Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation: The Next Hurdle in Device Recycling

JACC. Clinical Electrophysiology
Thomas C CrawfordKim A Eagle

Abstract

This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. A cleaning and sterilization protocol was developed that includes washing CIEDs in an enzymatic detergent, screw cap and set screw replacement, brushing, inspection, and sterilization in ethylene oxide. Validation testing was performed to assure compliance with accepted standards. With cleaning, the total mean bioburden for each of 3 batches of 10 randomly chosen devices was reduced from 754 to 10.1 colony-forming units. After sterilization with ethylene oxide, with 3 half-cycle and 3 full-cycle processes, none of the 90 biological indicator testers exhibited growth after 7 days. Through cleaning and sterilization, protein and hemoglobin concentrations were reduced from 99.2 to 1.42 μg/cm2 and from 21.4 to 1.03 μg/cm2, respectively. Mean total organic carbon residual was 1.44 parts per million (range 0.36 to 2.9 parts per million). Endotoxin concentration was not detectable at the threshold of <0.03 endotoxin units/ml or <3...Continue Reading

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Citations

Apr 18, 2018·Pacing and Clinical Electrophysiology : PACE·Stephen C Vlay
Oct 1, 2020·The New England Journal of Medicine·Paul Khairy, UNKNOWN Heart to Heart Investigators
Sep 14, 2018·Nature Reviews. Cardiology·Kevin WunderlyThomas C Crawford
Oct 1, 2020·The New England Journal of Medicine·Bogdan EnacheSorin Pescariu
May 11, 2021·Expert Review of Medical Devices·Eliane Molina PsaltikidisKazuko Uchikawa Graziano
Dec 5, 2021·Pacing and Clinical Electrophysiology : PACE·Iñigo Lorenzo Ruiz

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