Biomedical Engineer SOPs

About this template
This template contains Standard Operating Procedures (SOPs) for biomedical engineers working in healthcare facilities. These SOPs cover a wide range of activities, including conducting preventive maintenance on medical equipment, calibrating medical equipment, troubleshooting and repairing equipment malfunctions, and documenting maintenance activities. They also address the installation and commissioning of medical equipment, as well as the decommissioning and disposal of medical equipment.
The SOPs further detail procedures for managing equipment recalls and warranties, performing risk assessments for medical equipment, integrating medical equipment with IT systems, and ensuring cybersecurity for medical equipment. Each SOP provides step-by-step instructions, including the purpose and scope of the procedure, along with references to other related SOPs. The documents emphasize the importance of adhering to manufacturer guidelines, safety standards, and healthcare regulations.
Specifically, the preventive maintenance SOP outlines steps for planning maintenance, preparing tools, inspecting equipment, performing safety and functional tests, calibrating devices, cleaning and lubricating components, updating software, recording findings, and recommissioning equipment. The calibration SOP focuses on preparing for calibration, assembling tools, inspecting equipment, setting up the calibration environment, performing calibration, testing post-calibration, labeling equipment, documenting results, communicating completion, and ensuring compliance. The troubleshooting SOP details steps for receiving fault reports, inspecting equipment, reviewing documentation, diagnosing problems, developing repair plans, performing repairs, testing post-repair, documenting repairs, recommissioning equipment, and monitoring performance.
The documentation SOP covers setting up documentation tools, recording basic equipment information, documenting preventive maintenance activities, logging calibration data, capturing repair details, recording compliance and safety checks, attaching supporting documents, updating equipment status, reviewing and approving documentation, and storing and securing records. The installation SOP includes planning the installation, inspecting equipment upon delivery, preparing the site, assembling equipment, connecting power and network systems, conducting initial testing, calibrating and performing functional tests, training users, documenting the installation, and commissioning the equipment. The decommissioning SOP provides steps for assessing equipment, obtaining authorization, recording the process, preparing equipment for removal, evaluating disposal options, coordinating transportation, removing equipment from inventory, ensuring data security, providing documentation, and conducting a post-decommissioning review.
The SOPs also address managing recalls and warranties, performing risk assessments, integrating with IT systems, and ensuring cybersecurity. The recall SOP details monitoring for recalls, identifying affected equipment, assessing impact, coordinating actions, documenting management, reviewing warranties, submitting claims, overseeing repairs, communicating with stakeholders, and improving processes. The risk assessment SOP outlines establishing criteria, identifying equipment, gathering data, assessing risks, documenting assessments, developing mitigation strategies, communicating findings, implementing actions, reassessing equipment, and reviewing procedures. The IT integration SOP covers reviewing requirements, coordinating with stakeholders, preparing the environment, configuring equipment, installing software, testing connectivity, validating integration, training users, monitoring performance, and ensuring maintenance. Finally, the cybersecurity SOP focuses on assessing risks, updating software, securing networks, configuring settings, scanning for vulnerabilities, developing response plans, training staff, monitoring performance, establishing maintenance, and documenting activities.