The Conficker worm (aka Downup, Downadup, and Kido) has been found to have infected Medical Equipment accross the country and around the world. The worm which infects networked Medical Equipment built on a Microsoft Windows OS backbone, uses a combination of advanced malware techniques which has made it difficult to counter, and has since spread rapidly into what [...]

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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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In an email to the Biomedtalk-l listserv, Biomeds were warned of a potential terror issue. The Unconfirmed report issued by a non-govermental group warns of potential thefts that may be linked to terrorist activites.
The report warns that facilities experiancing a unusual number of stolen / missing EKG Lead wires and senors contact their local FBI [...]

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ECRI Institute , an independent, nonprofit organization that researches the best approaches to improving patient care, has issued a high priority medical device alert for several older models of infant radiant warmers.
ECRI Institute recommends the removal from service of a series of warmer models manufactured by Borning and Hill-Rom. Draeger purchased the product line from [...]

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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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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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Effective October 1, 2008 Medicare will no longer reimburse medical facilities for eight conditions that patients can acquire while being a patient at a medical facilty. These conditions known as “Hospital-Acquired Infections or HAIs and consist of the following conditions:

Bed Sores
Objects Left In A Patient After Surgery
In-Hospital Falls
Blood Incompatibility
Mediastinitis - inflammation of the tissues in the [...]

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Sonora Medical Systemsissued a warning letter to medical facilities and on its website that at least one third-party ultrasound service company has illegally modified the FirstCall probe testing software in an attempt to test probes that have never been validated by Sonora.
From the Warning Letter:
Hospitals should not allow 3rd parties to test their probes with [...]

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