MASSDEVICE ON CALL — FDA 510(k) clearances too slack: GAO. The Government Accountability Office claims that the FDA is putting patients at risk by clearing medical devices such as hip replacements and heart defibrillators under the same system the agency uses to approve power wheelchairs, stitches and catheters, reports The Associated Press.
The criticisms come more than two years after the government investigators first cited the problem to the FDA. The GAO faulted the FDA in 2009 for not reclassifying more than 26 types of devices so they are more rigorously test before entering the market. Since then, the FDA has cleared 67 individual, high-risk devices through the 510(k) program, through which the vast majority of devices are approved, the AP writes. The FDA cleared 2,654 new medical devices through the system last year.
The FDA in January revealed plans to implement 25 changes to the 510(k) program, but is holding off on any major moves until after the release of an Institute of Medicine report that’s slated to drop this summer. The changes (PDF) include the establishment of a public database of important device information — such as medical device photographs, labeling and summaries of the basis for the FDA’s decision to clear specific devices — in addition to requiring a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.
Many docs aren’t using their EMRs. Many medical practices spent a lot of time and money to put in place electronic medical record systems only to find that doctors end up finding them so cumbersome that they don’t use them, writes to The Wall Street Journal. Athenahealth Inc. (NSDQ:ATHN) created a group called a "burn unit" to handle these physician practices that have been "burned" by the old systems and are looking for a new solution, the publication wrote.
Obesity surgery improves memory: Study. There appears to be many health benefits, including treating diabetes, to bariatric surgery for weight loss, but improving patients memory may be one added benefit that no one was expecting. A preliminary study recently published in Surgery for Obesity and Related Diseases found evidence supporting the idea, writes The Wall Street Journal.
Massachusetts attempts to keep subsidized care costs down. Spending on the Bay State’s subsidized Commonwealth Care health insurance program is expected to remain level next year even as enrollment could increase 11 percent. Gov. Deval Patrick’s administration officials said the savings come because a number of the managed care organizations in the program submitted bids for the upcoming year that are lower than their current rates, writes Bloomberg.
House passes measure defunding healthcare reform, Planned Parenthood. The GOP-dominated House yesterday approved two resolutions that would amend the FY 2011 spending bill to block funding for Planned Parenthood and the Patient Protection and Affordable Care Act. House passage is largely symbolic, however, as the Democrat-majority Senate did not pass either of the bills, reports The Hill.