FDA: Providers should use revised PENTAX duodenoscope reprocessing instructions
AHA News Now
Feb 22, 2016
PENTAX has issued revised manual reprocessing instructions for its ED-3490TK Video Duodenoscope to replace those provided in the original device labeling, the Food and Drug Administration reports. Health care facilities using the duodenoscope should train staff on the new validated instructions and implement them as soon as possible, the agency said.
Topic: Advocacy and Public Policy
Tags: patient safety, regulation