Letter from Pew: Updates on the Unique Device Identifier System
A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
More info"As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill.
. . .
Allan Coukell, director of medical programs for the Pew Health Group, said while there is a recognition that rapid diagnostics are an important tool in treating serious infections, the incentive was not appropriately tailored. 'That provision wouldn't have gotten us there,' he said, noting that the incentive applied to the drug company, not the diagnostic manufacturer.
Further, Pew prefers the language in the Senate bill because while it includes a list of qualifying pathogens, but it is "illustrative," Coukell said. It provides the incentive for products treating serious and life-threatening diseases, but is worded such that the drug does not have to treat a pathogen on the pathogen list, Coukell said.
'Antibiotics don't get approved for bugs they get approved for infections,' he said."
Full Article (Subscription required)
- Date added:
- May 16, 2012
- Project:
- Innovate FDA
- Topic:
- Drugs and Devices at the FDA
- Related Expert:
- Allan Coukell
Related Resources
Letter from Pew to FDA on Postmarket Surveillance Plan
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.More info
Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification System
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 infoNational Public Health Week
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 info''Need to Know: Medical Devices''
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 Loophole That Keeps Precarious Medical Devices in Use''
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
More infoOne Step Closer to Medical Transparency: Pew's Analysis of the Final Rule for the Physician Payments Sunshine Act
On 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 infoComments on the Health Information Technology Patient Safety Action and Surveillance Plan
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''Let The Sunshine In: CMS Releases Transparency Rule''
"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 infoComments on Stage 3 of the the Meaningful Use of Health Information Technology
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. More info''One-Stop Shopping Proposed For Conflict Disclosure''
"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 infoSeeking Better and Safer Medical Devices
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''Report Says FDA Needs Workforce Improvements''
In 2007, an agency panel found that the FDA’s "scientific workforce does not have sufficient capacity and capability" and the agency is "not positioned to meet current or emerging regulatory responsibilities." The Pew Charitable Trusts wanted to know if that’s still the case, and asked the Partnership for Public Service to find out. "FDA has made progress," says the Partnership’s report, but the agency "continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed."
More infoStrengthening Our National System for Medical Device Postmarket Surveillance
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 infoPew Comments to the FDA Regarding the Unique Device Identification System
Pew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. Once implemented by the FDA and utilized by healthcare providers, the UDI system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices.
More info
