Articles Posted in Medical Devices

An estimated 161,000 Americans die each year because of preventable medical errors, according to a new study by Johns Hopkins University. The study, which was published by Leapfrog Group, a nonprofit which ranks hospital safety, shows that fatalities by preventable medical errors are trending downward. Three years ago, the number of preventable deaths stood at 206,000.

“We are cautiously optimistic we are going to see real change and that is good news from this report,” Leah Binder, President and CEO of the Leapfrog Group, told Modern Healthcare. “But 161,000 is still a lot of people it’s a terrible problem. We have a long way to go.” Binder continued to explain that the number of preventable deaths is likely an underestimate since the study only looked at 16 safety categories and the “subset of each safety issue” in each category. According to Leapfrog Group, 15 of the 16 measures used to judge patient safety are the same used by the Centers for Medicaid and Medicare Services (CMS) to judge nursing home quality.

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New York may join the rush of states requiring explicit informed consent for patients undergoing medical exams. The new law aims to prevent medical students and residents from performing pelvic, rectal or prostate exams on patients while they are under anesthesia. Amazingly, these medical exams are routinely performed on men and women while they are under anesthesia. Given the sensitive and personal nature of these exams, medical students and residents have long learned the procedure by using unconscious and anesthetized patients.

“There’s a surprising disconnect between the culture of medicine, where intimate exams without explicit consent of the patient are considered a defensible, standard practice, and the rest of us, who are horrified that a trainee could be allowed to perform a pelvic or rectal exam without asking,” said Amy Paulin, New York Democrat who sponsored the bill. Teaching universities across the country oppose the stricter consent laws, saying that practicing on unconscious patients is necessary to teach medical students. The Association of American Medical Colleges has denounced pelvic exams without explicit consent as “unethical and unacceptable.” According to the newspaper, most – but not all – of the country’s medical schools agree with the association and have already implemented policies requiring explicit consent at their hospitals.

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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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A New York doctor who claims he has performed over 40,000 abortions in the state pleaded guilty to reckless homicide in the death of a Queens woman. Dr. Robert Rho terminated the pregnancy of 30-year-old Jaime Lee Morales, who was six-months pregnant at the time of the procedure. After the abortion, Morales was “bleeding uncontrollably with a severed uterine aorta, ripped cervix and pierced uterine wall,” according to CBS News.

The doctor performed a follow-up procedure to stem the bleeding, but it was apparently unsuccessful. Despite poor vital signs and collapsing on the bathroom floor, Dr. Rho sent Morales home with her sister. The Queens woman, who had received two serious surgeries in the immediate preceding hours, passed out in the car ride. After an ambulance ride to the hospital, Morales was pronounced dead upon arrival.

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New York City paid over $123 million last year to settle medical malpractice lawsuits against the 11 city-run hospitals. In total, that amount settled only 198 of the cases pending against the hospitals in 2017. Since 2011, the city has paid an eye-watering $928 million to settle medical malpractice lawsuits.

City representatives state that the $123 million is the lowest settlement amount in five years. Hospital officials told The New York Daily News they have “dramatically reduced medical malpractice payouts” over the last 10 years by identifying trends and stopping their recurrence. In one example cited by the newspaper, a hospital that had a higher rate of birth complications received special training in preventing and effectively handling the hospital’s most common issues.

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