Used in electrophysiology (EP) and Cardiac Catheterization (CCL) labs and procedures indicated for procedural visualization aid, designed to specifically provide imaging using an ultrasound transducer.
Decontamination and cleaning:
- Accepted sheaths undergo prolonged soaking, cleaning and rinsing in pH-neutral enzymatic cleansers and sanitizers that are compatible with all device materials
- Catheters are prepared for sterilization by removing bacterial endotoxins and bioburden using a final rinse process
- Numerous validation tests are performed to evaluate the catheters’ ability to withstand stress during introduction or withdrawal, bioburden removal and biocompatibility
- Devices are tested in M-mode and Doppler for significant differences between reprocessed and original catheters
- Inline testing of the transducer to evaluate acoustic signal strength
Inspection, reassembly and performance testing:
- Components are thoroughly inspected under magnification to evaluate each device component for cleanliness and surface defects to ensure non-conforming products are rejected
- Devices undergo controlled performance testing including bi-directional steering range and curve profile assessment and hemostasis valve integrity testing
- Device transducers are evaluated for sensitivity (volts p-p), capacitance (pF), pulse width (ns), center frequency (MHz) and fractional bandwidth (%) against strict acceptance criteria
- Devices are tested against tolerance specifications for tip deflection
- Location sensor coils and associated circuitry is tested in a simulated clinical environment to identify any potential errors
After use, wipe down the catheter with clean, wet gauze to remove excess debris. Then, gently place the device in the Stryker provided DUC collection restraint.
The platinum plus program is a value-added service designed to promote sustainability and financial value for EP labs. This one-stop service provides supply cost reductions through the recycling of select catheters and their removal from the waste stream.
- All EP labs are eligible for this program
- Precious metals are recycled, such as platinum from catheters, in exchange for a payment based on platinum’s market value
- Use funds from the program to pay for future purchases, thereby lowering supply costs