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U.S. Department of Health and Human Services

Medical Devices

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Prevent life-threatening communication breakdowns

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

(Article reprinted from February Nursing2008, Volume 38, Issue 2.)

A MIDDLE-AGED MAN died after uneventful elective surgery because no one turned his implantable cardioverter defibrillator (ICD) back on after the procedure. The patient’s ICD had been inactivated before the surgery because exposure during surgery to any electromagnetic interference (EMI), and particularly to electrocautery devices, can cause ICD malfunction. This interference occurs when electromagnetic waves emitted by one device impede the normal function of another electronic device.1

After the patient was transferred to the postanesthesia care unit, he became unresponsive, apneic, and pulseless, and a code was called. Despite several external defibrillations, attempts to resuscitate him were unsuccessful. The cause of death was thought to be ventricular fibrillation that wasn’t immediately detected and treated because no one had turned the ICD back on after surgery.

What went wrong?

Increasingly, patients have implanted cardiac devices, such as permanent pacemakers to treat severe bradycardia and ICDs to detect and treat potentially lethal ventricular dysrhythmias.

Implanted electronic devices are susceptible not only to EMI, but also to radiation-induced errors from computed tomography or radiation therapy. Inappropriate defibrillator shocks can cause the patient pain and anxiety and can shorten the life of the device battery. To prevent inappropriate defibrillation shocks or discharges, the device may need to be temporarily inactivated when the patient is near electrocautery devices in use, radiofrequency energy, or diathermy. The device may need to be turned off when the patient is undergoing:

  • colonoscopy
  • joint replacement
  • radiation therapy
  • lithotripsy
  • nerve conduction studies
  • transcutaneous electrical nerve stimulation
  • any anticipated use of electrocautery.

Temporarily inactivating a device differs from permanently inactivating one when a patient with a terminal illness has made an informed decision.

What precautions can you take?

Although the patient’s primary care provider is responsible for deciding to temporarily inactivate an implanted cardiac device, this decision has important implications for the facility and all patient-care providers. A manufacturer’s representative or other trained person may modify the device settings by using a specialized programmer. Follow your facility’s policies and procedures, using these key points:

  • Ask to review the patient’s implanted device identification and registration wallet card so you know the model and manufacturer of the device. Document this information in the medical record.
  • As the patient moves through the system, clearly communicate with other professional staff about the type of device and its status. Make sure this information is also documented.
  • Provide continuous cardiac monitoring and keep emergency equipment and drugs readily available while the implanted cardiac device is inactive.
  • Ensure that the patient’s device is reactivated and reevaluated after procedures that posed EMI or radiation risks.
  • Teach and support the patient. If he has additional questions, refer him to his cardiologist.

The Food and Drug Administration’s Center for Devices and Radiological Health provides ongoing postmarket surveillance of approved medical devices to promote public health and safety. The event described here didn’t represent a device malfunction but rather a failure caused by human factors. Your clear communication and your facility’s patient-safety systems can help ensure that implanted cardiac devices function as intended.


REFERENCE

 1. de Sousa M, et al. Electromagnetic interference in patients with implanted cardioverter-defibrillators and implantable loop recorders. Indian Pacing and Electrophysiology Journal. 2(3):79-84, July 2002.

RESOURCES
Biotronik. http://www.biotronik.com/portal/home.

Boston Scientific. What you need to know about electromagnetic interference. http://www.bostonscientific.com/templatedata/imports/HTML/CRM/patient/index.html.

Food and Drug Administration, Center for Devices and Radiological Health.

Medtronic Patient Services. http://www.medtronic.com/patient-services/index.htm.

Sorin Group. Cardiac rhythm management. http://www.sorin-crm.com/sorin_elamedical/read/intl-patients.

St. Jude Medical. ICDs. http://www.sjm.com/resources/learnmoreabout.aspx?section=ImplantableCardioverterDefibrillatorSystem.

Web sites last accessed on January 2, 2008.


Although you need to support your health care facility’s adverse event—reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax:1-800-FDA-0178) or online at MedWatch. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety, is a cardiovascular nurseconsultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.


Roberta Sullivan is a nurse-consultant and Ann Ferriter is an issue manager at the Center for Devices and
Radiological Health.