INDUSTRY NEWS
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Figure 1. Medical device reports entered into FDA database, 2000–2004. Source: Center for Devices and Radiological Health. |
On January 18, the center released a report detailing its current mechanisms for monitoring approved devices and suggesting areas for improvement. The document comes after a comprehensive year-long internal inventory undertaken last year of its current safety monitoring program. During this review, CDRH looked at past recalls, as well as its medical device reporting (MDR) system and the MedSun hospital device surveillance network.
CDRH has identified the following four action steps that it says are essential to strengthening its postmarket monitoring:
• Developing a “culture of collaboration” on postmarket safety within the center.
• Developing world-class data sources and systems.
• Enhancing risk/benefit communication efforts.
• Focusing improved enforcement strategies on postmarket issues.
FDA has assembled a team to carry out the suggestions in the initiative. Members include senior-level employees at the agency, as well as three external consultants: Steve Niedelman, deputy for regulatory operations at FDA’s Office of Regulatory Affairs; former CDRH director Elizabeth Jacobson, PhD; and Jeff Brinker, MD, a professor of cardiology at Johns Hopkins University (Baltimore) who has also served as a consultant to FDA’s Circulatory System Devices Advisory Panel.
CDRH’s study is required, in part, by provisions under the Medical Device User Fee and Modernization Act of 2002. However, a number of widespread product recalls in recent years, both in the pharmaceutical and device industries, have placed FDA under greater scrutiny. In 2004, Merck and Company, Inc., withdrew its pain medication Vioxx from the market following concerns about serious side effects. Last June, Guidant Corp. recalled more than 100,000 of its implantable cardiac defibrillators after notifying FDA and patients about a potential safety flaw in the devices. In addition, the recall of a number of blood glucose meter models has raised concerns about the human factors design.
During a January 4 presentation on postmarket safety, CDRH director Daniel Schultz, MD, laid out some of the center’s challenges. For one, he noted that greater device complexity has decreased the margin of error. In addition, adverse events are often widely underreported by users or do not contain adequate information to identify the device used. According to CDRH’s report, the number of MDRs entered into the center’s database increased by 74% between 2000 and 2004 (see Figure 1). Even so, in 2004, 95% of the MDRs received came from device manufacturers, and only 2% from individuals. Part of the reason for this disparity, Schultz said, is due to the lack of “unique identifiers” for many devices. Also, manufacturers often continually develop modified versions of their products.
However, monitoring IVDs after approval poses different challenges from other medical devices. Although CDRH’s report notes that many adverse events recorded in the MDR database are due to user error, it is often difficult to separate performance error from clinical signals. Also, for some tests, environmental and other surrounding conditions can affect performance.
“Diagnostics are unique among medical devices in that there is a link between safety and effectiveness for these products,” says Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety. “Diagnostics also represent a virtually ubiquitous medical product. It is estimated that 10 billion tests are performed in the United States per year—about 33 per person—and that 80% of medical decision making relies on laboratory test results.”
Some of CDRH’s first efforts to tackle postmarket monitoring have focused on strengthening condition of approval studies, which are sometimes required when an approved device poses specific long-term safety and effectiveness concerns. In January 2005, the center established an electronic tracking system for these studies and transferred the responsibility for tracking and follow-up to postmarket staff. In addition, the center issued a guidance on preparing follow-up reports and has included epidemiology staff in the premarket review process.
Even so, to properly ensure the safety of diagnostics in the market, Gutman says that FDA needs to involve more than just manufacturers in the process. In particular, clinical laboratories should be essential partners in postmarket monitoring. “Better engagement of the laboratories is critical to improving postmarket performance of IVDs,” he says. “And finding better ways to engage this community and get them to report problems to FDA is unique to IVDs and is essential to any long-term improvements in the postmarket arena.”
