Medical Devices: Frequently Asked Questions
What is a medical device?
The Food, Drug, and Cosmetic Act defines a medical device as "an instrument, apparatus, . . . machine, implant, . . . or other similar article that is intended for use in the . . . treatment or prevention of disease." This includes many items, including some that most people would not consider a device, such as a condom or a tampon.
Who regulates medical devices?
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) regulates medical devices as required by Congress in the Food, Drug, and Cosmetic Act.
How do medical devices get approved for public use?
The 1976 Food, Drug, and Cosmetic Act requires that manufacturers get FDA approval prior to marketing their medical devices. In order to win approval, most manufacturers follow one of two routes based on risk potential and product complexity. The first category, 510(k), or "premarket notification," requires manufacturers to prove that the proposed medical device is similar to one that is already on the market. The second route is called PMA or "Premarket Approval Application." If the medical device is not similar to any product already on the market, this procedure requires the manufacturer to conduct clinical and preclinical scientific studies to demonstrate that the device is safe and effective for its intended use.
How are the devices that were created before the passage of the 1976 Food, Drug, and Cosmetic Act regulated?
Such medical devices were "grandfathered" in. However, the FDA may request safety and effectiveness data pertaining to such devices.
How many categories of medical devices are there?
Currently, there are 1,800 categories of medical devices, and they vary in complexity and risk potential. Some of the more common medical devices include ventilators, heart valves, pacemakers, and X-ray machines.
How many reports does the FDA receive each year regarding medical device problems?
On average, the FDA receives 90,000 reports of adverse events involving medical devices each year. 95% of the reports come from manufacturers. Only 5% come from hospitals, nursing homes, outpatient surgery and medical care centers, and dialysis centers.
How many of these reports come from nurses and physicians?
According to a General Accounting Office report, 82% of all device related incidents are discovered by nurses and physicians.
Are manufacturers, hospitals and other healthcare entities required to report problems with medical devices that lead to serious injury or death?
Yes. Manufacturers, hospitals, outpatient treatment centers, diagnostic and surgical care facilities, and long term care facilities, known as user facilities, are required by the FDA to report any problems with medical devices that lead to serious injury or death.
How does the FDA define a device-related "serious injury"?
According to the FDA, a device-related "serious injury" includes any injury or illness that is life-threatening, results in permanent impairment or damage to body function or structure, or necessitates medical or surgical intervention to prevent permanent impairment or damage to body function or structure.
Why do some user facilities fail to report serious injuries or deaths caused by medical devices?
Some healthcare professionals may not link the device to a patient's illness or death. In some instances, the medical staff is reluctant to alert the FDA because of fears of legal liability.
What types of problems can occur with medical devices?
Typically, medical device problems fall into three categories: device problems, use problems, and clinical problems. Device problems include malfunctions and manufacturer defects in product design, development or material. Use problems include inadequate or misleading labeling, confusing instructions, inadequate packaging, or inadequate training in the use of the device. Clinical problems include patient sensitivity or allergic reactions to a device.
Should I contact an attorney if I have been injured as a result of a medical device?
Perhaps. It may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits (Statute of Limitations) which affect your ability to sue.
How much does an attorney evaluation cost in these types of cases?
Nothing! Attorneys associated with InjuryBoard.com will evaluate your case free of charge. If a participating attorney agrees to handle your case, you will owe no fees or other costs unless that attorney recovers money for you.
How do I submit my case for a free evaluation?
Simply click on the free Ask an Attorney button and complete the online intake form. An attorney will evaluate your case and respond to you via email.
-- Article Courtesy of InjuryBoard.com
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