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

OBJECTIVES: This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). BACKGROUND: Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. METHODS: 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. RESULTS: 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 <3.0 endotoxin units/device. Cytotoxicity and intracutaneous reactivity tests met the standards set by the Association for Advancement of Medical Instrumentation and the International Organization for Standardization. CONCLUSIONS: CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10-6.

Feasibility of postmortem device acquisition for potential reuse in underserved nations.

OBJECTIVES: The purpose of the present study was to examine the feasibility and efficacy of a program to acquire devices with adequate battery life from crematories and funeral homes for potential reutilization in underserved nations. BACKGROUND: There exists a great health-care disparity between the industrialized world and underserved nations--specifically in the frequency of pacemaker implantation. METHODS: Flyers were mailed to all 1057 members of the Michigan Funeral Directors Association providing information to download a consent-for-explant form and request a postage-paid envelope from www.myheartyourheart.org in order to send explanted devices. Donated devices from funeral homes and crematories nationwide were also collected from World Medical Relief. Adequate battery life was defined as ≥75% or ≥4 years of estimated longevity. RESULTS: A total of 3176 devices (65% pacemakers, 21% implantable cardioverter-defibrillators [ICDs], 12% biventricular ICDs, and 3% biventricular pacemakers) were donated to the reutilization program. Five hundred fifty devices (21%; 95% confidence interval [CI] 19.4-22.6%) were found to have an acceptable battery life for reutilization. Among these devices, 313 were pacemakers (17.9%; 95% CI 16.1-19.8%), 118 were ICDs (17.9%; 95% CI 15.1-21.1%), 112 were biventricular ICDs (30.3%; 95% CI 25.6-35.2%), and 7 were biventricular pacemakers (17.3%; 95% CI 16.0-18.7%). CONCLUSIONS: Approximately 21% of donated devices and 30% of donated biventricular ICDs possess an adequate battery life for potential reuse. Device donations from funeral homes and crematories appear to be a potential resource for device reutilization for those in need in underserved nations.