Inspection, Regulations and Compliance

This course delves into the regulatory landscape governing electrosurgical units (ESUs) and related operating room equipment. Students will gain a comprehensive understanding of electrical safety testing methodologies, including leak current and ground continuity assessments, aligned with industry standards like NFPA 99. The curriculum emphasizes preparation for inspections by key accreditation bodies, such as the Joint Commission and CMS, covering documentation requirements and readiness strategies. Practical aspects include hands-on experience with inspection tools, interpreting technical data, and establishing robust maintenance record-keeping systems. Furthermore, students will explore processes for managing product recalls, reporting incidents, and contributing to a culture of safety and continuous improvement within healthcare technology management.

InstructorJacob Calhoun

Prerequisites

ESU 101 ESU 105 ESU 110 ESU 115

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Regulatory Compliance in Healthcare Technology Managementlecture

02Lesson 2: Overview of Electrosurgical Unit (ESU) Principles and Equipment Categorieslecture

03Lesson 3: Understanding NFPA 99: Health Care Facilities Code and Its Impact on OR Equipmentlecture

04Hands-on Lab: Electrical Safety Testing Fundamentals for Biomedical Equipmentlab

05Lesson 5: In-depth Electrical Safety Testing for Electrosurgical Units: Theory and Applicationlecture

06Lesson 6: Joint Commission and CMS Standards: A Focus on Equipment Management and Safetylecture

07Lesson 7: Developing and Implementing a Comprehensive Preventive Maintenance Programlecture

08Hands-on Lab: Advanced ESU Performance Testing & Midterm Reviewlab

09Lesson 9: Best Practices for Equipment Documentation, Maintenance Records, and Asset Trackinglecture

10Lesson 10: Product Recalls, Advisories, and Service Bulletins: Management and Responselecture

11Hands-on Lab: OR Equipment Inspection and Pre-Use Checklist Implementationlab

12Lesson 12: Incident Reporting and Root Cause Analysis for Medical Equipment Failureslecture

13Lesson 13: Risk Management and Quality Assurance in Electrosurgical Safetylecture

14Capstone Service Project: Comprehensive ESU and OR Equipment Compliance Auditassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Compliance in Healthcare Technology Management","Week 2: Lesson 2: Overview of Electrosurgical Unit (ESU) Principles and Equipment Categories","Week 3: Lesson 3: Understanding NFPA 99: Health Care Facilities Code and Its Impact on OR Equipment","Week 4: Hands-on Lab: Electrical Safety Testing Fundamentals for Biomedical Equipment","Week 5: Lesson 5: In-depth Electrical Safety Testing for Electrosurgical Units: Theory and Application","Week 6: Lesson 6: Joint Commission and CMS Standards: A Focus on Equipment Management and Safety","Week 7: Lesson 7: Developing and Implementing a Comprehensive Preventive Maintenance Program","Week 8: Hands-on Lab: Advanced ESU Performance Testing & Midterm Review","Week 9: Lesson 9: Best Practices for Equipment Documentation, Maintenance Records, and Asset Tracking","Week 10: Lesson 10: Product Recalls, Advisories, and Service Bulletins: Management and Response","Week 11: Hands-on Lab: OR Equipment Inspection and Pre-Use Checklist Implementation","Week 12: Lesson 12: Incident Reporting and Root Cause Analysis for Medical Equipment Failures","Week 13: Lesson 13: Risk Management and Quality Assurance in Electrosurgical Safety","Week 14: Capstone Service Project: Comprehensive ESU and OR Equipment Compliance Audit"]