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- Communication Improvement 4
- Culture of Safety 3
Education and Training
- Students 1
- Error Reporting and Analysis
- Human Factors Engineering 8
- Legal and Policy Approaches 5
- Quality Improvement Strategies 3
- Teamwork 1
- Technologic Approaches 2
- Transparency and Accountability 1
- Device-related Complications
- Diagnostic Errors 1
- Discontinuities, Gaps, and Hand-Off Problems 2
- Identification Errors 2
- Medical Complications 5
- Medication Errors/Preventable Adverse Drug Events 4
- Nonsurgical Procedural Complications 3
- Surgical Complications 8
- Internal Medicine 8
- Surgery 5
- Nursing 2
Search results for "Device-related Complications"
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.
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.
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.
Fillo KT. Bureau of Health Care Safety and Quality, Department of Public Health. Boston, MA: Commonwealth of Massachusetts; July 2018.
This report compiles patient safety data documented by Massachusetts hospitals. The latest numbers represent a modest decrease in serious reportable events recorded in acute care hospitals, from 1012 the previous year to 922. This presentation also includes events from ambulatory surgery centers. Previous years reports are also available.
Kerber R. The Boston Globe. June 23, 2005;Business section:E1.
This article reports on problems with medical devices and discusses whether manufacturers should directly notify patients regarding defects.
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.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Moss-Coane M, O'Connell K, Fishman N. Radio Times. April 28, 2011.
This radio program featured interviews with an infectious disease specialist and a patient who contracted a hospital-acquired infection, and discussed how patients and providers can reduce their occurrence.
Harasim P. Las Vegas Review-Journal. November 21, 2010;News:1B.
This article discusses how the organizational system of one hospital delayed an investigation into catheter line malfunctions.
Bernhard B, Kohler J. St. Louis Post-Dispatch. August 1, 2010:A1
In the context of system failures that contributed to the death of a patient, this newspaper article describes how never events are rarely publicized, even though hospital inspection reports are public records.
Rojas-Burke J. The Oregonian. May 8, 2010.
This newspaper article describes how lessons from the Keystone ICU Project have reduced central line infections in Oregon hospitals.
Consumer Reports. March 2010;75:16-21.
Bogdanich W. New York Times. January 24, 2010:A1.
First in a series on medical radiation, this news feature and accompanying video investigate patient deaths and injuries following mistakes related to radiation treatment. The journalists discuss the number of radiation therapy errors in New York and reveal that state law does not require public reporting of such mistakes.
Zarembo A. Los Angeles Times. October 15, 2009:A1.
This news piece describes communication gaps following a radiation overdose incident thought to involve more than 200 patients at one hospital.
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.
Journal Article > Study
Makary MA, Al-Attar A, Holzmueller CG, et al. N Engl J Med. 2007;356:2693-2699.
This survey revealed that nearly all surgical residents experience a needlestick injury during their training, but the majority are not reported. Feeling "rushed" or fatigued was a frequent contributing factor to needlesticks.
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.
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.
Gulliver D. Sarasota Herald Tribune. November 7, 2006:BS1.
This article reports on the death of a restrained patient and outlines the factors affecting the subsequent reporting of the event.