Inspection, Regulations and Compliance

This comprehensive course is designed for aspiring ventilator service technicians, focusing on the critical aspects of inspection, regulatory compliance, and safety for critical care ventilators. Students will delve into the requirements of key standards such as NFPA 99 for healthcare facilities, mastering electrical safety testing principles and techniques. The curriculum also covers essential preparation strategies for external inspections by bodies like the Joint Commission and CMS, emphasizing proper maintenance record-keeping, recall management, and accurate incident reporting. Through a blend of theoretical instruction and practical application, technicians will develop the expertise necessary to maintain compliance, ensure patient safety, and minimize risks associated with medical device operation.

InstructorPatrick Powers

Prerequisites

VEN 101 VEN 105 VEN 110 VEN 115

Course outline

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

01Lesson 1: Introduction to Regulatory Bodies and Standardslecture

02Lesson 2: NFPA 99: Healthcare Facilities Code - Chapter 16 and Electrical Safety Fundamentalslecture

03Lesson 3: Electrical Safety Testing: Principles, Equipment, and Procedureslecture

04Hands-on Lab: Electrical Safety Testing of Critical Care Ventilatorslab

05Lesson 5: Medical Device Reporting (MDR) and Incident Reporting Requirementslecture

06Lesson 6: Device Recalls: Identification, Management, and Implementationlecture

07Lesson 7: Documentation Best Practices: Maintenance Records and Service Logslecture

08Hands-on Lab: Maintenance Record Creation & Midterm Reviewlab

09Lesson 9: Joint Commission and CMS Inspection Readiness: Environment of Carelecture

10Lesson 10: Joint Commission and CMS Inspection Readiness: Equipment Management Planlecture

11Hands-on Lab: Simulated Inspection Audit and Compliance Checklistlab

12Lesson 12: Risk Management and Quality Assurance in Ventilator Servicelecture

13Lesson 13: Continuous Improvement and Staying Current with Regulationslecture

14Capstone Service Project: Comprehensive Compliance Audit of a Critical Care Ventilatorassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Bodies and Standards","Week 2: Lesson 2: NFPA 99: Healthcare Facilities Code - Chapter 16 and Electrical Safety Fundamentals","Week 3: Lesson 3: Electrical Safety Testing: Principles, Equipment, and Procedures","Week 4: Hands-on Lab: Electrical Safety Testing of Critical Care Ventilators","Week 5: Lesson 5: Medical Device Reporting (MDR) and Incident Reporting Requirements","Week 6: Lesson 6: Device Recalls: Identification, Management, and Implementation","Week 7: Lesson 7: Documentation Best Practices: Maintenance Records and Service Logs","Week 8: Hands-on Lab: Maintenance Record Creation & Midterm Review","Week 9: Lesson 9: Joint Commission and CMS Inspection Readiness: Environment of Care","Week 10: Lesson 10: Joint Commission and CMS Inspection Readiness: Equipment Management Plan","Week 11: Hands-on Lab: Simulated Inspection Audit and Compliance Checklist","Week 12: Lesson 12: Risk Management and Quality Assurance in Ventilator Service","Week 13: Lesson 13: Continuous Improvement and Staying Current with Regulations","Week 14: Capstone Service Project: Comprehensive Compliance Audit of a Critical Care Ventilator"]