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ON-DEMAND WEBINAR





ON-DEMAND WEBINAR

Guidance for cleaning, disinfection and sterilization of reusable medical devices

Published Date: September 18, 2019

All reusable devices should contain specific instructions for cleaning, disinfecting and/or sterilization of the device. In order to be compliant with global regulations, manufactures should have their instructions for use (IFU) validated to ensure patient safety and mitigating cross contamination. It is recommended to validate at least one method for each applicable stage of reprocessing of the medical device.

During this 45-minute webinar anyone involved in the manufacturing of reusable medical devices (from Design R&D teams to people working in Quality Assurance or Regulatory) will learn more about:

  • The full processing cycle (What is reprocessing and what devices should be considered for this type of testing)
  • How to comply with the new EU MDR
  • The validation of a cleaning procedure (To what extend the device design can impact the validation protocol)
  • Methods for disinfection or sterilization instructions
  • The importance of cytotoxicity testing after a reprocessing cycle
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Stefanie Roberfroid

Study Director Nelson Labs Europe

Stefanie Roberfroid gained her Master’s degree in Bioscience engineering in 2010 at the University of Leuven (Belgium). She worked on her Ph.D. with a focus on microbial biofilms until 2016. In 2017 she started her career at Nelson Labs Europe as study director at the Microbiology Department, focusing on all microbial testing for e.g. GMP batch release, quarterly dose audits and environmental monitoring. Furthermore she is specialized in in-vitro Toxicology testing and reprocessing validations, including steam sterilization, cleaning and disinfection validations.

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Melissa Galle

Study Director Nelson Labs Europe

Melissa Galle holds a bachelor’s degree in Biomedical Laboratory Science. She started her career at Nelson Labs Europe in 2014 as a Laboratory Technician, gaining a lot of experience in the technical conduct of projects related to microbiology, in-vitro toxicology, and healthcare reprocessing of reusable medical devices. In 2016, she was promoted to Study Director and started managing cleaning, disinfection and steam sterilization validation projects for manufacturers of reusable medical devices.

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