![]() ![]() Circumstances that caused the death of a patient, user or someone else, or that caused serious deterioration in the health of a patient, user or someone else.Ģ. ![]() ![]() The following circumstances must be reported:ġ. The investigation may lead to changes in new or already delivered devices or in instructions and guidance. Under the medical devices directive, the manufacturer must investigate the cause of accidents/incidents that occur and report them to the authorities concerned. The unit may also be a sterilizer that is a medical engineering product and which conforms to the EU medical devices directive, or which is constructed in a similar way to a medical device. The unit is a product in the GETINGE range. The report must be used to identify the cause of the accident or incident and to what extent the occurrence was due to the unit If an accident or an incident associated with the sterilizers occurs, this must be reported immediately in writing to the address below. Use this information when reporting incidents and accidents involving the unit. 31 General advice when using the sterilizer.
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March 2023
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