Working with manufacturers of health IT systems, it’s fascinating to watch organisations evolve and mature as they implement the SCCI 0129 safety management processes. I consistently see organisations pass through various stages of safety maturity. Proactive assurance and safe design is the ultimate goal. Yet so many organisations, without help, get lost along the way.
I summarise the stages, as I see them, below:
Stage 0 – No safety activity
Many health IT manufacturers begin without undertaking any formal safety assessment of their health IT products. Of course that is not to say that their products are unsafe – there are many examples of high quality engineering methods, best-practice design and quality assurance. But these organisations have never taken the step to objectively evaluate the clinical risk associated with their systems. Their hard work and diligent assurance goes largely unnoticed from a safety perspective.
Stage 1 – Reactive safety management
With a reactive approach to safety, organisations position themselves ready to engage safety expertise as emergencies arise. Typically, this is when a customer raises a defect, issue or complaint which they claim will impact care. The manufacturer quickly needs to determine whether the concern is valid and what the realistic level of clinical could be. The driver for these activities is often fear. Fear that there might be reputational damage, loss of confidence in the project or indeed litigation.
Stage 2 – Passive safety management
In passive safety management, the organisation takes the first step into objectively demonstrating safety and assurance. Stakeholders begin to develop materials such as hazard logs and safety cases. In the UK the driver is generally compliance with safety standard SCCI 0129 or SCCI 0160 which require that these mandatory deliverables are created. But what distinguishes this stage from the next is that the analysis has minimal or no material bearing on the product’s design, build or test. Essentially the assessment is a one-way street – an analysis which passively describes the safety position but fails to achieve any real-world risk mitigation. This might be one step up from box-ticking, but ultimately the manufacturer is offering an illusion of safety management.
So many organisations get stuck at Stages 1 or 2.
Stage 3 – Active safety management
The world of active safety management is a dynamic place of iteration and validation. Here the effort invested in performing the safety analysis feeds directly back into the product design process. Hazards are identified at an early stage in the development lifecycle and those learnings give rise to controls which are deliberately and systematically engineered into the product. It is at this point that one sees a step change in product quality, risk reduction and ultimately a return on the investment in safety management.
But the important thing to realise is that laboriously passing through Steps 1 and 2 to reach your goal is simply not necessary. Achieving Active Safety Management is perfectly straight-forward right off the bat once you have the right components and knowledge in place. In fact, organisations who have travelled this journey will report that the fire-fighting and bureaucratic approaches of Stage 1 and 2 simply zaps resources and the workforce’s energy with minimal gains.
So aim high and reap the rewards. With the right help, making safety management business-as-usual in health IT comes with countless rewards and turns box-ticking into a real driver for success.
Perhaps you recognise your own organisation stuck along the way?