Ahead of Extractables and Leachables Europe 2022, we spoke to Tim Petermann, Principal Chemist, Obernburg Laboratory Services at NAMSA.
Our interview covered an exclusive preview of his presentation on 'Endpoint determination of exhaustive extractions in medical device E&L studies – challenges, expectations and reality', as well as Tim's thoughts on the major challenges currently facing E&L professionals and NAMSA's work in the medical devices field.
Your presentation will look at endpoint determination of exhaustive extractions in medical device E&L studies. Can you give us a snapshot of what delegates will hear?
During the last year the dominant topics in the medical device E&L field have rather been related to instrumental analysis, like Relative Response Factors and Uncertainty Factors. I would like to take one step back and point to a topic that is omnipresent and taken for granted due to its rather rudimental character but at second glance comes up with some serious challenges: Exhaustive Extraction. The regulatory expectation for this extraction approach is pretty high while the guidance on how to properly determine the exhaustive endpoint is really vague.
My presentation will show the regulatory framework around exhaustive extraction, common approaches for exhaustive endpoint determinations as well as the challenges and discrepancy between expectation and reality.
Medical devices continue to be a very hot topic for our delegates, with implants being of particular concern. Can you tell us more about the work you and your colleagues are doing in that field?
Generally our focus lies on medical device chemical characterization studies per ISO 10993-Part 18. We see a lot of implants and in particular an increasing number of resorbable implants that pose a great challenge to the instrumental analysis and the study design in general, especially given the constant evolution of notified bodies’ expectations. That's why we are committed to working closely with our clients, bringing in all our experience in the field to achieve the best solution for each individual device.
What do you see as the major challenges that E&L professionals in general are facing? How might that change in the near-mid future – anything evolutionary/revolutionary on the horizon?
I think there are a lot of creative and reasonable methodological approaches to cope with the E&L challenges out there in the industry. However, in the end all these approaches should actually stand up to independent scrutiny by means of round robin studies or proficiency tests. And that is what everyone is lacking right now. So there is quite likely a huge variance between different laboratories.
In the beginning of the year FDA has published a scientific overview on how different E&L challenges are and can be addressed. And there are rumours that there is an official and comprehensive FDA guidance document still to come which might bring us into more standardized pathways.
What are you most looking forward to hearing about and discussing with your peers at E&L Europe 2022?
I am generally looking forward to learning about different points of view on controversial E&L topics and newest trends and tendencies within the industry.
