Quality and safety of detailed clinical models
1ecGroup Inc., Canada.
Abstract:
This chapter describes quality and safety risks related to the development and use of Detailed Clinical Models (DCM) and mechanisms which may be employed to mitigate such risks. The chapter begins with a brief discussion of DCMs and the role they can play in mitigating patient safety risk. There is then a brief description of the risks which DCMs themselves may introduce, followed by the introduction of a standards-based risk assessment method and the ways this assessment method may be applied to DCMs in particular. A general description is then made of the ISO 9000-based approach to quality management systems (QMS) and, specifically, how such an approach may be applied to DCM development, maintenance, deployment and use. The chapter concludes with a discussion of specific DCM quality and safety challenges and governance approaches which may be employed to help address these.
Insights
This chapter details risks associated with Detailed Clinical Models (DCMs) and introduces a standards-based approach to quality management for mitigating these safety and quality challenges.
Area of Science:
- Health Informatics
- Clinical Informatics
- Medical Device Development
Background:
- Detailed Clinical Models (DCMs) are increasingly used in healthcare, presenting unique quality and safety considerations.
- Existing risk management frameworks may not fully address the specific challenges posed by DCMs.
- Ensuring the safe and effective use of DCMs is crucial for patient care.
Purpose of the Study:
- To identify and describe quality and safety risks associated with the development and use of DCMs.
- To present mechanisms and methodologies for mitigating these identified risks.
- To explore the application of a standards-based risk assessment and quality management approach to DCMs.
Main Methods:
- Review of quality and safety risks inherent to DCMs.
- Introduction of a standards-based risk assessment methodology applicable to DCMs.
- Application of ISO 9000-based quality management systems (QMS) principles to the DCM lifecycle (development, maintenance, deployment, use).
Main Results:
- DCMs introduce specific risks that require dedicated mitigation strategies.
- A standards-based risk assessment method can be effectively applied to DCMs.
- ISO 9000-based QMS provides a robust framework for managing DCM quality and safety throughout their lifecycle.
Conclusions:
- Proactive identification and mitigation of DCM-related risks are essential for patient safety.
- Implementing a structured QMS, informed by risk assessment, is key to ensuring DCM quality and safety.
- Effective governance approaches are necessary to address ongoing DCM quality and safety challenges.
