Recently, concerns have been raised by Clinical Safety Officers (CSOs) regarding the potential risks to patient safety due to NHS trusts’ historical non-compliance with digital clinical safety standards. A BBC investigation revealed that 126 cases of serious harm, including three fatalities, were associated with IT problems across 31 NHS trusts. This situation underscores the dangers of the so-called “legacy debt,” a consequence of neglecting essential safety tasks such as hazard logging and safety case reporting for software.
The Legacy Debt Dilemma
The Issue of Outdated Systems and Non-Compliance
According to Faye Clough, a lead clinical safety engineer, many NHS trusts continue to operate with outdated systems and have consistently failed to meet critical compliance requirements. This includes not seeking manufacturer compliance under DCB 0129 or failing to conduct thorough in-house safety checks as stipulated by DCB 0160. Clough pointed out that this negligence can lead to patient safety incidents and significant reputational damage for NHS trusts. Comparing this to purchasing a house without a survey, she emphasizes the importance of incorporating CSOs in software procurement to ensure all relevant safety standards are met.
The problem is further compounded by the fact that NHS software often lacks rigorous oversight in contrast to medical devices regulated by the Medicines and Healthcare products Regulatory Agency. Standards enacted in 2012 have remained poorly enforced, largely due to the absence of CSOs in some organizations. This gap in enforcement has allowed many trusts to continue operating without meeting crucial safety protocols, putting patient lives at risk.
Imperative for New Safety Standards
As NHS England reviews digital clinical safety standards with plans to bolster them in 2025, the legacy debt issue has become increasingly pressing. The new regulations aim to implement changes that will enforce compliance more strictly. This review also underscores the critical need for NHS trusts to move promptly to address any gaps in their current systems and ensure that all safety protocols are followed to mitigate risks to patient well-being.
To assist in this transition, the CSO Council has proposed several measures, including conducting regular audits, maintaining a comprehensive risk register, and involving senior management in reviewing current issues. Ben Jeeves, Chair of the CSO Council, noted the challenges of addressing legacy debt but emphasized the necessity of high-level risk assessments for each system. By prioritizing systems that require immediate safety case evaluations, NHS trusts can take crucial steps towards achieving full compliance and ensuring patient safety.
Practical Solutions to Address Compliance Issues
Conducting Regular Audits and Maintaining Risk Registers
To mitigate legacy debt and enhance digital safety compliance, the CSO Council advises NHS trusts to conduct regular audits and maintain an updated risk register. Regular audits help identify potential compliance gaps and provide an opportunity to rectify them before they result in patient harm. By keeping a risk register, trusts can systematically document and monitor the risks associated with their digital systems, enabling a proactive approach to risk management.
In addition to audits and risk registers, it is crucial that top management be involved in reviewing and addressing these issues. Their involvement ensures that compliance and patient safety are prioritized at the highest level in the organization. Moreover, having senior management’s oversight helps secure the necessary resources and support needed to implement effective risk mitigation strategies.
The Role of Clinical Safety Officers in Procurement
Integrating Clinical Safety Officers into the procurement process is essential for ensuring that all digital systems meet established safety standards. CSOs bring specialized knowledge and expertise in clinical safety, enabling them to identify potential risks early in the procurement process and ensure that manufacturers adhere to the required standards. Their involvement can also help in developing comprehensive safety cases and hazard logs, which are critical components of digital safety compliance.
By actively engaging CSOs in the procurement and ongoing management of digital systems, NHS trusts can build a robust framework for safety compliance. This proactive approach not only helps mitigate risks to patient safety but also protects the organization from reputational damage and potential legal consequences. As NHS England moves towards strengthening digital clinical safety standards, the involvement of CSOs will be imperative in achieving and maintaining full compliance.
Conclusion
Recently, Clinical Safety Officers (CSOs) have raised significant concerns about potential dangers to patient safety stemming from NHS trusts’ historical failure to comply with digital clinical safety standards. A BBC investigation uncovered that 126 instances of serious harm, including the tragic loss of three lives, were directly linked to IT issues across 31 different NHS trusts. This troubling revelation highlights the critical problem of “legacy debt”—the neglect of crucial safety measures. Legacy debt results from NHS trusts not performing essential safety tasks such as hazard logging and comprehensive safety case reporting for software systems. These oversights have far-reaching implications for patient safety, as they compromise the integrity of healthcare delivery and can lead to severe, even fatal, consequences. Addressing these deep-rooted issues is vital for ensuring that digital health infrastructures are safe, reliable, and capable of meeting modern clinical safety standards. The situation calls for urgent attention and action to mitigate risks and protect patients effectively.
