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- Device-related Complications
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- Medication Safety 1
- MRI safety 1
- Nonsurgical Procedural Complications 1
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Search results for "Device-related Complications"
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.
Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2017.
Hazards in the magnetic resonance imaging environment can result in patient harm. This announcement raises awareness of inaccuracies and disruptions that may affect the safety of patients with implantable infusion devices who undergo an MRI exam. The statement recommends that patients inform their care team and carry an implant card with information about the implanted device to prevent these problems.
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.
Tools/Toolkit > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; October 2015.
Catheter–associated urinary tract infections (CAUTIs) are common complications in hospitalized patients. This toolkit was developed as part of a national implementation project to reduce rates of CAUTIs in hospitals and apply principles of the comprehensive unit-based safety program. The toolkit includes modules that focus on implementation, sustainability, and resources to help hospitals design CAUTI prevention efforts at the unit level.
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
Tools/Toolkit > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; January 2015.
Health care–associated infections are a known contributor to adverse events among patients on dialysis. Building on evidence and insights from clinicians, this four-part toolkit includes videos, assessment tools, and slide presentations regarding how to apply principles of teamwork, patient engagement, and safety culture to ensure dialysis centers provide safe care to patients with end-stage renal disease.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.