Reprocessed products
in the EP lab
EP catheters
EP cables
Intracardiac echocardiography (ICE) catheter
Catheter introducer sheaths
The science of reprocessing in the EP lab
Includes strict, repeatable validation tests required for FDA 510(k) clearance such as:
Identification of EP catheters by individualized serial numbers and unique device identification (UDI) numbers ensures stringent control of the life cycle of each device
Each catheter is soaked and brushed in a pH-neutral enzymatic cleaner
Diagnostic EP catheter electrical tests include: measurement and/or calculation of impedance, resistance, leakage current and handle dielectric strength
Torsion, deflection, 3-point bending, buckling, deflection/flexion fatigue, tensile, connector and simulated use tests to determine mechanical functionality and reliability of reprocessed EP catheters
Integrity of material construction electrode joint seals, and tip curvature are verified against stringent, device-specific specifications
Devices meet all industry standards for packaging and sterilization
Collection efficiency in the EP lab
Collections are customized to fit your hospital’s footprint. Our containers have been methodically designed to ensure we maximize your collections regardless of space and size limitations. The program is built for speed with minimal extra work for hospital staff.
- The staff should place EP catheters and cables, diagnostic ultrasound catheters and catheter introducer sheaths in Stryker’s clear plastic drawers. Just place them in the bin and Stryker will do the rest!
- Our representatives will collect these containers, on a schedule that meets your facilities needs, and ship them to our reprocessing production facility in Phoenix, Arizona.
