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What We're Reading: FDA Releases Medical Device Reports; Ebola Crisis Worsens; Germany Weighs Fines for Missed Vaccinations
The FDA has shut down a program that concealed medical device records for over 2 decades; more than 1000 Ebola-related deaths in 2 trading cities have been reported; Germany considers fining parents of school-age children who are not vaccinated for measles.
FDA Shutting Down Program That Concealed Medical Device Records
The FDA is ending its controversial “alternative summary reporting” program, which allowed makers of medical devices to conceal records that documented device malfunctions and injuries caused by products, according to Kaiser Health News. Millions of reports spanning more than 2 decades will be released to the general public within weeks. Medical device makers will now be required to file individual reports describing each case of patient harm caused by a device.
Ebola-Related Deaths Top 1000 As Crisis Worsens
The Congolese health ministry said Friday that over 1000 people have died from 1529 Ebola infections within the trading cities of Butembo and Katwa, raising the mortality rate to 66%, according to The Hill. The outbreak began last summer in the town of Beni and has spread south to the North Kivu Province. The ministry said that 132 cases have been confirmed over the past week alone. As the crisis worsens, response efforts have been obstructed by acts of violence against healthcare workers. The World Health Organization has recorded over 100 attacks against individuals or facilities dedicated to treating Ebola-infected patients, and 85 healthcare workers have been killed or injured since the beginning of the outbreak.
Germany Considers Imposing Fines to Raise Vaccination Rates
Amid concerns that the highly infectious and potentially deadly measles virus could make a comeback, Jens Spahn, Germany’s health minister, has considered imposing fines of up to 2500 euros ($2790) on parents of unvaccinated school-age children, the Associated Press reported. As a measure to protect other children who are either too young or medically unable to receive the vaccine, Spahn also proposed that children who weren’t vaccinated would also be banned from attending daycare facilities. It remains unclear if the proposals will be implemented as they have not yet been discussed by the Cabinet of Germany, which is the nation's chief executive body.
Urticaria Diagnosis Challenged by Overlapping Pruritic Skin Conditions
April 23rd 2025Urticaria is complicated to diagnose by its symptomatic overlap with other skin conditions and the frequent misclassification in literature of distinct pathologies like vasculitic urticaria and bullous pemphigus.
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New Research Challenges Assumptions About Hospital-Physician Integration, Medicare Patient Mix
April 22nd 2025On this episode of Managed Care Cast, Brady Post, PhD, lead author of a study published in the April 2025 issue of The American Journal of Managed Care®, challenges the claim that hospital-employed physicians serve a more complex patient mix.
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Personalized Care Key as Tirzepatide Use Expands Rapidly
April 15th 2025Using commercial insurance claims data and the US launch of tirzepatide as their dividing point, John Ostrominski, MD, Harvard Medical School, and his team studied trends in the use of both glucose-lowering and weight-lowering medications, comparing outcomes between adults with and without type 2 diabetes.
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ACOs’ Focus on Rooting Out Fraud Aligns With CMS Vision Under Oz
April 23rd 2025Accountable care organizations (ACOs) are increasingly playing the role of data sleuths as they identify and report trends of anomalous billing in hopes of salvaging their shared savings. This mission dovetails with that of CMS, which under the new administration plans to prioritize rooting out fraud, waste, and abuse.
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