• Regulatory NewsRegulatory News

    Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

    On 6 and 7 November, a US Food and Drug Administration (FDA) medical devices advisory committee will meet to discuss the use of ethylene oxide (EO) to sterilize medical devices and the risks of infection with reprocessed duodenoscopes. The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions and as postmarket surveillance studies ...
  • Regulatory NewsRegulatory News

    Georgia Seeks to Shutter BD Device Sterilization Facility

    Georgia Attorney General Chris Carr earlier this week filed a complaint in court to temporarily halt Becton, Dickinson and Company (BD) from operating its Covington, Georgia medical device sterilization facility. Carr alleges that in September, BD released 54.5 pounds of ethylene oxide, which is often used to sterilize devices, into the atmosphere because of “a lack of diligence and prolonged operator error rather than an equipment malfunction.” He also said that the...
  • Regulatory NewsRegulatory News

    ICH Reverts to Previous Version of Guideline on Residual Solvents

    The International Council for Harmonisation (ICH) has further explained why it decided to go back and change the Permissible Daily Exposure (PDE) for ethylene glycol (EG), and then more recently, to reverse that decision and revert back to the original figure. Prior to 2017, the ICH Q3C guideline, which deals with residual solvents, included a Summary Table 2 that listed EG as a Class 2 residual solvent with a PDE of 6.2 mg/day. But in 2017, ICH was notified by an exter...