Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.
The Food and Drug Administration published new rules Friday that require certain medical devices sold in the U.S. to carry a unique code, identifying its make, manufacturer and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.
The tracking system has been promoted by doctors and public safety advocates for more than a decade. But industry groups favored voluntary tracking efforts by individual companies.
The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators.
Explore further: FDA proposes new rules for heart defibrillators
© 2013 The Associated Press. All rights reserved.
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Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.
The Food and Drug Administration published new rules Friday that require certain medical devices sold in the U.S. to carry a unique code, identifying its make, manufacturer and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.
The tracking system has been promoted by doctors and public safety advocates for more than a decade. But industry groups favored voluntary tracking efforts by individual companies.
The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators.
Explore further: FDA proposes new rules for heart defibrillators
© 2013 The Associated Press. All rights reserved.
Medical Xpress on facebook
Related Stories
FDA proposes new rules for heart defibrillators
Mar 22, 2013
(AP)—The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.
FDA plans modest changes to medical device system
Jan 19, 2011
(AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.
US warns of cyber attacks on medical devices
Jun 13, 2013
US authorities on Thursday warned makers of medical devices and hospital networks to step up efforts to guard against potential cyber attacks.
FDA aims to change the way it monitors safety of defibrillators
Mar 26, 2013
Defibrillators are supposed to save lives by shocking a patient's heart back into a normal rhythm, but they have malfunctioned in about 45,000 cases since 2005, according to the Food and Drug Administration. So on Friday, ...
System to catch fake drugs has idled for years
Feb 16, 2012
(AP) -- The news this week that a fake version of the cancer medicine Avastin has made its way into the United States highlights a longtime concern: There are few safeguards to make sure fake drugs can be ...
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4 hours ago
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Sep 19, 2013
(HealthDay)—The pros and cons of shortening medical school to three years are discussed in two perspective pieces published in the Sept. 19 issue of the New England Journal of Medicine.
Microfluidics: The next wave of disruptive technology in radiochemistry?
Sep 19, 2013
Microfluidic technology may offer faster and more controlled ways to produce radiotracers for medical imaging, including studies into Parkinson's disease, thanks to a first of its kind approach in the Southern Hemisphere ...
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Dr. Donald Low, the public face of Toronto's response to the SARS outbreak in 2003, has died. He was 68.
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© Medical Xpress 2011-2013, Phys.org network
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