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Toxicological Risk Assessment for Breathing Gas Pathway Medical Devices
January 24, 2019 @ 11:00 am - 12:00 pm
Breathing gas pathway medical devices such as breathing systems, ventilators, anesthesia systems, nebulizers, and oxygen lines come into contact with patients at a particularly vulnerable point and time. As a result, the exposure assessment for these devices is an important step in the evaluation of device safety and needs to be particularly concerned with airborne releases, especially volatile organic compounds (VOCs).
In this hour-long webinar, Russell Sloboda will discuss the application of ISO 10993 and ISO 18562. While both standards may apply, in some instances, each standard recommends a very different technical approach to the measurement of releasable chemicals and different assumptions for the risk assessment. The key differences in these two methodologies will be illustrated, along with an analysis of how different risk estimates derived using these regulatory guidelines points out the need to justify the use of one analytical option over another.
- The analytical challenges that need to be addressed during study design will be discussed including:
- Determination of the volume of humidified vapor condensate for the risk assessment.
- Selection of air sampling intervals and total duration of sampling.
- Picking relevant extraction solvents and inclusion of appropriate medical device components for analysis.
- Case studies will be presented to illustrate several examples of study design and common problems encountered.