SOUND to Prevent Medical Devices Based Off Recalled Designs
An act being considered by the Senate and the House of Representatives takes aim at medical devices whose design was based off of previously recalled products.
The Safety of Untested and New Devices Act, known as SOUND, was brought about largely because of complications with a transvaginal mesh implant that had numerous complications. The issue arose because that item shared much in its design with a previous device that was recalled in 1999.
If instated, the bill would enable the Food and Drug Administration to deny approval of items based off of designs of devices that were recalled in the past or are in the midst of a recall. To gain approval, the makers of such devices would have to be able to explain the differences in the the two items. The bill is designed to close what a representative of the bill has called a loophole in the 510(k) device approval process.
One of the other medical devices that would fall under the scrutiny of the new bill is a hip implant device. The recalled DePuy ASR, for instance, was itself based off of the design of the defective Pinnacle hip implant.
As a personal injury attorney in San Jose, I’ll be keeping a close watch on developments with this story. With the bill being considered this summer, this could be a monumental change in the safety status of medical devices. It’s my hope as a San Diego personal injury lawyer that defective products in the market eventually become a thing of the past.