Medical Devices

Safety
by Food and Drug Administration (FDA)

Perfect performance of the nearly 100,000 different types of medical devices on the market is not possible. And when a medical device fails, the Food and Drug Administration wants to know about it.

The FDA must act quickly to respond to medical device problems in order to protect consumers from devices that fail to work properly or are likely to be misused in ways that may cause injury or death.

Medical devices range from surgical sutures and blood glucose monitors to pacemakers and prosthetic heart valves. Regulating medical devices - from evaluating them for safety and effectiveness before they are marketed, to ensuring their continued safety and effectiveness throughout their lifetime of use - is the responsibility of the FDA's Center for Devices and Radiological Health (CDRH).

Since the enactment of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the CDRH has directed a nationwide system called postmarket surveillance to monitor the performance of marketed medical devices. But today's medical devices are vastly different from those used 30 years ago. "The medical device industry is a very rapidly growing, rapidly changing industry," says CDRH Director Daniel Schultz, M.D. "The postmarket system that we set up 30 years ago is not designed to deal with all of the new things that are happening today in the device industry."

To respond to the growing and changing industry so it can better protect public health, the CDRH has launched the Medical Device Postmarket Transformation Initiative. This new program will allow the FDA to identify, analyze, and act on problems with medical devices more quickly, including alerting the public sooner of potential problems.

"With this initiative, we're going to improve the way we monitor the safety of medical devices and provide a stronger safety net to protect public health," says Schultz.

The CDRH undertook the initiative after completing a yearlong inventory in 2005 of the tools it uses to monitor medical device safety. The inventory identified many areas that are working well, says Schultz, but it also identified areas that challenge the FDA in its efforts to ensure device safety.

To guide the initiative and address the challenges, the CDRH has formed a special team of senior-level FDA managers and outside consultants experienced in device safety and product regulation. The leadership team, as a first step, will review the inventory and identify the areas that can most benefit from improvements. "We wanted the team to take a comprehensive, global look at the way we deal with postmarket safety information," says Schultz, "and figure out how we can make the process more effective. Of course we have limited resources, and so it's important for the team to consider how we can use those resources in the most cost-effective way."

Many of the challenges identified in the inventory arise from the nature of new device technology, the sheer numbers of devices in the marketplace, and the difficulties surrounding the reporting of problems, or adverse events, associated with the use of devices.

More Complex Technology, Smaller Size

"Devices are increasing in complexity," says Schultz, "and they are being miniaturized so that there's more technology in a tiny little device."

For example, implantable cardioverter defibrillators (ICDs) - devices that are surgically placed in a patient to jump-start the heart when dangerous rhythms are detected - have increased their memory capacity and shrunk in size over the past decade. Pacemakers, also, are smaller and more intricate.

Manufacturers continue to modify devices to fit more features into smaller spaces, increasing the number of parts that can potentially fail. And new technologies and stronger materials make for longer-lasting devices that remain in use for a decade or more, extending the time for problems to arise.

Certain models of ICDs and pacemakers were recalled in 2005 because of malfunctions that could lead to heart failure and death. Schultz says that these device recalls did not trigger the postmarket transformation initiative, "but certainly those individual events strengthened my belief that this was something that the center needed to make its highest priority for the next year."

In addition to complexity, the numbers and types of devices on the market further challenge the FDA's monitoring efforts. Today's medical device industry consists of about 15,000 manufacturers producing nearly 100,000 individual products. The annual number of ICDs implanted, for example, increased from fewer than 10,000 implants in 1990 to close to 100,000 in 2002, according to an FDA analysis of manufacturers' annual reports. And the number of pacemakers implanted increased from about 95,000 in 1990 to more than 267,000 in 2002.

Reporting Device Problems

The FDA depends on reports it receives about adverse events involving medical devices in order to monitor the products and take actions to protect public health. Device manufacturers and distributors, hospitals, nursing homes, and other health care facilities are required by law to notify the FDA promptly about deaths and serious illnesses or injuries that a device may have caused or contributed to. They report these adverse events through the FDA's Medical Device Reporting (MDR) system.

The agency also relies on several other systems - MedSun and MedWatch - for adverse event reports. Through MedSun, about 350 hospitals and nursing homes around the country report not only injuries and deaths, but also close-call and near-miss events associated with medical devices. "If we know about a potential problem before someone is injured or dies, we can act to prevent these serious events," says Susan Gardner, Ph.D., director of the CDRH's Office of Surveillance and Biometrics. The FDA encourages consumers and health professionals to use a voluntary system, MedWatch, to report any problems with medical products.

The FDA receives about 180,000 adverse event reports related to medical devices each year, yet congressional reports have estimated that perhaps as few as 1 in 100 medical device adverse events are actually reported. This under-reporting allows rare events to be missed. And even when a problem is detected, under-reporting makes it difficult to assess the true public health risk.

Many adverse event reports provide only sketchy information about how the device was used and what may have caused the problem, says Gardner. "We have to do a lot of follow-up to get better information."

Those who report adverse events may not be able to identify the specific device involved because devices lack unique identifiers and because manufacturers continually produce modified versions of their products. Device firms often are purchased by other companies, compounding the problem of product identification.

And the gradual shift in the use of medical devices from hospitals and clinics to patients' homes presents yet another challenge. "More and more devices that were originally intended for use by health professionals are now being used by consumers," says Schultz. Lay users often are not trained to recognize device-related problems, he says, nor do they all know the process for reporting adverse events.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.