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Hepatitis C Virus Infections From a Contaminated Radiopharmaceutical Used in Myocardial Perfusion Studies
Priti R. Patel, MD, MPH;
A. Kirsten Larson, MPH;
Amanda D. Castel, MD, MPH;
Lilia M. Ganova-Raeva, MS, PhD;
Robert A. Myers, PhD;
Brenda J. Roup, PhD, RN, CIC;
Katherine P. Farrell, MD, MPH;
Leslie Edwards, MHS, BSN, RN;
Omana Nainan, PhD ;
John P. Krick, PhD;
David Blythe, MD, MPH;
Anthony E. Fiore, MD, MPH;
Jeffrey C. Roche, MD, MPH
JAMA. 2006;296:2005-2011.
Context Nuclear pharmacies prepare radiopharmaceutical products for use in common diagnostic procedures, including myocardial perfusion studies. Hepatitis C virus (HCV) transmission has not been reported previously in the setting of nuclear imaging studies.
Objective To investigate an outbreak of acute HCV infection identified among patients who underwent myocardial perfusion studies on October 15, 2004, using an injected radiopharmaceutical.
Design, Setting, and Patients Outbreak investigation including molecular epidemiology and pharmacy site investigation at outpatient cardiology clinics and a nuclear pharmacy in Maryland. Ninety patients who received injections drawn from select radiopharmaceutical vials prepared on October 14-15, 2004, at a single nuclear pharmacy were offered testing for bloodborne pathogens. Pharmacy procedures were reviewed and HCV quasi species analysis was performed.
Main Outcome Measures Hepatitis C virus infection and quasispecies sequence similarity.
Results Sixteen patients with acute HCV infection were identified from 3 separate clinics. All patients received radiopharmaceutical injections drawn from a single pharmacy vial (vial 1). None of the 59 tested patients who received doses from 6 other vials had acute HCV infection. Blood from a potential source patient with HCV and human immunodeficiency virus (HIV) infection was processed for a radiolabeled white blood cell study in the pharmacy 12 hours before vial 1 was prepared. The HCV quasispecies sequences from this potential source patient were nearly identical to those from cases (97.8%-98.5% similarity). No acute HIV infections were identified. Pharmacy practices that could have led to blood cross-contamination included reuse of needles and syringes during dilutions and use of common flow hoods for some steps in the preparation of sterile and blood-derived products.
Conclusions Sixteen persons acquired HCV infection from a blood-contaminated radiopharmaceutical. The source and practices that could have facilitated breaks in aseptic technique were identified at the pharmacy. Nuclear pharmacies that handle biological products should follow appropriate aseptic technique to prevent contamination of sterile radiopharmaceuticals.
Author Affiliations: Office of Workforce and Career Development (Drs Patel and Castel) and Division of Viral Hepatitis, National Center for Infectious Diseases (Drs Ganova-Raeva, Nainan, and Fiore), Centers for Disease Control and Prevention, Atlanta, Ga; Maryland Department of Health and Mental Hygiene, Baltimore (Drs Patel, Castel, Myers, Roup, Krick, Blythe, and Roche and Mss Larson and Edwards); and Anne Arundel County Department of Health, Annapolis, Md (Dr Farrell).
Dr Nainan died September 3, 2005. During her career, she made substantial contributions to the understanding of molecular epidemiology of hepatitis viruses.
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