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Project

Medical Device Initiative

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Active
Protecting Human Health Through Better Device Tracking Other Resource

Protecting Human Health Through Better Device Tracking

Oct 3, 2013

On Sept. 20, the U.S. Food and Drug Administration issued final UDI regulations that will help improve the quality and safety of care for patients that rely on medical devices. Pew urges policymakers and the private sector to encourage the use of identifiers in clinical practice by including them in patients’ medical records and insurance claims. More
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Payor Coverage of Medical Devices Approved Under FDA's Humanitarian Device Exemption

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  • Apr 7, 2014

Patients with rare medical diseases sometimes lack effective medical treatments for their conditions. In these cases, the U.S. Food and Drug Administration may use a Humanitarian Device Exemption, or HDE, to bring new technologies more quickly to such patients in dire circumstances. But some health care payors—including Medicare, Medicaid, and insurance companies—do not always reimburse patients and providers for these products. More

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Pew Letter on New Meaningful Use Objective to Capture Identifiers for Implanted Devices

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  • Feb 12, 2014

The Pew Charitable Trusts drafted a letter to the HIT Policy Committee, Meaningful Use Workgroup of the Office of the National Coordinator for Health Information Technology regarding the new meaningful use objective for the capture of unique device identifiers (UDIs) in electronic health records (EHRs). In the letter, Pew asks the committee to consider how the proposed objective for UDI capture advances several goals of the meaningful use program and addresses feedback previously provided.

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Medical Device Innovation: Patient Access to High-Risk Devices for Unmet Medical Needs

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  • Jan 29, 2014

For patients in the United States with serious medical conditions, access to new medical technologies can make the difference between life or death. Those patients rely on new devices—such as implantable pacemakers or new cancer diagnostics—to treat, cure, or diagnose debilitating or life-threatening conditions. More

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Patient Access to High-Risk Devices for Unmet Medical Needs

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  • Jan 28, 2014

On Thursday, January 30, The Pew Charitable Trusts will hold an interactive conference with leading experts from FDA, the Centers for Medicare & Medicaid Services (CMS), the medical device industry, patients, consumers, private payors and other key health policy stakeholders to explore patient access to devices for unmet medical needs. More

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How Unique Device Identifiers Can Improve Patient Care

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  • Dec 6, 2013

On September 19, 2013, the House Medical Technology Caucus and The Pew Charitable Trusts held a briefing on how the Food and Drug Administration's (FDA's) new unique device identifier (UDI) system can improve patient care. Speakers discussed the implementation of FDA's new rule, as well as incorporation of UDI into healthcare delivery, particularly patients’ medical records, supply chain logistics and insurance claims.

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Protecting Human Health Through Better Device Tracking

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  • Oct 3, 2013

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.

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U.S. Lawmakers Urge OMB to Finalize Device UDI Rules

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  • Sep 13, 2013

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.

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Letter from the Healthcare Transformation Group on UDI Rule Delay

Issue Brief
  • Sep 10, 2013

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.

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Letter from Pew and Premier to the OMB on Unique Device Identifier Rule

Issue Brief
  • Jul 8, 2013

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.

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Letter from Pew: Release of the Unique Device Identifier Final Rule

Issue Brief
  • Jun 27, 2013

A 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

Issue Brief

Letter from Pew: Updates on the Unique Device Identifier System

Issue Brief
  • Jun 18, 2013

A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.

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Issue Brief

Letter from Pew to FDA on Postmarket Surveillance Plan

Issue Brief
  • May 30, 2013

FDA 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 New Democrat Health Care Task Force to FDA on Unique Device Identification System

Issue Brief
  • Apr 25, 2013

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.

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Pew Comments on Draft Recommendations for Meaningful Use, Stage 3

Issue Brief
  • Apr 4, 2013

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.

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Issue Brief

National Public Health Week

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  • Mar 29, 2013

This 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

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