In the wake of the multitude of recalls in 2005 of implantable systems – primarily pacemakers and implantable cardioverter defibrillators – the FDA’s Center for Devices and Radiological Health in January unveiled an intensified effort for the post-market surveillance and reporting of problems with all medical devices. Introducing a document titled “Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device Postmarket Safety Program,” the CDRH gave itself the goal “to shift to a culture that places more emphasis on the importance of our post-market efforts and on collaboration in identifying and solving post-market problems, both within the center and with outside constituencies.”

Besides laying out a variety of recommendations for improving this effort, the document makes at least two salient points: that post-market surveillance of devices offers “special challenges” and is more difficult than for drugs; and that adverse events related to devices is comparable to drugs, and that post-market surveillance of devices offers “special challenges,” and is thus more difficult than tracking adverse events for drugs.

The first of these points is laid out in one of the appendices to the report (Appendix B, “Epidemiologic Aspects of Postmarket Medical Device Safety”), saying that “the rates reported for medical devices have been comparable to those for drugs” – noting this statistic simply as “interesting.” It is extremely interesting indeed, since placing this observation in the context of the Institute of Medicine (Washington) report, To Err is Human, which estimated the deaths from adverse drug events at nearly 100,000 a year in U.S. hospitals. And it notes that CDRH funded a one-year study of visits to emergency departments, with the study finding that “in a one-year period, 452,000 visits to emergency departments were for injuries associated with medical devices. Of these, 58,000 patients died there or were hospitalized.” (The percentage of those who died and those hospitalized was not stated.)

And in general, the report in a variety of ways focuses on the extensive under-reporting of adverse medical events associated with the use of medical devices and the reasons for this:

• CDRH, it says, receives “tens of thousands” of reports concerning adverse events each year but that a preponderance provide only “sketchy information” about how the device was used and details about the actual cause of the problem. “This makes it difficult to assess the nature of the problem, and to distinguish between separate problems that may affect the same device.”

• Healthcare providers “generally do not document device use in patient records,” therefore making it difficult to determine the device used that resulted in the adverse event. “Devices lack unique identifiers, and manufacturers continually produce modified versions of their products. And device firms are often purchased by other companies, which compounds the problem of product identification. As a result, identifying information about the device often does not appear in large databases.”

• Off-label uses of a device make it hard “to determine whether an observed problem is inherent in the device, or whether it resulted from inappropriate use.”

• And the document also notes a “gradual shift” in the use of medical devices, more frequently into patients’ homes, so that devices are being used by non-professionals and thus producing “another element of uncertainty” in ascertaining the exact problem and the best solutions.

To address this issue, the document says that, based on a 2005 study of its postmarket safety programs, it will seek to develop a “culture of collaboration” for improving these programs within the center, including the development of “world-class data sources and systems” for identification and dissemination of adverse events and problems with medical devices and radiation-emitting systems.

It says that a senior-level team made up of “CDRH management and outside consultants experienced in medical device safety and product regulation will help guide the Center in this effort.” It does not provide a timeline for when this team will be established or when it will report results. And the document promises broader dissemination of safety problems and improved “coordination, consistency, quality and timeliness” of compliance and enforcement.

Thus, as part of the new program’s data gathering efforts, CDRH said it “will champion the development of a system to provide unique device identification, a standardized and globally accepted nomenclature for devices, and mechanisms and incentives for device users to include this information in healthcare records.”

It added: “We will work to develop an electronic reporting system, so that all postmarked information is available to all who need to use it.”

Besides outlining steps for making the improvement in post-market assessment and surveillance, the document, titled “Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device Postmarket Safety Program,” is intended to provide information concerning the ability of CDRH to do effective post-market surveillance under the Medical Device User Fee Act of 2002, it says, “if MDUFMA is reauthorized.”

AHA launches campaign of ‘urgency’

The American Heart Association (AHA; Dallas) in January launched what it called “the most ambitious public policy campaign” in the organization’s history. The campaign will rely on 22 million volunteers for a nationwide grassroots effort to influence policymakers at the national, state and local levels in order to combat cardiovascular disease and to “create a sense of urgency” around heart disease and stroke, the nation’s No. 1 and No. 3 causes of death, respectively.

The association’s “You’re the Cure” grassroots network consists of more than 100,0000 volunteers, including doctors, scientists, parents, heart and stroke survivors, who are actively involved in the organization’s public policy agenda and dedicated to finding cures for heart disease and stroke. The AHA’s goal is to expand the network to 250,000 volunteers by 2010. Among the initiatives to influence policymakers that the “You’re the Cure” advocates will undertake will occur on May 15-16 on Capitol Hill, when about 600 AHA volunteers from across the country will gather for Congressional Heart and Stroke Lobby Day.

The need for the all-out effort was described by Bob Carson, chairman of the board of AHA as a “perfect storm” made up of three elements. He said, “I hope it doesn’t happen, but . . . you have an aging population, combined with decreasing commitments to research and skyrocketing healthcare costs, which, of course, already deny healthcare access to a lot of people.” And, he cautioned, “It’s only going to get worse” unless the government intervenes with more funding for research. Carson said the AHA is the largest non-government organization funding cardiovascular research today.

“We can’t do it alone, we need good government funding support,” he said. “If we can get additional funding, we know this disaster can be avoided.” As support, he pointed to history, specifically the period between 1999 and 2003, when the budget of the National Institutes of Health (NIH; Bethesda, Maryland) was doubled. “During that period where the government and the not-for-profit and private sector worked together, death from coronary heart disease dropped nearly 17%, and the death rate for stroke dropped 12%,” he said.

However, the AHA said that for the first time in 35 years, the FY06 budget for NIH was cut below the previous year’s funding levels. Not only that, but the Rural and Community Access to Emergency Devices Program that places automated external defibrillators in many public facilities was slashed by 83%, which the AHA said could potentially eliminate the program in rural areas.

The AHA also estimated that cardiovascular disease would cost Americans an estimated $403 billion in lost productivity and medical expenses in 2006 alone – a figure that Carson points out is the size of the U.S. deficit. The aging of the population is projected to drive costs for cardiovascular diseases up 54% by 2025. Annual stroke deaths are projected to increase nearly 100% by 2032.

“We must reverse this trend,” said Alice Jacobs, MD, immediate past president of AHA. “Medical research plays a vital role in the discovery of treatments and cures for heart disease and stroke. It has yielded the medical breakthroughs we now take for granted.”

Among the association’s 2006 public policy priorities are to address inequalities in care experienced by women and minorities, address the rising epidemic of obesity among children, significantly increase federal funding for the NIH that will lead to advances that “predict and pre-empt” cardiovascular disease, and promote prevention through the work of the newly created Heart and Stroke Division of the Centers for Disease Control and Prevention (Atlanta).

Sibling heart disease a large risk factor

Having a sibling with a history of cardiovascular disease carries the same or greater risk as having a parent with a history of the disease, according to a new report from the long-standing Framingham Heart Study, conducted by the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). Personal risk of having a cardiovascular event, such as a heart attack, stroke, or peripheral artery disease, may be raised by as much as 45% in middle-aged people whose brother or sister has had such an event. The study appeared in the Dec. 28, 2005, edition of the Journal of the American Medical Association. Even when data was adjusted for the fact that siblings may have similar lifestyle-related risk factors and may be of similar ages, the risk associated with having a sibling with cardiovascular disease remained high.

“This study illustrates that even people who are not at high risk based on their own health status should talk to their doctors about the history of heart disease in their families, among siblings as well as parents, and ask what they can do to prevent a heart attack or stroke,” said Elizabeth Nabel, MD, NHLBI director.

Researchers evaluated siblings from among 1,188 men and 1,287 women, all participants in the Framingham Heart Study. Participants were followed for eight years.