Issue Brief
Nov 8, 2012
Pew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. More info| Summary | Type |
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Testimony before the Senate Committee on Health, Education, Labor and PensionsAllan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients. More info |
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Testimony before the Committee on Energy and Commerce Subcommittee on HealthU.S. House of Representatives PDF Download Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its cou More info |
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Strengthening Our National System for Medical Device Postmarket SurveillanceThe Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance." More info |
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Seeking Better and Safer Medical DevicesMedical devices range from common iteams such as stethoscopes to more complex products such as pacemakers and heart stents. 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. More info |
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Protecting Human Health Through Better Device TrackingThe 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 |
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Pew Comments on Draft Recommendations for Meaningful Use, Stage 3The 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 |
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National Public Health WeekThis year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives. More info |
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Letter from Pew: Updates on the Unique Device Identifier SystemA letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system. More info |
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Letter from Pew: Release of the Unique Device Identifier Final RuleA letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system. More info |
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Letter from Pew to FDA on Postmarket Surveillance PlanFDA recently updated the national medical device postmarket surveillance plan – listing device identification and registries as the cornerstones for effective product monitoring. In this letter, medical devices director Josh Rising applauds the agency for making unique device identifiers and registries central to this plan. |
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Letter from Pew and Premier to the OMB on Unique Device Identifier RuleThe 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 |
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Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification SystemThe 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 |
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Improving Medical Device Safety Through Better SurveillanceIn 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. More info |
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Facilitating Medical Device Innovation: De Novo ReformThe de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. More info |
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Expert Profile: Josh RisingJosh Rising, Project Director, Medical Device Initiative More info |
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The FDA announced that it will classify metal-on-metal hip implants as high-risk devices but hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing.
Pew joins other stakeholders in commenting on Health Information Technology Patient Safety Action and Surveillance Plan and urges the adoption of the UDI system for medical devices to improve the safety of medical care for patients.
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
Josh Rising
Director, Medical Devices
The Pew Charitable Trusts
Copyright(c) 1996-2012 The Pew Charitable Trusts. All Rights Reserved.
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