The Scope of Clinical Risk Management

Once financial, environmental and reputational forms of risk are excluded one might expect that what is left is a fairly tight definition of the factors which constitute clinical risk. Experience has shown however that there are many boundary cases that can be subject to debate. Clinical risk arises from the manifestation of one or more hazards. Hazards have an intrinsic relationship with harm but it is often in the definition of what constitutes harm where debate arises. 

In any CRM assessment one needs to define the boundaries of the analysis (as discussed in Sect. 11.1.1). Those systems, modules, components or areas of functionality which have the potential to impact care are often described as being safety-related . Thus, an entity can be considered safety-related if it  

Note that an important word in this criterion is contribute . The system does not need to be directly responsible for harm to make it safety-related. In the majority of cases there will be a human being between the system and the patient. This individual will typically have professional responsibihties and be required to apply chnical judgement. Essentially, an HIT system can only be one contributor to a chain of events that result in harm. 

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In anticipation of the introduction of risk management requirements under 1EC80001 (or in case of expansion of the scope of the Medical Devices Directive), the NHS Connecting for Health (CfH) Chnical Safety Group commenced creating and training a network of Trust based Clinical Safety Officers to assist in the safety management tasks associated with new systems deployment. 

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