Blog Articles

KFF Health News won the 2023 George Polk Award for Medical Journalism for its year-long investigation with CBS News into the failure of FDA-approved medical devices that were suspected of contributing to thousands of injuries and patient deaths. The George Polk Awards were established in 1949 by Long Island University to commemorate George Polk, a CBS correspondent murdered in 1948 while covering the Greek Civil War.

GE Healthcare has initiated a recall of its older incubator models, Care Plus and Lullaby, due to a risk that newborns could fall out because of improperly closed doors. The Food and Drug Administration (FDA) has classified this recall as a Class I event, indicating it’s a serious correction rather than a removal of the products from the market.

In a comprehensive examination of adverse health effects following influenza vaccinations, Dr. Ronald N. Kostoff’s opinion article presents a meticulous analysis based on Pubmed/Medline literature. Kostoff’s prior research highlighted potential issues with vaccine effectiveness and safety, particularly under the accelerated development timelines seen with COVID-19 vaccines. This backdrop set the stage for a deeper investigation into the adverse effects reported after influenza vaccinations.

Philips has initiated a Class I recall, the most serious category, for its BrightView SPECT imaging systems due to a potential hazard where a component might fail and cause the detector to unexpectedly move downward, posing a risk of injury to patients. This issue, reported in December 2023, affects the BrightView, BrightView X, and BrightView XCT models.

In fiscal year 2023, the healthcare industry saw a significant increase in settlements and judgments under the False Claims Act (FCA), with the Department of Justice (DOJ) reporting over $2.68 billion in total, of which more than $1.8 billion were related specifically to healthcare entities like managed care providers, hospitals, pharmacies, laboratories, long-term acute care facilities, and physicians.

The Food and Drug Administration (FDA) has issued a warning to patients about the risks of using smartwatches and smart rings that claim to measure blood sugar levels noninvasively, without piercing the skin. This caution comes in light of the discovery that numerous wearables, produced by a variety of companies and sold under many brand names, are being marketed with these claims, despite none having received FDA authorization for noninvasive blood glucose monitoring.

In a recent blog post, it was reported that Philips has issued a Class I recall, the most serious type, for its BrightView SPECT imaging systems, including BrightView, BrightView X, and BrightView XCT. This recall was initiated due to a potential issue where the detector of the system might move downwards unexpectedly, caused by a possible failure of a component known as the lead screw.

The article discusses significant issues with the U.S. Vaccine Injury Compensation Program (VICP), specifically related to COVID-19 vaccine injury claims. As of January 1, 2024, the Countermeasures Injury Compensation Program (CICP) has received 12,854 claims for injuries from COVID-19 countermeasures, including 9,600 for vaccine injuries. Of these, only 2,214 have been processed, with a mere 40 claims being eligible for compensation.

The FDA has issued a reminder to medical device manufacturers and sponsors about the critical importance of evaluating third-party laboratories conducting performance testing. This notice, dated February 20, 2024, highlights the responsibility of manufacturers to ensure that the data they submit to the FDA is both truthful and accurate. Recently, the FDA has noticed an increase in unreliable data from third-party labs, including cases of fabricated or duplicated data.

The article by Nick Iacovella and Jon Toomey highlights the severe drug shortage crisis in the United States, attributing it to the offshoring of drug manufacturing, regulatory failures of the FDA, and foreign government subsidies. The U.S. heavily relies on foreign manufacturers, especially from China and India, for essential generic medicines, which has led to numerous challenges including regulatory noncompliance and quality issues.