A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.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 testing.
The FDA's standards for review all high-risk medical devices before allowing them on the market are rooted in the Medical Device Amendments of 1976, which aimed to bring the agency's oversight of devices more closely in line with its regulation of prescription drugs. But it left holes."
"This interim solution was not supposed to last 37 years. Yet nearly four decades since Congress passed the Medical Device Amendments, the FDA still has not classified some of the temporarily "grandfathered" devices. As a result, potentially high-risk devices are continuing to reach the market without ever being tested in people."
"Other grandfathered devices include balloons inserted into the aorta and external pumps that circulate a patient's blood during bypass surgery. Companies can create new versions of these products and obtain clearance to market them with similar safety evidence that is required for medium-risk devices like electric stethoscopes, motorized wheelchairs and blood pressure cuffs.
Not all grandfathered devices -- and their substantial equivalents -- are unsafe or even high-risk. But that does not mean they should be regulated as medium-risk by default. Many patients rely on AEDs and other grandfathered medical devices, and stand to benefit greatly if the FDA would correctly classify these products without delay."
- Date added:
- Feb 27, 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.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
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
One Step Closer to Medical Transparency: Pew's Analysis of the Final Rule for the Physician Payments Sunshine ActOn Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights. More 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
''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
"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."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
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