Manual Endoscope Processing System
Steris BlackBox™ - Product Development from A to Z
Starting situation
Manual reprocessing of endoscopes is an important part of hospital infection control throughout the world. It involves a series of steps undertaken by trained technicians, from pre-cleaning at the point of use, thorough washing, and disinfection, to final drying and storage.
STERIS, a global leader in decontamination and infection control, identified the need for a compact, cost-effective device to standardize and guide the user through the steps of manual reprocessing of endoscopes between patients. The objective was to enhance the efficiency and safety of endoscope reprocessing while ensuring compliance with regulatory requirements. STERIS approached IMT Information Management Technology AG to design and engineer a cost effective device, which later would be marketed under the brand BlackBox™.
Project objectives
The primary objectives of the BlackBox™ project were:
- To help the busy hospital staff to perform the right reprocessing steps for endoscopes every time by providing workflow instructions on intuitive touch screen interface.
- To enable Leak Testing, Washing, Rinsing, Disinfecting and Purging of the endoscopes with the appropriate processing liquids - detergent, water or disinfectant – and air for purging.
- To integrate a printer for recording of reprocessing steps for traceability and regulatory compliance.
Technical implementation
Mechanical design
The mechanical design of the BlackBox™ focused on creating a compact and durable housing. Custom touchscreen interfaces and USB printer integration were key components of the design. High-quality materials were used to ensure the device could withstand the rigors of manual reprocessing and exposure to various chemicals. The design also included four easy-access ports for straightforward connection of the endoscope during manual processing. Special attention was paid to connectivity with various connectors for different models of flexible endoscopes. The device incorporated a leak and blockage tester as well as two flushing pumps - one designed for standard and one for the very small raiser bridge channel of a flexible endoscope.
Electronics
IMT designed and integrated various electronic components – touch screen, power supply unit, electrical boards to control the pumps, communication interfaces - of the BlackBox™. Rigorous testing was conducted to ensure the device's reliability and safety and EMC (Electromagnetic Compatibility) requirements of EN 61326.
Software
IMT developed the BlackBox™ software according to IEC 62304 and IEC 62366 to provide clear, step-by-step instructions for reprocessing procedure. The software was based on Windows CE platform and TFT with Touch standard components. The development was done using IMT’s proprietary frameworks and various programming languages to ensure robustness and efficiency. The software allowed for individual reprocessing steps to be selected and programmed according to either the manufacturer guidelines or local procedures.
System Acceptance Testing (SATs)
Extensive system acceptance testing was performed to validate the functionality and performance of the BlackBox™. These tests ensured that all components worked together seamlessly, and that the device met all specified requirements.
Production of first units (0-series)
A zero series production run of seven units was completed to refine the manufacturing process and identify any potential issues before full-scale production. This phase allowed for final adjustments and ensured that the production process was efficient and reliable.
CE approval
The BlackBox™ was developed in compliance with MDD regulations for Class IIB device, ensuring it met all necessary safety and performance standards. IMT supported STERIS through the entire CE certification process, ensuring that the device was ready for market launch. Clinical evaluation was undertaken by STERIS.
Transfer to Production
IMT provided extensive support to STERIS during the transfer to full-scale production. This included documentation, training, and ongoing assistance to ensure a smooth transition and maintain high-quality production standards.
Results
The development project of the BlackBox™ took 1 year and was a significant success. The device met all the specified requirements, especially in regards to target production costs and exceeded expectations in terms of performance and reliability. It was fully compliant with medical standards and ready for market launch. The BlackBox™ provides a standardized, efficient, and safe method for manual reprocessing of endoscopes, ensuring regulatory compliance and enhancing patient safety.
For more information on how IMT can assist in the development of cutting-edge medical devices, feel free to contact us.
