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Toxicological risk assessment of medical devices constituents; proposed changes to ISO 109930-17

The international working group is substantially revising ISO 10993-17, with the changes set to be discussed at the next ISO 10993 technical committee meeting. Ahead of this meeting, we spoke to Dr. Sherry Parker, Toxicological Director at Fresenius Medical Care and a member of the writing team, to get the latest on the proposed changes and discuss why it's an important topic for the industry to discuss. 

Q1. At E&L Europe 2018, you will be discussing the proposed changes to ISO 10993-17, could you explain in further detail what this entails?

The international working group is substantially revising ISO 10993-17, and changes will be discussed at the next ISO 10993 technical committee meeting in December. As a member of the writing team, I plan to present some of the proposed changes, and the impact of these changes on the biological evaluation of medical devices. The upcoming revised standard will expand from current guidance on establishing allowable limits of leachable substances, to conducting a toxicological risk assessment of medical device constituents. Topics to be addressed will include hazard identification, exposure assessment, dose-response assessment, and risk characterization. There will be emphasis on the use of expert judgement to determine whether the toxicological risks of exposure to extractable or leachable chemicals in medical devices are acceptable, and what additional steps may be taken to mitigate risk.

Q2. Why is this an important topic to discuss and share with the E&L community?

There have been many changes in standards and guidance for extractables and leachables in medical devices, pharmaceutical packaging and drug delivery systems resulting in more complete chemical characterization of these products. The toxicological risk assessment provides the means of evaluating and interpreting the chemistry data, to determine whether toxicological risks of constituents released from a medical device will be acceptable. E&L testing should be conducted in close collaboration with a toxicologist to ensure the provided chemical characterization data will be appropriate to support the toxicological risk assessment. Understanding how these data are used in the risk assessment will facilitate the development of successful E&L testing strategies.

Q3. Where do you foresee the industry headed in the next 5 years and why?

I see that improved guidance, and advances in tools and instrumentation for analytical chemistry will allow for more complete understanding of potential patient exposure to chemicals from medical devices and pharmaceutical products. Furthermore, tools for conducting toxicological risk assessments (e.g. QSAR, read-across) for prediction of toxicity are advancing. Over the next 5 years, I expect that chemistry and toxicological risk assessments will provide more specific information to address biological risks, reducing in vivo testing needed to support safety.  I hope that these advances in chemistry and risk assessment will accelerate the speed to market for new life-changing technologies.

Q4. What are you most looking forward to at E&L Europe 2018?

I am looking forward to attending E&L Europe for many reasons. Interacting with scientists/toxicologists outside of the US provides me with new perspectives on regulatory considerations and challenges.  I am looking forward to lively discussions about the changing standards, and approaches to risk assessment for different regulatory bodies. The conference also includes many opportunities to connect with other scientists during breaks and social events, and I am looking forward to seeing old colleagues and meeting new ones.

Dr. Parker will be presenting as part of the Medical Device and Drug Device Combination Products session at E&L Europe this November. Other speakers in the session include:

  • Dr. Clemens Günther, Director Nonclinical Safety Consumer Care at Bayer Healthcare Pharmaceuticals
  • Dr. Albrecth Poth, Senior Toxicologist at Dr Knoell Consult
  • Ronald Brown, former US FDA Toxicologist
  • Dr. Alexander Koerner, Project Manager - Biocompatibility at Roche

The session will also feature a panel discussion with the speakers above on the future of biocompatibility testing, ISO 10993 part 18 revision process, what can be learned from drug product E&L testing and vice versa, what is still needed to avoid animal testing and more. The panel will be led by Carsten Worsoe of Novo Nordisk.


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