Can some explain to me how something like this happens…. I just don’t get it.
From The Chronicle
Dozens of patients who were accidentally treated with tainted surgical instruments at Duke University Health System hospitals in 2004 filed a civil suit Tuesday in Durham against the companies contracted by the University to sterilize the equipment.
In November and [...]

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Draeger Medical announced yesterday the development of the new Online Draeger Medical Service Community (DMSC) for Clinical and Biomedical Customers.

From the Draeger Press Release:
DMSC was designed to address the ever-evolving nature of medical technology and the importance of accurate, updated information. Features and functions of DMSC enable both clinical and biomedical customers to better understand, use and [...]

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Medtronic (MDT: 32.15 +0.43 +1.36%, vol: 6,515,589, 52wk: 28.33 - 56.97) the manufacturer of the Physio-Control Lifepak Defibrillators has signed a Consent Decree of Permanent Injunction with the FDA.
The Consent Decree is related to the Physio-Control’s AEDs (Automatic External Defibrillators). The Decree prohibits the manufacture, distribution, and export of specific model AEDs from the Physio-Control [...]

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GE Healthcare and the University of Phoenix have teamed up to offer college credits for GE Clinical Systems Technical Training Classes.
GE initially launched the program for its own service engineers, but has extended it to Biomeds taking training classes at GE Healthcare.
The credits which can be used towards Bachelors and Masters Degress. To date there [...]

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When Medtronics(MDT: 32.15 +0.43 +1.36%, vol: 6,515,589, 52wk: 28.33 - 56.97) suspended shipments of its Physio Contol LIFEPAK Defibs in January 2007 the only reasons given were “quality control issues”.
Court Documents filed last week expose what Medtronics has been trying to hide. The FDA Injunction cites 11 Violations.
The Violations include:
Failure to investigate complaints involving the possible [...]

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The  FDA has issued Philips Medical a Warning Letter on April 1, 2008.  The Warning Letter details many failures in compliance with FDA code at Philips Medical’s Cleveland, Ohio plant. The Cleveland plant is where Philips Medical manufactures CT and Nuclear Imaging Systems.
Via The Biomedtalk ListServ
FDA Warning Letter 

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Cardinal Health/Alaris issued a recall on April 10, 2008, recalling its Alaris System/Medley Pump. The recall affects the Alaris System/Medley PC unit as well as, various Medley modules. The recall is related to the Grey IUI Connectors, U9 Socketed IC’s, and/or U19 Socketed IC’s.
Cardinal Health has received reports of channel errors with the Alaris System due to [...]

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Philips Medical Systems (PHG: 20.11 -0.03 -0.15%, vol: 450,210, 52wk: 14.71 - 41.68) announced today that it has acquired Shenzhen Goldway Industrial Inc. for an undisclosed price.
The purchase gives Philips a foothold into the Chinese Patient Monitoring Business.
Shenzhen Goldway is China’s second largest domestic patient monitoring company.
Philips Press Release 

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Cardinal Health (CAH: 36.58 +0.64 +1.78%, vol: 4,174,936, 52wk: 27.79 - 62.25) will be giving $1 million to 34 US Hospitals, Health Systems, and Clinics to develop new and innovative projects to improve patient care and enhance patient safety. 
Via Healthcare IT News
Cardinal Health Press Release

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AAMI the Association for the Advancement of Medical Instrumentation will be forming new standards for the Home Healthcare Industry.
The new standard titled IEC 60601-1-11: General requirements for basic safety and essential performance - Collateral Standards: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.
AAMI believes that as people [...]

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