Executive Summary

Medical devices are a cornerstone of modern healthcare, yet national reporting systems and investigative journalism reveal persistent risks from equipment failures, incorrect use, and inadequate governance. It has been shown that the consequences of such failures can be catastrophic, including patient deaths, severe harm, and significant care delays. Fragmented oversight and evolving reporting systems highlight the urgent need for a more robust and unified approach to device management and governance across the NHS.

1. Current State of Medical Device Safety

1.1 Reporting Trends and Data Gaps

The transition from the National Reporting and Learning System (NRLS) to the Learn from Patient Safety Events (LFPSE) system has created significant data gaps, making national trend analysis challenging.

• The NRLS, in operation until mid-2022, captured device-specific incident data.
• Public releases from the newer LFPSE system use broad categories and currently do not provide the same level of detail.

Despite these limitations, investigative reporting for 2022–2025 revealed:

• ~3,915 equipment malfunction incidents
• 522 incidents causing moderate harm
• 68 incidents causing severe harm
• 87 incidents resulting in patient deaths

These figures show that, even after the reporting system change, significant and preventable harm persists.

1.2 Nature of Device-Related Harm

Common high-risk failure modes include:

• Malfunctions: failures of critical devices such as ventilators, monitors, and infusion pumps.
• Incorrect use: training gaps, instruction misinterpretation, or consumable mismatches (e.g., wrong pulse oximeter probes).
• Software/IT failures: outdated operating systems, poor connectivity.
• Aged/out-of-life equipment: decreased reliability and higher breakdown rates.

2. Governance Challenges

Key issues undermining safety and performance include:

• Fragmented oversight between local NHS trusts, the Medicines and Healthcare products Regulatory Agency (MHRA), and manufacturers, causing inconsistent responses and delayed hazard mitigation.
• Reactive culture: addressing problems only after incidents occur, rather than through predictive maintenance and proactive risk control.
• Inconsistent post-market surveillance despite 2024–2025 regulatory updates.
• Reduced data transparency with LFPSE’s broad categorisation, limiting independent review.

3. Case for Improvement

The rationale for reform is clear:

• Patient harm: Device failures can result in fatalities or life-changing injuries.
• Financial burden: Equipment downtime, litigation, and harm-related care costs strain NHS resources.
• Systemic risk: Clusters of minor incidents may indicate a single underlying design or maintenance defect that could escalate into major harm.
• Regulatory demand: New post-market surveillance rules require stronger governance and compliance mechanisms.

4. Recommendations

4.1 Strengthen Asset Management

• Create a national medical device registry tracking equipment age, maintenance status, and safety notices.
• Standardise preventive maintenance strategies across all NHS trusts.

4.2 Enhance Reporting and Transparency

• Require LFPSE to publish device-specific incident breakdowns quarterly.
• Mandate immediate reporting of near-miss device failures with severe-harm potential.

4.3 Improve Training and Competence

• Implement regular, mandatory training for all device users.
• Use simulation-based assessments for high-risk equipment.

4.4 Strengthen Governance Structures

• Assign a Medical Device Safety Officer (MDSO) in every trust with defined accountability.
• Establish rapid escalation channels between trusts, MHRA, and manufacturers.

4.5 Adopt Predictive Safety Measures

• Use AI-powered predictive maintenance to flag equipment at risk of imminent failure.
• Support proactive recalls and software updates.

5. Conclusion

Medical device incidents have potential for catastrophic harm which makes them a national priority. A unified governance model, supported by transparent data, proactive maintenance and user training, with strengthened oversight, will save lives, improve operational efficiency, and rebuild public trust in NHS technology.

References

[1] NHS England – Patient Safety Data: Summary of key headlines and figures, Patient safety report 2025.docx.
[2] NHS England – Statistical work areas: Patient safety data, Patient safety report 2025.docx.
[3] The Guardian – Thousands harmed and 87 dead after NHS equipment failures in England, June 2025, Patient safety report 2025.docx.
[4] GOV.UK – Medical devices: post-market surveillance requirements, Patient safety report 2025.docx.