By Eileen K. Woo, RN, BSN
Center for Devices and Radiological Health
Food and Drug Administration Rockville, Md.
(Originally published July 1998)
As a 5-day-old infant was being transferred from an infant radiant warmer to an incubator, the pediatric nurse removed the skin temperature probe from the infant's lower back. She noticed that a blister with a 3-cm diameter had developed on the midback area near the infant's left buttock.
What went wrong?
Although the infant skin temperature probe is a relatively safe device, improper handling use, or care can cause blisters, bums, or rashes. In the past few years, the FDA has received nine reports of incidents of blister development on neonates.
What precautions can you take?
Follow these recommendations when using infant skin temperature probes:
- Read the instructions that come with the skin temperature probe.
- Make sure the skin temperature probe is compatible for use with the specific infant radiant warmer.
- Inspect the device, especially the tip of the temperature probe, to make sure it's free from defect.
- Place the probe tip on the infant's soft muscle area the abdomen is the most frequently recommended site. Avoid any bony area.
- Make sure the skin temperature probe is free from pressure (for example, never place the probe underneath the infant).
- Use a heat-reflective adhesive patch to secure the skin temperature probe to the infant. Don't use any type of lotion or dressing between the infant's skin and the adhesive patch.
- Keep the probe tip clean and free from foreign matter, particularly adhesives.
- When removing the skin temperature probe, first remove the heat-reflective patch. Then carefully remove the probe from the infant.
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.