Once-Hidden Database Reveals Millions Of Injuries, Deaths Caused By Medical Device Malfunctions
After two decades of keeping it hidden, the FDA published a database online, revealing 5.7 million medical device malfunctions and injuries publicly for the first time. KHN dives into the newly public reports. In other Trump administration news: EPA's air pollution chief resigns; challenges with setting air quality measures; and how new China tariffs would impact the medical-supply industry.
Kaiser Health News:
Five Things We Found In The FDA’s Hidden Device Database
After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time. The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database, bypassing the public FDA database that’s pored over by doctors, researchers and patients. Millions of reports, related to everything from breast implants to surgical staplers, were sent to the agency as “alternative summary” reports instead. (Lupkin, 6/27)
Politico:
EPA's Air Pollution Chief Steps Down After Ethics Probe Raises New Questions
The former utility lawyer who led much of President Donald Trump’s rollback of pollution regulations will leave the Environmental Protection Agency — a move that comes after he provided conflicting information to Congress about his connections to the industry, three sources knowledgeable about the matter told POLITICO. EPA air pollution chief Bill Wehrum’s ties to his old law firm and especially the Utility Air Regulatory Group, an influential collection of coal-heavy utilities that lobbied against climate regulations, drew scrutiny from House Democrats, who launched an investigation in April. (Guillen and Colman, 6/26)
Modern Healthcare:
Federal Effort To Align Quality Measures Won't Be Easy
While much of the attention this week from the Trump administration's executive order on transparency focused on prices, there's also a section of it that calls for alignment of quality measures across all federal healthcare programs. Provider stakeholders and quality researchers support the effort but say it will be a heavy lift. Tucked within the executive order, the administration notes that HHS, the Defense Department and the Veterans Affairs Department in the next six months will develop a strategy, called the Health Quality Roadmap, that will detail plans to consolidate quality measures publicly reported across Medicare, Medicaid, the Children's Health Insurance Program, the health insurance marketplace, the Military Health System and the VA health system. (Castellucci, 6/26)
The Wall Street Journal:
Medical-Supplies Companies Object To Proposed New Tariffs
Add one more group to the long list of industries working to block new tariffs on Chinese imports: medical-supply companies. Trade officials have left the pharmaceutical industry and other pockets within the health-care sector out of the trade conflict, but dozens of medical supplies—tongue depressors, exam gloves, surgical gowns and the like— used in everyday patient encounters are among the $300 billion in Chinese imports facing 25% tariffs under the Trump administration’s latest proposal. (Ferek, 6/26)
