On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled “Spontaneous explosion of implantable cardioverter-defibrillator” by Martin Hudec and Gabriela Kaliska. In the pdf of that case report a figure containing a color photo of the affected patient’s chest, chest X-ray, and two pictures of the extracted device (one seen here) were included.
The pictures and case presentation were dramatic and the case very rare. Both were perfect reasons to report such an important case to the medical literature. And so these doctors sent the case to Europace on June 29, 2010, and the article was accepted after revision on August 16, 2010, with the article appearing online September 27, 2010.
The authors must have felt very proud to have an article published relatively quickly, and the editors and reviewers of Europace must have thought the case was unique enough and important enough to have the article revised according to their specifications, then published online — until I reported the case on this blog on October 5, 2010, and included images from a portion of the case report’s figure.
Remarkably, later that same day, Europace removed the case report from its website without comment. The article simply vanished. I attempted to e-mail the editor of Europace to inquire about the reason for the retraction but received no reply, so I contacted the lead author, Martin Hudec, M.D. He kindly responded and I included his email response in the comments to my post two days later. Read more »
*This blog post was originally published at Dr. Wes*
A paper published in the February issue of Health Affairs – discussed at length in an article in the New York Times – contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD).
In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep brain stimulation. But misleading or biased information, no matter where it comes from, certainly undermines patients’ ability to calculate benefits and risks.
To enable deep brain stimulation, a surgeon must first implant electrodes in the brain and connect them to a pair of small electrical generators underneath the collarbone. Deep brain stimulation uses electricity to affect how brain signals are transmitted in particular areas of the brain. The image to the left, from the National Institute of Mental Health, shows how deep brain stimulation depends on the implantation of pulse generators below the collarbone and electrodes in the brain.
Specific concerns are raised by the article in Health Affairs (and in our own article on this topic last year in the Harvard Mental Health Letter). Read more »
*This blog post was originally published at Harvard Health Blog*
Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.
James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following:
The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.
By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBerry], and the Android Marketplace [Android OS]. Read more »
*This blog post was originally published at iMedicalApps*