Category: Design Control

Considerations Not Addressed in the FDA’s Communication Discussing Olympus’ New Instructions for Reprocessing the TJF-Q180V Duodenoscope

March 27, 2015 — On March 26, 2015, the FDA issued a safety communication: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here. This Olympus safety communication…

HLN-TV NEWS: “Dr. Drew responds to ‘superbug’ health scare” — Dr. Muscarella’s Reply

Dr. Muscarella’s following comments and perspectives are in reply to HLN-TV’s recent article: Dr. Drew responds to ‘superbug’ health scare | HLNtv.com (March 9, 2015) HLN-TV (a national television network)…

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…