ETO go home
****!!!! {Medical device sterilisation.} "As a sterilising agent, ethylene oxide’s days are numbered," "Furthering the progression away from EtO, the FDA newly approved a contract sterilisation facility for medical devices utilising CD gas in late 2020.1 This breakthrough advancement was awarded to ClorDiSys Solutions. The company was established in 2001, beginning as an adoption of technology the founders originally created within Johnson and Johnson. There, medical devices such as interocular contact lenses, sutures, artificial hip joints and more were sterilised internally using CD gas. This facility recently processed the first commercially sold medical device sterilised with CD gas that has US approval.
*****A draft Reference File for the use of CD gas has been created, which is developed from ISO and AAMI EtO guidelines. This serves to aid in submission packages to both the FDA and EU regulatory agencies. These tools provide a regulatory roadmap for validating the sterilisation process"