Following years of highly-publicized recalls on medical implants plagued by design and manufacturing flaws, a new electronic system will now be used to protect patients by catching problems earlier.
The Food and Drug Administration published new rules that require most medical devices sold in the U.S. – such as pacemakers and hip replacements – to carry a unique code used for tracking by federal health regulators. The make, manufacture date and lot number codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.
“Up until now medical devices were among the only products on the market that could not be uniquely identified,” said Josh Rising, director of Pew Charitable Trusts’ medical device initiative. “This is going to be a tremendous victory for all of those interested in improving the performance of devices.”
Hospitals and insurers will be able to add the codes to patients’ medical records, helping them to quickly identify people who have received problematic implants and devices. Read the full details here:
FDA required tracking codes on medical implants
If you have been injured due to medical malpractice, including faulty medical implants, please call to investigate your matter fully. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.