Medical Device Incident Reporting

Course Code: REL-ALL-0-MDIR

Hours: 0.75

Type: Online Course

Content Expiration Date: 12/31/2026

Learning Objectives:
Define medical devices.
Describe how medical device malfunction can contribute to medical errors.

Outline:

Section 1: Introduction

About This Course

Learning Objectives

Section 2: Medical Devices

What is a Medical Device?

The Safe Medical Devices Act

Know Your Medical Devices!

Medical Device Storage

Review

Summary

Section 3: Safety and Reporting

Promote a Culture of Safety

Using a Medical Device Safely

What About Medical Device Failures?

Case Study Reviews

Incident Reporting

Objective vs. Subjective Findings

Investigation

FDA Reporting

Review

Summary

Section 4: Conclusion

Course Summary

Course Contributors

References

Subject Matter Expert: Edward Bartels, RN, BSN, MICN

Ed has 30 plus years of nursing experience with clinical roles in trauma, emergency, critical care, skilled nursing, behavioral health, occupational health, home care, and is a certified clinical nursing instructor in North Carolina. Ed served as Director of Nursing for rural emergency services and physician practices. Ed earned his Bachelor of Science in Nursing from the University of North Carolina, Greensboro. Ed retired from the U.S. Coast Guard with 34 years served.

Target Audience:
The target audience for this course is: General Staff; in the following settings: All Healthcare Settings.

Relias Learning will be transparent in disclosing if any commercial support, sponsorship or co-providership is present prior to the learner completing the course.

Relias Learning has a grievance policy in place to facilitate reports of dissatisfaction. Relias Learning will make every effort to resolve each grievance in a mutually satisfactory manner. In order to report a complaint or grievance please contact Relias Learning at support@reliaslearning.com.

Course Delivery Method and Format
Asynchronous Distance Learning with interactivity which includes quizzes with questions/answers, and posttests.