Device Management

Algorithm for CIED Patients Undergoing Radiation Therapy

Risk stratification and management algorithm for patients with CIEDs who are undergoing radiation therapy.

Delegation Protocol for Patients with CIEDs Undergoing MRI

Care Pathways/CDS: Algorithm for RN-driven programming of CIEDs for Patients Undergoing MRI

Management of Pacemaker or Implantable Cardioverter Defibrillator (ICD) Devices in a Procedural Setting

Care 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.

Clinic Time Required for Remote and In-Person Management of Patients With Cardiac Devices: Time and Motion Workflow Evaluation

Workflows: This study aims to characterize the workflow and quantify clinic staff time requirements for managing patients with CIEDs.

FDA and Device Regulation

Presentations 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.

FDA Medical Device Advisory Committee Presentation

Presentations 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.

FDA Collaborative Communities and Early Feasibility Studies

Presentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.

FDA Investigational Device Exemptions IDE and IRBs

Presentations 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.

Device Recall Basics & Challenges: FDA Role, Risk Mitigation, Removals and Corrections

Presentations 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.

CIED Remote Monitoring Clinic Staffing Calculator

Tools: Tool to help clinics determine the number of full-time equivalent (FTE) staff needed to effectively follow patients with cardiac implantable electric devices (CIED) on remote monitoring (RM). Results consist of clinicians, administrative personnel, and third-party resources needed for safe and efficient administration of remote monitoring services.

Algorithm for CIED Patients Undergoing Radiation Therapy

Delegation Protocol for Patients with CIEDs Undergoing MRI

Management of Pacemaker or Implantable Cardioverter Defibrillator (ICD) Devices in a Procedural Setting

Clinic Time Required for Remote and In-Person Management of Patients With Cardiac Devices: Time and Motion Workflow Evaluation

FDA and Device Regulation

FDA Medical Device Advisory Committee Presentation

FDA Collaborative Communities and Early Feasibility Studies

FDA Investigational Device Exemptions IDE and IRBs

Device Recall Basics & Challenges: FDA Role, Risk Mitigation, Removals and Corrections

CIED Remote Monitoring Clinic Staffing Calculator

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