Will EtO gaz become a Medical Device?

When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that.
Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode.
►Who is Christina Ziegenberg?
Dr. Christina Ziegenberg can look back on a distinguished career in medical technology, the chemical industry and pharmacy. With an education at the HBLVA for Chemical Industry in Vienna, a diploma in pharmacy at the University of Vienna and a doctorate at the Private University of Liechtenstein (UFL), she has held management positions at Hilti Aktiengesellschaft, the Liechtenstein State Administration and most recently at BVMed, where she holds the position of Deputy Managing Director / Head of the Regulatory Affairs Department.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
BVMed website: www.bvmed.de
BVMed link: www.bvmed.de/de/english/bvmed...
Current BVMed Position Paper in German: www.bvmed.de/download/positio...
BVMed Position Paper with regards to the public consultation: www.bvmed.de/download/bvmed-p...
Information regarding EtO from ECHA: echa.europa.eu/de/information...
Assessment report: echa.europa.eu/documents/1016...
BPC Opinion: echa.europa.eu/documents/1016...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@user-gg7lt1lm8l]

Assuming the EO becomes a MD, at this point all steriliants will be and what about CO60?

[@EasyMedicalDevice]

This was also a question. Will this open the door to all other sterilants. So let‘s see where this will be going.

[@yadavmeghana6607]

Hi Monir, we are surgical blade manufacturer in India and devic eis gamma sterile. We are just thinking to add ETO also within our scope. But I watch this video and now we will have to think twice before going on ETO. What is your openion in this matter, should we still go with ETO or just need to stay with Gamma.

[@EasyMedicalDevice]

Hi, the problem for EtO will be on the manufacturer of such gas. If they accept to comply with the potential new rule then there will be no problem for you. But the risk is that EtO manufacturers are not following the rule and there can be a shortage in the market. So this is not easy to imagine what will happen