Keep Connections With Colleagues on Your Radar
Spring is the season for conferences and live events, which can go a very long way toward revitalizing your outlook....
This website uses cookies. to enhance your browsing experience, serve personalized ads or content, and analyze our traffic. By clicking “Accept & Close”, you consent to our use of cookies. Read our Privacy Policy to learn more.
By: OSD Staff
Published: 12/4/2009
The FDA is urging users of the Steris System 1 to find an alternative method to sterilize and disinfect instruments, saying in a safety alert yesterday that it has received reports of the popular SS1 tabletop liquid chemical reprocessor malfunctioning and that it could cause such "serious injuries" as infections to patients. The FDA also said it had received "reports of injuries, mostly burns from exposure to the sterilant solution, to health care facility staff operating the device," although it called these reports infrequent and said they could be the result of user error.
A Steris spokesman said company officials are reviewing the FDA's safety warning, which is the latest salvo in an ongoing battle between the FDA and Steris over the SS1.
The FDA issued yesterday's warning letter because, based on a recent inspection of Steris and meetings with the firm, the agency "isn't satisfied that the firm has been working effectively to transition its customers to replacements for the SS1." In addition, the FDA claims that Steris has been reassuring customers that there is no need for a change in their clinical practice and that the company is continuing to design or redesign new accessories for the SS1.
The FDA has prepared a question-and-answer document.
Spring is the season for conferences and live events, which can go a very long way toward revitalizing your outlook....
The U.S. Food and Drug Administration (FDA) announced this week that its ongoing investigation of plastic syringes for potential failures has found that the use of...
People often rise to leadership positions due to the excellent quality of their work, but then may have a tough time letting go of that work in their new position....