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Scholar Results 1 - 10 of about 33 citing Maisel: Medical device regulation: an introduction for the practicing physician. (0.11 sec) 

Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration …

- usc.edu [PDF] 
WH Maisel, M Moynahan, BD Zuckerman, TP … - Jama, 2006 - Am Med Assoc
Design and Setting Pacemaker and ICD annual reports submitted to the FDA for the
years 1990-2002 were reviewed. A pacemaker or ICD generator was defined as
having malfunctioned if it was explanted due to an observed malfunction, ...
Cited by 118 - Related articles - BL Direct - All 8 versions

Pacemaker and ICD generator reliability: meta-analysis of device registries


WH Maisel - Jama, 2006 - Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
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to make your experience on this site better. ... Context Despite there ...
Cited by 61 - Related articles - BL Direct - All 6 versions

Safety issues involving medical devices: implications of recent implantable cardioverter- …


WH Maisel - JAMA, 2005 - Am Med Assoc
This past spring, Joshua Oukrop, a 21-year old Minnesota college student with
familial hypertrophic cardiomyopathy, died of cardiac arrest when his
implantable cardioverter-defibrillator (ICD) short-circuited and failed to ...
Cited by 49 - Related articles - BL Direct - All 8 versions

Patent foramen ovale closure devices: moving beyond equipoise


WH Maisel, WK Laskey - JAMA, 2005 - Am Med Assoc
The off-label use of patent foraman ovale (PFO) closure devices in patients with
a PFO and a first cryptogenic stroke has increased despite a remarkable paucity
of supporting clinical data and a lack of US Food and Drug Administration ...
Cited by 32 - Related articles - All 2 versions

Who is responsible for evaluating the safety and effectiveness of medical devices? The …

- nih.gov
MD Feldman, AJ Petersen, LS Karliner, JA … - Journal of General Internal Medicine, 2008 - Springer
INTRODUCTION: The global medical technology indus- try brings thousands of
devices to market every year. However, significant gaps persist in the
scientific liter- ature, in the medical device approval process, and in the ...
Cited by 8 - Related articles - BL Direct - All 6 versions

The development and the implementation of new endoscopic technology: what are the …


RA Ganz - Gastrointestinal endoscopy, 2004 - Elsevier
Cited by 7 - Related articles - BL Direct - All 6 versions

Pulmonary artery catheters: state of the controversy

- critcaremed.org
SK Frazier, GJ Skinner - Journal of Cardiovascular Nursing, 2008 - journals.lww.com
Since 1970, pulmonary artery catheters (PACs) have been used in clinical
practice to monitor the hemodynamic status of critically ill and injured
patients. This technology was introduced and commercialized without ...
Cited by 7 - Related articles - BL Direct - All 6 versions

Monitoring device safety in interventional cardiology

- nih.gov
ME Matheny, L Ohno-Machado, FS Resnic - Journal of the American Medical Informatics …, 2006 - Elsevier
A variety of postmarketing surveillance strategies to monitor the safety of
medical devices have been supported by the US Food and Drug Administration, but
there are few systems to automate surveillance. Our objective was to ...
Cited by 7 - Related articles - All 9 versions

Recalls and safety alerts affecting automated external defibrillators

- psu.edu [PDF] 
JS Shah, WH Maisel - JAMA, 2006 - Am Med Assoc
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Cited by 6 - Related articles - BL Direct - All 6 versions

Malfunctions and adverse events associated with off-label use of biliary stents in the …

- potoukian.com [PDF] 
J Bridges, WH Maisel - American Journal of Therapeutics, 2008 - journals.lww.com
Biliary stents are approved by the US Food and Drug Administration only to treat
biliary strictures resulting from cancer. However, these devices are often used
off-label to treat peripheral vascular disease. This study was designed to ...
Cited by 6 - Related articles - BL Direct - All 7 versions


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