Home » Steris’ MedWatch Highlights Need for Communication
Steris’ MedWatch Highlights Need for Communication
A recent MedWatch about Steris’ System 1 (SS1) processor used to sterilize devices “blindsided the company,” Daniel Owczarski, a device
analyst at Avondale Partners who covers Steris, said of the notice sent earlier this month that advises healthcare facilities to find alternative processing
methods. Communication between CDRH and the company had dwindled in recent months, he added, as Steris assumed the agency was reviewing the 510(k) application
it submitted nearly a year ago in response to a warning letter. Steris disagrees with the MedWatch and insists the SS1 is safe and effective when used
as directed.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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