On 4 & 5 March, Nelson Labs Leuven hosted their annual Open House Days. The PDFs of the presentations from this two-day seminar are now available. Contact [email protected] for more information.
Leading Portfolio of Differentiated Services
Speaker: Eric Meyers
Download the presentation slides here.
Changes to ISO 10993-1 and relationship to Medical Devices Regulation
Speaker: Henry Sibun
The MDR comes into force in May 2020 bringing a step up in the expectations of medical device Notified Bodies. The 2018 revision of ISO 10993-1 goes hand-in-hand with the MDR to give clear and more detailed guidance on what is required. This presentation will highlight the increased focus on the chemical and physical nature of the product.
Download the presentation slides here.
The new ISO 10993-18 Standard and its Impact on Chemical Characterization of Medical Devices
Speaker: Dr. Ted Heise
To meet the heightened focus on chemical characterization in ISO 10993-1:2018, a major revision of ISO 10993-18 “Chemical characterization of medical device materials within a risk management process” was undertaken. The revised document published in January 2020. This conference session will focus on key parts of the new document, bringing in experience and lessons learned from multi-stakeholder development of the final standard.
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The role and challenges of toxicological risk assessment to support the process in ISO 10993-18:2020
Speaker: Dr. Carsten B. Senholt
After more than a decade of preparation by the working group experts, ISO 10993-18:2020 was recently published as a final international standard. In this document, there are extensive references to the need for toxicological risk assessment which goes far beyond the scope of ISO 10997-17:2009. With the focus on results from analytical testing, this presentation will outline the general purpose of toxicological risk assessment. Finally, examples illustrating some of the major challenges for a future revision of ISO 10993-17 will be given.
Download the presentation slides here.
MDR/IVDR – so you think your plastics supply chain can help? How MedPharmPlast is helping overcoming the potential challenges’
Speaker: Steve Duckworth
MDR/IVDR makes it essential for OEMs to understand what substances are in their devices. This pattern is repeated in impending USP regulations to use so-called ‘well-characterized materials’ Faced with these questions, and a growing list of ‘substances of concern’, how will you be in compliance ? The usual approach of ask my suppliers ‘Does it contain XYZ?’ is likely to result in some surprising answers! Maybe you feel you don’t have a necessary depth of plastics materials knowledge? Does this mean I need to test for everything? A good ‘risk management’ strategy is first to understand what information is possible to have and what not. In this presentation we look the practical challenges you will face to get the answers you will need. Also how MedPharmPlast Europe and its ‘vertical expertise’ can help overcome these challenges and tap into the 100s of years of combined plastics and regulatory know how.
Download the presentation slides here.
ISO 10993-18 in the MDR: understanding the restrictions and risk assessment for compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4)
Speaker: Dr. Annelies Vertommen
This presentation explains to what extent a chemical characterization study (ISO 10993-18) can assist in meeting the requirements of section 10.4 of the MDR. A workflow for both the labeling obligation as well as the risk assessment is proposed. This requires a clear understanding of the difference between a targeted and screening analytical approach and the corresponding level of quantification.
Download the presentation slides here.
The Essence of EU MDR
Speaker: Dr. Gert Bos
The enhanced focus of the EU-MDR on biocompatibility and toxicity will be placed in perspective of the overall changes in details and concept of the European expectations. This presentation will provide some insight in the motivations to enhance the effective regulatory burden in a way that will help understand what focus should be taken for regulatory compliance.
Download the presentation slides here.
The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device
Speaker: Dr. Sophie Michel
In the evaluation of medical devices for biocompatibility, the assessment of patient safety should be made based on risk rather than on a check-box approach. In this aspect, we will see how to construct a Biological Evaluation Plan as per ISO 10993-1 (2018). The presentation will especially show how understanding patient contact and gathering information is the key in defining an adequate biocompatibility testing program.
Download the presentation slides here .
Competent Authority Perspectives on Biocompatibility
Speaker: Dr. Pieter Van De Vijver
The first part of this presentation will consist of an overview of the structure, functioning and responsibilities of the FAMHP, the Belgian competent authority for Medical Devices and Medicinal Products. The second part of this presentation will focus on a number of specific issues (case studies) related to Biocompatibility that we have encountered in the recent past.
Assessing Alternatives to In-Vivo testing: Changing the Paradigm from In-Vivo to In-Vitro Toxicology
Speaker: Dr. Christian Pellevoisin
The successes achieved in replachng in vivo tests by alternative approaches in the field of cosmetics and chemicals are the starting point for a program initiated in recent years by the workgroup 8 of the technical committee 194 (ISO/TC 194/WG 8) for biocompatibility of medical devices. The irritation project aimed to replace the in vivo Draize test by an in vitro method using reconstructed human epidermis (RhE) models led to a new standard, the ISO 10993-23 for irritation, that should be released in 2020. Other projects based onto human reconstructed tissues are engaged for in vitro eye irritation, vaginal irritation or skin sensitization of medical devices. The translation of these in vitro approaches in updated or new ISO 10993 standards will provide adapted solutions in the coming years to progressively shift from animals to alternative approaches for risk assessment of medical devices.
The need to Identify “Unknowns” from a Risk Management Perspective
Speaker: Ron Brown
The toxicological risk assessment of extractable and leachable (E&L) compounds is ideally based on compounds that have been identified with a high degree of confidence. However, challenges in the analytical chemistry process may make confident identification difficult for some E&L compounds. This talk explores the toxicological implications of not identifying compounds with a high degree of confidence, of misidentifying compounds, and of not uniquely quantifying compounds in an extract. In addition, the presentation will describe proposals for conducting a toxicological risk assessment on tentatively and partially identified compounds and will describe how to prioritize compounds for more confident identification based on their potential toxicological risk.
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How to select a CRO for Chemical Characterization Testing
Speaker: Dr. Dennis Jenke
The collection, interpretation and utilization of extractables or leachables (E&L) data are not trivial processes and the scientific and practical requirements for performing these activities may be beyond the technical and/or resource capacities of many organizations. As Extractables and/or Leachables assessments can be extensive and expensive, a high level of diligence must be exercised in identifying, qualifying and utilizing a CRO to perform E&L studies. Thus, identifying, screening, qualifying and implementing the right CRO is an intentional, thoughtful and meticulous process that requires an investment on both the part of the client and the prospective supplier. In this presentation we will consider some of the technical and practical considerations that will ensure that a good and proper match is made between client requirements and expectations and the CRO’s ability to meet those obligations.
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Most Common Types of Observations in Regulatory Submissions of Chemical Characterization Results and how to address them
Speaker: Dr. Piet Christiaens
The observations of health authorities on the analytical approaches used in chemical characterization of medical devices are mainly given in order to guarantee that no errors will be made in the Chemical Assessment that could impact the outcome of a subsequent Toxicological Risk Assessment. The recently published series of articles “Errors in Chromatographic Screening” (PDA Journal) address the errors that can be made in chromatographic screening in Extractable Studies and also make the evaluation on how a supporting database could assist in avoiding the occurrence of such errors. The presentation will take a deeper dive in how the information that is gathered in a database can assist these regulatory observations.
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Introduction to Reprocessing of Medical Devices and physical/chemical impact
Speaker: Henry Sibun
The clinical use of medical devices as well as their subsequent reprocessing exposes them to processes that can significantly impact their physical and chemical nature. This presentation will introduce the processing cycle and factors that can impact their biocompatibility.
Download the presentation slides here.
Sterilization of your Medical Device
Speaker: Annick Gillet
The presentation will explain the difference between cleaning, disinfection and sterilization. We will briefly explain the concept of sterility assurance level and the different technologies that can be used to sterilize a medical device. Introduction to radiation technology ( E-Beam and Gamma) and Ethylene oxide sterilization .
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If something looks clean, is it really clean? Cleaning validations for reusable devices.
Speaker: Dr. Lise Vanderkelen
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Reprocessing Validations of reusable Medical Devices –
Speaker: Alpa Patel
Reprocessing validations of Reusable medical devices have seen overlooked for quite some time and therefore importance to these validations have taken a back seat until recently. With the upcoming MDR requirements and US FDA Scrutiny over reusable medical devices has shed a light to their importance and significance. The presentation will highlight some of the key aspects of what is required for validation studies for these type of devices and how to perform these validations. It will give a perspective of what is needed to overcome these validations and where in the design phase do these validations make their presence. The first presentation by Lise Vanderkelen will focus on cleaning validation and the second presentation by Alpa Patel will highlight the importance of disinfection validations as well as sterilization validations.
Download the presentation slides here.
