FDA wants to know whether a registry could help standardize feasibility trials for local treatment of small breast cancers with different ablation devices and therapies, according to a Federal Register notice. FDA particularly wants to understand how such trials can be designed to provide standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, postablation imaging and assessment, and tissue pathology of ablated specimens. In 2003, the notice says, FDA's General and Plastic Surgery Devices Advisory Panel discussed issues pertaining to the use of thermal ablation devices to noninvasively treat breast cancer. The panel also discussed clinical trial issues pertaining to local treatment of breast cancer using thermal ablation versus operative resection. FDA says the panel's discussion has significantly affected regulation of the technologies. And investigators studying feasibility of thermal ablation devices for treating...
July 18th, 2008
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An FDA inspection of a Cardinal Health facility in Dublin, OH that distributes point-of-use sharps containers has determined that the facility does not have adequate management controls as part of an effective quality system. The inspection found that a number of a quality system procedures have not been established, according to a May 28 warning letter. Among the procedures lacking are written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures. Additionally, FDA's letter says a management representative has not been appointed to ensure that the quality system requirements are met, and management reviews do not ensure that the quality system satisfies the requirements of CFR part 820. The letter also cites the firm for failing to conduct quality audits and failing to have a procedure for acceptance and rejection of incoming product. --James G. Dickinson
July 18th, 2008
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FDA announced that the agency and Advanced Bionics LLC have reached a settlement over alleged violations of federal law, stemming from a 2006 recall. The agency charged that Advanced Bionics shipped cochlear implants to customers in the United States without first filing appropriate supplemental information with the FDA, including notice of a change of a component supplier. The failure to submit supplemental information prevented the FDA from being able to evaluate the potential impact of the changes on the safety and effectiveness of the device. This, in turn, made the device adulterated, and posed a risk to patients. The product in question was the HiRes90k Implantable Cochlear Stimulator, a Class III device. In March 2006, Advanced Bionics recalled unimplanted devices containing components from an unapproved supplier because of excessive moisture that could leak into...
July 18th, 2008
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Companies that manufacture devices to treat life-threatening conditions could be immune to the recent economic woes. Although there are patients who might put off having cosmetic procedures or elective surgery, those who suffer from serious conditions aren't in the same position. St. Jude Medical's CEO was hopeful after the recent release of the company's quarterly results, and analyst Aaron Vaughn from Edwards Jones called St. Jude's 48% increase in net income "fantastic." The company even saw double-digit increases in its defibrillator sales, which have been sluggish in the past following product recalls. This doesn't necessarily indicate a recession-proof atmosphere, but as companies like Boston Scientific and Medtronic report their financials in the near future, industry might have a better idea of where it stands during these difficult economic times.
July 17th, 2008
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Congress voted to override President Bush's veto of the Medicare Improvement for Patients and Providers Act of 2008. The headlines are all about the bill's provision that nixes proposed Medicare payment cuts to physicians. But it also has implications for two competitive-bidding programs that are of interest to the device industry. First, it delays a competitive-bidding program for durable medical equipment. Industry had complained that the bidding process was flawed, and that a price-based system would cause quality to suffer. Second, the bill repeals the clinical laboratory competitive-bidding project that had been halted by a federal judge in April. Industry complained that its requirements were unworkable and patients would suffer as a result.
July 16th, 2008
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Peter Carstensen, founder and leader of CDRH's human factors engineering team, has retired from the agency and joined Wiklund Research...
July 15th, 2008
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We are beginning our yearly search for nominations for Medical Manufacturers of the Year. For every November issue, we select several device companies that are outstanding in some way, and profile them. We need your input to help us decide who should receive this honor. The competition is open only to sponsors of finished medical devices; contract manufacturers and other vendors are not eligible. The full criteria for eligibility and the nomination form can be found here. Nominations are due by August 27.
July 15th, 2008
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FDA has issued a public health notice alerting healthcare professionals that the X-rays used in CT scans may cause some electronic medical devices to malfunction. The agency says it has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. This has not yet been attributed to any deaths, though. Reported adverse events include unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and changes in pacemaker output pulse rate. These are not related to compatibility issues with MRI, which have been known about for years. The notice includes several recommendations that may prevent malfunctions.
July 14th, 2008
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FDA is seeking comment on documents from two study groups of the Global Harmonization Task Force. They are available for public comment until October 9, according to a Federal Register notice. The agency is particularly interested in whether stakeholders think any parts of the GHTF documents are incompatible with FDA regulations. Study Group 1 has published a final document called "Role of Standards." It provides information on the use of standards by a manufacturer when designing a medical device and, subsequently, when demonstrating that the device conforms to relevant essential safety and performance criteria. Study Group 5 has published a draft document called "Clinical Investigations." It discusses general principles of clinical investigations of medical devices and general principles when...
July 14th, 2008
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Intel Corp. has received FDA clearance for its personal health management tool. The Intel Health Guide helps healthcare professionals give their patients personalized care at home but enables patients to be more active in their treatment. The device connects to certain models of wired and wireless devices such as blood pressure monitors, glucose meters, pulse oximeters, and peak flow meters. Clinicians monitor patients using an online interface. Interactive tools include vital sign collection, patient reminders, multimedia educational content, and video conferencing. Information that the device stores is displayed on a touch screen, and data is securely sent to a host server for viewing by clinicians. Patients can use the device to communicate with their providers, get information about their health status, and learn about their health conditions. Intel anticipates to launch...
July 11th, 2008
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