The U.S. Food and Drug Administration (FDA) has released its review of implantable cardioverter defibrillator (ICD) and pacemaker (PM) malfunctions for the period from 1990-2002.
The findings were presented at the Heart Rhythm Society “Policy Conference on Pacemaker and ICD Performance” in Washington, DC.
The study found that thousands of patients were affected by PM and ICD malfunctions during the 12-year period, and that malfunctions were directly responsible for 61 confirmed deaths. While the study found a decrease over time in the annual number of malfunctioning pacemakers that were removed and replaced in patients (4.6 per thousand), there was an increase in the number of malfunctioning ICDs (20.7 per thousand), especially during the last three years of the study, when more than 50% of the reported malfunctions occurred.
Potential reasons for the increase in ICD malfunctions include the increased complexity of the ICD devices, manufacturing challenges posed by this complexity, and increased reporting by physicians. The authors stated that ICDs are a rapidly changing technology. Over the past 10 years, ICDs have shrunk in size, provided more therapeutic features, and increased their memory. The decrease in size has brought modifications to battery, capacitor, and circuitry design that may account for some of the malfunctions.
The study also concluded that careful monitoring of device performance is needed. That may include requesting more detailed information from manufacturers before the devices are approved for marketing and while they are in use by the clinical community. Another important step is finding ways to communicate more effectively with physicians and patients when the devices malfunction.
“The FDA is committed to continuing to improve the quality of information that patients and doctors have to make decisions about the safe and effective use of these critical, life-saving technologies,” said Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs. “Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks. All sophisticated medical devices like these have certain risks. Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use.”
In preparing this report, the FDA reviewed 366 PMA annual reports, covering hundreds of pacemaker and ICD models. In light of the findings, the FDA is considering doing analyses like this for ICDs and pacemakers on a periodic basis, so they can monitor the malfunction trends.
The FDA is also taking other steps to address the troubling information found in their report. They have begun to better coordinate their pre and post-market regulation of the devices, insuring that products are closely monitored after they are in clinical use. They are also considering asking manufacturers for more comprehensive data, and they are exploring ways to better communicate with physicians and patients.
The FDA has also established a defibrillator working group which is exploring the best way the FDA can make information about defibrillator recalls available to physicians and patients.
The FDA stressed that the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed.
“It is important for patients to understand that there is no action that they need to take as a result of this report. It does alert FDA that there is a trend that needs to be addressed and points out the need for the agency to improve the way it regulates these products, and we are doing just that,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health (CDRH).
The FDA has the following top-priority actions underway:
·Increasing CDRH’s ability to obtain critical information about medical device failures so they can communicate this information clearly and rapidly to both physicians and patients, allowing them to make informed medical decisions.
·For ICDs in particular, the formation of a working group so information can be quickly reviewed and evaluated by staff, and shared more rapidly with the public.
·Operational changes in CDRH’s post-market program to track the performance of medical devices once they each the market and are in general use. These changes include targeting resources to inspect firms that manufacture potentially higher risk devices, the design of an electronic system for adverse event reporting, and developing guidance for companies to insure that annual reports provide the types of information required for prompt and efficient review by the FDA.