An infectious disease physician presented seven-year data showing that coating central venous catheters with antibiotics minocycline and rifampin reduces the risk of bacteria getting into the blood. The data also showed no proof that the antibiotics promote resistance to bacteria, which some researchers had been concerned about. Issam Raad of the University of Texas M.D. Anderson Cancer Center presented his findings at the 18th annual scientific conference of the Society for Healthcare Epidemology of America. This could be a significant step in preventing catheter-related infections, which are responsible for 250 deaths each day in the United States. It is also good news for Cook Medical, which makes catheters coated with the antibiotics studied. Dr. Raad is the co-inventor of that pairing, and receives royalties from Cook. In other infection-control news, a study showed that for three kinds of surgery, ...
April 28th, 2008
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FDA has cleared the first device, an exam glove, made from natural rubber latex. This provides an alternative for the 3% to 22% of healthcare workers who are sensitive to traditional latex. The Yulex Patient Examination Glove is made from guayule latex, which comes from a desert bush found in the southwestern U.S., called the guayule bush. Arizona-based Yulex Corp. manufactures the glove and has been working on getting a safer alternative into the market for several years. In 2006, ASTM created a new category for natural rubber latex that specifies safety standards based on protein content.
April 25th, 2008
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FDA's ophthalmic devices panel will consider complaints about laser vision correction surgery, the Associated Press reports. At its meeting tomorrow, the panel will hear from patients who have had problems as a result of the surgery, as well as from the American Society of Cataract and Refractive Surgery, which says 95% of patients who have the procedure are satisfied with the results. The agency will ask the panel whether educational materials given to patients need to be changed, to better inform them of the risks. Between 1998, when the devices were first approved, and 2006, the agency received 140 complaints from patients. A large-scale study of patients' quality of life after the surgery has not been done, but the ASCRS will begin work on one soon. If negative publicity emerges from this, it could impact Advanced Medical Optics, Alcon, and Bausch...
April 24th, 2008
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Medtronic announced that it will pay $1.60 per share, or about $29 million, read more >>
April 23rd, 2008
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Boston Scientific showed a profit in the first quarter after two consecutive quarters of losses, reports the Associated Press. But sales of its two main product lines, stents and implantable cardioverter-defibrillators, have continued to be sluggish. The main reason for the profit: cost cutting. In the last half-year, the firm has shed 2300 jobs and sold off some of its businesses. Fruits from those moves are now starting to show up on the bottom line. Analysts remain concerned that the firm's "fundamentals remain depressed," however. The company earned $322 million in the first quarter, compared to a profit of $120 million the same period a year ago. Quarterly sales were $2.05 billion, down from $2.09 billion in the first quarter of 2007.

In other earnings news,...

April 22nd, 2008
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A lengthy article in the Boston Globe looks at some of the research going on with nanodevices, particularly in how they may be used to diagnose and treat cancer. The federal government has given $145 million in grants in this area. One project is using iron oxide nanoparticles as a diagnostic tool: If the particles are absorbed into the lymph node, that's an indicator as to whether cancer is present. Another is using the same material as a drug delivery device. When nanodelivery of cancer drugs becomes a reality, it will make today's chemotherapy regimens seem barbaric. This kind of research is probably not news to most of you. We have covered it in MD&DI, and much has been written about it in scientific journals. But it is nice to see it getting notice in the mainstream media, beyond the...

April 21st, 2008
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Transforming FDA LogoA bill proposed in the House of Representatives would require all medical devices being imported into the United States to be labeled with their country of origin, reports the Associated Press. The bill would also create a permanent foreign-inspection staff for FDA and mandate that overseas device and drug plants be inspected every two years. These measures are spurred by a slew of recent reports about tainted products from China, including a recall of heparin, which is used as a medical device coating. Also of significance is that the bill contains language that gives FDA the power to force recalls. Currently, they can only suggest that a...
April 18th, 2008
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As some manufacturers of new technologies promote interoperability with electronic health records, they need to consider patient privacy. An article in The New England Journal of Medicine raises concerns over the security of information contained in electronic records that would be maintained by companies like Microsoft or Google. The authors state that such companies aren't bound by the privacy restrictions set forth by the Health Insurance Portability and Accountability Act (Hipaa). Passed more than 10 years ago, Hipaa didn't foresee Web-based health records as an issue. The authors of the journal article, who are also proponents of electronic patient records, suggest safeguards that combine federal regulation with contract relationships, and other standards and education programs.
April 18th, 2008
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Thirty-three products have won Medical Design Excellence Awards, the premier award for medical product design. The winning products are profiled in the April issue of MD&DI. A ceremony to honor the winners will be held at 11 AM on Wednesday, June 4 at the MD&M East show in New York City. At that time, it will be revealed which products won Gold awards and which ones won Silver.
April 17th, 2008
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You may have seen a ubiquitous infomercial for Kinoki Foot Pads, which claim to be able to remove toxins from the skin. Does it sound too good to be true? FDA seems to think so, and is investigating the pads' maker, Xacta 3000, reports the Associated Press. Judging from the claims about the pads, you'd think they were medical devices, but they are not regulated as such. FDA spokeswoman Rita Chappelle said she could not disclose the details of the investigation, but noted that the agency often opens cases because of suspicion about whether a firm has violated rules on making false and misleading claims. Doctors interviewed for the AP story are skeptical about the pads' claims because the skin only excretes water and salt, not toxins. They also questioned the vagueness of the ingredient list on the read more >>
April 17th, 2008
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