FDA calls for imaging of recalled ICDs
Patients who have implantable cardioverter defibrillators with certain wire leads made by St. Jude Medical should have X-rays or other imaging to check for abnormalities in the insulation surrounding the lead, the Food and Drug Administration stated in an August safety advisory. The manufacturer recalled the "Riata" and "Riata ST" leads last November after reports of premature erosion of the insulation around the electrical conductor wires, which may malfunction. The agency is requiring the device maker to conduct post-market surveillance studies, and cautioned against removal of leads without evaluation of benefits and risks.
Related Articles
DNV updates physical environment standards
New NIAHO standards going into effect this month impact life safety, emergency management and more.
FDA updates requirements for hyperbaric chambers
The Food and Drug Administration's adoption of new standards could create conflicts with the Centers for Medicare & Medicaid Services regulations.
Managing the risks in health care facilities
Practical advice on building an effective risk management program and a culture of safety.