Inspection, Regulations and Compliance

INF 195 provides an in-depth exploration of the regulatory landscape governing infusion pump systems, emphasizing NFPA 99 standards for healthcare facilities, electrical safety testing protocols, and the specific compliance expectations of key accreditation organizations and federal agencies. Through theoretical instruction and practical laboratory sessions, students will master the intricacies of pre-use and periodic inspection procedures, proper maintenance record-keeping, and the correct handling of product recalls and adverse incident reporting. The curriculum is designed to equip future technicians with the knowledge and skills necessary to ensure device safety, operational integrity, and full regulatory compliance in a healthcare setting, fostering a culture of safety and accountability.

InstructorJacob Calhoun

Prerequisites

INF 101 INF 105 INF 110 INF 115

Course outline

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

01Lesson 1: Introduction to Regulatory Bodies and Standards in Healthcare Technologylecture

02Lesson 2: NFPA 99: Healthcare Facilities Code and Essential Electrical Systemslecture

03Lesson 3: Electrical Safety Testing Fundamentals for Medical Deviceslecture

04Hands-on Lab: Electrical Safety Testing of Infusion Pump Systemslab

05Lesson 4: Joint Commission Standards for Medical Equipment Managementlecture

06Lesson 5: CMS and Other Federal Agency Requirements for Device Compliancelecture

07Lesson 6: Documentation and Maintenance Records Managementlecture

08Hands-on Lab: Record Keeping, Documentation & Midterm Reviewlab

09Lesson 7: Incident Reporting: Adverse Events and Device Malfunctionslecture

10Lesson 8: Product Recalls: Identification, Communication, and Remediationlecture

11Hands-on Lab: Simulation of Recall Management and Incident Reportinglab

12Lesson 9: Preparing for Regulatory Inspections and Auditslecture

13Lesson 10: Continuous Quality Improvement and Compliance Strategieslecture

14Capstone Service Project: Comprehensive Compliance Audit and Action Planassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Bodies and Standards in Healthcare Technology","Week 2: Lesson 2: NFPA 99: Healthcare Facilities Code and Essential Electrical Systems","Week 3: Lesson 3: Electrical Safety Testing Fundamentals for Medical Devices","Week 4: Hands-on Lab: Electrical Safety Testing of Infusion Pump Systems","Week 5: Lesson 4: Joint Commission Standards for Medical Equipment Management","Week 6: Lesson 5: CMS and Other Federal Agency Requirements for Device Compliance","Week 7: Lesson 6: Documentation and Maintenance Records Management","Week 8: Hands-on Lab: Record Keeping, Documentation & Midterm Review","Week 9: Lesson 7: Incident Reporting: Adverse Events and Device Malfunctions","Week 10: Lesson 8: Product Recalls: Identification, Communication, and Remediation","Week 11: Hands-on Lab: Simulation of Recall Management and Incident Reporting","Week 12: Lesson 9: Preparing for Regulatory Inspections and Audits","Week 13: Lesson 10: Continuous Quality Improvement and Compliance Strategies","Week 14: Capstone Service Project: Comprehensive Compliance Audit and Action Plan"]