PLYMOUTH MEETING, PA-ECRI Institute®, an independent, nonprofit organization that researches the best approaches to improving patient care, has issued a high priority medical device alert for several older models of infant radiant warmers. ECRI Institute recommends the removal from service of a series of warmer models manufactured by Borning and Hill-Rom. Draeger purchased the product line from Hill-Rom in 2004 but did not sell any units, which were last made in 1998. The complete findings and recommendations are posted for free public access on ECRI Institute's Web site in its Patient Safety Center (https://www.ecri.org/PatientSafety/Pages/default.aspx).
These recommendations are based, in part, on ECRI Institute's involvement in the investigation of a hospital nursery fire that resulted in burn injuries to an eleven-hour-old infant receiving oxygen. After extensive testing and analysis, ECRI Institute and the other experts on the team concluded that the fire was likely caused by a hot particle falling from the warmer heater-element assembly above the bassinet into the oxygen-enriched materials near the infant's head. ECRI Institute believes that similar events, while unlikely, are possible, and recommends immediate action to remove and replace the affected models.
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"Given the age of these units-none have been manufactured in 10 years-and the potential seriousness of any subsequent incident, we urge hospitals to remove these models from service as soon as feasible," says Mark Bruley, Vice President, Accident and Forensic Investigation Group, ECRI Institute.
Consistent with ECRI Institute's patient safety mission, this alert is being made publicly available due to the potential seriousness of such an incident. Numerous other alerts are issued weekly in Health Devices Alerts, a component of membership in ECRI Institute's Health Devices System™, Health Devices Gold™, and SELECTplus™ programs. Each alert includes a priority level, problem summary, perspectives, and recommendations for responding to the problem.
Full access to the high priority alert, "Infant Radiant Warmer Fire Prompts ECRI Institute Recommendations for Replacement," (2/4/09), is available for free at https://www.ecri.org/PatientSafety/Pages/default.aspx.
For more information about ECRI Institute's medical device membership resources, please visit www.ecri.org, or contact us by phone at (610) 825-6000, ext. 5891, by e-mail at clientservices(at)ecri.org, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462. ECRI Institute's European office can be contacted at info@ecri.org.uk, ECRI Institute's Asia-Pacific office can be contacted at asiapacific(at)ecri.org, and ECRI Institute's Middle Eastern office can be contacted at middleeast(at)ecri.org.
ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to uncover the best approaches to improving patient care. As pioneers in this science for 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. ECRI Institute is designated a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is designated a Patient Safety Organization by the U. S. Agency for Health and Human Services under the Patient Safety and Quality Improvement Act of 2005. For more information, please visit www.ecri.org.