C is for Clinical Safety

There are two fundamental elements of Digital Clinical Safety required for compliance with the DCB1029 standard:

Proactive Approach

• Creating safe products that are designed to minimise clinical risks as much as possible.

  
  

Reactive Approach

• Delivering an appropriate response to clinical incidents as they arise.

  
  

Both approaches employ systematic methods for identifying, assessing, analysing, and controlling risks.

Clinical Risk Management

Clinical Risk Management is integral to ensuring clinical safety. It involves the practical application of safety protocols and procedures throughout the entire health software product lifecycle. This includes product design, software architecture, development, testing, implementation, and end-user training. Furthermore, clinical safety also encompasses Clinical Incident Management.

Clinical Incident Management

Clinical Incident Management guarantees that systems and processes are established to effectively manage clinical incidents (and near misses) when they happen and to prevent additional patient harm. In the realm of digital clinical safety, differentiating between clinical incidents and near misses can be unclear. Although a digital product might not directly harm a patient, a clinical incident in this context refers to the occurrence of a clinical hazard that could have resulted in an accident but did not. Incidents or near misses are deemed pertinent to the manufacturer if their product played a role in the event.

Numerous factors may contribute to a clinical incident, including but not limited to:

User Error

• Data entry mistakes

• Misunderstanding system operation

• Unclear user interfaces

• Insufficient training

• Intentional misuse

• Fatigue

  
  

Technical Defects

• Undetected bugs during testing

• Changes that have not been fully regression-tested affecting other system areas

• Interoperability challenges

• Infrastructure problems (e.g., network access, firewall restrictions)

• Issues related to third-party components