"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 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.More info
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.More info
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 U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls."More info
"Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier."More info
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.More info
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.More info
"Medical groups and patient advocates are clamoring for the FDA to release a final rule requiring most medical devices distributed in the U.S. to carry a unique alphanumeric code allowing for better information tracking."More info
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.More info