Readability of “Dear Patient” device advisory notification letters created by a device manufacturer

Author:

Mueller Luke A.,Sharma Arjun,Ottenberg Abigale L.,Mueller Paul S.

Publisher

Elsevier BV

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference28 articles.

1. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and GuidelinesEndorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE)

2. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports;Maisel;JAMA,2006

3. Medical device regulation: an introduction for the practicing physician;Maisel;Ann Intern Med,2004

4. US Food and Drug Administration. FDA 101: product recalls: from first alert to effectiveness checks. Silver Spring, MD: US Food and Drug Administration [updated May 18, 2010; cited August 24, 2012]. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm#RecallClassifications. Accessed August 24, 2012.

5. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions;Maisel;JAMA,2005

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