Managing risk is a critical component in medical device manufacturing, with risk factors influencing decisions at the initial design stage and continuing throughout the device life-cycle.
Incorporating human engineering factors (HEFs) in the initial development stage will enable the analysis, specification, design, verification and validation of usability, as it relates to the safety of a device. This can help to identify the risks associated with abnormal use, but will not assess or mitigate them.
At last years American Medical Device Summit, Pat Baird (Technical Director at Baxter Healthcare) highlighted the importance of usability as a critical factor for consideration within the risk management process. He recommended that in order to develop a comprehensive understanding of device use, manufacturers should consider:
- Differences in the behavior of individuals, user groups, and cultures.
- The natural limits of human ability, cognition, perception, and memory.
- The interaction with other devices and the cleanliness of the environment.
When developing a risk management strategy for medical devices, there are 4 key questions that must be addressed; What are you trying to do? What can go wrong? What are you going to do about it? Did it work?
These questions are applicable to the progressive stages of development and will inform the overall risk management strategy.
Risk Analysis – What are you trying to do?
- Intended use
- Identification of characteristics related to safety
- Estimation of risk (s) from hazardous situations
Risk Evaluation – What can go wrong?
Risk Control – What are we going to do about it? Did it work?
- Risk control option analysis
- Implementation of risk control measure (s)
- Residual risk evaluation
- Risk/benefit analysis
- Risks arising from risk control measures
- Completeness of risk control
Reporting, Production and Post-production information – Did it work?
- Evaluation of residual risk acceptability
- Generating the risk management report
- Production and post-production information to inform analysis and decisions moving forward
To find out more about building a cohesive risk management strategy for medical devices, attend the next installment in the American Medical Device Summit series, taking place in Chicago on September 21st-22nd, 2015.
*The information in this post was sourced from the presentation given by Pat Baird, Technical Director, Baxter Healthcare, at the American Medical Device Summit 2014