Trending News Today: Many Hospitals Fail to Report Patient Deaths from Medical Devices
Top news of the day from across the health care landscape.
FDA inspection results reveal that 12 hospitals in the United States failed to promptly report patient injuries of deaths linked to medical devices. According to California Healthline, this also includes well-known medical centers located in Boston, Los Angeles, and New York. Federal rules state that hospitals are required to report serious injuries potentially caused by devices to the manufacturer within 10 days. Furthermore, they are required to notify the FDA and manufacturer about any deaths that have resulted. Manufacturers are then required to file reports to the FDA within 30 days of receiving notice. The FDA reviewed 17 hospitals, and found that 6 did not properly report both patient deaths and injuries linked to devices within 10 days. Five other hospitals didn’t report serious injuries in a timely manner, reported Healthline. Among these hospitals were Massachusetts General Hospital, New York Presbyterian Hospital, the Ronald Reagan UCLA Medical Center, and Cedars-Sinai Medical Center.
Newly released data finds that complications from measles resulting in child death is more common than previously believed, reported The Washington Post. Children and babies infected with measles can later develop subacute sclerosing panencephalitis (SSPE). It was once believed that the risk of developing SSPE was 1 in 100,000, according to the Post. However, newer research in Germany found that among children who became infected with measles before the age of 5 years was 1 in 1700. Unfortunately, new findings indicate that babies who get measles before being vaccinated have a SSPE rate of 1 in 609.
The FDA has rejected a rheumatoid arthritis treatment because of deficiencies found in a French plant. According to The Wall Street Journal, Regeneron reported that concerns by the FDA during an inspection of a Sanofi facility where sarilumab syringes are filled has nothing to do with the safety and efficacy of the drug. Sanofi stated that they have already submitted a plan to correct the issues, reported the WSJ.