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 (HARH23/36/45 indicated for use up to 7mm).
Ultrasonic scalpels are used in open and laparoscopic general, plastic, pediatric, urologic and gynecologic procedures, and are exposed to orthopedic structures (such as spine and joint space).
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 100% verified
- All blades are inspected and tested to ensure they are free of any microscopic cracks, fissures or damage
- New Teflon pads are applied to each device
- All handles are glued and pressed together to prevent breakage and to maintain alignment for proper jaw activation
- Devices are connected to OEM generators 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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