Clinical Safety is a big issue

About 1 in 10 patients are harmed in healthcare according to the World Health Organisation (WHO). Half of this harm is classed as preventable. 50% of harm is attributed to medications justifying a focus on the safety of medication management systems. https://www.who.int/news-room/fact-sheets/detail/patient-safety

This level of patient harm, WHO suggests, reduces global economic growth by 0.7% per annum, amounting to trillions of dollars. Additionally, this global body, suggest that investment in reducing patient harm can lead to better patient outcomes and in significant cost savings.

Investment in clinical software is a key pillar for securing future patient safety. This article suggests that healthcare should look beyond current clinical safety assurance with respect to such technologies. We should consider how best to secure safety improvements through the design, development, and deployment of healthcare software. To ensure that new opportunities for supporting safer care are fully realised manufacturers of clinical software need to provide leadership.

Key Areas for Consideration

I concluded that there were at least four important elements to software development as a component of safer patient care. These were:

  1. Support for clinicians at the point of care to deliver safe interventions. At a basic level this includes ensuring that the clinician has access to patient records, can easily navigate the system to prescribe, order tests and interventions and track progress. It does, however, also extend to providing alerts, for examples for allergies and interactions, prescribed “best practice” workflows and clinical decision support.
  2. Systems must support the delivery of coordinated care. This would include care within the hospital, clinic, or primary care centre and extend to the wider system. Key questions are. How can software systems better support multidisciplinary team working? Can they underpin more effective transitions for clinicians such as shift handovers? Can continuity of care be improved for patients through better discharges? Do new systems provide the level of interoperability to ensure more comprehensive access to records and plans across local healthcare systems?
  3. Software also offers the opportunity to empower people within the delivery of their own care. This includes access to records and the ability to contribute readings and preferences for care. The patient is a much-ignored layer of safety. Research suggests that providing patients with access to their electronic health records can improve medication management safety. This should not be a surprise as it is likely that individual patients will be more “eagle eyed” than the busy clinician. Finally.
  4. Software analytics that allow healthcare providers to look at key trends and support quality improvement and performance management. For example, does a new staffing model on a ward have an influence on the numbers of falls, pressure areas or healthcare acquired infections?

A change in focus

To date, the main clinical safety focus has been on the safety of software products. In a sense this obeys the diktat “first do no harm” and is understandable; new technologies like new drugs must prove their safety. The means to provide that assurance are relatively established particularly in the NHS. Safety considerations need to move to a much more proactive approach. This seeks to ensure that new opportunities to improve safety are fully realised as technology develops. Furthermore, approaches need to ensure that software development focuses on developing functionality that will make a real-world difference to patient safety. Development organisations must not waste time on low impact functionality.

How to Change the Focus?- A Dynamic Approach

I believe that this requires:

  • Clinical Safety clinicians who are very familiar with the clinical workflows that are being supported by software. It is vital, for example, that medicines administration software is supported by clinicians who have undertaken drug rounds and understand the process in the real world.
  • Clinicians with safety expertise being embedded within development teams. In terms of agile software development this means, at a minimum, they should attend sprint reviews during the design and development process. Clinical safety must not be an “end of project” assurance process.
  • Greater collaboration between customers and manufacturer clinicians to seek opportunities for further safety improvements. I am personally a strong advocate of secondments from healthcare organisations that bring clinicians into development organisations for six to twelve months. This has all sorts of career benefits but, in this regard, will improve clinical input into software development. I also strongly support a position where clinicians whose “day job” is technology safety and development maintain some clinical practice. And
  • Digital Clinical Safety leadership having a high profile within both customer and manufacturer organisations. We are in the foothills of this development, but Chief Clinical Information Officers are now emerging as senior healthcare figures and, in some cases, becoming board members.

Conclusion

This clinically driven, diverse partnership approach will, I believe, lead to the development of software that substantially improves the safety of healthcare for patients. It will allow us collectively to fully realise the opportunities offered by Artificial Intelligence, Machine Learning, Analytic developments as well as a host of other opportunities that will arrive.

Assuring software safety will continue to be essential but let us also focus on designing and developing for safety.