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Comment & Response
February 3, 2015

Sterilization of Endoscopic Instruments—Reply

Author Affiliations
  • 1Hospital Epidemiology, University of North Carolina Health Care, Chapel Hill
JAMA. 2015;313(5):524. doi:10.1001/jama.2014.17584

In Reply We are aware of only 1 liquid chemical sterilization process that was cleared by the FDA in 1988, the Steris System 1 sterile processing. In December 2009, the FDA ordered all health care facilities that used the System 1 processors to replace the unit with a legally marketed substitute.1 In April 2010, the FDA approved the Steris System 1E Liquid Chemical Sterilant (SS1E). The SS1E uses a chemical sterilant, peracetic acid, to process devices. After treatment with peracetic acid, the device is considered to be liquid chemically sterilized. However, the SS1E then rinses the processed device with extensively treated, but not sterile, water to remove the chemical residues to ensure the processed devices are safe for the intended use.