Articles Posted in Medical Devices

New York hospitals continue to rank poorly compared to the rest of the country, according to the nonprofit LeapFrog’s rankings released last month. According to Washington D.C. organization, which ranks hospitals on 12 factors related to patient safety and then assigns a letter grade between A and F to each hospital, New York is the 47th worst state for patient safety at hospitals. Just 7.5 percent of New York hospitals received an “A” – a pathetically low percentage compared to states like Maine, Utah and Virginia, which received “A” at 50 to 60 percent of their hospitals. 

The Empire State has almost three times as many hospitals with a “D” rating (30) than an “A” rating (11), according to LoHud.com. Unlike the federal government which takes medical outcomes and other indicators of quality into account when assigning its maligned star-rating system, Leapfrog Group focuses on preventable safety issues. Examples include mistakes like leaving sponges or medical equipment in bodies or preventable infections caused by unsanitary conditions. The nonprofit told Lohud.Com that its ranking system provided more helpful information to patients “because it focuses on the most serious life-or-death measures.” 

Here are the patient safety rankings for hospitals in the Hudson Valley, published for Fall 2019: 

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The FDA has quietly expanded a so-called “exemption database” allowing medical device manufacturers to shield the injuries and fatalities attributed to their devices from public scrutiny. According to a recent article in Kaiser Health News, the number of malfunctioning devices submitted as an “alternative summary report” not available to the public numbered between 431,000 and 481,000 in the last three years. According to the FDA, the alternative database originated two decades ago to prevent medical device makers from reporting the same injuries multiple times. However, since its inception the exemption database has grown exponentially and, no longer providing clarity and efficiency, now assists in concealing harmful devices from public scrutiny. The FDA declined to provide Kaiser Health News with a list of exempt devices, although the federal agency did say the number of devices was “over 100.”

This development is unfortunate for doctors and patients who rely on public information about medical devices to make their health care decisions. Surgical staplers provide a good example of how the FDA’s alternative database harms patients. Surgical staplers are “designed to cut and seal tissues or vessels quickly,” according to the health news organization. These staplers also commonly malfunction, between 1994 and 2001 malfunctioning staplers reportedly caused 112 deaths in the country. In 2001, the medical manufacturers of these surgical staplers received an “exemption” from the FDA, which meant the majority of the injuries and fatalities caused by these devices would no longer show up in the public database. In 2011, the total number of injuries and fatalities attributed to surgical staplers was only 18. In 2017, the FDA removed the device from the exemption list and the number of reports skyrocketed to 79.

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