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FDA Consumer
magazine
July-August 2003 Issue
By Carol Rados
Medical devices help to alleviate pain, overcome disability, and sustain life. They also, on occasion, fail to operate properly or are misused in ways that are associated with injuries and deaths. Betty Davis' wheelchair, for example, caught fire, badly burning over 25 percent of her body in January 1999. A quadriplegic confined to a wheelchair since 1976, the 65-year-old Tucson, Ariz., resident knows the importance of a well-maintained machine that works as intended. "I'm a very active quad," she says, but when the fire started, "all I could do was sit there and watch my arms and legs burn." Faulty wiring short-circuited the battery charger in Davis' wheelchair. Davis says she put the chair on charge after a blinking light indicated the battery was running low. But Davis detected a spark, and immediately disconnected the charger. The spark, however, turned into a flame. Though authorities don't know why, Davis' attempt to reach 911 through her emergency medical pendant failed. Fortunately, a neighbor was nearby at the time and threw water on her to extinguish the fire.
"My legs and arms were on fire and my hair was burning," Davis recalls. "And from the burns, my skin is so thin you can rub it off."
According to the Institute of Medicine (IOM), about 1.3 million Americans are seriously injured each year by adverse events involving medical products. More people die in any given year due to medical errors occurring in hospitals (between 44,000 and 98,000) than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).
Inadequate device design, poor manufacturing quality, improper device maintenance, and user error all contribute to adverse events associated with medical devices. In 2002 alone, the FDA received reports of more than 111,000 adverse events, including serious injuries and deaths, related to medical devices.
Whether it's failure of a device to operate properly or failure of the user to operate the device correctly, the Food and Drug Administration says that many of the adverse events associated with product problems are preventable. In Davis' case, for example, a $5 fuse would have prevented the short that occurred between the charger and the wheelchair's battery. Davis' wheelchair should have been designed with one.
Nearly 1,800 categories of medical devices exist, and they vary in both complexity and risk potential. That means that the problems associated with medical devices are as diverse as the number of medical devices on the market. Moreover, as health care and the system that delivers it become more complex, opportunities for errors increase.
While it's unlikely that product-related problems and patient injuries can be eliminated, the FDA believes that many adverse events can be prevented by designing systems that make it hard for people to do the wrong things and easy for them to do the right things. "In many cases," says Mary Weick-Brady, deputy director of the FDA's Division of Surveillance Systems, "a device may have been designed properly but the user may have used it wrong." In short, manufacturers can design errors out of the system and build checking and monitoring functions into the system.
For example, because breathing tubes used in ventilators often pop out of place, manufacturers have alarms built into the ventilators to alert health care workers when a tube becomes disconnected. Future designs featuring networking systems could recognize that health care workers are not always present when an alarm goes off. Built-in networking systems would allow the appropriate health care providers to be notified of an alarm wherever they may be.
FDA guidelines now call for manufacturers to consider the needs of the users and patients when designing equipment. Well-designed devices are consistent with the user's experience, and they are logical and not confusing. Also, they minimize the need for depending on the user's memory and making mental calculations; do not overtax the user's strength, dexterity, visual ability, or auditory capacity; alert the user to device-related problems; prevent users from making fatal errors that could otherwise occur easily; and are supported by readable and understandable labeling.
And the FDA wants products to be tested under actual or simulated use conditions to demonstrate that the potential for user error has been minimized.
The agency currently guides the development of new devices, evaluates the results of clinical trials and new products before they are marketed, ensures quality systems are in place in manufacturing plants, and continues to identify and respond to adverse events that are reported in the United States. The FDA plans to expand its knowledge of medical device errors by linking with new sources of data, perhaps from other government and outside organizations. In addition, the agency will focus on educating patients and health care professionals on how to avoid potential threats posed by medical devices.
Improved patient safety through reducing preventable adverse health events is one of five agency priorities set by Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. Other priorities include science-based risk management, better information for consumers, counterterrorism, and a strong FDA at the forefront of biomedical science and technology.
Simply defined, a medical device is an instrument, such as a stethoscope or an artificial hip joint, used for diagnosis, treatment or prevention of disease, injury or other condition that is not a drug, biologic or food. The FDA regulates more than 100,000 medical devices ranging from simple thermometers, tongue depressors and heating pads to heart pacemakers, intrauterine devices, and kidney dialysis machines. Some devices, such as bandages, have retained their same basic form and function, while others have become more complex.
Heart defibrillators, for example, designed to deliver electric shocks to restore normal heart rhythms, have progressed from large machines to devices small enough to be implanted inside the chest wall. Other developments include surgical tools that enable surgeons to operate on a fetus while still in the womb. Diagnostic devices also have evolved so that many tests, such as those used to determine whether a woman is pregnant or to detect blood clotting, can be used at home. And some surgical procedures, such as gallbladder removal, can now be done using laparoscopic instruments that require only small incisions, which can reduce hospital stays and help speed recovery. Patient care has improved dramatically as a result of these changes.
Once a medical device goes into widespread use, unforeseen problems can still arise. But through the use of regulatory controls and the device classification process, the FDA provides reasonable assurance that the product will be effective, while not posing unacceptable risks to patients once it is on the market. (See "Class Clarification.")
Postmarket medical device problems--those seen after a device has been approved and is in general use--generally fall into one of three broad categories: device problems, use problems, and clinical problems.
Mechanical, electrical or software-related malfunctions, manufacturing defects in product design or development, or problems with materials are all considered to be device-related problems. Use problems may be associated with inadequate or misleading labeling, confusing instructions, inadequate packaging, design problems that make the device difficult to use, or inadequate training in the use of the device. Clinical problems can occur with a patient who is sensitive or allergic to a device, or who has a pre-existing condition that makes the device difficult or risky to use.
The following simple steps can help consumers and health care providers avoid common problems associated with medical devices:
Reporting medical device problems is an important part of patient safety. Concerns about the quality, performance, or safety of any medical device should be reported. Consumers and health care providers using medical devices are in the best position to provide the information that manufacturers and the FDA need to determine whether an adverse event presents a public health risk.
"By reporting adverse events to the FDA," says Suzanne Rich, a registered nurse who works in the FDA's Division of Postmarket Surveillance, "health care providers help to rapidly identify significant health hazards associated with these products, and the FDA can provide timely feedback to the health care community about safety issues involving medical products." This reporting, she adds, translates into patient safety.
The FDA is improving several systems for reporting adverse events that are associated with the use of agency-approved products. These systems advance the public's health by giving the agency quicker and more detailed information on potential problems with health care products.
The key to effective reporting is to understand the difference between the FDA's two complementary systems for national medical device adverse event reporting. Through the Medical Device Reporting (MDR) system, manufacturers and distributors of devices, as well as user facilities (hospitals, outpatient treatment, diagnostic and surgical facilities, and nursing homes) are required to promptly notify the FDA about device-related events that have or may have caused or contributed to a death, serious illness or injury. The manufacturer of Davis' wheelchair, for example, was required under MDR to report the fire associated with her burns.
MedWatch, the FDA's medical products reporting program, is a voluntary system that encourages health professionals and consumers to notify the FDA and manufacturers, not only about adverse events involving serious injury and death, but also about other problems with medical products.
Reporting through MedWatch is quick and simple. Consumers and health care professionals can report by telephone, fax, mail, or online, as follows:
The Manufacturer User Facility and Distributor Experience (MAUDE) database contains reports of adverse events consisting of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. (Visit MAUDE online at www.fda.gov/cdrh/maude.html.)
Through these systems the FDA currently receives more than 100,000 adverse event reports annually from manufacturers, hospitals, health professionals, and consumers.
Another important system through which the agency receives adverse event and product problem information is MedSun. This program educates and encourages hospital and nursing home personnel to accurately identify and report not only injuries and deaths, but also close-call and near-miss events associated with medical devices. The system is composed of a subset of user facilities that confidentially report detailed adverse event information about potential problems involving medical devices. User facilities interested in learning more about the MedSun program can visit the MedSun Web site or call the MedSun staff at 301-588-0177.
The vast amount of information about adverse medical outcomes that reaches the FDA through these systems is analyzed and, if necessary, requests are made for additional information and studies to determine the need for further action. Such reporting ultimately forms the basis for several actions the FDA may take once an adverse event or product problem has been identified:
A company-initiated recall took place in early 2000 when Invacare Corporation, the manufacturer of Davis' wheelchair, voluntarily sent letters to its dealers stating that battery wiring harnesses were configured improperly and had the potential to cause a fire. The wide-ranging recall has been expanded to include additional wheelchairs, and is still ongoing.
Once it is determined that a product will be recalled, an evaluation of the health hazard it presents is conducted by the FDA. The agency then assigns a numerical value (I, II, III) to the recall to indicate the relative degree of health hazard (see "Class Clarification"). The recalling firm develops a strategy for recalling the device, based on FDA-mandated criteria, such as the health hazard evaluation results, ease in identifying the product, degree to which the product's deficiency is obvious to the consumer, and more. Ordinarily, the recalling firm is responsible for conducting recall effectiveness checks--a means of verifying that their customers have received the notice and have taken appropriate action, as requested by the recalling firm. Only after the FDA reviews the firm's efforts and determines its success will the agency issue a "close-out" letter terminating the recall.
Cooperation between the FDA and its regulated industries has proven to be the quickest and most reliable method to remove potentially dangerous products from the market, says Christy Foreman, chief of the FDA's Orthopedic, Physical Medicine and Anesthesiology Devices Branch. "We do rely heavily on the firms to be honest, truthful and forthcoming in their reporting," she adds. "A warning sign of an ineffective recall is hearing about additional accidents."
And from where Davis sits, that translates into yet another grave concern. "My friends in wheelchairs didn't hear about this problem until it happened to me," she says, adding, "The word doesn't always get out."
How and whether people find out about device recalls depends largely on manufacturers' and retailers' diligence, consumer vigilance, and media assistance. Recalls are officially announced in two ways: the FDA publishes a press release and a weekly Enforcement Report that contains all enforcement actions including recalls, field corrections, seizures, and injunctions. This report is published on the Internet at www.fda.gov/opacom/Enforce.html. Secondly, manufacturers distribute recall notifications to communicate the potential medical device hazard.
For various reasons, however, medical device recalls can go unnoticed--some say because reporting systems are voluntary, recall information doesn't get into the right hands, registered letters are sent to old addresses, hospitals don't see notices because they are swamped with so many other responsibilities, or perhaps there are mixed signals on the urgency of the problem.
Consumers and health care professionals who don't want to rely on their own vigilance can regularly access the most serious alerts and get additional safety information from the FDA home page. For device-related information, click "Medical Devices," and then the "Safety Alerts" link under "Health Topics." MedWatch is another source of safety information about devices and other FDA-regulated medical products. MedWatch posts safety alerts for all Class I recalls of devices, drugs, and biologics. E-mail notification of the recalls reaches MedWatch partners and about 30,000 subscribers at the time of the Web posting. This information can be accessed on the MedWatch Web site at www.fda.gov/medwatch/safety.htm. These two Web sites give instructions for how to sign up to receive e-mail notification of new safety alerts.
The FDA now has another means to communicate device safety information to health care personnel: FDA Patient Safety News, a news show that is broadcast on medical satellite networks to over 4,000 hospitals and nursing homes across the country. Designed for physicians, nurses, pharmacists and risk managers, the show features information on new medical products, FDA safety notifications and product recalls, ways to protect patients when using medical products, and more.
"The future holds still more promise," says McClellan. The current systems "and other great strides are part of a vision of what can be accomplished if all of us in government, the health professions, academia and industry continue to work toward better health information systems--and more generally," he says, "toward a health care system that helps patients and health professionals make better decisions supported by safer and more effective medical treatments."
|
Within 5 days |
Within 10 days |
Within 30 days |
Semiannually |
Annually |
|
|---|---|---|---|---|---|
|
User Facility |
Deaths (also report to Manufacturer) |
Serious injuries (report to Manufacturer or FDA if Manufacturer unknown) |
Report of deaths and serious injuries (January 1 and July 1) |
||
|
Manufacturer |
5-day report on events requiring immediate remedial action and other designated events |
30-day report of deaths, serious injuries and malfunctions Baseline report to identify and provide basic data on each reported device |
Certification of compliance with regulation |
Source: FDA Center for Devices and Radiological Health
The terms Class I, Class II and Class III are used by the Food and Drug Administration in two different ways, both for categorizing medical devices by their complexity and potential risk, and for indicating the seriousness of a product recall. This double use can be confusing: for example, Class I medical devices are those that are the least complex and carry the least risk, but a Class I product recall is the most serious kind, indicating that the problem could cause serious injury or death.
The FDA has established classifications for the approximately 1,800 different generic types of devices and grouped them into 16 medical specialties. Each of these types is assigned to one of three regulatory classes based on the level of control necessary to assure safety and effectiveness. The three classes and the requirements that apply to them are:
The Food and Drug Administration assigns a numerical designation of I, II, or III to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.