Reducing Medical Device Injuries : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

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:

• Call 1-800-FDA-1088 to report by phone
• Fax report to 1-800-FDA-0178
• Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Log onto the MedWatch Web site at www.fda.gov/medwatch/.

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.

Alerting the Public

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:

Publication in the media and clinical peer-reviewed journals alerts health care practitioners to hazards associated with medical device use.

Labeling changes may be required of the manufacturer to add new information to the product's packaging that alerts users to precautions during device use.

Boxed warnings may be required of the manufacturer to be placed in a prominent place on the product's labeling to ensure that patients and doctors won't miss them. The agency reserves these warnings for the most serious adverse events, including life-threatening problems occurring that were not observed in clinical trials.

Medical and safety alerts in the form of letters and Web Notifications are used to provide important safety information about a product to health professionals, hospital administrators, risk managers, pharmacists, news media, and others. They are also sent (by e-mail or fax) to the MedWatch Partners — more than 170 health professional specialty and consumer organizations that work with the FDA to help keep their members informed about medical product safety information and reporting.

Product recalls and withdrawals involve the firm's correction or removal of a product from the market and may require taking the product off the market permanently. Recalls usually are conducted voluntarily by the manufacturer, and are completed within six to 12 months. In rare instances, where the manufacturer or importer fails to initiate a recall voluntarily, the FDA has the regulatory authority to order the firm to recall the defective device.

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."

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.