Medical devices serve a vital role. When operated effectively, they preserve patient health, minimize suffering and reduce cost of care. But they don’t always work as intended. In fact, devices fail far more often than most people realize. And these malfunctions cause injuries, accidents, and far too many deaths. Manufacturers insist, doggedly, that their products are safe, even when compelling evidence to the contrary is presented. And although device recalls occur with regularity, they come too late for thousands of patients.
Which Devices Are at Risk for Failure?
FDA Recall Rules May Soon Change—for the Worse
The FDA, which controls product recalls and safety, admits that device malfunction is underreported. Nevertheless, the agency is seeking to loosen restrictions on reporting. Currently, known issues must be reported within 30 days of discovery. Proposed changes would allow manufacturers an entire quarter to alert the public. Consumer advocacy groups are alarmed; they argue that the public deserves more a more robust alert system, not a more lenient one.
Contact our Washington D.C. medical malpractice attorneys if someone you love suffered injury due to a defective or poorly monitored medical device.
Tagged Safety Recalls