Narrow Results Clear All
- Communication Improvement 3
- Culture of Safety 2
Education and Training
- Students 1
Error Reporting and Analysis
- Error Reporting 11
- Human Factors Engineering 3
- Legal and Policy Approaches 1
- Quality Improvement Strategies 3
- Teamwork 1
- Technologic Approaches 2
- Device-related Complications 7
- Discontinuities, Gaps, and Hand-Off Problems 1
- Medical Complications 2
- Medication Errors/Preventable Adverse Drug Events 9
- Surgical Complications 4
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.
Roxane Laboratories Initiates a Nationwide Voluntary Recall of a Single Manufacturing Lot of Azathioprine Tablets in the U.S. and Puerto Rico.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 13, 2006.
This news release announces the recall of a manufacturing lot of Azathioprine. Bottles may have been erroneously filled with another medication, which could lead to serious health effects for those taking the drug.
Kaiser Family Foundation, Agency for Healthcare Research and Quality; September 2006.
This survey follows up on a prior study from 2004, asking patients about their perceptions of health care quality and medical errors. The study found minimal change since 2004 in overall impression of US health care quality, with approximately half of respondents stating they are "dissatisfied" with quality, particularly with coordination of care. More patients are aware of information comparing the quality of hospitals, health care plans, or providers, but only a small minority report using this information to make health care decisions. A large proportion of patients reported taking recommended actions to improve safety, such as bringing a list of their medications to appointments or following up on test or procedure results. As found in other studies, survey respondents overwhelmingly expressed support for full, mandatory disclosure of all preventable errors, and two-thirds felt errors should be publicly reported.
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.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Rockville, MD: US Food and Drug Administration; February 20, 2009.
This fact sheet discusses the role of the Food and Drug Administration (FDA) in reducing medication errors and describes examples of such errors for consumers.
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.
Rockville, MD: Agency for Healthcare Research and Quality.
In this annual publication, AHRQ reviews the results of the National Healthcare Quality Report and National Healthcare Disparities Report. Providing a 5-year update on the National Quality Strategy, this report highlights that a wide range of quality measures have shown improvement in quality, access, and cost.
Web Resource > Government Resource
Centers for Medicare & Medicaid Services.
The Centers for Medicare and Medicaid Services (CMS) provides consumers with publicly available information on the quality of Medicare-certified hospital care through this Web site. The site includes specific information for both patients and hospitals on how to use the data to guide decision-making and improvement initiatives. Most recently, listings from the Hospital-Acquired Condition Reduction Program (HACRP) and data on Department of Veterans Affairs hospitals were added to the reports available.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Tavernise S. New York Times. January 15, 2015.
This newspaper article discusses an investigation into how a saline solution that had been manufactured specifically for training purposes was inadvertently distributed and used for actual care and led to patient harm and death.
Herman B, Fei F. Mod Healthc. December 2, 2016.
Underserved communities face challenges to receiving high quality care. This magazine article reports on pervasive problems in the Indian Health Service (IHS) that result in an unsafe care system, such as chronic lack of funding and high workforce turnover. The article includes insights from tribe advocates seeking improvement in the IHS.
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.
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.
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.
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.