Could New Tracking Codes on Medical Implants Save Lives?
The U.S. Food and Drug Administration (FDA) published new rules Friday that will help keep millions of medical devices in check. According to federal health regulators, from pacemakers to hip replacements, a new electronic system that's designed to protect patients by catching problematic implants earlier will be easily identified via a code, manufacture date and lot number that makes the devices more accessible to the database in order for safety issues to be monitored.
In fact, this tracking device, which has been greatly promoted and supported by medical staff and public safety advocates alike, could create a safer and more positive environment for medical devices.
"The rule that came out today is a victory for patients, hospitals and clinicians," said Josh Rising, director of Pew Charitable Trusts' medical device initiative, according to the Associated Press. "Up until now medical devices were among the only products on the market that could not be uniquely identified. This is going to be a tremendous victory for all of those interested in improving the performance of devices."
Many doctors, hospitals and insurers are able to add the codes to patient's medical records in order to more quickly help them identify patients who may have received problematic implants or devices.
This tracking system is based on years of highly-publicized recalls that often involve defibrillators, artificial hips and drug pumps, many of which have been harmed due to design or manufacturing laws.
In fact, some recalls include defibrillator wires made by St. Jude Medical that could crack and cause horrendous malfunctions for the heart-zapping devices. Johnson & Johnson also recently recalled more than 100,000 artificial hips since a 2010 discovery that they would likely break down early and cause both pain and inflammation.
The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators.