Related Experiment Video
Updated: Feb 10, 2026
Fabrication of Fully Solution Processed Inorganic Nanocrystal Photovoltaic Devices
Published on: July 8, 2016
Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation: The Next Hurdle in
Thomas C Crawford1, Craig Allmendinger2, Jay Snell3
1Division of Cardiovascular Medicine, Department of Internal Medicine and Frankel Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan; Project My Heart Your Heart, Ann Arbor, Michigan.
Insights
A new sterilization protocol for cardiac implantable electronic devices (CIEDs) was developed and validated. This method ensures CIED reuse is safe, potentially reducing healthcare disparities globally.
Area of Science:
- Biomedical Engineering
- Infectious Disease Control
- Medical Device Reprocessing
Background:
- Significant disparities exist in access to cardiac implantable electronic devices (CIEDs) between high-income and low- and middle-income countries.
- Reprocessing and reuse of CIEDs present a potential strategy to mitigate these global access inequalities.
Purpose of the Study:
- To develop and validate a reproducible sterilization protocol for cardiac implantable electronic devices (CIEDs).
- To ensure the safety and efficacy of reprocessed CIEDs for clinical application.
Main Methods:
- A multi-step cleaning protocol involving enzymatic detergent, component replacement, brushing, and inspection.
- Sterilization utilizing ethylene oxide (EtO) gas.
- Rigorous validation testing, including biological indicators and chemical residue analysis, to meet international standards.
Main Results:
- Significant reduction in bioburden from 754 to 10.1 CFU per device after cleaning.
- Complete elimination of microbial growth in biological indicators after EtO sterilization (sterility assurance level of 10^-6).
- Substantial reduction in protein and hemoglobin residuals, with undetectable endotoxin levels and successful biocompatibility testing.
Conclusions:
- The developed standardized protocol effectively cleans and sterilizes CIEDs.
- The protocol achieves a 12-log reduction, meeting stringent sterility assurance level requirements for medical devices.
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.
More Related Videos
04:35Author Spotlight: Innovative Methodology for Implanting and Securing Neural Probes in the Rodent Spinal Cord
Published on: July 12, 2024
09:18Feeding Experimentation Device FED: Construction and Validation of an Open-source Device for Measuring Food Intake in Rodents
Published on: February 21, 2017
Related Concept Videos
01:30Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
01:23Mnemonic Devices
Acronyms
Acronyms are created by using the initial letters of a series of words to form a new word or phrase. This approach condenses complex information into a single, memorable entity. For example,...
00:51Non-ohmic Devices
Consider a simple circuit consisting of a battery, a diode, and a resistor. A...
01:29Reliability and Validity
01:30Design Example: Identifying the Locations of Monuments in the Field Using Global Positioning System Device
01:30Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...