April 2009, Volume 39 Number 4 , p 59 - 59
Dwyer, Diane RN, BSN
Issue: Volume 39(4), April 2009, p 59 Publication Type: [Department: …&more: DEVICE SAFETY] Publisher: © 2009 Lippincott Williams & Wilkins, Inc. Institution(s): Although you need to support your healthcare 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 http://www.fda.gov/medwatch/how.htm . The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Diane Dwyer, RN, BSN , who coordinates Device Safety , is a nurse-consultant at the Center for Devices and Radiological Health at the FDA in Rockville, Md.
THE INFANT HEEL WARMER, used routinely in neonatal care settings, is an instant chemical heat pack. It increases capillary circulation in an infant's heel to facilitate blood collection by heel stick. This nonsterile, single-use, disposable ...