Proposed Topic (Most preferred): :
Clinical Safety and Quality Service I (Projects aiming to improve efficiency and effectiveness of care delivery to meet international standards)
Proposed Topic (Second preferred): :
Clinical Safety and Quality Service II (Projects aiming to enhance clinical safety and outcomes, clinical governance / risk management)
Authors (including presenting author) :
LAU HYA(1), WONG KC(2)
Affiliation :
(1)Prosthetic and Orthotic Department, Prince of Wales Hospital, (2)Department of Orthopaedic and Traumatology, Prince of Wales Hospital
Introduction :
In the realm of medical device production using additive manufacturing technology, quality is of utmost important. A comprehensive quality management system (QMS) is indispensable to ensure the highest standards throughout the clinical application process. This is especially true for point-of-care 3D printing, where meticulous documentation, streamlined workflows, and careful material tracking are paramount for patient safety.
Objectives :
NTEC 3D Printing Office has integrated three robust components within the HA network for quality assurance. The task management platform, namely HATeams, meticulously tracks the progress of each case, ensuring visibility and accountability throughout the process. To foster seamless communication, HAChat automatically creates dedicated chat rooms involving the requester and 3D printing team members, facilitating real-time collaboration and knowledge sharing. The Patient Inventory System (PIS), developed in Microsoft Access, meticulously stores job details and material usage for each patient, ensuring traceability and compliance with regulatory requirements.
Methodology :
The coherence of the entire workflow can be achieved with three smart processes.
Initiation: The QMS springs into action with a user's request in HA CMS. This triggers the automatic creation of a dedicated chat room in HAChat, where relevant parties gather and notified to discuss job requirements and surgical planning, enhanced by the seamless sharing of pictures, videos, and 3D model web addresses.
Collaboration and Tracking: HATeams provides a centralized platform for team collaboration, defining working timeframes and facilitating file sharing. Users can access the progress of their cases with appropriate permissions, while case prioritization is expertly managed with the aid of Gantt charts.
Data Storage and Reporting: The PIS serves as a comprehensive repository for all job details and traceable patient data. It empowers users to generate reports on caseloads from different specialties, resource utilization, and printing material usage for each patient, providing valuable insights for continuous improvement.
Result & Outcome :
This meticulously designed QMS aligns with the rigorous requirements of international standards and FDA guidelines for additive manufacturing quality management. Its successful implementation demonstrates the feasibility of in-house medical device production using 3D printing technology, supported by HA's native IT infrastructure so the 3D printing office can deliver the highest quality and standards with the smart solution to ensure optimal patient outcomes and advancing the frontiers of medical innovation.
