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By Linda Bren
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).
The medical device industry has grown rapidly in both numbers of manufacturers and numbers of individual products. |
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.
"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.
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.
The transformation initiative leadership team will recommend ways to improve postmarket device safety, but the CDRH has already begun to address some of the challenges through a number of actions. One of them is planning postmarket studies of devices even before they are approved.
The agency requires manufacturers of certain devices, such as long-term implants, to continue studying the devices after they are on the market. "Premarket clinical trials are not 10 years long," says Gardner, yet many devices are going to be in the patient for a decade or longer, so it's important to continue studying them.
Gardner says that the CDRH has added to the premarket review team epidemiologists who can advise the manufacturer on how to study a device after it's on the market. "Early on, we want to think about what the possible postmarketing problems might be with a device if it is to be approved. Then by the time the product is on the market, the postmarketing study is already in place."
Other actions to strengthen the device postmarket safety program focus on four areas: collaboration, automated systems, communication, and enforcement.
The CDRH has enlisted the help of professional medical organizations and the medical device industry to strengthen its postmarket device safety program.
In September 2005, FDA medical and scientific staff met with physicians, other health care providers, the medical device industry, and the public in Washington, D.C., at a conference on pacemakers and ICD performance sponsored by the Heart Rhythm Society. Participants discussed how to improve the quality of information that is made available to doctors and patients for making individual medical decisions about the use of those products. The CDRH has also formed a defibrillator working group to explore better ways to make information about the benefits and risks of defibrillators and pacemakers available to patients and health care providers.
In February 2006, the FDA and an industry advocacy group, the Advanced Medical Technology Association (AdvaMed), held the first in a series of public workshops to discuss postmarket device safety. The two-day workshop set the stage for further collaboration to improve postmarket device monitoring and follow-up.
Better sources of data on device performance and better systems to allow the FDA to quickly collect and analyze reports of safety problems are needed. The CDRH is seeking a system of unique identifiers for devices to help associate adverse events with the right model and type of device. It is also exploring mechanisms and incentives for health professionals to include certain standardized information about devices in the health care records of patients who use the devices.
The CDRH is developing an electronic reporting system to replace the current, "antiquated, paper-based system," says Gardner, which requires staff resources to be spent entering data into the system about adverse events reported by faxes, e-mails, and phone calls. "We're moving to an electronic MDR system that will allow us to get information to CDRH analysts more quickly," says Gardner, adding that a fully electronic system is expected to be in place within the next several years.
Once a medical device problem is identified and evaluated, the FDA must quickly inform health care professionals, patients, caregivers, and consumers of the device's risks and benefits.
As part of the Medical Device Postmarket Transformation Initiative, the CDRH is partnering with outside professional groups, using the media to help spread its messages, and creating easier access to CDRH device information. "We are using a lot of varied tools to make information flow better and reach the broadest audience possible," says Lynne Rice, director of the CDRH's Office of Communications, Education, and Radiation Programs.
Capitalizing on the Internet, the CDRH reaches out to consumers through electronic newsletters, mailing lists, and Web sites that provide information on new device approvals, device recalls, and benefits and risks of individual products. The center is increasingly using e-mail subscription services, says Rice. "It gives you the ability to sign up for very specific information, and you'll receive only new or updated information on that topic. You won't have to go searching for it--we are going to push the information out to you, and we're only going to send you the information you're interested in."
The CDRH also provides device information on a continuing basis to health care professionals through public health notifications and "FDA Patient Safety News," a monthly video news show available online and distributed across the United States via satellite to about 4,000 hospitals.
Under the Medical Device Postmarket Transformation Initiative, the CDRH is assessing the effectiveness of current enforcement strategies and is working to improve inspections of manufacturers, reporting of problems, and enforcement issues. One improvement already under way focuses inspection efforts on "risk-based inspections"--using the FDA's limited field resources to inspect manufacturers whose medical devices present the greatest risk to public health. The agency is also using accredited private firms to do some of the inspections of facilities that produce devices that have lower safety risks.
The FDA is working with its counterpart agency in Canada on a pilot program to conduct joint inspections of facilities that market devices in the United States and Canada. The program would save resources for both agencies, says Schultz, as well as for the manufacturers who are required by law to be inspected by different jurisdictions. "Instead of having multiple inspections over a short period of time, manufacturers would have one inspection that would cover multiple jurisdictions."
The FDA encourages consumers, health professionals, and caregivers to report adverse events related to medical devices, drugs, or other medical products to MedWatch, the agency's voluntary reporting program. You can report by telephone, fax, mail, or online:
Call (800) FDA-1088
Fax report to (800) FDA-0178
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Log onto the MedWatch Web site at www.fda.gov/medwatch/
Patient identification is kept confidential and is protected from disclosure by the Freedom of Information Act.
Medical Device Postmarket Transformation Initiative
www.fda.gov/cdrh/postmarket/mdpi.html
Medical Device Information for Consumers
www.fda.gov/cdrh/consumer/index.html
New Device Approvals
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list+1
"FDA Patient Safety News"
www.fda.gov/PSN