DCB0160 Clinical Risk Compliance Services
DCB 0160 is the counterpart standard to DCB 0129. Whereas the former applies to manufacturers of technology, DCB 0160 applies to public health organisations who are deploying the technology. The requirements of the two standards are almost identical.
What is DCB0160?
DCB0160 is a mandatory clinical safety standard for public healthcare organisations who are purchasing and deploying any healthcare technology. The applicability of DCB0160 is the same as DCB 0129, just that it applies to healthcare organisations and not vendors. Deploying organisations must ensure appropriate clinical safety activities have taken place prior to, at the time of, and after the deployment of any technology and appoint a Clinical Safety Officer (CSO) to lead on all clinical safety processes.
DCB 0129 & DCB 0160
As mentioned, these two standards are almost identical in scope, just that they apply to different parties. DCB 0129 applies to vendors when creating any technology to be deployed in a healthcare setting and DCB 0160 applies to deploying organisations.
Deploying organisations need to appoint a CSO
They need to ensure clinical safety processes have been drawn up and embedded within the organisation at scale
They need to review the DCB 0129 paperwork provided to them by the vendor whose technology they are buying
They need to consider any other hazards that may apply specifically to their deployment (e.g. data migration, configuration, interfacing with other systems)
Vendors must also appoint a CSO
They must produce the requisite paperwork in line with DCB 0129 to be reviewed by the deploying organisation
They must ensure ongoing compliance through incident and release cycle management
DO I need to comply with dcb0160?
If you are a public healthcare organisation who is buying and deploying healthcare technology in your environment, then yes, DCB0160 will apply. You will need to ensure you have covered the above steps for all of your products being deployed in the future, but also ones already deployed (as you may be liable to internal or external audits on compliance).
Here at The AbedGraham Group, we can help you with navigating your existing vendors as well as future procurements, so get in touch to find out more.
How We Ensure
DCB 0160 Compliance
Ensuring your vendor network is fully compliant with their requirements and then ensuring your own processes are in place is almost an impossible task for any single CSO in a healthcare organisation as there may be dozens if not hundreds of applicable products. Our two-step approach can supercharge your overall compliance with these two standards.
SUPPLY CHAIN AUDIT
The first step we can help healthcare organisations with is a supply chain audit of all your vendors currently deployed. If there are dozens or hundreds of suppliers, this can be a huge task for any single person. However, at The AbedGraham Group, we have a unique process of benchmarking, stratifying and delivering DCB 0129 compliance at scale for your existing vendors. The outputs of this exercise will streamline and improve the efficiency of your associated DCB 0160 processes.
DCB 0160 processes
Depending on the maturity of your clinical safety processes, we can audit your current position and implement a set of best practices, standard operating procedures and human resource plans to ensure that all vendors, whether existing or new, can be appropriately managed, reviewed and signed off. The counterpart DCB 0160 processes required can then be run at scale to ensure you as a deploying organisation are fully compliant as well as your vendor network.
Why Choose The AbedGraham Group for Your DCB0160 Compliance?
At The AbedGraham Group, we have provided risk management and consultancy services covering hundreds of health IT products.
We have overseen clinical safety for hundreds of products deployed in the NHS. Our unparalleled expertise in this field and the meticulous detail within our documents set the highest standard in the industry.
Achieving clinical safety compliance is most effective when you have a Chief Safety Officer (CSO) with some level of clinical experience related to the specific healthcare product. With a track record of successfully overseeing more than a hundred products across various healthcare domains and a team boasting decades of hands-on experience across all sectors, we are exceptionally equipped to navigate risk for any product in the NHS.
Peace of Mind
Navigating clinical safety is complex, especially when delving into product specifics, interacting with deploying organisations, or engaging with regulators. Ensuring the reliability, evidence-based foundation, and trustworthiness of your materials are paramount. With our extensive experience overseeing numerous products, we've encountered a myriad of requests and queries from regulators, healthcare entities, and partners. Many organisations fall into the trap of superficially addressing clinical risk management or retrofitting existing compliance materials, often leading to complications during document reviews and clinical safety incidents.
Is DCB0129 mandatory?
DCB0129 is mandatory if your product is considered applicable, as part of the Health and Social Care Act 2012. You must show evidence of a suitable risk assessment and appoint a Clinical Safety Officer to manage DCB0129 compliance on an ongoing basis. If you are unsure as to whether your product is applicable, then contact us for a free consultation.
What is clinical risk in the NHS?
Clinical risk management in the NHS is centred around the deployment of two standards: DCB0129 (applying to vendors) and DCB0160 (applying to healthcare organisations). Vendors must ensure they have covered all parts of the standard to ensure compliance that they can show to healthcare organisations, regulators and partners.
What is digital clinical safety?
Digital clinical safety is about ensuring that technologies deployed in the NHS are safe to use, but also that those technologies then help to improve patient safety. The Digital Clinical Safety Strategy published in 2021 outlines the nationwide strategy and the stakeholders involved in maintaining this.