The FDA issued a Public Health Notification last week warning of the potential risk of Device Malfunction caused by CT Scans.
Apparently, CT scans can cause internal and external medical devices to malfunction. This is due to the x-ray being emitted as part of the CT Scan; and the higher the setting/dose, the greater the risk of causing [...]

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The Baltimore Sun reports that the FDA with Computer Programmers and IT Experts have found the medical equipment malfunction my not be caused by poorly designed of badly made device, but rather due to faulty programmed code operating the device.
From the Baltimore Sun Article:
“After a routine piece of medical equipment started mysteriously killing hospital patients [...]

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JAMA, The Journal of the American Medical Association published a study titled “Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment” that raises the concern that RFID (Radio-Frequency Identification) Tags can cause “potential hazardous incidents” in medical equipment.
Here is the study abstract:
“Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in [...]

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This months Medical Dealer Magazinehas a great analysis of the Joint Commission’s MRI Sentinel Event Alerts by Robert Junk and Tobias Gilk.
Mr. Junk and  Mr. Gilk analyze all ten points of of the sentinel alert and give their recommendations and critiques of each one.
Here’s a couple of excerpts from the article:
“The Joint Commission’s Sentinel Event Alert [...]

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ECRI issued a Critical Alert on Curlin Medical’s Infusion Pumps.
The Curlin Medical 2000 CMS, 4000 CMS, 6000 CMS and PainSmartPumps were  tested by ECRI and were found to have serious defects that can potentially lead to over-infusion.
Engineers at ECRI found that the pump doors do not fully compress the tubing during operation, which can potentially result [...]

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Medtronic (MDT: 56.01 +1.53 +2.81%, vol: 13,696,671, 52wk: 44.26 - 57.99) 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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Health Care Notification Network (HCNN) is a secure online service that delivers urgent patient safety alerts to healthcare providers.
From the HCNN FAQ page:
1. What is the Health Care Notification Network (HCNN)?
The HCNN is the new online service that delivers important patient safety alerts that are product-related and mandated by the FDA, to physicians and other [...]

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The new Daylights Savings which has first implemented in 2007 has gone into affect this past Sunday morning at 2am. What does that mean for Biomeds? It means that all equipment with clocks manufactured more then one year ago will probably need to be manually reset.
Gonna be lots of fun resetting all those clocks, getting all those calls from [...]

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Here are this weeks recalls and alerts:
05 Mar 2008| MDA/2008/012 - Medication cassette reservoir for CADD® Legacy and CADD® Prizm infusion pumps manufactured by Smiths Medical
03 Mar 2008| MDA/2008/011 - Automated peritoneal dialysis systems. Homechoice/Homechoice Pro by Baxter Healthcare Ltd
03 Mar 2008| MDA/2008/010 - Ambulift hoist. All models manufactured by Arjo or Mechanaids
03 Mar 2008| [...]

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