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Search results for ""
Web Resource > Database/Directory
Rockville, MD. Food and Drug Administration.
This website provides information to consumers about health-related issues of current interest to the general public.
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.
FDA public health notification: MRI-caused injuries in patients with implanted neurological stimulators.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; May 10, 2005.
In response to reports of injuries in patients with implanted neurological stimulators who underwent magnetic resonance imaging procedures, the Food and Drug Administration suggests related precautions for radiology personnel and physicians.
Web Resource > Government Resource
US Food and Drug Administration.
MedWatch, the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, serves both health care professionals and consumers of health care products. The site shares safety information about medications and medical products that are regulated by the FDA.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 27, 2005.
This announcement alerts patients and practitioners to a problem with glucose meters made by Abbott Diabetes Care. The meters have a measurement setting that, if inadvertently switched, could cause an inaccurate reading.
Risk of electromagnetic interference with medical telemetry systems operating in the 460-470 MHz frequency bands.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 16, 2005.
This announcement notifies health care practitioners of possible interference with medical alarms and patient monitoring systems caused by mobile radio transmitters.
FDA preliminary public health notification: update of information about Ralstonia spp. associated with Vapotherm Respiratory Gas Administration device.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; December 20, 2005.
This safety alert for health care practitioners discusses bacterial contamination of gas devices and recommends alternatives be used until the source of the contamination is identified.
Journal Article > Review
Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients.
Johnson JR, Kuskowski MA, Wilt TJ. Ann Intern Med. 2006;144:116-126.
The investigators reviewed the literature on two types of antimicrobial urinary catheters and found that the evidence supports their ability to prevent infection.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.
Federal Register. April 10, 2006;71:18039-18053.
The U.S. Food and Drug Administration (FDA) is proposing to amend good manufacturing practice to include several strategies for minimizing medical gas-related patient safety incidents. The proposal is open for public comment through July 10, 2006.
Health Care Inspection. Washington, DC: VA Office of Inspector General; April 10, 2006. Report No. 06-01642-126.
This report shares the results of an inspection into two mistakes at a Veterans Affairs (VA) health facility involving appropriate sterilization of implantable medical devices.
Office of the Inspector General. Washington, DC: US Department of Health and Human Services; September 2006. Report No. OEI-09-04-00350.
This report presents findings from an investigation into the reporting of and response to restraint and seclusion-related deaths.
Food and Drug Administration (FDA) Patient Safety News. Show #57. November 2006.
This video news segment recaps concerns over the use of an infusion pump with an identified design defect.
Grant > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; June 2008.
This announcement describes the 19 projects funded by the Agency for Healthcare Research and Quality in 2006 that studies the potential of simulation to improve patient safety.
Food and Drug Administration (FDA) Patient Safety News. Show #59. January 2007.
This video segment warns about potential dosing errors for an epileptic seizure treatment due to equipment design and provides instructions to minimize user error.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; April 18, 2007.
This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. December 4, 2007.
This announcement includes safety instructions for avoiding entrapment and suffocation in a recalled model of a patient bed.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; January 15, 2008.
This notification alerts providers to the potential danger of unretrieved device fragments (UDFs), types of adverse events that may occur, and prevention strategies.
Journal Article > Study
Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.
Cope JU, Morrison AE, Samuels-Reid J. Pediatrics. 2008;121:e1133-e1138.
This study examined more than 1600 medical device adverse event reports and categorized the frequency and cause of each event. The authors conclude that the adolescent population warrants special consideration when using device technology and a greater understanding of the safety problems that face this patient group.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.