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How Human Factors Lead to Medical Device Adverse Events
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document.write("By Suzanne Rich, RN, CT, MA FDA Medical Device Safety Website Human factors is the science that focuses on understanding and supporting how people interact with technology. To minimize human factors problems, devices should be designed according to users' needs, abilities, limitations, and work...
FDA's Sentinel Initiative
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document.write("FDA Website On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety. The Sentinel System will enable FDA to query multiple, existing data sources,...
Request for Proposals: Research in Patient Safety
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document.write("National Patient Safety Foundation NPSF Call for Letters of Intent to Conduct Research and Development in Patient Safety Applications invited for grant projects beginning 2009 The National Patient Safety Foundation's (NPSF) Research Grants Program seeks to stimulate new, innovative projects...
Mismatching Medical Devices and Accessories
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document.write("Pennsylvania Patient Safety Authority PA-PSRS Patient Safety Advisory We are posting this information because we continue to see reports describing injuries to patients from the use of incompatible device parts. The article entitled, 'Mismatching Medical Devices & Accessories,' from the...
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Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories. To see recently submitted MedSun Cardiovascular and EP Device Reports, see Cardiovascular including EP Devices. For more details about heart devices visit Heart Health.Lead-Associated Endocarditis: the Important Role of Methicillin-Resistant Staphylococcus Aureus
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document.write("PubMed BACKGROUND: Infection is a potentially life-threatening complication of cardiac device implantation. Lead-associated endocarditis (LAE) may be the most serious complication since it is associated with a high mortality. METHODS: The medical records of patients referred to our institution for...
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
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document.write("PubMed **in process...
Pacemaker and ICD leads: Strategies for Long-Term Management
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document.write("PubMed Pacemaker and defibrillator therapy is on the rise as a result of expanding indications. Unfortunately, this trend is associated with an increased number of cardiac device-related complications. Lead failure, device infection and vascular complication are not uncommon and may cause...
Recently Recalled Devices
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document.write("To view recently recalled devices, please visit the website listed under Additional Information...
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Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units. To see recently submitted MedSun Neonatal and Pediatric Device Reports, see Neonatal and Pediatric Devices.Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
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document.write("FDA MedWatch Safety Alert FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile...
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Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA?s Office of In Vitro Diagnostics. To see recently submitted MedSun Laboratory Device Reports, see Laboratory/In Vitro Diagnostic Devices.Point-of-Care Testing
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document.write("Lynn Henley, M.S., M.B.A., Patient Safety Staff, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration Introduction It is no secret to laboratorians that laboratory testing has changed considerably during the last twenty years. This shift...
Highlighted Reports
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document.write("This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of...