AMA on Sterilization


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This week we’ve invited Jody Birks from the Eagle Medical for an exclusive AMA (ask me anything) session on Sterilization.

If you’re not signed up yet, be sure and RSVP here.

What challenges are you currently facing as you work through your sterilization process? What feels unclear?

Ask us anything!

Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.

P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!

If you have run into problems, send a message directly to @Etienne and let us know!

Link to Zoom meeting.


19 replies

Will eBeam sterilization be covered in this AMA session?

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@Christoffer - I just heard from Jody and yes, we can talk about eBeam!

I have a new device design with new materials used in its construction, will you talk about how sterilization can affect them?

Our device products are sterilized with EO by contract sterilization services. Do we need to do EO monitoring at our warehouse facility? Thanks.

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What are some of the specifics that we need to be thinking about when we transition from one sterilization process to another (Gamma to EO, for example)

I have a new device design with new materials used in its construction, will you talk about how sterilization can affect them?

@remorgan  AAMI TIR17:2017 is a really great resource that goes into material compatibility across the common modalities!

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Do you think ETO sterilization could be replaced by an irradiation type of sterilization? (It seems like the go-to sterilization method for implantable devices is always ETO and I'm wondering why other solutions are not used)

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Is gamma dependable if one wants to increase brittleness of a polymer in order to reduce wear?

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What are people experiencing as validation timelines for new devices compared between the modalities?

 

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what is everyone else doing now with regards to the worldwide Tyvek shortage?

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What is the benefit of Chlorine Dioxide/Nitrogen Dioxide versus ETO?

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What are your thoughts on parametric release from a validated / monitored sterilization process versus dosimeter release for Gamma or BI release for gas sterilization?

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What should you do if your quarterly dose audit fails with eBeam? Meaning, you have more than 2/10 samples failing the sterility test.

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Why is the sterility test conducted with a much smaller dose than standard sterilization?

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What organism is the toughest for sterilization to kill?  Are some sterilization methods better at some organisms than others?

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If 1/10 samples falil the sterility test, you're OK, but should'n you be concerned that your device may not be sterile?

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Are there good predicates to refer to for H2O2 sterilization?

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Have you seen situations where mockup devices were used for validation with a good rationale? Let's say you have motors that the internal parts are completely sealed from the outsite, could you use mockups of these motors with the same material and outside geometry?

@Amy Wang  EO sterilization validation will provide data and aeration compensation for EO residual on the product.  The off-gassing of the product is generally performed under heat in an aeration chamber at the sterilizer after the the sterilization cycle.   EO monitoring in your warehouse (I am assuming for worker safety) should not be necessary, as a general rule.  However, if your warehouse is the designated location for off-gassing, it would be important to run a risk assessment and determine if monitoring is necessary.

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