Risk management clinical

For non-medical devices the answer to better clinical risk management is not additional regulation but rather an improved understanding of how organisations can efficiently and effectively execute self-assessment and practical risk mitigation. 

The Oxford English Dictionary defines risk as [Exposure to] the possibility of loss, injury, or other adverse or unwelcome circumstance a chance or situation involving such a possibility [4]. The focus here, as with a number of other definitions is that risk involves the loss of something we value. In the context of Clinical Risk Management (CRM) this is likely to be our health, wellbeing or indeed our... 

Health and Social Care Information Centre. ISB0129. Clinical risk management its application in the manufacture of health IT systems version 2. UK Information Stemdaid Board for Health and Social Care 2013. 

ISB 0129 (DSCN 14/2009) [7] - Clinical Risk Management its Application in the Manufacture of Health IT Systems... 

These publications were based on standards ISO/TR 29322 2008(E) and ISO/TS 29321 2008(E) which had been drafted by CEN/TC251 to address the need for an International Standard for Clinical Risk Management of HIT systems. However the proposed Technical Specification and Technical Report failed to gain formal international ratification. Uptake of ISB 0129 and 0160 in the UK was slow partly due to their complexity and lack of a clear enforcement framework. In 2012 major revisions were undertaken with a focus on separating out requirements and guidance. The result was a set of four easy to use documents (two for manufacturers aud two for healthcare organisations) with content similar to ISO 14971. 

Ensuring that the clinical risk management team is competent to perform then-role is a key function of senior management. 

---