Biological Not following probe model specific manufacturer IFUs for cleaning unique features of probe (e.g., grooves or indentations) Potential infection to subsequent patients due to failed cleaning/disinfection. Follow manufacture IFU for cleaning with regards to cleaning of grooves and/or indentations. Low Biological Not conducting additional probe specific tests as per manufacturer IFU (e.g., leak test for transesophageal echocardiography probes) Damage to ultrasound equipment potentially leading to compromised image quality and misdiagnosis or injury to patients. Identify any probes that have additional probe specific tests and ensure manufacturer IFU is followed when conducting tests. Ensure end-users are aware of additional requirements for specific probe models. Low Chemical/ Biological Chemical/biological exposure to cleaning agent (e.g., enzymes, detergents, chemicals). Potential chemical injury. Ensure PPE is available and is used by end users when cleaning according to manufacturer IFUs and policy. Ensure adequate ventilation and environmental requirements met. Low Physical Improper cleaning of probe (e.g., unsealed surface probe soaked beyond window, unsealed intracavity probe handle soaked). Damage to ultrasound equipment potentially leading to compromised image quality and misdiagnosis or injury to patients. Ensure manufacturer IFU for cleaning is followed and end-users are aware of special requirements for specific probe models. Visually inspect probes before use to ensure there is no visible damage or cracks. Low Physical Improper installation of sinks and cleaning tools. Physical injury to Ensure that installation of and other cleaning tools are undertaken by a skilled professional and are installed as per manufacturer instructions. Low Environmental By-products unsafe for disposal in sink. Damage to the environment. Dispose unsafe by-products in correct disposal units (e.g., biohazards disposed in contaminated waste containers.) Low Institution: Department: Document Number: Written by: Date: Approved by: Date: Next review due:
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