FDA To Begin Tracking Medical Devices Inside Patients
By Katie Wike, contributing writer
The Food and Drug Administration recently released its new regulations for unique tracking on medical devices like pacemakers and other artificial implants
The Food and Drug Administration will shortly begin to track millions of medical devices and artificial implants in an effort to better manage them. The New York Times reported the new rules require medical devices “carry a unique code, identifying the make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.”
Josh Rising, director of Pew Charitable Trusts’ medical device initiative says, “The rule that came out today is a victory for patients, hospitals and clinicians. Up until now, medical devices were among the only products on the market that could not be uniquely identified.”
Health Aim reported, “The system is designed to protect the patients with the devices by catching any implants that are problematic at an earlier stage.
“Many hospitals, insurers and doctors will be able to add the device’s code to the medical records of the patient that will allow them to more quickly respond and identify patients who might have been given implants or other devices that are problematic.”
According to the Winnipeg Free Press, “The FDA will begin phasing in the new system in the coming year, requiring identification codes on high-risk devices like heart stents and defibrillators. The tracking requirement will then be expanded to moderate-risk devices such as X-ray systems, surgical needles and power wheelchairs. Makers of those devices will have three years to implement the tracking codes. Many low-risk devices, such as bedpans and examination gloves, will be exempt from the requirements.”
The Free Press also notes, “The FDA tracking system follows years of highly-publicized recalls involving defibrillators, artificial hips and drug pumps, which have been plagued by design and manufacturing flaws. Recent recalls have included tens of thousands of defibrillator wires made by St. Jude Medical, due to risks they can crack and cause the heart-zapping devices to malfunction. Johnson & Johnson has recalled more than 100,000 artificial hips since 2010 after discovering they are more likely to break down early, causing pain and inflammation.”