A recent report by the Institute of Medicine recommended that the federal government completely abandon and replace its system for regulating moderate-risk medical devices like artificial joints and external defibrillators. The current system, the study found, is dangerous and flawed beyond repair and many New York defective products lawyers agree.
The report faults the FDA's existing system for failing to assess the safety and effectiveness of many medical devices before they are offered for sale.
Currently, manufacturers of moderate-risk medical devices are only required to show that they devices are "substantially equivalent," or similar, to other devices already on the market. This allows devices to piggyback on one another without specific verification of their safety or value.
Several high-profile device recalls have occurred in recent years, affecting thousands of patients. Many patients have suffered injury or permanent disability as a result of the recalled devices, leading critics to question the wisdom of the current regulatory process that seems to approve first and ask questions later.
The FDA had originally commissioned the review to investigate specific procedures that could be used to improve the device approval process. FDA officials were taken off guard when the panel concluded that the system should be rebuilt from scratch.
Unfortunately, the FDA is not required to comply with recommendations set forth in the report because it was merely advisory in nature. At the very least, however, it has drawn scrutiny from lawmakers on an issue that clearly needs greater attention.
The study did not address the approval of high-risk devices such as pacemakers and artificial heart valves, which go through a more extensive regulatory process before sale.