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Media Coverage
''FDA Probing Safety of Metal-on-Metal Hip Implants''
"While thousands of Americans have benefited from hip replacements over the years, problems with metal-on-metal implants can lead to troubles requiring surgery to replace defective devices, experts say.
Specifically, experts say, tiny fragments of metal can shear off from these joints, causing chronic pain or infection and raising levels of metals in the bloodstream. Experts estimate that more than 500,000 Americans have received a metal-on-metal hip joint, mostly between 2003 and 2010.
Worry over the failure rate of the implants, and the speed at which they were initially approved for the U.S. market, has led to a special two-day session, beginning Wednesday, by experts at the U.S. Food and Drug Administration.
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Writing earlier this month in the New England Journal of Medicine, Dr. Joshua Rising of the Pew Charitable Trusts, and colleagues said that "there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials; indeed, one type of metal-on-metal hip has a failure rate of nearly 50 percent at 6 years."
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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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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.
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'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."
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A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
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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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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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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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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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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.
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The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices. Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts.
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The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing
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In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care.
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"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."
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In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives.
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The Pew Health Group and Medtronic, Inc. file a joint letter to the U.S. Department of Health and Human Services urging implementation of the Physician Payments Sunshine Provision, which will require that manufacturers of drugs, devices,biologics or medical supplies report to the agency payments made to physicians and teaching hospitals.
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