AAMI Releases New Guidance for Radiation Sterilization
AAMI released new guidance to update best practices for radiation sterilization validation and routine control of single-use systems.
AAMI released new guidance to update best practices for radiation sterilization validation and routine control of single-use systems.
The AAMI Foundation has awarded more than $45,000 in Kilmer Fund Committee grants for projects on improving sterilization.
The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation.
AAMI released new guidance to update best practices for radiation sterilization validation and routine control of single-use systems.
Shreis Scalene Therapeutics will fast-track the manufacture and distribution of the CE-marked SHYCOCAN under U.S. FDA ”Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
Read MoreSalt Lake City-based healthcare management company oneSOURCE announces a partnership with Pfiedler Education, a subsidiary of the Association of periOperative Registered Nurses, to offer free access to a webinar course from sterile processing expert Rose Seavey.
Read MoreThis project began at the request of longtime research partners at Mount Sinai. As the pandemic worsened in New York City, and the shortage of PPE deepened, they asked if Rensselaer could develop a way to make critical resources last longer without losing their effectiveness.
Read MoreVaporized hydrogen peroxide (VHP) failed to completely sterilize surgical tools 76% of the time when the tools were soiled with salts or blood and not cleaned prior to sterilization, according to a study published in Infection Control & Hospital Epidemiology.
Read MoreThe recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois and the closure and potential closure of two other large-scale sterilization facilities in Georgia has raised concerns about potential shortages of certain sterile medical devices. Here is what the FDA is doing about it.
Read MoreECRI Institute announces that it opposes a total ban of commercial ethylene oxide (EtO) sterilization because it could result in widespread shortages of sterile medical devices.
Read MoreThe FDA-cleared, low-temperature sterilization system utilizes vaporized hydrogen peroxide and ozone to achieve terminal sterilization of heat- and moisture-sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, making it a cost-effective infection control solution for hospitals.