Last week, the U.S. Food and Drug Administration announced a plan to keep tabs on high-risk medical devices. The plan will require devices like hip implants, stents, heart defibrillators and catheters to be coded with a unique device identifier (UDI). As Reuters stated, identifying defective medical devices will enable medical professionals to pull them from the market faster.
The Wall Street Journal reported that this plan was initially proposed in a 2007 federal law. The plan is to be enacted late this year and the director of the FDA’s medical device center told WSJ that codes should appear by early 2014.
Until now, the FDA had no means of tracking how faulty a medical device is or how often it was reported. In the past year, the agency has been criticized for being too lenient with medical device manufacturers. Under the FDA’s fast track approval program, manufacturers are able to quickly gain approval for their devices without much testing.
WSJ noted that, in five years, more than 17,000 deaths were reported to the FDA due to faulty medical devices.
According to the FDA, some benefits of the new UDIs will include:
- more accurate reporting;
- fewer medical errors;
- a consistent process to entering information;
- a standardized identifier to aid in device management; and
- prevention of counterfeit devices.
The new plan will expedite the FDA’s ability to determine which devices or models are associated with high failure rates by tapping into databases owned by the government, insurance companies, and hospitals
Some critics suggest that the new system will not be enough to ensure patient safety. “For devices that disappear after being surgically removed, there should be criminal penalties for not reporting a malfunction,” said cardiologist Robert G. Hauser.
What do you think? Is the plan enough? Could the agency do more? Tell us your thoughts in the comment section below.