Overview of Medical Equipment Management Regulations

The Taipei Veterans General Hospital has established regulations for managing medical equipment to ensure the safe use and efficient management of medical devices. These regulations cover the entire lifecycle of the equipment, from procurement, installation, maintenance, to disposal, using the PDCA management cycle to reduce risks.

Key Contents

1. Management Objectives

   • Ensure the safety and quality stability of clinical use of medical equipment.
   • Guide operators on the correct use of equipment and simple troubleshooting.
   • Maintain and repair equipment according to risk levels.
   • Reduce maintenance costs and improve the quality of medical services through integrated management.

2. Scope

   • Applicable to all medical equipment within the hospital. Equipment from other units used in the hospital must also comply with these regulations.

3. Responsibilities

   • The Medical Engineering Department is responsible for overall management, with secondary units including the Smart Healthcare R&D Division, Precision Medicine Development Division, and Equipment and Instrument Management Division.

4. Training

   • New staff must be guided by senior colleagues and complete capability assessments.
   • Clinical operators must complete relevant training and keep records.

5. Operational Procedures

   • New medical equipment must go through procurement procedures and asset registration.
   • User units must perform first-level maintenance according to the original manufacturer's manual. Second and third-level maintenance should be performed by professional engineers or manufacturers.

6. Handling of Abnormal Events

   • Follow the abnormal management guidelines to handle equipment recalls and emergencies.
   • Hold regular meetings each year to review and improve abnormal events.

7. Others

   • Conduct annual review and updates of the regulations.

This comprehensive approach ensures that medical equipment is safely and effectively managed, reducing potential risks and enhancing the quality of healthcare services.