Manufacturing site evaluation: the device was not available for physical evaluation by the manufacturer.Although no physical examination was performed, a similar investigation exists related to improper color transition of the indicator dots.To date, the reported ink failures have not been replicated without deviating from the product labeling or instructions for use.The device history records (dhr) were reviewed for the reported lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Additionally, product retains from three (3) different lots, manufactured around the same time, were evaluated.All retains had been stored according to protocol prior to the testing.The processed retains transitioned correctly and were not discolored or faded.To date, the reported ink failures have not been replicated without deviating from the product labeling or instructions for use.Therefore, the likely root cause was determined to be improper storage conditions.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilant.After usage the indicators should not be retained as a permanent record of exposure but rather a photo of the indicator should be utilized due to the indicators' sensitivity to light.The following guidelines should be followed to prevent this failure mode from occurring; avoid prolonged exposure to direct sunlight or uv lighting.Avoid storage at or near any hydrogen peroxide sterilizer.Avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.
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