It looks like this could be the week where defibrillators take center stage. Yesterday, we learned that FDA wants to improve the design, safety, and effectiveness of defibrillators. Another story making the rounds says that these devices aren't as useful in hospitals as they are in public places.
A study in the Journal of the American Medical Association (and also reported at the American Heart Association's meeting currently under way in Chicago) says that defibrillators actually increase the risk of death in the hospital setting.

"The common sense was that AEDs in...

November 16th, 2010

After telling makers of CT scanners to step up their efforts, FDA has now honed in on defibrillators (specifically, automated external defibrillators or AEDs). These devices have been the subject of a number of recalls, and regulators say that malfunctions may have contributed to patient harm or death.

"While the FDA continues to advocate use of these important life-saving devices and is not recommending any change to current clinical practices, we believe the devices can be improved in ways that materially improve patient safety," the agency said in a report released on Monday.
The agency pointed to one example where a button that activates the device's electrical charge was covered. Such a design flaw is easy to fix, FDA says.
The agency also says that a variety of problems have cropped up in AEDs from all manufacturers (this...

November 15th, 2010

From our friends at MPMN:

Japanese researchers have developed thin, flat, and flexible organic transistors and complementary integrated circuits (ICs). Incorporated into a thin polyimide sheet, the ICs can be wrapped around a catheter, enabling measurement of physical or chemical properties inside the device. “Flexible organic ICs are biologically friendly, so they can be used potentially in wearable and implantable electronic [products],” remarks Takao Someya, an electronic engineering professor at the University of Tokyo. The research results will be published in the December issue of Nature Materials.

Read a...

November 15th, 2010

Big Brother may be watching us, but it's debatable whether those eyes are on medical devices too. As of right now, there's no universal method of tracking them. The latest call for an automated tracking system for these products comes from a study published in the Journal of the American Medical Association. The researchers, led by Frederic Resnic, MD, of Boston-based Brigham and Women's Hospital, say that a computerized tracking system that scans data might help find faulty medical devices.
The research team examined data from more than 74,000 heart procedures involving seven medical devices used on Massachusetts patients between 2003 and 2007. The researchers looked for three common problems that could occur with each. A test run of the group's system yielded two products with potential safety problems. Note that this doesn't mean that the devices are faulty...

November 11th, 2010

There are apps for everything, so it comes as no surprise that developers have created an app at the point where sex, electronics, and diagnostics meet. The UK Clinical Research Collaboration, a consortium of doctors and tekkies, has invested 4 million pounds into the development of a system that will be able to determine in minutes whether someone has a sexually transmitted disease.
The app, which draws from nanotechnology and microfluidics, would allow a user to put urine or saliva onto a computer chip about the size of a USB drive. After inserting the chip into the phone (or a computer), the user would receive a quick diagnosis of common STDs such as herpes, chlamydia, and gonorrhea.
The creators are...

November 10th, 2010

The agency wants OEMs to add safety features to their devices and better educate the people who use them.
"Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks," CDRH director Jeffrey Shuren said in a statement on Tuesday.
To that end, the agency has sent its recommendations—which include operator alerts for high radiation doses, extra training programs, and appropriate dose information that is easily found in one section of a user manual—to the Medical Imaging and Technology Alliance (MITA) in a letter dated November 8.

MITA has worked with the FDA recently to address the agency's concerns. The group said in a statement that "in the end, the optimal solution will require action by all stakeholders including manufacturers, users, and regulators."...

November 10th, 2010

In a piece of larger industry news, federal investigators have dismissed misconduct claims against CDRH for the second time this year. The Office of Inspector General for HHS said in a one-page memo that there is "no evidence of retaliation" against whistleblower employees. If you recall, nine current and former scientists alleged that agency managers meddled in product reviews and improperly overturned decisions. The staffers said that they were then intimidated when they intimated their concerns to the public. The memo, which is dated October 14, concludes "this case is closed." —Lawrence Lloyd

November 9th, 2010

Miniaturization continues to be a trend in medical electronics, and an upcoming project from Medtronic seems to capture the essence of less is more. The company is working on a new mini pacemaker that is about the size of a large vitamin. The device has been in development for about a year now, and Medtronic says it is about five years away from the market (assuming FDA approves it).


Medtronic is not necessarily depending on the United States market for this venture, though. The mini pacemaker wouldn't require the same level of expertise needed to implant traditional pacemakers, which...

November 8th, 2010

Oregon State University engineers have come up with a way to speed the production rate of nanoparticles by 500 times. What does this mean for nanotechnology? For starters, this advance could make nanotechnology products more commercially practical.
In addition to an arrayed microchannel reactor, the engineers used a laminated architecture made up of parallel stacked sheets filled with thousands of microchannels. The parallel arrangement helps to provide control of the processes involved. The research, recently published in Nanotechnology, has potential applications in medical imaging and electronics. —Lawrence Lloyd

November 5th, 2010

A few imaging-related items are making the rounds...

  • In an x-ray vs. CT scan comparison study, researchers have found that advanced CT imaging can reduce lung cancer deaths among heavy smokers by 20%. The $250 million study, sponsored by the National Cancer Institute, yielded results that were "so conclusive that the study was terminated prematurely last week and letters were sent to all the participants advising them of the results."
  • FDA has reclassified full field digital mammography systems, which produce computerized x-ray images of the entire breast, as Class II (i.e., medium-risk) medical devices (previously Class III).
  • GE Healthcare ...
November 4th, 2010