In a move that seems long overdue, the U.S. Food and Drug Administration is implementing a database which will track medical devices enabling physicians and patients to obtain information about medical devices and allowing the FDA, in a centralized system, to track potential problems with medical devices.
Starting September 20, the FDA has instituted a final rule requiring medical device manufactures to provide a unique tracking code to medical devices. This code — known as Unique Device Identifier (UDI) — is a code on the device label, packaging or product which identifies the device and the production lot/batch, serial number, manufacturing date and expiration date of a device. The device database will contain other information about the device such as whether the device is sterile or needs to be sterilized, whether it contains rubber latex, whether it is safe with MRI machines and whether the device is prescription or over the counter.
Medical devices such as hip implants, transvaginal mesh implants, knee implants, heart wires, and pacemakers will all be required to have a UDI.
It is hard to believe that up until this system, the FDA really had no centralized way to track medical devices that failed. In fact, medical devices unlike most products sold on the market could not be uniquely identified. The FDA has received more than 17,700 reports of medical-device related device and thousands more patients have been injured by defective medical devices, some of them seriously.
Device registry systems have been in place in other countries, including England and Australia, and help researchers quickly identify medical devices with a high rate of failure to alert physicians and patients and to provide a system in which faulty devices can be pulled off the market.
Take for example the DePuy ASR XL hip implant device. The ASR was marketed implanted in approximately 100,000 patients across the globe but, because the U.S. did not track the device, it is unknown how many patients received the device. In England and in Australia, the medical authorities were alerted as early as 2008 that the hip implant had a high failure rate and they removed the device from their markets. In The United States, the FDA started receiving hundreds of complaints about the DePuy hip implants but DePuy continued to sell the hip implant devices until a recall was announced in 2010. Unfortunately, thousands of people suffered serious complications from the device.
New Database Improves Patient Safety
To date, medical devices were one of the fewer consumer products in the U.S. that lacked a tracking system. Patients were often stressed because they would hear in the news about a medical product such as a hip implant being recalled but they had no idea which make and model of hip implant was implanted in their own bodies without contacting their surgeon and requesting their medical records.
The new system of UDI’s should insure patient safety by identifying devices with a high failure rate early in the process. Physicians and hospitals must do their part by recording the UDI codes into a patient’s health records.
Bellevue Attorney Represents Patients with DePuy Hip Implants
Herbert G. Farber, the founder of The Farber Law Group, represents many patients who have suffered injury due to the defective DePuy hip implant. Mr. Farber has a lot of compassion to hip implant patients since he has two hip implants himself. He has made it his mission to obtain compensation for patients whose health has been compromised due to these defective hip implants.
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