With the 2012 Presidential election months away, several projects or regulations will face delays as politicians as bureaucrats shrink from any potential controversy, real or imagined. One such set of regulations that could be the exception are those surrounding Universal Device Identifiers (UDI) for medical devices.
The march toward UDI adoption took a big step forward this week with the introduction of the bipartisan Ensuring Safe Medical Devices for Patients Act by Senators Jeff Merkley(D-Ore.), Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI).
A framework for the UDI system was signed into law in 2007. The system is intended to assign a unique label to each medical device as specified by the FDA. This would allow for the tracking of medical devices and the results they produce for the purpose of identifying problems or defective devices.
In addition to addressing quality or safety concerns, UDIs would tackle issues associated with the medical device supply chain including the tracking of costs, device location, and inventory.
The proposed legislation would require the FDA to issue a final Unique Device Identifier (UDI) rule by the end of 2012 and add medical devices to the Sentinel, a national, integrated, electronic system, which currently monitors prescription drug safety after FDA approval.
In discussing the new bill, the senators alluded to the recent spate of medical device recalls such as that of the ASR hip implants by DePuy Orthopaedics. Some speculate the cost of the recall could reach $1 billion for the device maker.
“When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldn’t have to worry that the device that is supposed to improve their health could actually make them sicker,” Merkley said.
“Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market.”
Merkley hinted at the bipartisan nature of the bill, giving hope to the possibility of it being signed into law.
“These common-sense reforms will not only protect patients, but improve efficiency in the health care system. I look forward to working my colleagues for Senate adoption of this important initiative to improve the health and safety of Americans who rely on medical devices to improve, sustain, and in many cases, save their lives,” he said.
This building momentum for UDIs adds to the feeling that some type federal system for tracking medical devices is inevitable. Karen Conway, executive director of industry relations for GHX, a company that automates supply chain management, recently wrote in her company’s blog she is seeing the companies that she works with already preparing for the switch.
“(M)any of the suppliers working with GHX (especially makers of implantable devices) are busy getting their shops and production lines ready for UDI,” Conway wrote.
“After all, as the FDA has stated many times since Congress originally passed the law requiring the UDI (back in 2007), it can mandate that suppliers label their products, but real value comes when we actually use the same language to identify the products used in the patient care.”