Clinical Safety Ensuring safe and effective products

Clinical safety is of paramount importance when it comes to developing and delivering products and services and should be a core tenant from any organisation operating in the health space, yet is often overlook.

It requires a mature approach to quality, underpinned by effective risk management, and where necessary compliance with national and international standards to ensure that health related products are safe and effective.

Understanding regulatory requirements from the outset and embedding quality and risk management early on will pay dividends downstream when it comes to launching and scaling a product or service. At the same time, it is important to understand requirements and scope so as not to create a rod for your own back or become a slave to bureaucracy.

Depending on the scope of product or service some standards (such as Medical Device) may or may not apply. Even when they do apply, when it comes to early stage concepts and pilots they may not be necessary.

In the UK NHS DCB0129 and DCB0160 for the manufacture and deplyment of clinical applications usually come in to play. Depending on the use case these can be recommended or legally required.

It is important to understand that quality and safety is not a one off exercise but embded end to end in operational systems and processes. Doing this from the outset will ensure safety aware operating culture.

Example projects and experience

Over 20 years experience in and around health technology gained through various positions and projects, including 7 years in the NHS. Relevant examples include :

• NHS Clinical Safety Officer training
• Project safety lead for NHS National Hearing Screening Programme
• eRedbook product delivery, assurance and endorcement by RCPCH
• Digi.me NHS integration and assurance

Do you need support?

If you have a particular need within your team please feel free to reach out and discuss your requirements. Support can be provided in a number of areas including :

• Shaping, strategy, plans and business development
• Guidance and advice for project/product development
• Input to bid development
• Project / product delivery

Flexible arrangements to meet your specific needs. Choose from single-day(s), block draw down arrangements, or regular monthly commitment.

Useful references

• DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems
• DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
• ISO 13485 Medical Devices
• ISO 9001:2015 Quality management systems
• Regulating medical devices in the UK