Inspection, Regulations and Compliance

This course delves into the critical aspects of intra-aortic balloon pump (IABP) system inspection, regulatory compliance, and ongoing maintenance. Students will gain an in-depth understanding of relevant safety standards, including general healthcare facility codes and electrical safety requirements. The curriculum emphasizes preparation for accreditation body inspections, meticulous record-keeping, and the proper procedures for managing recalls and reporting adverse incidents. Through a blend of theoretical knowledge and practical application, technicians will develop the skills necessary to ensure IABP systems operate safely and in full compliance with industry regulations, safeguarding patient care and institutional integrity.

InstructorPatrick Powers

Prerequisites

IAP 101 IAP 105 IAP 110

Course outline

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

01Lesson 1: Introduction to IABP Regulations and Compliance Overviewlecture

02Lesson 2: General Healthcare Facility Safety Standards (e.g., NFPA 99) Applied to IABP Systemslecture

03Lesson 3: Electrical Safety Principles and Grounding for IABP Deviceslecture

04Hands-on Lab: Electrical Safety Testing & Device Inspection Fundamentalslab

05Lesson 5: Performance Verification Testing for IABP Systems and Associated Equipmentlecture

06Lesson 6: Documentation and Record-Keeping Requirements for IABP Maintenancelecture

07Lesson 7: Understanding Accreditation Body Standards (e.g., Joint Commission, CMS) for IABP Programslecture

08Hands-on Lab: Inspection Readiness Simulation & Midterm Reviewlab

09Lesson 9: Incident Reporting, Adverse Events, and Medical Device Recallslecture

10Lesson 10: Cybersecurity and Data Integrity for Networked IABP Systemslecture

11Hands-on Lab: Advanced Troubleshooting & Compliance Checklist Applicationlab

12Lesson 12: Quality Assurance, Continuous Improvement, and Audit Preparednesslecture

13Lesson 13: Professional Ethics and Legal Responsibilities in Medical Device Servicinglecture

14Capstone Service Project: Comprehensive IABP Compliance Audit & Remediation Plan Developmentassignment

Syllabus

["Week 1: Lesson 1: Introduction to IABP Regulations and Compliance Overview","Week 2: Lesson 2: General Healthcare Facility Safety Standards (e.g., NFPA 99) Applied to IABP Systems","Week 3: Lesson 3: Electrical Safety Principles and Grounding for IABP Devices","Week 4: Hands-on Lab: Electrical Safety Testing & Device Inspection Fundamentals","Week 5: Lesson 5: Performance Verification Testing for IABP Systems and Associated Equipment","Week 6: Lesson 6: Documentation and Record-Keeping Requirements for IABP Maintenance","Week 7: Lesson 7: Understanding Accreditation Body Standards (e.g., Joint Commission, CMS) for IABP Programs","Week 8: Hands-on Lab: Inspection Readiness Simulation & Midterm Review","Week 9: Lesson 9: Incident Reporting, Adverse Events, and Medical Device Recalls","Week 10: Lesson 10: Cybersecurity and Data Integrity for Networked IABP Systems","Week 11: Hands-on Lab: Advanced Troubleshooting & Compliance Checklist Application","Week 12: Lesson 12: Quality Assurance, Continuous Improvement, and Audit Preparedness","Week 13: Lesson 13: Professional Ethics and Legal Responsibilities in Medical Device Servicing","Week 14: Capstone Service Project: Comprehensive IABP Compliance Audit & Remediation Plan Development"]