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
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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
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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
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The American Cancer Society and other health groups have decided to recommend the use of virtual colonoscopies for detection of colorectal cancer, reports the New York Times. This comes after new studies showed that the procedure, which involves undergoing a CT scan to look for abnormal growths, is more effective than thought. The groups also endorsed the use of a test that examines a stool sample for DNA that would indicate abnormal DNA associated with cancer. Patients might be more willing to undergo these tests than regular colonoscopies, which are notoriously invasive. The groups included colonoscopies, virtual colonoscopies, stool DNA tests, and four other tests on a list of procedures that should be considered for anyone over 50 and for those under 50 with symptoms or risk factors for colon cancer.
March 7th, 2008
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Transforming FDA LogoAn article published in today's New England Journal of Medicine finds fault in FDA's regulatory system for medical devices, using the recall of Medtronic's ICD lead in 2007 as part of the basis for the criticism. According to author William Maisel, MD, the combination of the number of patients affected, money at stake in the market, and dialogue between doctors and patients about the product's performance "highlight the shortcomings of the regulatory system...and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them." Part of the problem, he writes, is...
March 6th, 2008
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We all know that documents are important because they prove to everyone, including FDA, what is going on with your design and manufacturing processes. But a lot of device companies tend to forget that they are also important because they can show whether a firm placed revenue goals ahead of patient-safety ones. And that can not only get a firm in trouble with FDA, but also expose it to product-liability lawsuits. With that in mind, Nancy Singer, president of Compliance-Alliance Inc. and a member of MD...
March 5th, 2008
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In its first two years, the Medical Device Regulatory, Reimbursement, and Compliance Congress at Harvard has devoted tracks to reimbursement and to fraud and abuse, and it will do so again this year. But a different angle for the conference is a track on the challenges of disseminating information about medical devices. This has become an extremely important, yet often overlooked, issue in recent years. How much information is appropriate for a device company to give to doctors? A number of firms have gotten in trouble for getting this answer wrong. And yet, the landscape may be changing, as a new FDA draft guidance contains a provision that would allow, for the first time, device companies to disseminate peer-reviewed studies of off-label uses.   The agenda for the track covers everything from what physicians want to hear to what device companies want to say (...
March 5th, 2008
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Shares of Cochlear Ltd., an Australian firm that makes the world's best-selling hearing implant, are on the rise after one analyst felt its stock price was undervalued, Bloomberg News reports. Its stock had taken a hit when it missed an estimate because of slower-than-expected sales in China. It fell 21% after the firm's first-half earnings report was released in January, but rose 3.3% yesterday. The firm is working with a Taipei-based charity to sell 15,000 of the devices to patients in China. But the effort has suffered from a lack of properly-trained healthcare workers, and less than 600 have been sold so far. Sales otherwise grew about 18% for the first half of the firm's fiscal year. So Alexander Smith, a healthcare analyst at JP Morgan Chase's Sydney office, deemed the stock undervalued and raised his rating on it.
March 5th, 2008
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Cardinal Health, a wholesaler of drugs and other medical products, has agreed to buy a firm that specializes in infection control for $490 million, Reuters reports. Enturia Inc. is best known for ChloraPrep, an antiseptic formulation that is applied to a patient with an applicator before surgery. Its products fit in with other Cardinal properties geared toward infection prevention, such as surgical apparel.
March 4th, 2008
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FDA has reversed itself over patient-recruitment and statistical-analysis issues for Vasogen Inc.'s Celacade System, a combination product that treats heart inflammation. Responsibility for lead review has been switched from CDRH to CBER (though the product will remain regulated as a medical device). CDRH had asked the company to use a Bayesian study design, but it now says the approach is not justified because of concerns about how patients in the product's two main studies were recruited. The company says it will respond to the agency soon. Vasogen was named one of MD...
March 3rd, 2008
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