- OSHA Healthcare Advisor - http://blogs.hcpro.com/osha -

FDA gives Steris more time to replace System 1 processer

In the long battle starring Steris Corp.’s System 1 processor, the FDA has extended the life of the processor and given healthcare providers until February 2, 2012, to replace it.

The System 1 processor  has been in the spotlight since the FDA issued its first warning in December 2009 . Since then, STERIS has been working to transfer its customers to the new System 1E product, reports medcitynews.com. [1]

STERIS reported that it asked the FDA for an extension while the agency is looking over a 510(k) application for a replacement part, reports Medcitynews.com. The application for the part was filed sometime after April 2010, though the part isn’t a necessity to activate the System 1E.

To read more about the FDA’s concerns and IC tips for healthcare facilities, take a look at OSHA Healthcare Advisor’s [2] reports.