Medical Devices Vigilance Program Pilot – TGA Initiative

1. Purpose and Objectives

The Medical Devices Vigilance Program Pilot is an initiative by the Therapeutic Goods Administration (TGA) to strengthen post-market surveillance of medical devices in Australia. The program encourages voluntary reporting of device-related incidents, near misses, and safety concerns directly from healthcare professionals, hospitals, and other users. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

The primary objectives are to:

• Improve early detection of emerging safety issues
• Capture incidents that may not be reported through mandatory channels
• Enhance the quality and timeliness of safety data available to the TGA
• Support more proactive risk management and regulatory action

2. Scope and Eligibility

The pilot targets a range of medical devices, particularly those used in clinical settings where users can observe performance issues or adverse events. Reports may include:

• Device malfunctions or failures
• Adverse events (including those not meeting mandatory reporting thresholds)
• Near misses or use errors
• Concerns about design, labelling, or instructions for use

Healthcare professionals, clinical departments, biomedical engineers, hospital procurement teams, and other device users are encouraged to participate. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

3. Reporting Mechanism

Reports are submitted voluntarily through a dedicated online form on the TGA website or via email. The reporting process is designed to be straightforward and time-efficient, requiring key details such as:

• Device identification (brand, model, ARTG number if known)
• Description of the incident or concern
• Patient outcome (if applicable)
• Reporter contact information (optional for anonymous reporting)

No patient-identifiable information is required unless it is essential to understanding the incident. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

4. How Reports Are Handled

Submitted reports are triaged by the TGA's vigilance team. Depending on the severity and nature of the issue:

• High-priority incidents are fast-tracked for assessment
• Trends or clusters are analyzed for potential safety signals
• Sponsors/manufacturers may be contacted for further investigation or corrective action
• De-identified data contributes to broader post-market surveillance activities

Reporters may receive acknowledgment and, where appropriate, updates on actions taken. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

5. Benefits of Participation

Participation in the pilot provides several benefits:

• Contributes directly to improved device safety in Australia
• Helps identify issues that may affect multiple patients or facilities
• Supports evidence-based regulatory decisions
• Enhances collaboration between healthcare providers and the regulator

The program also complements mandatory reporting obligations placed on sponsors and manufacturers.

6. Pilot Status and Evaluation

The vigilance program is operating as a pilot to test the feasibility, effectiveness, and user experience of voluntary user reporting. Feedback from participants is being collected to inform potential permanent implementation or further refinements. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

The TGA continues to monitor the program's impact on signal detection and response times.

7. How to Get Involved

Healthcare professionals and facilities interested in participating can access the reporting form and guidance materials directly on the TGA website. The TGA encourages broad participation to maximize the program's value in protecting patient safety. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-devices-vigilance-program-pilot

This pilot represents an important step in building a more comprehensive and responsive medical device vigilance system in Australia.