Date: Wednesday, February 12
8:30 a.m. - 9:30 a.m.
The Global Transformation of Biocompatibility, What Happened and where are we Going?
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC
We have never seen a year as dynamic as 2019 was for biocompatibility, and 2020 is on track to be worse. With new regulations (MDR, 10993-1, 10993-17, 10993-18, among others) and the uncertainty with what is chemical characterization and how is it applied to medical devices companies that are struggling to be prepared for regulatory submissions. In this track, we will cover what has changed in the standards and regulations and look forward to what will be new in the coming months. We will use case studies to demonstrate best practices and learn from past mistakes, and in the end we will have a better understanding of what biocompatibility submission look like for this new decade.
9:30 a.m. - 10:30 a.m.
Chemistry for Toxicological Risk Assessment – Transitions in Expected Approach
Speaker: Matt Jorgensen, PhD, DABT, Chemistry & Materials Scientist, Nelson Labs, LLC
The basic theory of how medical devices should be evaluated for biocompatibility has been in a period of flux. A cornerstone of the new ISO 10993-1:2018 is that evaluation should be focused on a rational and risk-based approach that minimizes unnecessary animal tests. A large part of that approach relies on the use of chemistry and material information to make determinations regarding biocompatibility. Changes to regulatory policy have complicated this process. This presentation will provide an overview of the process for medical device chemistry studies, how this process has changed, and highlight recent examples implementing these changes in biocompatibility submissions to the FDA.
10:45 a.m. - 11:45 a.m.
Ethylene Oxide: Annual Requalification Review
Speaker: Russ Gonsiorowski, Sterigenics
Requalification is a critical aspect to maintain EO sterilization process effectiveness. How can you ensure the requirements in the standard are satisfied? This presentation will cover the necessary requirements and guidance regarding requalification under the ANSI/AAMI/ISO 11135:2014 standard and include real life scenarios.
- How to categorize devices
- Hands on sample preparation discussion ( know when to use coupons and how to represent a final device)
- Hands on E&L examples
1:30 p.m. - 2:30 p.m.
What's New in Radiation Sterilization & Discussion on Gamma/Electron Beam/X-ray
Speaker: Martell Winters, Director – Scientific Competency, Nelson Labs, LLC
This presentation will review new approaches/documents and microbiological aspects of radiation sterilization and a discussion on gamma/electron beam/X-ray, including the science of each and advantages and disadvantages.
2:30 p.m. - 3:30 p.m.
Common Approaches to Meeting the Requirements of Packaging Validations
Speaker: Wendy Mach, Consulting Manager, Nelson Labs, LLC
This presentation will go through a common life cycle approach to packaging validations and how to meet the requirements in ISO 11607. Additionally a brief look into some of the most common test methods used to meet these requirements.
3:45 p.m. - 4:45 p.m.
The Fast Changing World of Reusable Device Processing
Speaker: Emily Mitzel, Technical Consulting Manager, Nelson Labs, LLC
With the EU MDR now requiring processing validations for reusable medical devices along with a new classification of Ir the appropriate cleaning, disinfection, sterilization, and end of use life of reusable devices needs to be carefully defined. There are also other standards that will be published soon that will define the acceptance criteria for these validations. These standards include ISO 17664-2, updated 17664-1, ISO 15883-1, ISO 15883-5, and AAMI ST98. In this presentation you will learn how to meet the requirements of the EU MDR and other standards which saves medical device companies a lot of time and money.