Medical devices range from common iteams such as stethoscopes to more complex products such as pacemakers and heart stents. The laws authorizing the Food and Drug Administration (FDA) to regulate medical devices have been around for decades with little or no updates over time. The Medical Device Initiative project seeks to improve the tracking of medical device safety and to foster innovation that benefits patients.
Project Director Josh Rising has a personal connection to the value of medical devices and he explains the importance of the Initiative and the goals of the program.
- Date added:
- Nov 27, 2012
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of medical devices, with certain exceptions, to place a unique identifier on the label of medical devices. Some medical devices would also need to be directly marked with the unique identifier.More info
"The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls."More info
"Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier."More info
On September 12, Four House Democrats sent a letter to the Office of Management and Budget (OMB) calling for the release of long overdue regulations on unique device identifiers (UDI). Their message emphasized that a device identification system will enable the FDA to more quickly identify devices with safety problems and then swiftly correct or pull them from the market.More info
Five prominent health systems, known as The Healthcare Transformation Group (HTG), sent a letter to the White House’s Office of Management and Budget urging a prompt review of the unique device identifier (UDI) rule. Like Pew, HTG believes further delay of the rule’s release will impair the Food and Drug Administration’s ability to conduct important surveillance of medical devices.More info
"Medical groups and patient advocates are clamoring for the FDA to release a final rule requiring most medical devices distributed in the U.S. to carry a unique alphanumeric code allowing for better information tracking."More info
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.More info
'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. 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."More info
A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.More info
The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.More info
The Pew Charitable Trusts submitted comments on preliminary recommendations regarding Stage 3 meaningful use objectives and standards for electronic health records (EHRs) to the Office of the National Coordinator for Health Information Technology. These comments follow remarks at recent meetings of the Health Information Technology (HIT) Policy Committee and HIT Standards Committee.More info