Having a mastectomy leads to not only a physical change, but it also has a personal effect on a patient. Many patients opt for reconstructive surgery, and a new treatment option in breast reconstruction gives women a more natural appearance (due to its natural feel before, during, and after tissue regeneration) without leaving permanent material behind. Diana Reynolds, global plastic and reconstructive and ENT product manager at Cook Medical, gave me some insight on the new technology—the Biodesign Nipple Reconstruction Cylinder—and how it differs from other methods of breast reconstruction.
 
 
The Biodesign tissue generation matrix is a noncross-linked, nondermis-based biologic graft that rebuilds the breast through generating new tissue. It can be used for breast reconstruction, breast revision and mastopexy. “Unlike many dermis-based grafts often used to reconstruct the breast, Biodesign is carefully processed to maintain its...

November 5th, 2010
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While everyone looks forward to that extra hour of sleep this weekend, they should also make sure that certain medical devices are prepped for the time shift, according to Health Canada. The agency says that medical equipment that was built prior to 2007, which is when the start and end dates of daylight time were changed, may not perform optimally if the manufacturer hasn't updated the device to account for the new dates.
 
Affected devices could include implanted pacemakers and defibrillators with sleep modes that can only be adjusted by physicians, holter monitors, and glucose monitors. However, Health Canada has not received any reports of device malfunctions due to the revised time change. Contact Health Canada at 866/225-0709 with questions. —Lawrence Lloyd

November 5th, 2010
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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."
 
The results may represent the next step forward in treating lung cancer because chest x-rays have not been shown to be effective in indentifying tumors. Scientists behind the study are still parsing the data and would like to have an article prepared for publication within the next few months. NCI director Harold Varmus says that the research team will not make any recommendations about routine screening as a result of the study. Such recommendations, he says, should wait until the data have been analyzed—not to mention that they are typically...

November 4th, 2010
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More questions are being raised about FDA's oversight of medical devices, this time from across the pond in the British Medical Journal. In a report published this week, authors Jeanne Lenzer and Shannon Brownlee criticize FDA's lax oversight of medical devices, citing Cyberonics' vagus nerve stimulator as an example.
 
The device was approved in 1997 on the condition that Cyberonics conduct a postapproval study to examine the device's safety. The study was carried out but did not mention any deaths among patients who received the device (900 deaths have been reported since the device was approved, but Cyberonics contends that these deaths were not attributable to its device—in fact, the company says that patients who use the device are less likely to die than those who do not).
 
FDA spokeswoman Karen Riley echoed Cyberonics' statement that there was no evidence that any of the 900 deaths were caused by the device....

November 3rd, 2010
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It's been a long wait, but IEC 80001 has just been approved. This is a standard governing risk management for networks incorporating medical devices. Read more details on the MED blog. —Lawrence Lloyd

November 2nd, 2010
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Every year MD+DI conducts a comprehensive Salary Survey. The results of this survey will be published in the December issue (click here for 2009 data).

For 2010, we wanted to give you a peek at the topline data. The results by category, are detailed below:

Acquisitions 2010

Age 2010

Compensation 2010

Job Security 2010

Salary 2010

 

 —Heather Thompson

November 1st, 2010
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October 29, 2010
Newtown, PA

Traditional wound care products are growing at a relatively slow pace due to the market shift toward advanced therapies. The advanced wound care segment generated more than $6 billion in revenue in 2009 and is forecast to grow to more than $16 billion by 2017.

The United States accounted for about 90% of the worldwide wound care market in 2009. However, markets in Europe, Japan, and other developed nations are forecast to grow at a significantly fast pace, especially in their use of advanced wound care treatments. While 80% of U.S. hospitals are using advanced methods, most hospitals in foreign markets are still using traditional therapies.

Companies are investing in products and therapies that can be used for a wide range of indications. Angiogenesis is an innovative therapy that restores the body’s natural ability to grow new blood vessels to heal wounds and restore blood flow to tissues after injury. This essential...

October 29th, 2010
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As the adage goes, there's more than one way to skin a cat. Turns out there's more than one way to insert heart stents, too. Cardiologists at the Ohio State University Medical Center are one of the relatively few teams that have started performing stenting through the wrist. Although stenting through the wrist requires a bit more precision than traditional methods, it can lower bleeding complications and facilitate a quicker recovery.

 

October 27th, 2010
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AAMI's HE75 has been recognized by FDA, giving manufacturers a method to demonstrate use of human factors in device design and development.

The guidance document was released early in 2010. The nearly 500-page document—intended for manufacturers, clinical engineers, biomedical equipment technicians, regulators, and students—covers a variety of topics, such as visual displays, software-use interface, packaging design, usability testing, and user documentation.

FDA's recognition of the guidance gives the association and the document more prominence. It also cements the agency''s growing interest in human factors as a risk prevention tool.

Increasing emphasis on human factors is a crucial part of medical device manufacturing, as OEMs turn more and more to...

October 26th, 2010
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For years researchers have been developing technologies that analyze breath samples for diseases like lung cancer. Advantages to such devices have included a less invasive approach and real-time results. A University of Florida professor is taking breath sampling a step further with an add-on device that touts more sensitivity and thus more accuracy in detecting chemicals, cells, and microorganisms in exhaled breath. Paul Davenport, PhD, developed the device to work in conjunction with existing breath testers, which should improve the function of the tests while also reducing costs. The device uses high frequency oscillation to apply vibratory air pressure waves to increase the concentration of substances in a breath sample...

October 25th, 2010
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