What is clinical safety? And, how do we ensure that the health tech products we use every day; whether at home, or in a healthcare setting are deemed to be ‘clinically safe’?
What is Clinical Safety?
Clinical safety is the prevention of harm to patients, healthcare staff, and visitors in a healthcare setting. It involves clinical risk management and the implementation of safety protocols and procedures to reduce the risk of harm, medical errors, adverse events, and other potential hazards.
Clinical risk and safety management is the practical process of ensuring that everything from the design, architecture, development protocols and implementation of a product meets the national safety standards (DCB0129 and DCB0160) as set out by the NHS in the Digital Technology Assessment Criteria (DTAC). The ethos behind these standards is ‘safety by design’ which encourages manufacturers of health IT systems to consider clinical safety in line with product development.
As a registered nurse, I have lived and breathed clinical safety on the front line but as a clinical safety officer it requires a whole systems approach to factor in the wider implications of the technology and its implementation across the NHS. At 8foldGovernance, we have seen the successes and pitfalls that customers have experienced over the years when tackling clinical safety and clinical risk management. That’s why we have developed ‘go-to market’ processes that not only ensure the highest standards in clinical safety are met but that also support suppliers to seamlessly move through the procurement process, whether that’s for a departmental, trust wide or regional implementation.
But, what makes a health tech product clinically safe?
The risk profile of digital health technologies varies significantly from product to product. Clinical safety applies to all products which have the potential for patient harm. A ‘safe’ digital health product is one where the risk of harm has been reduced to defined acceptable levels as outlined in the DCB0129 and DCB0160 safety standards. The intention with many of the products we work with is to reduce any potential risk of harm to lower than that of existing processes, while providing assurance that risk has not been introduced in other ways.
How do we determine whether a product is clinically safe?
Our team of Clinical Safety Officers provide clinical assurance by working closely and collaboratively with health tech manufacturers. It’s extremely important to have involvement from a multidisciplinary team to do this effectively. In doing so, we support the implementation of functional Clinical Risk Management Systems where team members fully understand their roles and responsibilities for maintaining high standards of clinical safety.
The gold standard in clinical risk management is to introduce these processes at the beginning of a project to help avoid problems later on. Where this has not happened, we carry out a deep dive to thoroughly risk assess retrospectively and ensure that all clinical risks have been identified and mitigated. In many cases, these mitigations will already be in place, however our priority is to work with our customers to ensure they are effective and there is evidence is available to support them.
Outsourced clinical safety support ensures that clinical safety practices do not become an afterthought. Instead, they are embedded into the architecture of both the product and the business. This provides the assurance that NHS organisations are looking for when implementing new digital health technologies.
The risk management process is closely aligned to the software development life cycle. Clinical Safety does not end when ‘signing off’ the Clinical Safety Case Report. It’s a live process that is continually monitored and updated to ensure that any new functionality and features are safe, and that clinical incidents are managed effectively. At 8fold, we provide long term clinical safety support to ensure the clinical risk management system is followed and iterated throughout the product life cycle and development. This allows us to flag risks or alerts using pre-defined internal governance processes. As part of this, we provide training to manufacturers and hold regular clinical safety meetings to discuss current and future development plans.
Clinical assurance for patients and the NHS
Clinical and patient safety is at the heart of what we do and in line with our mission to ensure that ‘transformative health technologies reach everyone who needs them’, we also aim to provide confidence to the patients and healthcare professionals using the digital health products that we have clinically assured them so they are safe to use. We do this by making sure that all the products we assess are subject to rigorous risk and safety assessments.
Whilst DCB0129 is certainly the framework required by the NHS for doing this, I believe it should not be seen as a ‘tick box’ exercise for compliance. Instead, we should think in more general terms to consider; ‘how can we assess, maintain and improve patient safety through the use of our product?’. The DCB0129 standard provides a structured approach to documenting and evidencing the safety practices and assessments which can in turn be used by our NHS colleagues to facilitate the NHS DCB0160 assessment.
