Sterilization

[MedDev12]

Hello,

I am seeking advice from anyone with experience in Sterrad sterilization or hydrogen peroxide sterilization methods. We have a few questions and would appreciate your insights:

1. Are there any acceptance criteria for hydrogen peroxide residues on medical devices, such as implants?
   We have reviewed various standards and articles but have not found clear information regarding residue acceptance criteria for hydrogen peroxide on medical devices. The closest we found was related to ointments and food products. Could anyone point us to relevant guidance or standards for medical devices?
2. Is there any available testing to determine the decomposition rate of hydrogen peroxide into water and oxygen during the Sterrad sterilization process?
   We are interested in understanding how quickly hydrogen peroxide breaks down during the sterilization process and if there are recommended testing methods for this.
3. If no specific standards exist for establishing residue acceptance criteria, what would be the best approach to ensure residue levels remain within safe limits?
   In the absence of clear standards, what steps would be advisable to establish or validate safe residue levels for medical devices?

Thank you!

 

[planB]

You might want to have a look into ISO 22441:2022, Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices and into this recent 3-part webinar series from NelsonLabs (not affiliated).

HTH,