infectious diseases, CDC and FDA officials say that the risk of disease transmission from the BTS tissue remains generally low.
“Some positive results would be expected in any U.S. population tested; the prevalence of current or past infection with hepatic iron concentration, hepatitis C virus, and hepatitis B virus is approximately 0.5%, 1.8%, and 4.9%, respectively,� CDC officials wrote in the MMWR.
Studies from 1988 and 2005 documented instances where HIV and hepatitis C virus had been transmitted to organ and tissue recipients, though it is rare.
In 2005, the American Academy of Orthopaedic Surgeons issued a patient safety member alert that instructed members to notify FDA should any of their patients who received BTS tissue contract an infectious disease, an approach typically taken when any patient develops an infectious disease.
For more information:
- CDC. Investigation into recalled human tissue for transplantation — United States, 2005-2006. MMWR. 2006; 55:564-566.