Whether you are a hospital deploying a new digital system, or a manufacturer developing new software, the DCB Safety Standards are your first line of defence against avoidable patient injury and your ticket to successful procurement and deployment
Breaking the Silence – What Are These Standards?
The two safety standards, DCB 0129 & 0160, mandated by the 2012 Health and Social Care Act are act together to protect patients against new risks that digital technologies introduce to clinical care.
- DCB 0129, The Manufacturers Responsibility: Apply should you construct, create, or alter a health IT system, ensuring clinical safety is interwoven within the design and development cycle. You need to systematically identify and mitigate possible risks and effectively communicate them to your clients with your Clinical Safety Case Report (CSCR).
- DCB 0160, The Healthcare Providers Responsibility: This is an obligation for NHS trusts, social care providers and GP surgeries which implement the technology. DCB 0160 acknowledges that clinical incidents involving digital technology are often a product of the environment they are deployed within. They are required to do their assessment of their local risks and generate their own CSCR prior to going live.
The Stark Reality – Why You Can Not Look Away.
It is a common misconception that safety compliance can be circumvented or addressed post deployment. The most recent study shows that there is a disturbing compliance gap, with the majority of digital tools in practice not being properly safeguarded. Even software with a non-clinical or administrative functionality are subject to safety regulations. It should never be economically or ethically justifiable to ignore safety assurance process and the is strictly prohibited from NHS utilising software that has not passed DTAC, DCB 0129 & DCB 0160.
The dangers are real: an incorrectly labelled patient record, a malfunctioning clinical calculator developed in software or an alert that does not fire. These are not merely bugs but direct causes of threats to patient safety. These standards are put in place to ensure threats are identified and addressed in a systematic manner before they cause damage.
Manufacturers of health tech – A guide to practicality.
To developers and innovators, you have a mission: safety by design. Here’s your action plan:
- Begin at Square One: Implement clinical risk management from the first design sprints and prototyping. It is excruciatingly costly and time-consuming to retrofit safety.
- Select Your Clinical Safety Officer (CSO): You require a qualified and registered clinician who has been trained in health IT safety. They are your new set of eyes, proofreading your product and identifying risks that your engineering department may overlook. To discover more read “Navigating DCB 0129: A Guide for Health Tech Innovators”.
- Live your Hazard Log: It is a living document that lists all the hazards identified, their possible cause, their estimated risk level and what you have done to manage them. It is evidence of your hard labour invested in minimising patient harm.
- Expand Your Horizons: DCB 0129 applies to a variety of software products that are utilised in any area of patient care, such as scheduling, communication, or data management. If you are unsure if DCB 0129 applies to your product, visit our DCB Decider
A Practical Guide to Healthcare Providers
- Safety with Procurement: Do not sign any contract without seeing the supplier’s DCB 0129 Clinical Safety Case Report.
- Conduct Your Local Safety Assessment (DCB 0160): Your organisation must develop its own, individual CSCR. Written by your Clinical Safety Officer. How will this system impact your staff, patients and your existing working processes and your existing systems?
- Own the Ongoing Vigilance: It is not a one-time pre-launch event. According to the DCB 0160 standard, new risks must be constantly monitored after go-live, particularly when the system is updated or safety incidents occur.
Consider the implementation of a new prescription management system. One of the hazards that your local DCB 0160 evaluation could reveal is the inability of staff to access important patient allergy warnings because the screen due to sub-optimal screen design. This could possibly cause a serious drug reaction. Your Clinical Safety Officer will identify possible causes, such as ineffective user interface (UI) design, and identify possible mitigations. These can include collaborating with the vendor to make a change in the UI, update training documents and ensure the hazard is actively monitored in the live environment.
What’s Next? Transforming Expectations of a Digital Future.
DCB 0129 and 0160 are undergoing an upgrade to reflect the rapid evolution in new health technologies. Version Two is expected in 2026 and will hopefully address new challenges such as:
- Artificial intelligence (AI) and machine learning: Defining how to handle the novel, diverse risks of algorithmic technologies.
- Role Clarity: Additional explanation of the duties and needs of the Clinical Safety Officers.
- Diversified Technology Landscape: The traditional relationship between manufacturers and healthcare providers has evolved into an often-confusing web of third part suppliers, developers and specialist providers. Clarity is required to ensure the responsibility for patient safety is easily understood.
Keeping up to date with these changes will be of upmost importance to ensure you stay ahead of the regulatory curve.
The Unbreakable Connection between Innovation and Safety.
DCB 0129 and DCB 0160 is the safety glue that holds technology creators and bedside users together. They make sure that in the rapid acceleration of digital healthcare, we never sacrifice the core value of our profession, which is to first do no harm.