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Cases & Commentaries
- Web M&M
Vinod K. Bhutani, MD, and Ronald J. Wong; October 2017
A newborn with elevated total serum bilirubin (TSB) due to hemolytic disease was placed on a mattress with embedded phototherapy lights for treatment, but the TSB continued to climb. The patient was transferred to the neonatal ICU for an exchange transfusion. The neonatologist requested testing of the phototherapy lights, and their irradiance level was found to be well below the recommended level. The lights were replaced, the patient's TSB level began to drop, and the exchange transfusion was aborted.
Web Resource > Multi-use Website
Human Factors Engineering Team, Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (OCER), Division of Device User Programs and Systems Analysis (DDUPSA), 1350 Piccard Drive, HFZ-230, Rockville, MD 20850.
Human factors engineering (HFE) helps improve human performance and reduce the risks associated with use error. The U.S. Food and Drug Administration (FDA) works with manufacturers to ensure the application of HFE in the design of new products. In addition to providing information on these design issues, this site facilitates the reporting of unsafe incidents with medical devices.
Journal Article > Study
Laxmisan A, Malhotra S, Keselman A, Johnson TR, Patel VL. J Biomed Inform. 2005;38:200-212.
Using the concepts of "sharp" and "blunt" ends of practice, this article explores health professionals' differing opinions on biomedical device-related errors. Investigators requested that study participants express their views on events surrounding three true-error scenarios. Analysis of the transcribed responses revealed that interpretation varied widely between groups. While clinicians focused on clinical and human factors, biomedical engineers focused on device-related issues, and administrators emphasized documentation and training. The authors conclude that individual expertise largely mediates an error analysis, as no single interpretation provides a comprehensive view of all contributing factors.
Kerber R. The Boston Globe. June 23, 2005;Business section:E1.
This article reports on problems with medical devices and discusses whether manufacturers should directly notify patients regarding defects.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.