CDRH is not only taking actions related to the 2010 priorities announced earlier this year, but is also working towards a better understanding of standards. “Standards are an important part of the lifecycle of a device,” said Jeffrey Shuren, MD, CDRH’s new director, at AAMI’s 20th annual International Conference on Medical Device Standards and Regulation yesterday. Standards also help facilitate improvements in product design and raise the bar for safety and effectiveness. As part of Shuren’s effort to increase collaboration and provide more transparency, the new director announced that CDRH staff...
CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center's acceptance of the standard also includes "all collaterals and particulars," said Herman. She anticipates CDRH will publish a Federal Register notice by June 1, and from that point, there will be a three-year transition period. The third edition of IEC 60601-1 deals with the general requirements for basic safety and essential performance of medical electrical equipment.
March 11th, 2010
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According to FDA, a study for Medtronic's deep-brain stimulation system for epilepsy treatment failed to meet a study goal. The goal was regarding a reduction in the rate of seizures over a three-month span. The agency did concede, however, that in the third month of treatment, Medtronic's system did reduce the rate of seizures compared with patients not using an activated device.
The system is already FDA approved for the treatment of Parkinson's disease, OCD, and several movement disorders. On Friday, FDA's neurological devices panel will review the device.
March 10th, 2010
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Wright Medical Group will not face any enforcement actions from the Securities and Exchange Commission related to foreign sales practices. The SEC’s Division of Enforcement dropped its informal investigation of the medical device maker, according to a government filing.
Wright was one of many medical device makers that came under SEC scrutiny in June 2008 over potential violations of the Foreign Corrupt Practices Act. The Foreign Corrupt Practices Act prohibits U.S. companies from bribing foreign officials to get or keep business. Learn more about the regulation here.
March 9th, 2010
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James V. Mazzo, president of Abbott Medical Optics, will take the reins of AdvaMed chairman. He is succeeding Michael Mussallem, CEO of Edwards Lifesciences, who held the position since 2008.
According to an AdvaMed press release, Mazzo has chaired the group's International Board Committee and worked to improve the medical device approval process in Japan and China. He has also worked to increase the Committee's presence in emerging markets.
During his tenure as AdvaMed chairman, the industry group says that Mazzo "will lead the industry’s efforts to: support the FDA’s review process so patients continue to have timely access to safe and effective medical technologies; ensure innovation thrives as payers and providers experiment with new healthcare delivery models; and support global regulatory harmonization efforts."
March 5th, 2010
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Baxter International has issued a recall of its HomeChoice dialysis machines after the device firm received reports of patients overfilling their abdominal cavities. FDA has classified the recall as Class I. The company says it is still trying to find the source of the problem, but Baxter also says that the devices don't need to be physically returned and that they are still usable. Device users should be on the lookout for signs of abdominal overflow, which can include vomiting, difficulty breathing, or spitting up.
March 3rd, 2010
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FDA's top medical device reviewer is stepping down to take a job in Microsoft's lobbying office.
Donna Bea Tillman told staffers in a note she is resigning as director of the office of device evaluation, after 15 years with the FDA. Tillman said she will serve as director of regulations and policy for Microsoft Corp.'s health information unit. In the note to staffers, Tillman said that after several interviews, it became clear that this was the right next step to take.
Tillman was one of several FDA officials criticized by lawmakers for their handling of the knee repair device, Menaflex, made by ReGen Biologics Inc. The device was approved in late 2008 despite repeated objections from FDA scientists who questioned its safety. However, Tillman maintains that her departure is not related to the ReGen issue.
At Microsoft, Tillman plans be part of the company's effort to beef up the development of medical information-technology systems and expand the profile of...
March 2nd, 2010
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Neuroscientists from MIT (Cambridge, MA) have developed an MRI sensor that could greatly improve brain imaging. The sensor changes its magnetic properties in response to dopamine. "This new tool connects molecular phenomena in the nervous system with whole-brain imaging techniques, allowing us to probe very precise processes and relate them to the overall function of the brain and of the organism," says Alan Jasanoff, associate professor of biological engineering at MIT. Since the sensor responds to the chemicals involved in information processing in the brain, they can more precisely measure brain activity. Measuring dopamine in the brain could have potential for shedding light on neurodegenerative conditions such as Parkinson's disease as well as how dopamine works in relation to addiction and motivation.
March 1st, 2010
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Are endoscopes labeled for use with the Steris Corp. System 1 sterile processing system misbranded? That's what endoscope manufacturers want to know. According to MedCity News, FDA sent a letter to endoscope makers on February 22 that urged them to change their labeling if it recommended use of the Steris product. However, the agency did an about face on February 23, sending an e-mail to the manufacturers that seemed to recall the previous letter.
Steris is unsure what to make of the agency communication. A company representative said that Steris had called FDA, but had not yet received an answer, according to MedCity News.
FDA has previously issued a warning letter to Steris about the sterile processing system. You can read more about it in February's Washington Wrap-Up. ...
February 25th, 2010
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Three giants in their respective industries—GE Healthcare, Intel Corp., and Mayo Clinic—have announced that they are studying a new model of healthcare delivery, specifically for patients at increased risk of rehospitalization. The Mayo Clinic will take the lead in a yearlong study to determine whether using Intel's remote patient monitoring technology in the homes of patients with chronic diseases will reduce hospitalizations and emergency visits.
The research study will involve 200 high-risk Mayo Clinic patients over age 60 who receive care in Rochester, MN. Study participants will measure their vital signs such as blood pressure, pulse, and weight, and respond to questions specific to their diseases on a daily basis, with all data reviewed by the clinical care team working with their primary care provider. Intel's technology, which enables videoconferencing, allows the care team to assess the patient for signs...
February 24th, 2010
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