Viruses adsorbed on musculoskeletal allografts are inactivated by terminal ethylene oxide disinfection

Abstract

In 1987 it was anticipated that unsterilized tissues would transmit virus diseases such as hepatitis and HIV-1 from infected donors so a freeze-drying process for musculoskeletal tissue was developed to include terminal ethylene oxide (EO) exposure for 14 h. We found no studies of EO efficacy when viruses were associated with human allografts so we studied the antiviral effect of terminal EO disinfection using all but the final freeze-drying phase of this clinical processing protocol (CPP). Specifically we looked at EO inactivation of HIV-1, a human hepatitis B surrogate and test viruses known to be highly resistant to disinfecting agents, including irradiation. Freeze-drying, ordinarily required after EO disinfection and part of the CPP, was not done. Suspensions of HIV-1, Bovine viral diarrhea, Reovirus type 3, Duck hepatitis B, Poliomyelitis and Canine parvovirus were adsorbed on glass, demineralized bone powder, and preprocessed strips of femoral cortex, iliac wedges, cancellous blocks and patellar bone-tendon-bone preparations and subjected to EO disinfection. Test viruses were inactivated at the end of 7 h of EO disinfection, providing a safety factor in the CPP of at least 100%.Because allografts can transmit viruses, terminal EO disinfection should provide safer musculoskeletal allografts than nondisinfected tissues or those irradiated with a standard irradiation dose. New spontaneously appearing viruses would probably be inactivated with this terminal EO disinfection but they and viral bioweapons will require individual validation to assure viral inactivation.

Development of a bacteriophage model system to investigate virus inactivation methods used in the treatment of bone allografts

“…One possible explanation for this is that the bone utilised in this study was prepared according to a protocol that had been demonstrated to more efficiently remove fatty marrow components, (Lomas et al 2000), possibly rendering it less likely to absorb ETO. It is unlikely that the discrepancies seen between the results reported here with bacteriophage and those of Kearney et al are due to any protection afforded to the virus by bone, as Moore et al (2004) have shown that ETO could inactivate a range of pathogenic viruses or surrogates absorbed onto the surface of bone allografts or inorganic materials with equivalent efficiency.…”

Disinfection of human musculoskeletal allografts in tissue banking: a systematic review

“…One study was also able to eliminate all viruses from contaminated bone samples using an ethylene oxide treatment, reducing the logarithmic bioburden by >5.3 fold (Moore et al 2004). Heating of samples at 82.5 °C reduce the logarithmic viral bioburden by > 4.26 fold (Pruss et al 2003b).…”

“…Ethylene oxide (214 mg/dl) exposure at 25 °C for 4 h was able to completely eliminate the contamination rate to 0 % (Moore et al 2004). Although tissue viability was not monitored at 25 °C, increasing the treatment temperature to 37 °C was also effective in decontamination and did not induce cytokine induction when aeration was excluded from the protocol (Lomas et al 2001).…”

Vreden Russian Research Institute of Traumatology and Orthopedics

“…потенциальную опасность для пациента составляют остаточные продукты Оэ, такие как этиленхлоргидрин, образующийся в результате реакции с хлоридом, и этиленгликоль, образо-ванный в результате реакций с водой. Оба веще-ства способны вызывать гемолиз и воспаление, а также обладают токсическими, мутагенными и канцерогенными свойствами [42,44].…”