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U.S. Department of Health and Human Services

Medical Devices

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Disposable Devices: Time for a Change

By Chris Parmentier, RN
Nurse-Consultant
Caroline Webb, RN, CCRN, BSN
Nurse-Consultant
Center for Devices and Radiological Health
Food and Drug Administration, Rockville, Md.

(Originally published July 1997)

When a patient in the ER suffered cardiac arrest, a nurse new to the ER attempted to defibrillate him. After placing gel pads on his chest, she put the defibrillator paddles on the gel pads and tried to deliver the current. Instead of delivering a shock to the patient as intended, the current arced between the paddles. In addition to creating a potential hazard to the patient and the health care staff, the incident delayed efforts to resuscitate the patient, further jeopardizing his condition.

What went wrong?

An investigation revealed that the expiration date on the gel pads had passed. The gel on the pads may have dried out-acting as a barrier to the current instead of conducting it.

What precautions can you take?

This example illustrates why you shouldn't use medical devices after the labeled expiration date. Most disposable devices, such as electrocardiographic pads, I.V. catheters, and glucose test strips, degrade over time and no longer function properly. The FDA is reviewing the need for expiration dates on many medical devices that don't currently carry them.

Make sure you:

  • familiarize yourself with which devices have expiration dates on the label
  • check the expiration date before using the device , remove outdated devices and any devices that may have damaged packaging
  • check for discoloration or other changes in the material store medical devices as the labeling recommends, at 1 the correct temperature, and in a manner that won't damage the packaging
  • schedule routine checks for outdated devices and rotate hospital stock frequently according to your facility's policies.

Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn't perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178). The opinions and statements contained in this report are those of the author and may not reflect the views of the Department of Health and Human Services.