In response to complaints from consumer advocates that its warnings database was difficult to navigate, the FDA’s Center for Devices and Radiological Health (CDRH) has issued new guidelines for reporting potential medical device problems in the future. The CDRH is responsible for premarket approval and overseeing manufacturing, performance and safety of all medical devices. It is revamping how it tracks “emerging signals” that a medical device has a problem that puts patients at risk.
The FDA comes under pressure from manufacturers to speed the approval of new medical products, while consumer advocates want to see slower, more careful testing and approval processes. In a public notification, the FDA
stated, “All medical devices have benefits and risks. FDA weighs probable benefit to health from the use of the device against any probable risk of injury or illness from such use in determining the safety and effectiveness of a device. Once FDA has made its determination, health care providers, patients, and consumers must weigh these benefits and risks when making patient management decisions. However, not all information regarding benefits and risks for a given device may be known before the device reaches the market.”
This warning was proven by some high-profile medical device malfunctions in recent years. An investigation into four common medical devices by Consumer Reports found that many implanted surgical mesh, lap-bands, metal hips and cardiac devices had not been tested for safety, resulting in approximately 29,000 deaths or injuries.
“While the majority of medical devices that hit the market—both in the United States and other developed geographies like Europe—are safe and effective, dangerous products occasionally make it to the market,” reported qmed.com
. For example, an endoscope made by Olympus that was related to deaths from infections somehow came to be marketed without FDA clearance. Another case was that of metal-on-metal hip implant products that injured patients, which the New York Times
called “one of the biggest medical device failures in recent decades.”
If a defective medical device has injured you or someone you love, Epperly & Follis stands ready to help you obtain appropriate compensation for your injuries.
has extensive experience in litigation, negotiating and settling suits, and providing legal opinions on liability and insurance coverage. You can reach him at (888) 703-0109 or via email at firstname.lastname@example.org