Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.
The patches of concern include both brand name and generic products and patches [...]

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Models Include: All COLLEAGUE Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163
 
DEERFIELD, Ill., March 11, 2009 – Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s January 23, 2009 Urgent Device Correction letter to customers regarding U.S. COLLEAGUE® Volumetric Infusion [...]

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Welch Allyn today announced a voluntary worldwide recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007.
There is a remote chance that these devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference.  If such issues arise, it may prevent defibrillation [...]

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Physio-Control announced today the FDA has cleared them to market the Likepak 15 defibrillator in the US. Official notification of the FDA 510(k) Premarket Notification was posted to the FDA website on March 16, 2009, and can be viewed at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=28973
“With the LIFEPAK 15 monitor/defibrillator, Physio-Control is delivering on its commitment to provide innovative, reliable and [...]

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The FDA has published a 2009 calendar titled “2009 Medical Device Safety Calendar (Luer Misconnections). The Calendar is available for download at the FDA’s website, and Clinical Facilities can order printed copies free of charge by emailing luersafety@fda.hhs.gov.
Download the 2009 Medical Device Safety Calendar
FDA Luer Missconnections Calendar site

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The GAO (Government Accountability Office) released a report earlier this month in which it directs the FDA’s CDRH to “ensure that high-risk device types are approved through the most stringent premarket review process”.
Here are the highlights:
Why GAO did this study:
The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is [...]

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Seems like the FDA is getting into a whole heap of trouble these days (reminds me of my High School Days)…
Here is the article:
The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.
Moreover, the [...]

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FDA CDRH Scientists Complain To Obama in a scathing letter detailing widespread misconduct at the government agency.
Here is the article:

WASHINGTON – In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
“The purpose of this letter is [...]

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Fluke Biomedical has submitted the new Impluse 7010 Defib Analyzer Accessory for FDA 510(k) clearance. The Impulse 7010 Accessory for the Impluse 7000DP Defib Analyzer is the only product available today that has the ability to test defibrillators beyond 175 Ohms.
I was curious as to why Defibrillator Analyzers and accessories needed 510(k) clearance, so I contact Fluke Biomedical and this [...]

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The FDA posted the Medtronic Physio Control recall Friday on its Medwatch Website which is dated August 28, 2008.
The recall is for the Lifepak CR+ AED manufactured between May 20, 2004 and August 11, 2007. The reason for the recall is due to:
The AED instructs the responder, by voice prompts, to press the shock button. However, [...]

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