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What is DCB 0129?
DCB 0129 represents the regulatory standards issued by NHS Digital regarding patient safety. This standard mandates that manufacturers of Healthcare IT systems conduct a specific risk assessment on their products. This assessment verifies the product’s suitability for deployment in live healthcare environments. As outlined on NHS Digital’s official documentation, compliance with DCB 0129 is obligatory under the Health and Social Care Act 2012.
As a manufacturer what do I need to do?
If you are the manufacturer of a Healthcare IT system and wish to provide your product/platform to the NHS then you need to be able to comply with the following, and it is advisable that you are considering this process as part of the initial design & development phase:
You will need to appoint a Clinical Safety Officer who will be responsible for your clinical risk management requirements and will also be required to sign off specific documentation in line with DCB 0129. Your CSO will need to be a clinician, with a current registration with a recognised professional body, and have undergone training in Clinical Risk Management.
Clinical Risk Management needs to be robust and repeatable, and therefore requires a systematic approach to be used. The DCB 0129 standard has a structured approach to Clinical Risk Management, with specific deliverables stored in your Clinical Risk Management File. Within this file you need to show how your organisation is going to meet the requirements of the DCB 0129 standard. This process is documented in one of the required deliverables, the Clinical Risk Management Plan.
The risk assessment reviews various aspects of the product/platform such as functionality and architecture and considers what harm could be done to a patient if something goes wrong. The CSO may facilitate clinical risk management workshops, which are generally multidisciplinary in nature, to help create the Hazard Log, the document where the risks assessment is recorded. This is also stored, as one of the DCB 0129 deliverables, in your Clinical Risk Management File.
One of the other requirements of the DCB 0129 is for the manufacturer to provide the Clinical Safety Case Report, a document that provides the justification that the product/platform, in a defined environment, is acceptably safe for the patient. This is signed off by your Clinical Safety Officer and stored in your Clinical Risk Management File.
Once the Clinical Risk Management Plan has been developed, the Hazard Log populated and the Clinical Safety Case Report produced, and the platform/product is live, the Clinical Risk Assessment activities need to be maintained and and documentation updated in your Clinical Risk Management File. That is, new risks may become apparent with the addition of new functionality, reporting of bugs (if software), complaints from end-users and potentially clinical safety incidents. This is all overseen by your Clinical Safety Officer.