David Embrey, Neil Hunter and Jamie Henderson, Human Reliability Associates Ltd
Human factors in medical device design is an area of increasing practical and regulatory importance. It is widely recognised that human error (‘use error’) associated with the use of medical devices is a significant contributor to adverse medical events and patient injury. This has prompted greater regulatory focus on the integration of human factors within the device development process.
IEC 62366-1:2015 – Medical devices – Application of usability engineering to medical devices outlines the requirement for incorporating human factors within the medical device design and development lifecycle (contextual analysis/ research, concept development, formative and summative evaluations). Whilst methods such as FMEA (Failure Modes and Effects Analysis) are commonly used, there still appears to be only a sporadic use of a structured human factors focused risk analysis process during device design and development.
Purpose of the workshop
This workshop will introduce the SHERPA (Systematic Human Error Reduction Prediction Approach) methodology as a reliable and practical process for human factors risk assessment for medical devices.
SHERPA was first developed as a means for combining risk analysis techniques from engineering (e.g. Failure Modes and Effects Analysis) with human factors-focused techniques such as hierarchical task analysis and human error analysis. It has been applied in many sectors where human error can give rise to serious safety or cost-related outcomes such as chemical manufacturing, pharmaceuticals, aviation and healthcare.
The facilitators will draw on their experience in using SHERPA in both safety-critical industry sectors and healthcare to illustrate its application to medical device design. They will illustrate how systematic human factors analysis can significantly improve the quality of medical devices, reduce the likelihood of use errors and reduce costs associated with their development.
Medical device design manufacturers, human factors professionals in the medical device design sector, human factors consultants, engineers and designers, regulators, researchers and academics.
The workshop will introduce participants to the SHERPA methodology. In particular it will provide exposure to task analysis, predictive human error analysis and performance influencing factor analysis. In addition to providing a formal framework for the risk assessment process, the facilitators will show how the SHERPA methodology provides other outputs such as identification of human factors design requirements, identification of performance criteria for validation studies, risk assessed Instructions for Use (IFU) and device training recommendations. The session will include case studies and workshops, with exercises to introduce participants to the main elements of the SHERPA process.
- Session 1: Introduction to the session and setting the scene
- Session 2: Hierarchical Task Analysis (HTA)
- Session 3: Predictive human error assessment and analysis of performance influencing factors
- Session 4: Verification and validation
- Session 5: Instructions for use and device competence management
- Session 6: Concluding discussion
“It was good to have the opportunity to discuss the concepts of SHERPA ,HTA and uFMEA with others during the workshop.” NS