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- Communication Improvement 2
- Education and Training 5
- Error Reporting and Analysis
- Human Factors Engineering 4
- Legal and Policy Approaches 5
- Quality Improvement Strategies 4
- Technologic Approaches 2
- Device-related Complications 10
- Medical Complications 4
- Medication Errors/Preventable Adverse Drug Events 8
- Surgical Complications 2
- Family Members and Caregivers 1
- Health Care Executives and Administrators 17
Health Care Providers
- Nurses 1
- Non-Health Care Professionals 12
- Patients 7
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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.
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.
Journal Article > Study
Wysowski DK, Swartz L. Arch Intern Med. 2005;165:1363-1369.
This study analyzed reports of suspected adverse drug events (ADEs) submitted to the U.S. Food and Drug Administration (FDA). Using more than 30 years of collected data, investigators discovered nearly 2.3 million case reports for the 6000 drugs in the database. These reports resulted in additional safety warnings, a greater list of known ADEs with specific drugs, and a small percentage of drugs pulled from the market. The authors advocate for continued vigilance and reporting to ensure the safety of drugs prescribed to patients.
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.
Office of the Inspector General. Washington, DC: US Department of Health and Human Services; August 2006. Report No. OEI-06-05-00060.
This report shares findings from an inspection of the FDA's National Drug Code Directory, which found that the directory is both incomplete and inaccurate in its listings of marketed prescription medications.
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.
Federal Register. February 12, 2008;73:8112-8183.
These proposed rules seek to support the implementation of portions of the Patient Safety and Quality Improvement Act of 2005 including how entities are defined as a patient safety organization (PSO) and how PSOs will collect and protect safety incident data. The comment period on the proposed rules is now closed.
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.
Tools/Toolkit > Fact Sheet/FAQs
Center for Drug Evaluation and Research, US Food and Drug Administration.
This Web site provides information on and access to quarterly reports and an interactive dashboard of medication-related incidents culled from FDA's Adverse Event Reporting System (FAERS) database and identifies potential safety issues.
Shuren J. Federal Register. October 23, 2008;73:63153-63157.
This announcement invites field review of proposed information elements to be included in a Food and Drug Administration portal designed to collect drug- and product-related adverse event reports. The comment collection period is now closed.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-07-00471.
The Tax Relief and Health Care Act of 2006 mandated that the Office of Inspector General (OIG) report to Congress a series of analyses with the first related to understanding the issues around hospital-based adverse events. This related and simultaneously released report identifies and describes state reporting systems and how they utilize the captured information. The report concludes that as of January 2008, 26 states had reporting systems in place, 23 states used the data to hold individual hospitals accountable, and 18 states reported using the data to promote learning and develop prevention strategies. A past AHRQ WebM&M perspective discusses the role of state reporting systems in advancing patient safety.
Journal Article > Commentary
Common formats allow uniform collection and reporting of patient safety data by patient safety organizations.
Clancy CM. Am J Med Qual. 2010;25:73-75.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 5, 2010. Report No. OEI-06-09-00360.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; July 2012. Report No. OEI-06-09-00092.
This report built on earlier research to examine rates of adverse events reported to state-level reporting systems compared with hospital data. It found that, even in states with required hospital reporting of adverse events, only about one in nine events is reported to the state. Because few of the events were found in each hospital's incident reporting system, the investigators concluded that the low rate of reporting was likely due to hospital failure to identify events rather than hospitals failing to report known events.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Avery L, Bennett R, Brinsley-Rainisch K, et al. Atlanta, GA: Centers for Disease Control and Prevention; October 9, 2018.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2015. Report No. OEI-01-13-00400.
A widely-reported meningitis outbreak in the United States uncovered quality and safety issues associated with the use of compounded sterile preparations. This publication describes an analysis of five accreditation organizations and their ability to provide oversight and inspection of Medicare hospitals that contract with compounding entities. The authors offer recommendations to help hospitals determine if their compounded sterile preparations contracts ensure products are prepared safely for use, including targeted training for surveyors related to compounding and improved contracting processes.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; September 17, 2015.
Use of incompletely cleaned medical devices has been linked to health care–associated infections. Drawing from reports submitted to the FDA regarding infections related to reprocessed flexible bronchoscopes, this announcement offers recommendations to enhance the reliability of scope sterilization methods.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.