FDA to Track Potentially Defective Medical Products

The Food and Drug Administration published new regulations on Friday requiring most medical devices sold in the U.S. to carry a unique code used to identify and track the product’s make, manufacture date, and lot number. The codes will be stored in a public database for easy monitoring of potential safety issues due to faulty design or manufacturing flaws, and doctors and hospitals will be able to add the codes to patients’ medical records.

Medical devices were among the only products on the market that could not be uniquely identified.

“Up until now medical devices were among the only products on the market that could not be uniquely identified,” director of Pew Charitable Trusts’ medical device initiative Josh Rising told USA Today. Of the millions of medical products that will be coded and tracked, the most high-risk devices, such as defibrillators and heart stents, will be the first products to receive a unique code. Moderate-risk devices like X-ray systems, surgical needles, and power wheelchairs will be next in line. The new system will begin next year, and manufacturers will have three years to implement the codes.

The tracking system seems to be in high demand: faulty defibrillators, artificial hips, and drug pumps are among the most highly recalled devices in the medical field. In 2007, medical device company Medtronic recalled their Spring Fidelis defibrillator lead, or the part which connects the body’s pulse to the heart. Medtronic later reported that the defective defibrillator leads caused at least 13 deaths. In 2010, Medtronic agreed to pay $268 million to settle lawsuits over their alleged faulty defibrillators. The company is currently in the midst of a federal lawsuit under similar accusations, with the plaintiff accusing the company of using bribery and deception to implant defective defibrillators in patients.