Articles Posted in Infections

fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

opioid-graficAlthough Americans may like to think that it doesn’t or shouldn’t matter as much as it does, where they live can have major effects on their health. Geography isn’t an absolute determinant, but key differences have been discerned in how it affects the prescribing dangerous opioid drugs, cancer death rates, some air pollution harms, and risks of insect-related infections. Let’s look at specifics:

Opioid prescribing dips but data show big regional differences

The federal Centers for Disease Control and Prevention has provided a rare glimmer of good news about the nation’s epidemic of powerful painkiller abuse, finding that the peak of doctors’ opioid drug prescribing appears to have occurred in 2010 and has dropped sharply since.

kessler-203x300Even as congressional Republicans advance their counter-factual campaign to strip patients who have been harmed while seeking medical services of their rights to seek legal redress, another state appeals court has rejected key GOP arguments about medical malpractice lawsuits.

An appellate court in Wisconsin has declared unconstitutional that state’s $750,000 cap on non-economic damages, reinstating a jury’s decision that a Milwaukee woman and her husband should be paid $16.5 million for their pain and suffering after emergency doctors failed to inform her fully about the severity of a strep infection she had and that led to the amputation of her arms and legs.

The jury assessed total damages against the doctors and their insurers of $25.3 million, including $8 million for the medical and other care the 57-year-old mother of four will require for the rest of her life. But the defendants appealed the total, arguing the couple, under Wisconsin law, should get no more than $750,000 for non-economic harms like pain and suffering.

Nursing-home-holding-hands-300x200Federal regulators need to ramp up their oversight of nursing homes, big time, with recent news reports and studies finding persistent abuses of elderly patients, including during crackdowns on problem operators, and facilities failing to care for vulnerable charges so they don’t lapse into emergency or hospital care.

Jordan Rau and the independent Kaiser Health News Service deserve kudos for digging into Uncle Sam’s “special focus status,” in which the nation’s “most dangerous” nursing homes get an ultimatum to correct major and continuing harms to patients or they may lose crucial Medicaid and Medicare funds from the federal government.

Rau found that more than half of the 528 homes deemed since 2014 to require the supposedly stringent “special focus” from regulators and that still are operating have since harmed patients or put them in jeopardy in the last three years.

legionnaires-232x300Hospitals and nursing homes, by failing to properly maintain their water systems, may be putting older patients at high risk of an unusual form of pneumonia, with federal officials tracking 1 in 5 suspected or confirmed  cases of life-threatening Legionnaire’s Disease to health care facilities.

Anne Suchat, acting director of the Centers for Disease Control and Prevention, has urged caregivers to redouble their efforts to stamp out Legionella bacteria contamination in areas where poor maintenance may allow infections to flourish, including in water storage tanks, pipes, cooling systems, showers, sinks, and bathtubs. She said Legionnaire’s cases were too widespread, “deadly … and preventable.”

CDC researchers analyzed 2,809 of 6,079 Legionnaire’s cases nationwide in 2015 alone. They found 553 cases in 21 different and targeted jurisdictions, including Virginia, definitely or possibly occurring in a nursing home or hospital. The infections caused 66 deaths.

kid-belts-300x300Keeping kids safe is a constant challenge. Here are some new cautions from recent news reports:

Seat belts save lives—if used, and correctly

Although seat belts can be big lifesavers and a major way to protect passengers from injury, they don’t work if they’re not used—and correctly—especially with children. More than 4 in 10 youngsters killed in vehicular crashes between 2010 and 2014 were improperly restrained, particularly in vehicles’ front seat, or they weren’t buckled in at all, researchers found after studying National Highway Traffic Safety Administration data.

Blausen_0601_LaparoscopicGastricBanding-300x300They once got a ton of hype with radio, TV, and print ads, as well as billboard campaigns by proponents who later proved to be nothing less than sketchy. But the much-touted lap-band weight surgeries have fallen out of favor. The number of the procedures performed annually has nose-dived.

Researchers, based on a longer view, are finding that, among bariatric weight-loss options, lap-band surgeries offer some of the poorest results and result in frequent added procedures—at big costs, both economic and to disappointed, suffering patients.

Vox, the online news site, deserves credit for pulling together a painful review of what once was the most common way for overweight Americans, mostly women, to tackle one of the nation’s epidemic conditions: obesity.

hopkins-300x240It long has been a controversial bit of conventional wisdom. But big teaching hospitals may be a better place for older, sicker patients to go for care, a new study finds. They also may pay more for the treatment, as these institutions have become so large, bureaucratic, and revenue oriented.

Researchers at Harvard and hospitals in the Boston area published an observational study of 21 million Medicare hospitalizations, finding older, sicker patients had better 30- and 90-day mortality rates in 250 major teaching hospitals as compared with 894 institutions with minor teaching roles and 3,339 nonteaching hospitals.

When adjusting for factors that might affect results, the percentage of patients who died within 30 days of hospitalization—one quality measure— was 8.3 percent at major teaching hospitals, versus 9.2 percent at minor teaching hospitals and 9.5 percent at non-teaching hospitals, Stat, the online health information site has reported. That data means one fewer patient dies for every 83 the teaching hospitals treat.

measles-300x205
Call it the million-dollar lie: Minnesotans are finding how costly it can be to allow vaccination foes to spread counter-factual misinformation in vulnerable populations. Doing so has helped fuel one of the North Star state’s worst recent outbreaks of measles among international refugees in the Twin Cities area. The highly contagious infection has swept through the state’s sizable community of Somali immigrants, felling several dozen children, most younger than 10 and all but two un-immunized.

Public health officials blame the disease’s surge, which they say has not peaked yet and has resulted in kids sick enough to need hospitalization, on anti-vaxxers’ exploitation of immigrants’ uninformed fears about American medicine, particularly modern science’s inability to explain precisely what causes autism.

To be crystal clear, no evidence or science ties vaccines to autism. But almost a decade ago, shortly after the government, churches, and nonprofits helped many Somalis—who were fleeing famine and strife in their native African nation and resettling legally in Minnesota—a public health scare erupted. The newcomers feared then that disproportionate numbers of their children were showing signs they were autistic. Health officials investigated and found no higher incidence of the developmental disorder.

maternal-300x170new investigation of one of the great shames of American medical care raises big questions about why labor and delivery is more dangerous to new mothers in the U.S. than just about anywhere else in the civilized world.

To their considerable credit, National Public Radio and Pro Publica, a Pulitzer Prize-winning investigative news site, have joined forces to examine why 700 to 900 American women die each year from pregnancy related causes, and 65,000 nearly die.

The news organizations say Americans are “three times more likely to die in childbirth than women in Canada, and six times more likely than Scandinavian women.” And while U.S. maternal deaths are rising, their numbers were plunging in developed countries from England to South Korea.

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