The failure of the Food and Drug Administration to take stronger action in both premarket and postmarket oversight of Class III medical devices--which includes pacemakers and replacement heart valves--is raising serious concerns about the organization's regulation of those devices, according to a new report from the Government Accountability Office (GAO).
On the premarket side, Marcia Cross, GAO's director of health care, told the House Energy and Commerce Health Subcommittee last week that FDA was not reviewing all class III devices through its most stringent premarket review process. Unless an exemption is made by regulation, all new devices must clear FDA premarket review using either the 510(k) premarket notification process, which is used to determine if a new device is equivalent to another legally marketed device, or through the more stringent premarket approval (PMA) process, which requires manufacturers to supply evidence showing "reasonable assurance" that the device is safe and effective.
In 1976, GAO said that Congress envisioned the FDA would eventually approve all class III devices through the more stringent PMA process; however, GAO investigators said this process was incomplete. The investigators found that in fiscal 2003 through 2007, FDA cleared 228 submissions representing 24 types of class III devices through the 510(k) process.
GAO recommended in a January 2009 report that the FDA take steps to issue regulations requiring PMAs—or reclassify class III device types currently allowed to enter the market via the 510(k) process. In response, in April, FDA required manufacturers to submit information on the safety and effectiveness of these types of devices. However, FDA did not specify a timeframe for how quickly it will reclassify them or require PMAs for those devices in class III.
In the postmarket phase, GAO said FDA also faces challenges as well. In 2008, GAO reported that the number of adverse event reports associated with medical devices increased substantially from 2000 to 2006. Both GAO and FDA, however, have identified shortcomings in FDA's postmarket oversight. For example, in 2006 FDA reported that while they have a number of strategies to prioritize their reviews of adverse event reports, they still cannot review all the reports they receive.
William Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, told the panel that in light of high-profile device safety issues and FDA's ability to monitor the safety and effectiveness of these devices, additional consumer safeguards are needed.
Despite the toll the recession has taken on many of our nation's nursing homes, customer and employee satisfaction increased last year, according to the 2008 National Survey of Consumer and Workforce Satisfaction in Nursing Homes by My InnerView.
The recent report details the results of satisfaction surveys completed by employees, residents, and family members in 5,075 U.S. nursing homes in 2008. The data gives long-term care leaders insight into the factors that affect employee and consumer satisfaction, opportunities for improvements, and how satisfaction impacts other areas of facility operation. Some key findings include:
The percentage of nursing home consumers and employees who rated satisfaction as "excellent" or "good" increased for the first time since 2005, which is when My InnerView began publishing these satisfaction reports
Consumer and employee satisfaction are interrelated. Facilities with higher employee satisfaction have higher consumer satisfaction and facilities with lower employee satisfaction have lower consumer satisfaction.
"The care and services provided by the employee—and the employee/resident relationship—are the most consistent predictors of consumer recommendations," according to the report.
Nursing home employee and consumer satisfaction is higher in states with pay-for-performance programs.
Although satisfaction is on the rise, there are still many opportunities for improvement that long-term care leaders should explore. My InnerView found that "facilities with higher employee satisfaction tend to have lower staff turnover and better clinical outcomes," according to the report.
Ultimately, long-term care leaders can improve a variety of facility operations by increasing employee satisfaction. Some opportunities for improvement identified by nurses and nursing assistants who completed the surveys are:
People with robust health insurance are putting off doctors’ appointments and skimping on prescriptions because they can't afford the increasing costs of copayments and deductibles, according to managers of patient-assistance hot lines in Massachusetts. With many consumers struggling to pay rising healthcare costs amid today's shrinking family budgets, these tough choices are becoming commonplace—even among families with employer-provided health insurance, consumer advocates say.
According to the American Hospital Association, about 68% of public hospitals have a chaplaincy program. But few have Buddhist monks, and none compares with the program at Beth Israel in Manhattan, where more than 20 Buddhist chaplains and chaplains-in-training offer bedside meditation, interdenominational prayers, and other assistance to pregnant women, dying cancer patients, and even stressed hospital workers.
Junior surgeons at Massachusetts General Hospital have been working too many hours in violation of patient safety rules, according to the Accreditation Council for Graduate Medical Education that is threatening to put the hospital's surgery training program on probation. The Accreditation Council cited the hospital because a significant number of its residents were exceeding hour limits and working seven days straight. The organization believes these workloads contribute to fatigue-related mistakes, and has given the hospital until Aug. 15 to fix the problem.
Nonprofit health-insurance cooperatives are gaining favor among lawmakers working to revamp the U.S. healthcare system, but whether these entities could rein in prices by competing with private insurers is unclear. The idea represents a compromise on one of the most contentious points in trying to craft a bipartisan bill. President Obama is pushing for a government-run health-insurance plan that would compete with private insurers as a way to help extend coverage to 45 million uninsured Americans, but most Republicans and some moderate Democrats counter that the government's cost advantage would unfairly upend the private market.
The pharmaceutical industry agreed to reduce Medicare drug costs, as medical-industry groups accept cuts now in an apparent effort to stave off potentially more-burdensome givebacks under the Democrats' health-overhaul plan. Drug makers outlined a proposal to forgo $80 billion in revenue over a decade, largely by covering more of the cost of brand-name prescription drugs under Medicare. That would make up part of the $313 billion in government health-spending cuts that President Obama has proposed over a decade to help pay for the overhaul plan.
New York City investigators have admitted that the staff at a city-run hospital in Brooklyn failed to provide basic medical care to a psychiatric patient who died on a waiting room floor, and then tried to cover up their neglect. In a report released exactly one year after the death of patient Esmin Green in Kings County Hospital Center's psychiatric emergency room, the city's Department of Investigation said its review had found a "systemic failure" to care for Green.
Representatives of the three House committees with oversight of healthcare reform--Energy and Commerce, Ways and Means, and Education and Labor--released an 852-page discussion draft this afternoon that their committees will begin to publicly review next week.
The draft proposal, which is light on details on how it will be paid for, contains a number of reforms on providing healthcare, including a public option. "It builds on what works, and fixes what needs to be fixed," said Rep. Henry Waxman (D-CA), chairman of Energy and Commerce.
The provisions call for:
Maintaining the ability for people to keep the insurance coverage that they want.
Investing in healthcare workforce to improve access to primary care.
Creating a new national health exchange that permits states the option of developing a state or regional exchange
Offering sliding scale credits to ensure affordability for low- and middle-income individuals and families;
Providing a public insurance option.
Improving delivery of care and reducing ethnic and racial disparities.
Improving Medicare, including fixing the physician Sustainable Growth Rate.
Making sure physicians, nurses, and other health providers are available to meet patients' needs
Promoting a stronger network of community health centers.
Enhancing prevention and wellness programs.
In response to recent reports that the American Medical Association opposes a public insurance option, Waxman said, "I don't know what the AMA position is. I want them to look at our draft. I think there is lot of misinformation about the idea of a public option."
The Department of Health and Human Services today released $6 billion in new Children's Health Insurance Program funding that is expected to expand coverage to an additional 4 million children this year.
The new funds were placed in the CHIP Reauthorization Act of 2009, which was signed into law by President Barack Obama on Feb. 4. CHIPRA provides additional funding that will help states and territories maintain existing CHIP enrollment and expand their programs.
"We are taking an important step to provide quality, affordable health care to millions of children," HHS Secretary Kathleen Sebelius says. "Through CHIPRA, states and territories will receive additional funds to provide health insurance to 11 million children, including 4 million who were previously uninsured. Parents now have more help if their children fall ill."
Of the $6 billion in new funding under CHIPRA, HHS has released more than $1 billion and expects to allocate the remainder to the states and territories by the end of September. CHIP provides health insurance for children of working families whose incomes are too high for traditional Medicaid, but too low for either employer-sponsored family plans or other private coverage.
While CHIP is optional, each state and every territory operates a program. Similar to Medicaid, CHIP is jointly funded by states and the federal government. However, the federal government pays states a higher share of their CHIP costs than for their Medicaid programs.
CHIPRA gives states the option to provide children with "Express Lane Eligibility," in which Medicaid and CHIP eligibility requirements may be satisfied based on information available through other government agencies.
