Diagnostic Electrophysiology (EP) Catheters
Reprocessed EP catheters are a safe and effective equivalent to costly options sold by the original equipment manufacturer.
Reprocessed diagnostic EP catheters are designed to transmit electrical impulses for endocardial stimulation and recording.
The device is comprised of a flexible polymer shaft with platinum/iridium electrodes on the distal tip that are attached to conductors contained within the shaft. The shaft is attached to an electrical connector at the proximal end that allows the device to be connected via an accessory cable to the console that generates and receives the electrical impulses.
For steerable EP catheters, the shaft is attached to a proximal handle with a uni-directional steering mechanism that allows the user to control the curve/deflection of the distal tip. An electrical connector at the proximal end of the handle allows the device to be connected to the console via an accessory cable that generates and receives the electrical impulses.
Upon receipt of the clinically used medical devices, the reprocessing of these devices starts with the critical step of cleaning. The cleaning process is designed to remove soil and chemical residue. The removal of organic and inorganic contamination is necessary to ensure that terminal sterilization is effective. In addition, the chemicals (cleaning agents) utilized to clean the devices must also be removed once the cleaning process has been completed.
Innovative Health’s cleaning process has been specifically designed and tested to provide consistent and repeatable results. The first step in reprocessing is the removal of contamination. This cleaning step specifically targets visual contamination and the following end markers: hemoglobin, protein and Total Organic Carbon (TOC). This is achieved utilizing manual debris removal techniques, enzymatic cleaners, and Reverse Osmosis (RO) water.
The second step of the cleaning process is designed to remove the chemical residues (cleaning agents). This is achieved utilizing RO water with specific rinse times and flow rates.
Testing and Inspection
Physical, mechanical and electrical testing is performed to provide objective evidence that the reprocessed device meets specifications and functions as intended. All testing is designed with the clinical procedure in mind. Testing methods mimic clinical conditions and are used to challenge the device under worst case conditions.
The following tests are performed on all EP catheters:
- Visual inspections – Inspection of device under magnification to assess defects and identify any imperfections to the product.
- Curve template/tip deflection testing – Device curves and deflection patterns are verified using controlled and validated curve templates and compared to new original manufacturer devices.
- Auto ID Verification (as applicable) – Devices are tested to ensure the compatibility with all current EP consoles that are found in EP labs. The proprietary software verifies that information on a device meets the verification activities needed by the original manufacturer’s console.
- Static and dynamic continuity testing – Electrical testing is completed during full deflection to represent clinical use. The electrical properties are assessed during a full range of motion and under worst case conditions during the movement of the tip and shaft of the device.
Reprocessing diagnostic EP catheters involves the following steps*:
*Some tests are performed during validation activities only.
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