In a recent regulatory update crucial for healthcare professionals, the Medicines and Healthcare products Regulatory Agency (MHRA) published Field Safety Notices (FSNs) issued from 22 to 26 September 2025. These notices serve as mandatory communications to inform operators and users about safety-related actions for registered medical devices.
The release impacts clinical, quality, and regulatory teams tasked with ensuring compliance and patient safety. Prompt attention is required to evaluate and act upon these notices to mitigate potential risks in device performance or operation.
What are FSNs?
Field Safety Notices (FSNs) are official alerts issued by medical device manufacturers to notify users of any identified safety risks or required corrective actions for devices already in use. These notices ensure compliance with post-market surveillance obligations under EU Medical Device Regulation (MDR) and UK regulations.
FSNs may address diverse concerns such as labeling errors, software flaws, hardware malfunctions, or any other safety issue that could compromise device performance or patient outcomes.
Key Findings in the Notices
The FSNs issued between 22 and 26 September 2025 highlight several significant concerns across a range of devices:
- Implantable devices: Issues regarding sterilization processes and potential contamination risks.
- Diagnostic equipment: Software irregularities identified in imaging systems, potentially leading to inaccurate results.
- Monitoring devices: Battery malfunction warnings for portable monitors reported by various manufacturers.
Healthcare providers using these devices must thoroughly review the details in each FSN, compare them against their deployed inventory, and implement the manufacturer-recommended corrective actions.
Who Is Affected?
Stakeholders impacted by these notices include:
- Clinical teams operating or handling alerted medical devices.
- Hospital administrators responsible for equipment safety management.
- Regulatory compliance officers ensuring adherence to safety standards.
Manufacturers and distributors may also be required to provide additional support or information to healthcare facilities implementing corrective actions.
FAQ
1. What should healthcare providers do upon receiving an FSN?
Healthcare providers must immediately follow the actions stated in the FSN, which may include removing affected devices, communicating risks to clinical staff, or performing corrective actions.
2. How are FSNs distributed?
FSNs are distributed through official channels, including national regulatory agencies, registered manufacturers, and direct communication to healthcare facilities.
3. What happens if an FSN is not followed?
Non-compliance with FSNs can lead to regulatory investigations, increased patient safety risks, and potential legal liability for healthcare institutions.
Conclusion and Actions
FSNs issued from 22 to 26 September 2025 include vital safety updates for healthcare facilities and regulators. Every stakeholder must prioritize a review of these notices to confirm compliance and safeguard patient outcomes.
Immediate actions include reviewing FSNs against the current device inventory, communicating risks to staff, and implementing the outlined safety measures. Timely responses are key to maintaining regulatory compliance and minimizing patient safety risks.
Disclaimer
This content is intended for informational purposes only and does not constitute legal advice. Readers should consult qualified professionals for regulatory or legal guidance specific to their situation.
Detailed Announcement
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/field-safety-notices-22-to-26-september-2025