Medical Device Daily Washington Editor
FDA said recently that it has added stent grafts for aneurysms of the thoracic aorta to the list of high-risk devices it expects manufacturers to track for the lifetime of the device. This class of devices joins stent grafts for abdominal aortic aneurysms, prostheses for temporomandibular joint disorder and a host of devices intended for cardiovascular disease on the list that FDA wants manufacturers to keep tabs on for as long as the device is in the patient.
One of the apparent complicating factors for manufacturers is that a patient can refuse to disclose any and all identifying information needed to track the device – such as their name, Social Security number and so on – but the agency states that such a decision on the part of the patient "does not relieve the manufacturer of its obligation to account for the tracked device."
Another area of ambiguity is the declaration that manufacturers must make a "reasonable effort" to track devices implanted in patients living outside the U.S.
Joe McGrath, director of public relations for the cardiovascular division at Medtronic (Minneapolis), told Medical Device Daily that the company's tracking policy already covers this class of devices, "so the new guidance will have no impact on our procedures."
As for patients who do not want to divulge their identifying information, he said, "the reporting of the adverse event can be completed without the patient." He said the data in question is only for stent grafts that are associated with adverse event reports, typically filed in the MAUDE (Manufacturer and User facility Device Experience) system. "The importance of these tracking systems is to identify patterns," McGrath said, so the refusal of a patient to allow identifying information to be forwarded to the company is not necessarily problematic. He also said that healthcare authorities in other nations are pretty good about forwarding similar data to FDA, so the foreign tracking requirement is not overly onerous.
McGrath said the market for stent grafts for aortic aneurysms is growing. He said the literature suggests that about 1.2 million people in the U.S. have such aneurysms, but that only about 120,000 are diagnosed. Of this number "about half are treated with a stent graft, the other half via surgical repair." He said Medtronic is "working to introduce stent grafts to increase the number of patients who can be treated. With the next generation of stent grafts, we're seeking to treat 70% of patients," and the following generation of stent grafts will hopefully work on 80% of patients.
Geometry is a more significant consideration than size, McGrath said. An aorta with twists and turns complicates the procedure, and Medtronic already has a "sufficiently diverse range of sizes to accommodate all [patient aorta] sizes."
CMS adds pediatric data to Hospital Compare
The Centers for Medicare & Medicaid Services has added data on outcomes for pediatric patients to its database at the agency's Hospital Compare web site.
According to this week's announcement, the upgrade includes a 30-day mortality measure for pneumonia in adult patients and for pediatric patients, the site will track the use of "relievers for inpatient asthma, and systemic corticosteroids for inpatient asthma."
Kerry Weems, the agency's acting administrator, said in the statement that the upgrade will "cement the web site's role as a key driver in improving the quality and reliability of care in the nation's hospitals." The CMS statement notes that the measures for pneumonia mortality, "like its predecessors, has been endorsed by the National Quality Forum and is supported by the Hospital Quality Alliance."
CMS also has posted a rating system that compares a hospitals mortality rates against a national standard, which will give the viewer an assessment of "better than," "no different from," or "worse than" the U.S. national average. CMS states that this type of scoring might prompt hospitals to more quickly "work toward achieving the level of the top-performing hospitals in the country."
NHGRI doles out $20M for genome assays
The National Human Genome Research Institute (NHGRI) at the National Institutes of Health recently awarded more than $20 million in grants to boost efforts to make human gene sequencing inexpensive enough to make it a routine part of medical care. According to the Aug. 20 announcement, the agency wants to cut the cost of a full human DNA sequencing effort to $1,000 per person. At present, a full personal DNA sequence runs more in the neighborhood of 100 times that sum.
Alan Guttmacher, MD, acting director of NHGRI, said in the statement that a $1,000 sequencing "is the type of quantum leap needed to usher in an age of personalized medicine where healthcare providers can use an individual's genetic code to prevent, diagnose, and treat diseases."
Among the grantees are Daniel Branton, PhD and Jene Golovchenko, PhD, of Harvard University (Cambridge, Massachusetts), who took in a grant of $6.5 million for four years of research into the use of electronic sequencing in nanopores. Branton and Golovchenko seek to "optimize nanopore technology using novel electronic control and sensing methods to eventually lead to a nanopore detector chip capable of sequencing a mammalian genome within a day on a single instrument," the statement indicated.
Several other groups are pursuing nano-sized receptacles to capture DNA, but Di Gao, PhD, of the University of Pittsburgh, snared a grant of $370,000 for two years of research into stretching DNA away from a solid surface using an electrical field that will pull the DNA clear of the surface. The measurement of the force needed to separate the DNA along with an unspecified imaging technology using fluorescence may allow the researcher to identify each bit of DNA in the strand.