Mapping Catheters

Diagnostic cardiovascular navigational catheters reprocessed by Innovative-Health are a safe and effective device equivalent to costly options sold by the original equipment manufacturer. Mapping catheters from Biosense Webster integrate with EP technologies to facilitate atrial fibrillation ablation and ablation procedure success through quick EP mapping and accurate cardiac anatomical reconstruction. The Reprocessed mapping catheters are indicated for electrophysiological mapping of cardiac structures. The catheters can be used with mapping features that rapidly and accurately create an electronically generated map throughout the chambers and pulmonary veins, resulting in a reliable high-resolution reconstruction image aiding in the diagnosis and treatment of advanced arrhythmias. Reprocessed Biosense Webster mapping catheters are available through Innovative Health.

Cleaning

Innovative Health’s validated cleaning process has been specifically designed in accordance with industry standard AAMI TIR-30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and FDA recommendations. This standard is considered to be the gold standard in cleaning medical devices. It is also intended to demonstrate consistent and repeatable results with high confidence and reliability.

The fundamentals of the cleaning process include successfully demonstrating 3 critical markers of cleanliness. First, the reprocessing process is designed to show reduction of organic
contamination (e.g. hemoglobin, protein) and chemical residue (e.g. Total Organic Carbon (TOC)). This is achieved by using various manual debris removal techniques, enzymatic cleaners, and Reverse Osmosis (RO) water. Secondly, bioburden, the living matter on the device, is reduced using a controlled method for cleaning and rinsing. Lastly, the physical remnants of the bacteria are removed using physical agitation and scrubbing. Once all 3 of those cleanliness endpoints are met, the device is in compliance with industry standards.

Testing

Packaging Performance: testing includes visual inspection (pre and post peel), dye penetration, and seal strength. Dimensional and Visual Inspection verify that the reprocessing steps used to clean and sterilize the device did not damage the external surfaces and there was no significant impact to the device dimensional specifications

Location Sensor Testing: the purpose of this test is to evaluate the sensitivity of the reprocessed device’s location sensors compared to OM device tolerance

Dynamic/Static Electrical testing: the purpose of this test is to determine if an electrical path can be established between the electrodes on the catheter’s distal tip and the connector

Tip Buckling Force: the purpose of this test is to measure the force required to buckle the catheter when the tip is advanced straight on to a flat surface (heart wall)
Tip Deflection Force: the purpose of this test is to measure the force exerted by the catheter tip on a flat surface under full deflection in each direction and plane

Simulated Use: the purpose of this test is to challenge the device prior to component joint strength testing by subjecting the device to the rigors of worst case clinical use conditions within a torturous anatomical pathway

Torque Testing: the purpose of this test is to ensure the device components and material transition joints were not compromised by the reprocessing and simulated use conditioning

Catheter Electrode and Joint Leak Test: the purpose of this test is to challenge the device to ensure the electrode sealant and shaft joints on the distal end of the catheter were not negatively impacted by reprocessing and simulated use conditioning

Tensile Testing: the purpose of this test is to ensure the device components and material transition joints were not compromised by the reprocessing and simulated use conditioning

Dielectric Current Leakage Testing: this test was performed per IEC 60601-2-2 by an approved test laboratory. The Dielectric Current Leakage test was designed to evaluate how well the handle and outer shaft of the device contains and insulates from voltage leaks

System Compatibility Testing: the purpose of this test was to verify that the functionality and compatibility of the device with Biosense Webster CARTO 3 System is not affected post reprocessing

Inspection

Physical, mechanical and electrical testing is performed to provide objective evidence that the reprocessed device meets specifications and functions as intended.

The following tests are performed on 100% of the devices during reprocessing:

  • Location Sensor Testing
  • Electrical Testing
  • Visual Inspection
  • Curve Template/Functional (Steering Mechanism) Testing

Reprocessing Mapping Catheters involves the following steps*:

*Some tests are performed during validation activities only.

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Rafal Chudzik, VP of R&D and Operations, discusses the DECANAV Diagnostic EP Catheter


IFUs