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Medical Devices

Biliblanket Phototherapy Light: Follow These Tips to Use it Safely


By Eileen K. Woo, RN, BSN
Center for Devices and Radiological Health
Food and Drug Administration Rockville, MD.

A 6-day-old, 34-week-gestation infant was being treated with a biliblanket phototherapy light for hyperbilirubinemia. When the nurse removed the biliblanket from the infant, she noticed a scratch and some blood on the infant's knee. 

The biliblanket, used to treat jaundice, consists of a fiber-optic pad and a portable illuminator from which therapeutic light is delivered to the infant. The pad should be, covered completely with a disposable cover and placed underneath or wrapped around the infant. Any alteration of the cover, such as cutting it in half, may contribute to an adverse event.

What went wrong?
Investigation of the infant's scratch revealed that the disposable cover had been cut crosswise in half, exposing the infant to a small amount of dried adhesive where the cable was connected to the pad. Fortunately, the injury was minor.
What precautions can you take?
Follow these tips to ensure that you use the biliblanket safely:
  • Inspect the biliblanket phototherapy system to make sure the fiber-optic pad is smooth and free from flaws. Make sure the cable and illuminator work properly.
  • Check that the disposable cover completely protects the fiber-optic pad, including the area where the cable is connected to the pad. Don't cut or alter the cover.
  • Secure the disposable cover around the pad cable with self-adhesive tabs.
  • Expose as much of the infant's skin as possible to the illuminating side of the fiber-optic pad.
  • Remove everything except the disposable cover from between the infant's skin and the light pad. The infant may wear a diaper, clothing, or a blanket over the pad.
  • Shield the infant's eyes from direct exposure to the light with an opaque eye mask.

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. Device Errors is coordinated by Chris Parmentier, RN. 

Page Last Updated: 08/04/2015
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