On April 26th Nelson Labs opened their doors in Leuven for the Open House day event, edition 2023. The PDFs of the presentations from this seminar are now available. Contact [email protected] for more information.
Welcome and introduction to Sotera Health and it’s BU
Speaker: Eric Meyers, Managing Director Nelson Labs Europe
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ISO 10993-1: a matchmaker guide for a biologically safe relationship between a medical device and a patient
Speaker: Lise Vanderkelen PhD, Dep. Head Microbiological Services – Nelson Labs Europe
How to evaluate a potential biologically safe relationship between a medical device and a patient? It is a challenging question that we need to address for each new or modified device. This kick-off presentation will highlight the importance of ISO 10993-1 in the matchmaking process using a 3-step approach: Plan, Test, Evaluate. In addition to this, you will understand how today’s topics are linked to ISO 10993-1.
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ISO 10993-18 – Introduction to Extractables and Leachables testing for medical devices: From device to chromatogram
Speaker: Ans De Roeck PhD, Senior E&L Expert – Nelson Labs Europe
This presentation will start with a brief introduction on Extractables and Leachables testing for medical devices, as described in ISO 10993- 18. Starting from the test item, by applying extraction solvents, ratios and conditions, extracts containing the compounds that might migrate from the medical device into the patient are obtained. These extracts are subsequently analyzed by chromatographic screening techniques resulting in chromatograms. Luckily, the concept of the analytical evaluation threshold has been developed so that not all compounds present need to be identified and quantified.
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Good Identification Practices in Non-Targeted Screening Analyses: the key-information to link a compound to its structure and relevant toxicological information
Speaker: Ward D’Autry PhD, Senior E&L Expert – Nelson Labs Europe
Identification is a vital part of the non-targeted screening data interpretation during a chemical characterization study of a medical device. A correct identification is a key element for the toxicological assessment since the toxic potential of a compound is directly linked to its chemical structure. Assigning a wrong identity inevitably leads to a flawed toxicological assessment where, in a worst-case scenario, the safety of the patient may be at risk. Adherence to good identification practices should mitigate the risk of securing incorrect identifications. In this presentation our suggested good identification practices will be explained in more detail. Additionally, strategies to upgrade the identification level of reported compounds will be discussed.
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Current and Novel Approaches in the Quantitation Strategy for Results of a Non-Targeted Screening Analysis: implications for the AET calculation.
Speaker: Dennis Jenke PhD, Principal Advisor – Nelson Labs Europe
Extractables and/or leachables from medical devices must be identified and quantified to establish their potential effect on patient health and safety. Accurate quantitation is essential to quantitative toxicological safety risk assessment to properly establish patient exposure to these chemicals. It is an unfortunate circumstance that accurate quantitation in E&L screening is complicated by the complexities of non-target analysis (NTA). In this presentation, the questions of when and how to quantitate are considered and the science-based approach adopted by Nelson Labs is discussed.
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Looking into the Future of Extractable testing to support Chemical Characterization: What can we learn “Non-Targeted Analysis”- Approaches and Practices applied in other Industries
Speaker: Piet Christiaens PhD, Scientific Director – Nelson Labs Europe
It has now been more than 3 years ago since the adoption and implementation of the new ISO 10993-18 standard in Chemical Characterization for Medical Devices. With this implementation the science of E/L-testing on medical devices, which is mainly based on Non-Targeted Analysis (NTA), has improved substantially. However, there is a clear consensus from both the Industry as well as from the Regulators that more guidance and harmonization is needed and necessary. Aspects in Quantification and Identification will need to be better defined if the outcome of E/L-studies should be comparable between different labs. While the outcome of a structure elucidation (identification) exercise for detected compounds is binary – it is either true or false – for quantitation based upon the existing quantification practices lead to a broad range of reported concentrations for compounds. An idea on how to harmonize on the quantitative aspect of an E/L study is to introduce the concept of “protective concentrations” versus accurate concentrations. The presentation will also explore what consequence this would have on the currently existing and accepted AET calculations.
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The Chemical Characterization to Support Biological Evaluations of Devices with Different Levels of Risk
Speaker: John Iannone Global Head, Biocompatibility, Toxicology, Sterility, & Microbiology – Cardinal Health
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NVR Reconciliation – Expectations versus Reality
Speaker: Lindsay Frankart PhD, MBA, DABT, Staff Toxicologist, Toxicology/Biocompatibility
Non-volatile residue provides important information for the exhaustive extraction process. What are the expectations from regulators on the reconciliation between NVR and the analytical data? What are labs capable of reconciling? In this case study, a toxicologist will provide their perspective on the process of reconciling NVR data to analytical data during an FDA 510(k) submission. Lessons learned, including the importance of prompt laboratory communications and additional testing to reconcile NVR values will be presented.
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Lessons Learned in Chemical Characterization: Manufacturer Experiences from FDA and EU Notified Body Submissions
Speaker: Matthew R Jorgensen PhD, DABT Toxicologist, Global Biocompatibility – Teleflex
Chemical characterization plays a pivotal role in ensuring the safety of medical devices. The focus of this presentation is to share valuable insights and lessons learned from a manufacturer’s experiences in submitting chemical characterization data to the FDA. We will discuss the regulatory requirements, challenges faced during submission, and best practices for successful submissions. Using real-world case studies, we aim to offer valuable guidance for experts in chemical characterization to navigate the complex regulatory landscape and improve patient safety and outcomes.
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From Hurdles to High-Fives: Navigating towards EU MDR Compliance
Speaker: Rodrigo Feliciano PhD, Sr Manager, E&L, Renal Care Renal GBU – Baxter R&D Europe
In this presentation, the impact that EU MDR has brought to the E&L world will be discussed, as well as the efforts required to sustain market access for Acute Solutions and Renal Care medical devices provided by Baxter to millions of patients. This presentation will also highlight the challenges that EU MDR has placed on the medical device industry, as well as provide hints on E&L testing strategies for EU MDR.
At a high-level, the long journey that EU MDR represents to manufacturers will be demonstrated with specific examples and case studies of deficiencies received by different notified bodies and how Baxter has turned hurdles into high-fives. Lastly, the presentation will provide an insight to what the post- MDR world might look like in terms of change controls driven by the constant challenges in the current uncertain global supply chain environment.
Presentation not available for download.
