If you have use errors in your risk management file and you rely on the clinician's education and knowledge as a form of risk control, how can you verify that risk control?
-Usability studies are too costly and impractical for most class 1 and 2 devices.
-Information for use cannot be used to reduce risk, therefore it cannot be used as a form of risk control
Example 1:
-Hazardous Situation: Clinician does not position implant properly.
-Sequence of Events: Clinician use error
-Risk Control: Clinician's education and certification process
-Control Verification: ????
Example 2:
-Hazardous Situation: Clinician forgets to remove ancillary device from patient post surgery
-Sequence of Events: Clinician use error
-Risk Control: Clinician's education and certification process
-Control Verification: ????
any help would be greatly appreciated.
-Usability studies are too costly and impractical for most class 1 and 2 devices.
-Information for use cannot be used to reduce risk, therefore it cannot be used as a form of risk control
Example 1:
-Hazardous Situation: Clinician does not position implant properly.
-Sequence of Events: Clinician use error
-Risk Control: Clinician's education and certification process
-Control Verification: ????
Example 2:
-Hazardous Situation: Clinician forgets to remove ancillary device from patient post surgery
-Sequence of Events: Clinician use error
-Risk Control: Clinician's education and certification process
-Control Verification: ????
any help would be greatly appreciated.