Device Care
The Cardiocases website provides example device tracings and useful explanations to help clinicians improve their skills. The content is provided in English and French – just click on the appropriate…
Read MoreThe document outlines the process for managing device generator replacements, focusing on cases with elective replacement indicator (ERI) or recommended replacement time (RRT) alerts. It includes protocols for echocardiograms based…
Read MoreRisk stratification and management algorithm for patients with CIEDs who are undergoing radiation therapy.
Read MoreCare Pathways/CDS: Algorithm for RN-driven programming of CIEDs for Patients Undergoing MRI
Read MoreCare Pathways/CDS: The purpose of this guideline document is to establish a process for the safe management of patients with Cardiovascular Implantable Electronic Devices (CIED) around the time of surgeries or procedures.
Read MorePresentations and Graphics: In this slideshow presentation, the learner will explore the mission and history of the FDA and Center for Device and Radiological Health (CDRH), how the CDRH and FDA contribute to a device’s classification, approval, and post-approval maintenance, and an overview of the Total Product Lifecycle Advisory Program Pilot.
Read MorePresentations and Graphics: In this presentation, the learner will explore the purpose and structure of a medical device advisory committee, how they function, and recent guidance.
Read MorePresentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.
Read MorePresentations and Graphics: Slideshow presentation that explore what an investigational device exemption is, significant risk versus non-significant risk device studies, and how IRB’s and the FDA factor in to decisions around device studies.
Read MorePresentations and Graphics: Succinct presentation slides exploring heart rhythm device recalls, FDA’s roles and responsibilities relating to recalls, and recall communications. Also includes risk assessment and mitigation for recalled devices.
Read More