Inspection, Regulations and Compliance
This course is designed for aspiring anesthesia machine service technicians to develop a thorough understanding of the regulatory landscape governing medical equipment. Students will delve into critical standards such as those related to healthcare facilities, electrical safety, and maintenance documentation. Emphasis will be placed on practical application of these regulations, including preparing for and responding to inspections by accreditation organizations and governmental bodies. Topics also cover essential aspects of post-market surveillance, including managing product recalls and understanding incident reporting procedures. Through a blend of theoretical knowledge and hands-on activities, students will gain the skills necessary to ensure anesthesia delivery systems are maintained and operated in full compliance with all applicable guidelines.
InstructorPatrick PowersCourse outline
Lectures, virtual labs, and graded assignments — completed in your browser.
Syllabus
["Week 1: Lesson 1: Introduction to Regulatory Compliance in Healthcare Technology","Week 2: Lesson 2: Overview of NFPA 99: Health Care Facilities Code (Part 1)","Week 3: Lesson 3: Overview of NFPA 99: Health Care Facilities Code (Part 2)","Week 4: Hands-on Lab: Electrical Safety Testing Fundamentals and Equipment Calibration","Week 5: Lesson 4: Electrical Safety Standards and Testing for Anesthesia Systems","Week 6: Lesson 5: Documentation and Maintenance Records Management","Week 7: Lesson 6: The Joint Commission and CMS: Accreditation and Inspection Readiness","Week 8: Hands-on Lab: Mock Joint Commission/CMS Inspection & Midterm Review","Week 9: Lesson 7: Manufacturer Service Bulletins and Product Recalls","Week 10: Lesson 8: Incident Reporting and Medical Device Vigilance","Week 11: Hands-on Lab: Developing a Compliance Audit Checklist and Strategy","Week 12: Lesson 9: Quality Assurance and Continuous Improvement in Service Operations","Week 13: Lesson 10: Legal and Ethical Considerations in Medical Device Servicing","Week 14: Capstone Service Project: Comprehensive Compliance Audit and Readiness Plan"]