Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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The operation manuals containing reprocessing instructions have been updated to reflect newly validated manual cleaning and high-level disinfection procedures. given publicized reports of multi-drug resistant bacteria on certain duodenoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures and in an abundance of caution fujifilm has been working with the fda to validate revised reprocessing procedures that have been provided in the operation manuals. healthcare providers are being instructed to follow the exact instructions for reprocessing provided in the revised operation manuals in order to minimize the risk of disease transmission.