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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.
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.
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.
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.
Web Resource > Government Resource
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. April 12, 2016.
This website alerts clinicians and patients to risks for patient harm associated with implanted electronic medical devices, such as insulin infusion pump and pacemakers, when x-rays are used during CT examinations.
Audiovisual > Audiovisual Presentation
Food and Drug Administration (FDA) Patient Safety News. Show #79. September 2008.
This collection of video segments offers information on common types of medical errors, particularly medication errors, based on reports to the Institute for Safe Medication Practices.
10-State project to study methods to reduce central line-associated bloodstream infections in hospital ICUs.
Rockville, MD: Agency for Healthcare Research and Quality; February 19, 2009.
This announcement highlights a program in 10 states that will test methods of reducing central-line–associated blood stream infections in hospital intensive care units.
Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens.
FDA Alert [US Food and Drug Administration Web site]. March 19, 2009.
This announcement alerts clinicians and patients that insulin pens and insulin cartridges are never to be used on more than one patient.
Journal Article > Commentary
Kaufman D, Weick-Brady M. Home Healthc Nurse. 2009;27:300-307.
This article surveys the main concerns in using medical devices at home and focuses on two initiatives by the US Center for Devices and Radiologic Health that help home health care workers report medical device failures and near misses.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 9, 2009.
This alert notifies health care providers of the potential for patient harm if a particular inhalation powder is reconstituted and incorrectly administered.
Web Resource > Government Resource
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 2010.
This Web site provides information on an initiative to reduce radiation exposure and mitigate risks involved with medical imaging examinations that use high radiation doses. An accompanying report highlights specific issues in promoting safe use of medical imaging devices.