The FDA issued a notice on December 3, 2009 advising U.S. facilities utilizing a System 1 Sterile Processing System (SS1) to immediately begin planning a transition to alternative processing methods. The FDA cited ongoing concerns regarding patient and healthcare worker safety, and recommended that healthcare facilities in the US discontinue use of the SS1. This notice was further updated by the FDA on February 2, 2010.
AVOID LIABILITY AND NEGATIVE ATTENTION
Given the high level of public attention this FDA notice has received including extensive coverage by the media, Hospitals that continue to use the SS1 will be under greater scrutiny and potential liability following hospital acquired infections or patient injury involving those treated with devices that were reprocessed in the SS1 regardless of the actual source.
- IT’S MORE COMPLICATED THAN YOU MIGHT THINK
- THE TIME TO ACT IS NOW
- WE CAN DO IT FASTER
Don’t miss the opportunity to engage the ISH team of clinical experts before the deadline encroaches.
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