FDA has posted a public health advisory noting that patients being treated for abdominal aortic aneurysms are more likely to die five years down the road if they have been treated with Medtronic's AneuRx stent-graft system as compared to conventional surgery, the Wall Street Journal reports. The agency singled out Medtronic's product because it is the only stent-graft system that has five-year data. The company says that the advisory fails to take into account that the system has a lower rate of short-term deaths than surgery.
March 19th, 2008
0
CDRH Director Daniel Schultz said yesterday that long-awaited guidance on drug-eluting stent testing should be ready in a matter of days or weeks, Reuters reports. Much controversy has occurred over the safety of drug-eluting stents, with studies conflicting over how likely they are to cause blood clots. The guidance should give manufacturers a better idea of what sorts of physical and safety tests need to be done to satisfy these concerns.
March 18th, 2008
0
Transforming FDA LogoThe Senate has passed a resolution to give an additional $375 million to FDA's fiscal year 2009 budget, reports the New York Times. The main impetus appears to have been Baxter's tainted heparin that might have never reached these shores had FDA inspected the Chinese plant where the problem occurred. For some Senators, that incident amplified the numerous recently released reports stating that the agency does not have nearly enough funds to accomplish its mission. It is not yet known whether the House would agree to the contents of the resolution. There is no similar language in the budget bills...
March 17th, 2008
0
Device and drug companies aren't letting publicity over the safety of manufacturing facilities in China get in the way of their presence in the country. For years now, manufacturers have cited lower operation costs and a presence in the Asian market as reasons for either establishing or relocating sites to China. The Boston Globe reports that companies like Covidien Ltd. and Inverness Medical Innovations Inc. are expanding their production there. Covidien is tripling its workforce at the site, and Inverness Medical is relocating a plant from England to China. However, a lawyer quoted in the article says it's easier to win damages against a company that is sells defective products manufactured in China than in the United States. The Baltimore attorney, Ronald Miller of Miller...
March 14th, 2008
0
Michael Mussallem, chairman and CEO of Edwards Lifesciences, has been voted to a two-year term as chairman of the board of directors of AdvaMed, the nation's largest trade association for the medical device industry. He replaces Edward Ludwig, chairman, president and CEO of Becton Dickinson. Mussallem for the past two years has chaired AdvaMed's Board Payment and Health Care Delivery Subcommittee. He said his priorities will include raising awareness about the value of medical technology, enhancing industry ethics, and strengthening relationships with key stakeholders.
March 13th, 2008
0

Implanted devices that use wireless technology are vulnerable to being `hacked,' or accessed in an unauthorized manner, a new study finds. The authors of the study, which was performed on a lab bench and not in live patients, were able to send unauthorized commands to wireless devices such as pacemakers and implantable cardioverter-defibrillators. These commands enabled them to reprogram settings, retrieve patient data, and even deliver potentially fatal shocks. The study won't be presented until May at a computer security symposium. But its findings, conducted by a team from the Beth Israel Deaconess Medical Center, the University of Massachusetts, and elsewhere, were reported in the Boston Globe this morning. William Maisel, MD, the study's lead author, emphasizes that it takes extreme technical skill to be able to...

March 12th, 2008
0

Today's New York Times has an essay by cardiologist Sandeep Jauhar, MD that depicts and decries the excessive consultation and testing -- especially medical imaging -- that he believes is the prime driver of the United States' spiraling healthcare costs. While he seems to believe some of the blame lies with greedy doctors, patients who confuse quality of care with quantity of care, and overuse of new technology, he says the main culprit is the "perverse financial incentives of our current [healthcare] system." CMS adapted to rising healthcare costs by cutting reimbursement rates. Since doctors get paid what they bill, many have responded by increasing the quantity of services. If you get paid by the task, and you're going to get paid less for each task you perform, and you want your level of income to remain the same, you're going...

March 11th, 2008
0

True and robust Corrective and Preventive Action (CAPA) systems are more than just a formal mechanism for tracking problems, says an FDA expert on quality systems. They must encompass a number of data sources, including complaint handling, nonperforming product mechanisms, Medical Device Reporting, corrections, removals, and recalls, said Jan Welch, a quality systems expert in CDRH's Office of Compliance. She spoke as part of an audioconference on implementing an effective CAPA system, held March 6. It was sponsored by FOI Services and moderated by Nancy Singer, president of Compliance-Alliance Inc. and a member of MD&DI's Editorial Advisory Board. A lot of firms who have been cited by FDA have not gotten this message, she said. She did an analysis of FDA-483 observations issued in 2007 and found that 964 of...

March 10th, 2008
0
Today's Star Tribune of Minneapolis has a feature on Transoma Medical Inc.'s Sleuth, a wireless implantable device that monitors the electrical activity of the heart and, via a handheld device carried by the patient, transmits the data to caregivers. The firm received FDA approval for Sleuth in October and the article follows one of the first 50 patients to receive it. The technology could make for faster diagnosis, more efficient treatment management, and fewer visits to the hospital -- which would save money. Interestingly, Transoma started out as a pharmaceutical research firm and developed what became the Sleuth technology to monitor the effects of drugs on animals. It didn't think of the technology as a device that could be used in humans until other firms started making wireless implantable devices. It plans to aim the product at those with chronic conditions...
March 10th, 2008
0
Rollprint Packaging Products Inc., which invented the header pouch, a package commonly used for medical devices, in 1969, kicked off a yearlong 75th anniversary celebration yesterday. Rollprint was also one of the first converters to introduce coated Tyvek to the medical packaging market, and has also invented heat-seal coatings. As part of the celebration, the firm has introduced a new generation of peelable chevron header pouches and formed a joint venture with a company in Singapore, Acme Packaging Co. Ltd. The venture, Allianz Flexible Packaging, will serve China and other locations in Southeast Asia.
March 7th, 2008
0