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- Communication Improvement 2
- Culture of Safety 2
Education and Training
- Students 1
Error Reporting and Analysis
- Error Reporting 12
- Human Factors Engineering 2
- Legal and Policy Approaches 1
- Quality Improvement Strategies 2
- Teamwork 1
- Technologic Approaches 2
- Device-related Complications
- Discontinuities, Gaps, and Hand-Off Problems 1
- Medical Complications 5
- Medication Errors/Preventable Adverse Drug Events 5
- MRI safety 1
- Nonsurgical Procedural Complications 1
- Surgical Complications 4
Search results for "Device-related Complications"
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.
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.
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.
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.
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.
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.
Journal Article > Government Resource
Schechter MA, O'Brien PJ, Cox MW. J Vasc Surg. 2013;57:276-281.
This review article characterizes the types of clinical issues that can occur when an intravascular device becomes malpositioned or damaged. A case of a broken peripherally inserted central venous catheter (PICC) that required surgical removal is discussed in an AHRQ WebM&M commentary.
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.
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.
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.
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.
FDA public health notification: MRI-caused injuries in patients with implanted neurological stimulators.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration; May 10, 2005.
In response to reports of injuries in patients with implanted neurological stimulators who underwent magnetic resonance imaging procedures, the Food and Drug Administration suggests related precautions for radiology personnel and physicians.