Health IT systems can play a large role in patient care from managing electronic prescriptions of medications and storing medical history to tracking disease and medical devices. In fact, the House of Representatives passed an amendment to the 21st Century Cures bill on July 10 that is meant to boost safety monitoring of medical devices. In particular, unique device identifiers (UDI) will now be part of patients’ EHR systems.
Rep. Mike Fitzpatrick, (R., Pa.), introduced the amendment, which supports the inclusion of the make or model of a medical device in patients’ records stored in health IT systems in order to track safety and potential harm of these technologies, according to The Wall Street Journal.
“The unique device identifier (UDI) is an extremely important patient-safety tool, and can help identify safety concerns with devices more quickly or disprove a suspected problem,” Congressman Bill Pascrell, Jr. said in front of the House in support of the Fitzpatrick Amendment. “I support the inclusion of UDI in electronic health records, as this amendment encourages. But I have also been working in the Ways and Means Committee to include the UDI in Medicare claims. As is the case with any new medical technology, not all adverse events are detected in the product’s market approval or clearance processes. However, we can mitigate the impact on patients with a robust post-market surveillance program.”
Pascrell continues by explaining that between 2013 and 2014, the Food and Drug Administration (FDA) recalled more than 120 medical devices. Additionally, the recalls occurred after hundreds or even thousands of patients had the devices implanted or utilized by other means. This put many patients’ lives at risk and caused significant upswings in healthcare costs. By including UDIs in health IT systems and EHRs, medical devices can be monitored more closely and recalls could occur much sooner before hundreds of lives are put at risk.
The passage of the 21st Century Cures Act by the House of Representatives marks the progress of accelerating innovative treatments for cancer patients. The National Brain Tumor Society advocated the passage of this legislation.
“The 21st Century Cures Act is a critical piece of bipartisan legislation for the hundreds of thousands of Americans who are currently living with a primary brain tumor and their families, as the bill contains a number of provisions that can jumpstart new treatments for brain tumors and many other cancers while also optimizing the U.S. Food and Drug Administration’s approval process,” Sally Davis, Chief Executive Officer of the National Brain Tumor Society, said in a public statement. “NBTS thanks the bill’s sponsors, Representatives Fred Upton (R-MI) and Diana DeGette (D-CO), for their leadership in passing this important legislation.”
As research and development of new cancer treatments and medical devices expands over the coming years, the Fitzpatrick Amendment will play a key role in improving patient safety and monitoring devices to ensure medical errors are reduced and potential recalls can occur much earlier. Including UDIs in EHR and health IT systems will boost patient care and population health outcomes throughout the nation.
