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
"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.
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."
- Date added:
- Jun 28, 2012
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
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.More info
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 testingMore info
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.More info
"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."More info
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.More info
''Drug and medical-device makers are bracing for a new U.S. rule that will require them to report physician-payment information to the government--a rule some companies and doctors fear will be overly broad and could mislead the public.''More info
Medical 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
Nearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold. Test your antibiotics IQ and take the quiz.More info
The 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
"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."More info