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- Communication Improvement 2
- Culture of Safety 1
- Education and Training 5
- Error Reporting and Analysis
- Human Factors Engineering 5
- Legal and Policy Approaches 8
- Policies and Operations 1
- Quality Improvement Strategies 10
- Teamwork 1
- Technologic Approaches 3
- Transparency and Accountability 2
- Device-related Complications 11
- Discontinuities, Gaps, and Hand-Off Problems 1
- Medical Complications 7
- Medication Errors/Preventable Adverse Drug Events 9
- Nonsurgical Procedural Complications 1
- Surgical Complications 2
- Family Members and Caregivers 1
- Health Care Executives and Administrators 29
Health Care Providers
- Nurses 1
Non-Health Care Professionals
- Media 2
- Patients 8
- United States of America
Search results for ""
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
Bennett CL, Nebeker JR, Lyons EA, et al. JAMA. 2005;293:2131-2140.
This article summarizes the structure, funding, organization, and methods of an independent and clinically based surveillance program identifying serious and unrecognized adverse drug events (ADEs). The authors provide a detailed account of the process involved, from investigating a possible serious ADE to disseminating their findings to the Food and Drug Administration (FDA), manufacturers, conferences, journals, and the news media. They also share initial results of their operations with details of 16 drugs associated with serious ADEs, including tabular display of the cases reported and the inconsistencies in the dissemination of safety information. The authors conclude by sharing potential implications of the program's efforts and how this surveillance method may provide additional opportunity to detect and prevent serious ADEs.
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.
Journal Article > Commentary
Clinton HR, Obama B. N Engl J Med. 2006;354:2205-2208.
This commentary is written by Senators Hillary Rodham Clinton (D-NY) and Barack Obama (D-IL), who coauthored the National Medical Error Disclosure and Compensation (MEDiC) Act. Providing context for the bill, the senators advocate for necessary improvements in patient safety and the medical liability environment through a series of important and interdependent strategies. These include reducing the rates of preventable patient injuries, promoting open communication between physicians and patients, ensuring patients' access to fair compensation for legitimate medical injuries, and reducing liability insurance premiums for providers. The senators further discuss the implications of each approach and specifically outline the major provisions of the bill, including how it will foster and promote the necessary improvement efforts.
VA Health Care: Selected Credentialing Requirements at Seven Medical Facilities Met, but an Aspect of Privileging Process Needs Improvement.
Washington, DC: United States Government Accountability Office; May 2006. Publication GAO-06-648.
This report reviews findings from a federal inspection indicating that Veterans Affairs (VA) facilities, while complying with basic credentialing policies, are not routinely submitting malpractice data as required to be used by the VA to inform privileging determinations.
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.
Falls Church, VA: TRICARE Management Activity, Office of the Assistant Secretary of Defense; 2006.
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.
Health-Care-Associated Infections in Hospitals: An Overview of State Reporting Programs and Individual Hospital Initiatives to Reduce Certain Infections.
Washington, DC: United States Government Accountability Office; September 2008. Publication GAO-08-808.
This report describes state reporting programs for health care–associated infection (HAI), hospital initiatives to reduce MRSA (methicillin-resistant Staphylococcus aureus), and challenges encountered in HAI reduction.
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.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.