Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet
MedSun: Newsletter #23, April 2008

Prevent life-threatening communication breakdowns

By Roberta Sullivan, RN, BSN, MPH and Ann Ferriter, BS

FDA Medical Device Safety Page (Article reprinted from February Nursing2008, Volume 38, Issue 2.)

A patient died after uneventful elective surgery because his implantable cardioverter defibrillator (ICD) was not turned back on after the procedure. The ICD had been inactivated because exposure during surgery to any electromagnetic interference (EMI), and particularly to electrocautery devices, can cause ICD malfunction. The article gives tips on communication strategies and utilization of the facility’s patient-safety systems to prevent these types of adverse events.

Additional Information:

Prevent life-threatening communication breakdowns. Sullivan, Roberta; Ferriter, Ann. FDA Medical Device Safety. February 7, 2008.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun