Example Risk Assessment Template for Ultrasound Probe Disinfection/Sterilization Product/Process: Room Locations: Likelihood of hazard occurring Harm Example mitigations (if risk rating Risk After Hazard Type Hazard Potential harm(s) Risk and severity >low) Mitigation resulting in harm Disinfection/sterilization Damaged equipment Ensure the disinfection/sterilization process not deemed could lead to process is deemed suitable by the Chemical/ compatible by ultrasound compromised image manufacturer and follow the Low Physical equipment manufacturer quality and manufacturer’s IFU regarding disinfection leading to damage to misdiagnosis or injury or sterilization. ultrasound equipment. to patients. Key parameters not met Following the manufacturer’s instructions during for use with respect to disinfection/sterilization of disinfection/sterilization protocol. leading to failed cycle: Using a validated, automated Incorrect disinfection/sterilization method that is Pathogens may remain disinfectant/sterilant also deemed compatible with the probe on the probe and contact time manufacturer. Biological potentially create Low Incorrect Using indicators or other monitors to infection risk to disinfectant/sterilant indicate whether the subsequent patients. temperature sterilization/disinfection cycle has been validation not completed successfully. incorporated in Using labels on sterilized/disinfected disinfection/ probes to indicate the level of reprocessing sterilization process undertaken on probe. Maintain logbook in the cleaning area to Inability to recall document and record each disinfection or Traceability not ultrasound device or sterilization cycle including date and time, Biological incorporated in recall patients that may end-user information and Low disinfection process. have been harmed due disinfection/sterilization completion and to process failure. success status. Ensure that reprocessing records are linked to patient records.
Example Risk Assessment Template for Ultrasound Probe Disinfection/Sterilization Product/Process: Room Locations: Hazard Type Hazard Potential harm(s) Likelihood of hazard occurring and resulting in harm Harm severity Risk Example mitigations (if risk rating >low) Risk After Mitigation Chemical/ Physical Disinfection/sterilization process not deemed compatible by ultrasound equipment manufacturer leading to damage to ultrasound equipment. Damaged equipment could lead to compromised image quality and misdiagnosis or injury to patients. Ensure the disinfection/sterilization process is deemed suitable by the manufacturer and follow the manufacturer’s IFU regarding disinfection or sterilization. Low Biological Key parameters not met during disinfection/sterilization of leading to failed cycle: Incorrect disinfectant/sterilant contact time Incorrect disinfectant/sterilant temperature validation not incorporated in disinfection/ sterilization process Pathogens may remain on the probe and potentially create infection risk to subsequent patients. Following the manufacturer’s instructions for use with respect to disinfection/sterilization protocol. Using a validated, automated disinfection/sterilization method that is also deemed compatible with the probe manufacturer. Using indicators or other monitors to indicate whether the sterilization/disinfection cycle has been completed successfully. Using labels on sterilized/disinfected probes to indicate the level of reprocessing undertaken on probe. Low Biological Traceability not incorporated in disinfection process. Inability to recall ultrasound device or recall patients that may have been harmed due to process failure. Maintain logbook in the cleaning area to document and record each disinfection or sterilization cycle including date and time, end-user information and disinfection/sterilization completion and success status. Ensure that reprocessing records are linked to patient records. Low
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