Examples of some of the DCB0160 requirements which MUST be met by a deploying organisation when considering the deployment of a system such as COVID Oximetry @home are:
- identifying and documenting known and foreseeable hazards to patients (Section 4)
- estimating the initial level of clinical risk for each hazard (Section 4)
- evaluating whether the initial clinical risk is acceptable (Section 5)
- identifying appropriate clinical risk control measures to remove an unacceptable clinical risk. (Section 6)
- implementing the clinical risk control measures. (Section 6)
This is not a complete list of requirements and is included for illustration purposes.
Deploying organisation’s responsibilities
Organisations responsible for manufacturing, developing and modifying health and social care IT Systems which have a direct impact on patient care must follow DCB0129. This is also a mandatory standard which has been followed during the development and manufacture of COVID Oximetry @home by NHS Digital.
Some hazards were identified during the development of COVID Oximetry @home where the responsibility for implementing the control measures to reduce the level of clinical risk associated with the deployment will fall on the deploying organisation. Therefore, it will be necessary for the deploying organisation to consider the hazards identified during the development of COVID Oximetry @home and their control measures when carrying out their own risk analysis.
These hazards and control measures are recorded in the DCB0129 Clinical Safety Case Report titled ‘Clinical Safety Case Report for COVID Oximetry @home’ and the associated Hazard Log. The latest versions of these documents can be found on the NHS Digital COVID Oximetry @home web page.
DCB0160 Support Tool
To help deploying organisations ensure they are compliant with the mandatory DCB0160 standard, a useful support tool titled ‘Compliance Assessment Template’ can be found in the ‘Previous Release’ section of the DCB0160 webpage. This is in the form of an Excel spreadsheet and has been developed to help manufacturers and health and care organisations measure compliance with the standard.
The tool lists the requirements of the standard and has an option to record the level of compliance. The level of compliance is recorded in the Summary tab of the spreadsheet. The tool can also help organisations to check compliance of their clinical risk management processes before undertaking a project.