Narrow Results Clear All
- Communication Improvement 3
- Education and Training 5
- Error Reporting and Analysis
- Human Factors Engineering 8
- Legal and Policy Approaches 5
- Quality Improvement Strategies 4
- Technologic Approaches 1
- Transparency and Accountability 1
- Device-related Complications
- Diagnostic Errors 2
- Discontinuities, Gaps, and Hand-Off Problems 2
- Identification Errors 1
- Medical Complications 5
- Medication Errors/Preventable Adverse Drug Events 4
- Nonsurgical Procedural Complications 3
- Surgical Complications 3
- Internal Medicine 6
- Surgery 3
- Nursing 4
- Family Members and Caregivers 3
- Health Care Executives and Administrators 16
Health Care Providers
- Nurses 1
- Non-Health Care Professionals 11
- Patients 10
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
Vicente KJ, Kern S. Can J Nurs Leadersh. 2005;18:82-88.
The authors surveyed 1000 Ontario nurses to determine awareness of the Health Canada Medical Device Problem Reporting Form. Although 72.5% of nurses polled had encountered problems with medical devices, 94.2% were unaware of the reporting form.
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.
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 > Study
Increased catheter-related bloodstream infection rates after the introduction of a new mechanical valve intravenous access port.
Maragakis LL, Bradley KL, Song X, et al. Infect Control Hosp Epidemiol. 2006;27:67-70.
The authors report an increased infection rate due to the implementation of a new technology in one U.S. hospital.
Journal Article > Study
Freer Y, Lyon A. Arch Dis Child Fetal Neonatal Ed. 2006;91:F327-F329.
The authors found that clinicians were not likely to alter their practice in response to adverse incident alerts if the recommended change was not supported by evidence. A related editorial ties this finding to the need for timely patient safety improvement.
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.
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.
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.
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.
Gould M. Health Service Journal. September 15, 2008:22-24.
This article describes the state of general practitioner incident reporting in the United Kingdom.
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.
Journal Article > Study
Influence of state laws mandating reporting of healthcare-associated infections: the case of central line–associated bloodstream infections.
Pakyz AL, Edmond MB. Infect Control Hosp Epidemiol. 2013;34:780-784.
Twenty-seven states mandate reporting of central line–associated bloodstream infections. However, these regulations do not appear to have any effect on infection rates.
Leeds, UK: Clinical Support Audit Unit, Health and Social Care Information Centre. December 9, 2015. ISBN: 9781783865697.
The NHS Safety Thermometer is a tool developed by the National Health Service to facilitate staff participation in measuring patient harm in various care environments. This report explores the data collected on four types of health care–acquired conditions (pressure ulcers, falls, catheter–associated urinary tract infections, and venous thromboembolisms) in NHS patients over a 1-year period.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.
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.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.
Mohr H, Weiss M. Associated Press. November 27, 2018.
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.