''Move Forward on Medical Device Tracking''

''Move Forward on Medical Device Tracking''

''You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-­changing, potentially lifesaving products made by the medical device industry.

But chances are you or a family member will be a patient some day. The number of knee replacements performed annually is projected to soar 673 percent by 2030, for example, with hip replacements increasing by 174 percent in the same time frame.

That's why it isn't just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they're on the market or in use. The millions of people in Minnesota and elsewhere who already rely on medical devices, and the millions more who will do so in the future, deserve to have this important new public health protection in place as soon as possible.

Whether that happens is now in the hands of the Obama administration, which has a frustrating history of foot-dragging when it comes to issuing the rules and regulations that make important new consumer protection laws a reality. The Food Safety Modernization Act and the Physician Payment Sunshine Act are two examples.

Regrettably, officials appear to be taking the same sluggish approach with medical device tracking.

This week, the administration missed a congressional deadline to issue the final regulations for the Unique Device Identifier (UDI) system. When this guidance will be issued is unclear."


''Recent device failures have shown the need to improve our ability to detect problems. A unique ID is a critical and necessary part of such a system,'' said Dr. Joshua P. Rising, medical device director for Pew Charitable Trusts. "Until this rule is released, we run the risk of repeating history.''

Full Article