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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During the validation of a new instrument testing revealed that use of a gravity steam cycle with one of the listed instrument trays did not produce the sterility assurance level (sal) of 10-6 recommended by industry standard (ansi/aami st77:2006). a subsequent investigation of all medtronic xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of sal10-6 during gravity steam sterilization cycles. the trays identified through the testing are the subject trays involved in this field action. instruments that are sterilized in the "worst-case" locations of the identified trays have a higher potential to be inadequately sterilized. an instrument that is inadequately sterilized can become the source of cross-contamination or cross-infection when used in multiple surgical procedures. at this time medtronic has no evidence in the complaint files to indicate there have been any reports of inadequate sterilization cycles (i.E. cycle failures) or adverse events (infections) caused by inadequate sterilization of instruments in the subject instrument trays. note: this issue only involves gravity steam sterilization cycles. the listed instrument trays have been demonstrated to be satisfactorily validated for prevacuum steam sterilization cycles as detailed in the instructions for use that accompany medtronic xomed and medtronic xomed instrumentation manual surgical instruments.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.