Ultrasonic Scalpels cut and coagulate tissue simultaneously by using ultrasonic vibrations. These devices are used to cut and coagulate tissue and vessels up to 5mm in size.
Ultrasonic scalpels are used in open and laparoscopic general, plastic, pediatric, gynecologic and urologic surgery.
Reprocessed ultrasonic scalpels are distributed to customers in original equipment manufacturers (OEM) case quantities.
Decontamination and cleaning:
- Accepted scalpels are completely disassembled on proprietary custom fixtures
- All components are subjected to a decontamination and cleaning process that includes the use of enzymatic detergents compatible with device materials
- During decontamination and cleaning, ultrasonic scalpels undergo inspection for damage and non-conforming parts
- Stryker’s acceptable limits are based on AAMI TIR30: A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices
Inspection and performance testing:
- Every ultrasonic scalpel is inspected to verify that parts are free of structural damage and conform to acceptance criteria
- Device shafts are inspected under video magnification and shaft straightness is verified by a drop test into a calibrated cylindrical fixture.
- All blades are inspected to ensure they are free of any microscopic cracks, fissures or damage
- As shafts are reassembled, new Teflon pads are applied.
- All handles are welded ultrasonically to prevent breakage and to maintain alignment for proper jaw activation.
- Devices are connected to transducers and OEM generator to verify proper activation, smooth jaw function, button function and conformance with all device requirements.
Ultrasonic scalpels should be collected in designated 17-gallon collection containers.
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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