Confusion Surrounds FDA Handling of Steris Product

Are endoscopes labeled for use with the Steris Corp. System 1 sterile processing system misbranded? That's what endoscope manufacturers want to know. According to MedCity News, FDA sent a letter to endoscope makers on February 22 that urged them to change their labeling if it recommended use of the Steris product. However, the agency did an about face on February 23, sending an e-mail to the manufacturers that seemed to recall the previous letter.

February 25, 2010

1 Min Read
Confusion Surrounds FDA Handling of Steris Product

Steris is unsure what to make of the agency communication. A company representative said that Steris had called FDA, but had not yet received an answer, according to MedCity News.

FDA has previously issued a warning letter to Steris about the sterile processing system. You can read more about it in February's Washington Wrap-Up

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