Nursing Informatics Online - View Single Post - [medinformatics] FDA Stops Medical Device Reporting Project

Medical Informatics News · 08-03-2005, 05:25 PM

The Food and Drug Administration has halted plans to closely monitor deadly malfunctions and misuses of medical devices through a new computer reporting system.The system, known as MedSun, allows doctors nationwide to directly report to the FDA problems with medical devices such as pacemakers, stents, and defibrillators. The FDA hoped to connect 500 of the nation's 5,000 eligible hospitals. To date, there are 350 facilities are*in the system but the FDA won't fund further expansion for the next several years.More doctors will continue to use an older system, through which they report problems to the manufacturers, who then notify regulators--a process which potentially allows device makers to downplay bad news to the FDA. The FDA estimates that problems with medical devices cause 300,000 deaths and injuries annually.ReadPermalink*|*Email this*|*Linking*Blogs*|*Comments

Ads by Google

http://www.medicalinformaticsinsider...ice-reporting/

08-03-2005, 05:25 PM	#1 (permalink)
Medical Informatics News Medical Informatics News Join Date: Nov 2004 Posts: 1,275	[medinformatics] FDA Stops Medical Device Reporting Project The Food and Drug Administration has halted plans to closely monitor deadly malfunctions and misuses of medical devices through a new computer reporting system.The system, known as MedSun, allows doctors nationwide to directly report to the FDA problems with medical devices such as pacemakers, stents, and defibrillators. The FDA hoped to connect 500 of the nation's 5,000 eligible hospitals. To date, there are 350 facilities arein the system but the FDA won't fund further expansion for the next several years.More doctors will continue to use an older system, through which they report problems to the manufacturers, who then notify regulators--a process which potentially allows device makers to downplay bad news to the FDA. The FDA estimates that problems with medical devices cause 300,000 deaths and injuries annually.ReadPermalink\|Email this\|LinkingBlogs\|Comments Ads by Google http://www.medicalinformaticsinsider...ice-reporting/