ECG leads provide connection between patient applied electrodes and various telemetry and bedside monitoring units allowing for non-invasive monitoring of electrical impulses generated by the heart over a period of time resulting in an electrocardiogram.
Decontamination and cleaning:
- Reprocessed ECG leads and cables are initially inspected for visible damage.
- Devices found with exposed or damaged circuitry are rejected immediately.
- Every ECG lead then undergoes pre-processing through a multi-step process that involves:
- Visual inspection and removal of any debris on the connectors.
- Visual inspection and manual removal of residual contamination.
Performance testing and inspection:
- Every ECG lead and cable is functionally tested for continuity to ensure substantial equivalence to the original equipment manufacturer’s device.
- Functional testing development and validation has been performed according to ANSI/AAMI EC53- 1995/(R)2008 and IEC 60601-1:2005 standards.
- Every device is visually inspected at multiple stages to ensure non-conforming products are rejected.
- Devices are inspected for debris, contamination and for overall device integrity.
- Routine quality control audits are completed to ensure process integrity.
- Reports are provided to senior management for operating line performance and control.
- Additionally, finished product performance attributes including cleaning end points are routinely subjected to random sampling and testing.
Savings Direct is a program that enables healthcare organizations to manage their reprocessing programs internally, and is designed to support their efforts to reduce supply costs and environmental impact. Participating organizations drive collection and shipment of single-use devices (SUDs) to potentially maximize their savings.
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