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- Journal Article 1
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- Book/Report 5
- Legislation/Regulation 2
- Newspaper/Magazine Article 11
- Tools/Toolkit 1
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- Press Release/Announcement 4
- Communication Improvement 4
- Education and Training 5
- Error Reporting and Analysis
- Human Factors Engineering 6
- Legal and Policy Approaches 12
- Logistical Approaches 1
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Search results for "Governmental Reporting"
- Governmental Reporting
Jewett C. Kaiser Health News. May 3, 2019.
Transparency has been heralded as a cornerstone to improvement in health care. This news article reports on a government alternative summary reporting program that allowed medical device makers to conceal safety events and malfunction reports associated with medical devices. A new program that expands access to information about device-related failures will be put in place.
St. Paul, MN: Minnesota Department of Health; March 2019.
The National Quality Forum has defined 29 never events—patient safety problems that should never occur, such as wrong-site surgery and patient falls. Since 2003, Minnesota hospitals have been required to report such incidents. The 2018 report summarizes information about 384 adverse events that were reported and found pressure ulcers and invasive procedure events increased, while fall-related deaths decreased. Reports from previous years are also available.
Koba M. Fortune. January 6, 2015.
Harrow, Middlesex, UK: The Patients Association; 2013.
This publication provides patient and family accounts of incidents involving inadequate care or harm and highlights the need for improvements recommended in a National Health Services report.
Web Resource > Government Resource
National Patient Safety Agency.
This Web site provides data on safety incidents from the United Kingdom in the form of workbooks sorted by either organization or region.
Web Resource > Multi-use Website
Drawing from data reported by the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), this website provides grades for hospitals in the United States based on their safety. The 2018 results are the sixth generation of the scores, which now include a medication error score. A related report from the Armstrong Institute examines avoidable death associated with grading hospitals.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Web Resource > Multi-use Website
The Institute for Safe Medication Practices Canada.
This Web site facilitates consumer reporting of medication safety issues in Canada.
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.
Rojas-Burke J. Oregonian. January 30, 2007:B01.
This article reports on results from the first round of error data reported to the Oregon Patient Safety Commission voluntary reporting program.
St. Paul, MN: Minnesota Department of Health; January 2009.
This report provides background on the Minnesota Never Events reporting initiative, tips for patients on how to receive the safest care possible, and a table of events reported by all hospitals in the state.
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 identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
Mohr H, Weiss M. Associated Press. November 27, 2018.
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.
O'Donnell J. USA Today. August 6, 2014.
This newspaper article reports on changes to publicly reported data on the Hospital Compare Web site. Several avoidable hospital-acquired conditions, such as air embolism or retained foreign objects, are no longer included. Working with the National Quality Forum, the Centers for Medicare and Medicaid Services (CMS) decided to modify the list to make it easier for consumers to use and understand.
Cohn M. Baltimore Sun. July 26, 2014.
This news article reports weaknesses in a Maryland reporting program, including poor understanding about which errors should be reported and lack of regulations regarding disclosure. Limited public access to comprehensive incident reports and insufficient performance measurement hinder consumers' ability to select hospitals based on safety.