Safety
These outpatient surgical instructions are intended for patients undergoing a pacemaker implant, pacemaker generator replacement, or pacemaker lead revision. The document provides guidance on how to prepare for the procedure,…
This policy outlines the management of patients with cardiovascular implantable electronic devices (CIEDs) undergoing radiotherapy treatment. It includes risk stratification flowcharts and example forms for documenting provider correspondence and CIED…
This resource provides clear, easy-to-understand information for patients with pacemakers or implantable cardioverter-defibrillators (ICDs). It explains what to expect after device implantation, how to care for your incision, safety tips…
This document outlines a standardized protocol for safely performing MRI scans in patients with cardiac implantable electronic devices (CIEDs), including both MRI-conditional and legacy systems. It details eligibility criteria, device-specific…
This resource outlines a standardized policy for safely performing MRI examinations in patients with legacy (non–MR conditional) or mixed cardiac implantable electronic device (CIED) systems. It defines patient eligibility criteria,…
These documents describe an IRB-approved research study and clinical safety workflow that allows patients with pacemakers/ICDs (CIEDs) to undergo clinically indicated MRI with standardized monitoring, device programming, and follow-up, while…
This patient-facing educational handout explains the process, risks, and safeguards involved when patients with legacy (non–MRI-conditional) pacemakers or implantable cardioverter defibrillators (ICDs) undergo MRI imaging. It is designed to support…
This patient-facing educational resource explains the Convergent Hybrid Ablation procedure for atrial fibrillation, a two-stage treatment option designed for patients with persistent or long-standing AF who continue to have symptoms…
This patient-facing educational handout provides clear, step-by-step guidance to help reduce infection risk and support optimal recovery for patients undergoing implantable cardiac device procedures. Designed for use before pacemaker, ICD,…
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.