FDA Hosts Medical System Sterilization City Corridor – The Journal of Healthcare Contracting

FDA Hosts Medical System Sterilization City Corridor – The Journal of Healthcare Contracting



March 20, 2024 – Sterilization is an important step within the manufacturing technique of sure medical units. Sterilization of medical units helps stop severe infections. Insufficient sterilization can result in life-threatening infections.

Medical units are sterilized in a wide range of methods, together with utilizing moist warmth (steam), dry warmth, radiation, ethylene oxide (EtO) gasoline, vaporized hydrogen peroxide, and different sterilization strategies (e.g., chlorine dioxide gasoline, vaporized peracetic acid, and nitrogen dioxide).

On March 21, 2024, the FDA will host the subsequent in a sequence of medical system sterilization city halls to debate:

  • The worth and use of consensus requirements in pre-market overview
  • The function of the CDRH Requirements program within the improvement and recognition of consensus requirements
  • Not too long ago acknowledged consensus paperwork on the sterility of units and their potential use in pre-market overview, and
  • The worth of taking part within the collaborative requirements improvement course of.

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