With increasing healthcare demand, environmental concerns and waste management in healthcare, particularly in the operating room (OR), are significant issues. Disposable surgical energy devices, like vessel sealers, gain popularity in veterinary healthcare, but reusing them is officially forbidden by law and presents challenges. Objective: This research aims to clinically validate reprocessing the Ethicon HARMONIC® HD 1000i for safe reuse in veterinary healthcare. The study assesses the feasibility of using readily available disinfection methods and evaluates the device’s functionality and safety. The research’s scope is limited to a case study (functional analysis) on the Ethicon HARMONIC® HD 1000i. Methods: A comprehensive device analysis was performed using Hot Spot Mapping and Disassembly Map methods, followed by mechanical stability testing during sterilization conditions. A design update was proposed for easier disassembly. The functionality of 2x new, 2x reprocessed and 2x redesigned Ethicon HARMONIC® HD 1000i’s after reprocessing (disinfection, disassembly, reassembly, sterilization) was evaluated in a bench-top study. Tissue transsections on 120 cm pork fillets (6-11mm thickness) per device and pinch force measured with newly developed sensor (40 movements/device) were performed. Furthermore, 2 burst pressure measurements per device on frozen and embalmed artery sections were performed in collaboration with Amsterdam Skills Centre for Health Science. Results: In the disassembly analysis, 42 operations were needed, involving 40 parts and 10 steps with 6 tools. The disassembly time was 429 seconds (07:09 minutes) total. In tissue transsection, the new and reprocessed devices performed similarly, with mean task times ranging from 62.3 to 66.8 seconds. The redesigned devices had slower task times (averaging 196.1 seconds and 104.7 seconds) resulting in lower marching speeds (0.5-1.0 mm/s compared to 1.5-1.6 mm/s for new and reprocessed devices). In pinch force measurements the new devices performed best with average pinch forces of 19.1 N and 20.2 N. The reprocessed devices had slightly lower performance (16.8 N and 16.7 N), while the redesigned devices performed the worst with pinch forces of 5.6 N and 8.8 N, representing a significant drop in performance compared to the new devices. The burst pressure measurement tests showed that none of the devices were able to effectively seal the arteries, resulting in no pressure buildup. Discussion: Overall, reprocessed devices performed similarly to new devices in tissue transsection, showing the effectiveness of reprocessing. Achieved marching speeds by reprocessed and redesigned were considerable given tissue thickness differences, highlighting reprocessing’s potential to extend device lifespan. New devices had 15% higher pinch force than reprocessed, while redesigned had 63% lower force due to a weakened casing. Strengthening redesign and adding new jaw ends could improve modularity and power transmission. Burst pressure tests revealed all Ethicon Harmonic devices (new, reprocessed, redesigned) couldn’t effectively seal
arteries, likely due to frozen artery characteristics and tissue alterations from embalming. Conclusion: This study emphasized the potential of modular medical devices with improved disassembly time, demonstrating that a modular design approach combined with reprocessing strategies holds promise to ensure a more sustainable healthcare system. This research is a collaboration between the Technical University of Delft, Johnson & Johnson Netherlands and GreenCycl.
Keywords: ETHICON, harmonic, ENSEAL, Ligasure, ster- ilisation, reprocessing, medical instruments, healthcare, veterinary, redesign, modular, burst pressure, tissue transection, pinch force