Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were published between 8 and 12 September 2025, addressing safety concerns related to medical devices. These notices are issued when manufacturers identify risks associated with their products that may impact patient safety or device performance. Professionals handling medical devices must examine these alerts promptly to ensure compliance and protect public health.
What changed?
Between 8 and 12 September 2025, regulatory authorities received reports of multiple Field Safety Notices issued by medical device manufacturers. Each FSN outlines specific risks, instructions for use, or corrective actions that healthcare providers and users must implement. These notices are critical for maintaining device effectiveness and reducing patient harm, especially where vulnerabilities or non-compliance issues emerge.
Which devices are affected?
The affected devices include varied categories—implantable devices, diagnostic tools, and treatment systems. Manufacturers have identified issues potentially arising from malfunction, wear-and-tear exceeding expected endurance, inaccurate readings, or software configuration errors.
The FSNs specify device names, lots, serial numbers, and model ranges subject to safety concerns. Examples include:
- Cardiovascular implants facing durability risks during extended use.
- Imaging systems where software updates caused inaccurate diagnostics.
- Certain surgical tools flagged for non-conformance with sterilization standards.
Healthcare professionals must refer to the respective FSN for the detailed scope of affected serial or batch numbers.
How should regulatory teams respond?
Regulatory and quality professionals must review the Field Safety Notices for actionable measures. Typical responses include:
- Conducting risk assessments to determine device usage in current workflows.
- Following manufacturer-specified corrective actions, such as device inspection, return for repair, or substitution.
- Communicating with user facilities to educate clinical teams about updated practices or recalls.
- Evaluating continued device suitability against intended performance per MDR Annex XIV standards.
Healthcare organizations should maintain documentation proving compliance with the measures advised by these FSNs.
Frequently Asked Questions (FAQ)
1. What are Field Safety Notices (FSNs)?
FSNs are official communications issued by device manufacturers to alert users of significant safety issues or corrective instructions related to medical devices.
2. Are FSNs mandatory to act upon?
Yes. FSNs are legally binding for manufacturers and healthcare providers. Proper adherence ensures public health protection and compliance with applicable regulations.
3. Where can professionals access FSNs?
FSNs are generally distributed via regulatory authority websites, like the UK Medicines and Healthcare products Regulatory Agency (MHRA), or directly from manufacturers.
4. What happens if FSNs are ignored?
Ignoring FSNs can lead to significant consequences, including device-related injuries, legal action for non-compliance, and reputational damage to facilities.
Conclusion and Actions
The Field Safety Notices published from 8 to 12 September 2025 highlight critical risks tied to medical devices. Clinical, quality, and regulatory teams should prioritize reviewing these notices and implementing corrective actions. Engaging in these activities ensures patient safety, upholds regulatory standards, and avoids operational disruptions.
Professionals are advised to act swiftly, document responses, and ensure internal communication systems propagate changes outlined in FSNs.
Disclaimer
This article comprises informational content intended for professional regulatory and healthcare audiences. It is not legal advice or binding guidance. Consult official notices or legal experts for specific compliance requirements.
Full announcement details
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/field-safety-notices-8-to-12-september-2025