Requesting Authorization for Urgent Changes to Medical Devices

Requesting Authorization for Urgent Changes to Medical Devices

For urgent issues affecting medical devices, changes may be necessary outside of standard procedures to ensure patient safety and device functionality.

When to Request an Urgent Change

Submit a request in high-priority situations where:

• A critical device malfunction affects patient care
• A security risk is identified, requiring immediate action
• A temporary fix is needed to maintain device operation

Urgent changes should be exceptional. Regular updates should follow the standard change management process.

Procedure for Requesting an Urgent Change

Follow these steps:

1. Submit a high-priority ticket detailing:
   • The issue or threat
   • Necessity for urgent change
   • Details of proposed change (plan, testing, rollback)
2. The Change Manager will review swiftly
3. Upon approval, schedule and execute the change as instructed
4. The Emergency Change Board will review the action plan

Final approval is required from the Medical Director and key personnel based on risk assessment.

Guidelines for Implementing Urgent Changes

Ensure adherence to these rules:

• Assemble a qualified team for swift execution
• Have vetted rollback plans ready
• Communicate downtime and impacts clearly
• Follow best practices for testing and peer review
• Document actions comprehensively for audit purposes

Urgent changes must be well-documented to comply with regulatory standards. Do not hesitate to request an urgent change when necessary to maintain patient safety and device operation.