Reducing Medical Device Injuries : Part 4

by Food and Drug Administration (FDA)

(Page 4 of 4)

Knowing Where to Look

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.

Looking Ahead

"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."

Class Clarification

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.

Device Classifications

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:

Class I, General Controls — subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than the other classes of devices.

Class II, General Controls and Special Controls — those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods, such as special labeling requirements or mandatory performance standards, are available to provide such assurances.

Class III, General Controls and Premarket Approval — the most stringent regulatory category for devices for which insufficient information exists to assure safety and effectiveness solely through general or special controls. These devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.

Recall Classifications

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.

• Class I recalls represent the highest level of risk and are reserved for products that could likely cause serious health problems or death.
• Class II recalls represent a moderate likelihood of death or serious injury.
• Class III recalls represent those in which exposure to the defective product isn't likely to cause any health consequences.

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.