The U.S. Food and Drug Administration (FDA) released new guidelines requiring most medical devices sold in the United States to identify its make, manufacture date, and lot number. The codes, imprinted on the medical devices, will be stored in a database available publicly. The idea is to help doctors, regulators, and medical device manufacturers identify safety issues in medical implants in a more timely manner.
Doctors and public safety advocates have been pushing the new guidelines for many years. The use of ‘unique identifiers’ has been used in other industries for decades, such as the widely-known Vehicle Identification Number (VIN) system for automobiles. Prior to these new FDA guidelines, medical devices were one of very few products that could not be uniquely identified.
The new guidelines will affect various medical devices. In light of recent medical device recalls, the changes should help protect patients and their doctors. Higher risk devices will be first to require the unique identification, including heart stents and defibrillators. In three years, moderate risk devices will have the identification. Low risk medical devices like bandages will be exempt.
The Law Offices of Larry H. Parker is currently pursuing litigation against the manufacturers of faulty medical devices, including the DePuy ASR Hip Implant, the intrauterine device (IUD) Mirena®, and vaginal mesh devices. If you or a loved one has been harmed by a recalled medical device, contact our offices today at (800) 333-0000 or send us an email for a free, confidential consultation. You may be entitled to compensation.