Medical Device Daily Washington Editor
The push toward quality care continues with the launch yesterday of Nursing Home Compare at the Medicare web site, which will give viewers a shorthand approach to evaluating nursing homes in their areas.
While the site is intended to make it easier for users to get a bird's-eye view of which nursing homes are better than others, at least one industry group objects to the system, describing it as "poorly planned, prematurely implemented and ham-handedly rolled out."
Speaking on a telephone conference call yesterday, Acting CMS Administrator Kerry Weems told reporters that while the agency hopes "that this new system will make choosing a nursing home even easier ... no web site can substitute" for a visit by the resident-to-be and his or her family.
Weems acknowledged that the data are based on information collected by state authorities rather than CMS, stating, "There is some variation in the way that states carry out the inspection process." However, he asserted that the agency's data handling methods account for those differences. He also said that rather than reject outright a home with only one or two stars, users of the web site should use the ratings as a "guide to the conversation you want to have with a nursing home."
When asked about the nursing home industry's reaction to the site, Weems said, "I would say that their input has been extraordinarily helpful," but that he expects "you will hear criticisms by nursing homes." He said "we welcome those criticisms ... which will only make us better."
The rating system awards five stars to homes that score "much above average," four stars for "above average," and so on to only one star for "much below average." The rankings will be updated quarterly or more frequently.
Weems stated that the measures are based on three review areas, including three-year reviews of health inspections by state authorities and on staffing levels. The final measure is an aggregate of 10 quality measures.
Larry Minnix, president/CEO of American Association of Homes and Services for the Aging (AAHSA; Washington), said in a statement that the five-star rating system is "a great idea [that is] prematurely implemented." He said AAHSA supports "a consumer-friendly nursing home rating system based on reliable quality information that the public can understand," but charged that the system as is does not measure up.
Minnix stated further that AAHSA members would like to see an "overhaul of the survey and certification system, with funding provided for a new system."
Japan moves to speed device approvals
Most people in the device industry might say that any newcomers who think it's easy to get into Japan either hasn't tried or has been very lucky, but recent reports of device makers gaining a toehold seem to indicate a thaw.
According to the Advanced Medical Technology Association (AdvaMed; Washington), there is more good news: Japan's Ministry of Health, Labor and Welfare (MHLW) has rolled out an action program to make access by outside companies easier.
In a Dec. 18 statement, Stephen Ubl, president/CEO of AdvaMed, said MHLW will triple the number of medical device reviewers in Japan by 2013, which will "speed the availability of innovative medical technologies to patients in Japan by creating a more efficient and predictable medical device review process."
Ubl said that the five-year program also includes a more stringent set of performance goals for the department, which are designed to speed the turn-around of applications, but that those faster review times will come at the cost of "higher industry user fees."
The tweaks to the review process will include "key areas such as partial change requirements, stability testing requirements, and clinical data requirements," he said, but device reviewers will also "receive extensive training so they can meet the new performance goals."
Ubl added that the changes will bring review times "closer to those in the U.S. and Europe."
Space-age cancer-cure devices recalled
FDA said earlier this week a Class 1 recall for two devices that have not been approved via a PMA or cleared via a 510(k), because the manufacturers "claimed their devices treated conditions ranging from cancer to migraines" without sufficient supporting data.
One of the companies, VIBE Technologies (Greeley, Colorado), earned a warning letter earlier this year (Medical Device Daily, Nov. 4, 2008) because of a range of violations, including claims that the VIBE (Vibrational Integrated Bio-photonic Energizer multi-frequency field generator) machine could "bring the vibrational level of your body back to its natural state of being," which was purported to ward off cancer at a web site that had been linked to the manufacturer's site, which is now defunct. The Vibe is apparently little more than a high-end flashlight.
The other object of this pair of recalls is the HLX8, purportedly a magnetic resonance field generator, made by Nebion (Los Angeles). FDA inspected Nebion's plant in June and discovered a number of deviations from good manufacturing practices and quality systems regulations.
Nebion recalled eight of the HLX8 units in July and notified their customers to "stop using the devices immediately and to contact Nebion for their retrieval," according to FDA.
The use of a Class 1 recall is based on the possibility that because of the claims, "patients may forgo approved therapies, and that this could result in more severe illness or death," the FDA statement noted.
Dan Schultz, MD, director of the Center for Devices and Radiological Health at FDA, said in the statement that the recalls "underscore the importance of taking action against manufacturers who make false medical claims for their devices." He also stated that one of the agency's "primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process."