TALLAHASSEE, Fla. - People might be surprised to learn that the medical devices surgically implanted in their bodies are subject to almost no government regulation, testing or monitoring. The Consumers Union is one group looking to change that. Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents.

Lisa McGiffert, who directs the Consumers Union "Safe Patient Project," says seniors are especially at risk, since surgical complications can be more serious later in life.

"Having to do any surgery when you're older is a dangerous endeavor, but having to do it over again if something goes wrong can really cause a lot of harm."

In addition to medical device testing, another concern is the use of surgical mesh, which has been known to cause problems after surgery. McGiffert says the mesh is being used more often instead of sutures.

"It's placed internally so that if it goes awry, it's very, very difficult to remove the mesh and can cause pain for the rest of someone's life."

She adds that more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective before being cleared by the FDA for distribution or sale. And according to the General Accounting Office, more than 700 medical devices are recalled each year.

McGiffert says Congress needs to reauthorize the Medical Device User Fee Act this year in order to maintain at least some medical device monitoring. The law requires manufacturers to submit their own clinical data to support their claims, and also that they report incidents in which a medical device contributed to a death or serious injury. Groups
such as the Consumers Union are pushing for provision for tougher oversight, more testing and safety monitoring.




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By Jazmin Orozco Rodriguez for KFF Health News.
Broadcast version by Alex Gonzalez for Arizona News Connection reporting for the KFF Health News-Public News Service Collaboration

In Matthew Roach’s two years as vital statistics manager for the Arizona Department of Health Services, and 10 years previously in its epidemiology program, he has witnessed a trend in mortality rates that has rural health experts worried.

As Roach tracked the health of Arizona residents, the gap between mortality rates of people living in rural areas and those of their urban peers was widening.

The health disparities between rural and urban Americans have long been documented, but a recent report from the Department of Agriculture’s Economic Research Service found the chasm has grown in recent decades. In their examination, USDA researchers found rural Americans from the ages of 25 to 54 die from natural causes, like chronic diseases and cancer, at wildly higher rates than the same age group living in urban areas. The analysis did not include external causes of death, such as suicide or accidental overdose.

The research analyzed Centers for Disease Control and Prevention death data from two three-year periods — 1999 through 2001 and 2017 through 2019. In 1999, the natural-cause mortality rate for people ages 25 to 54 in rural areas was only 6% higher than for city dwellers in the same age bracket. By 2019, the gap widened to 43%.

The researchers found the expanding gap was driven by rapid growth in the number of women living in rural places who succumb young to treatable or preventable diseases. In the most rural places, counties without an urban core population of 10,000 or more, women in this age group saw an 18% increase in natural-cause mortality rates during the study period, while their male peers experienced a 3% increase.

Within the prime working-age group, cancer and heart disease were the leading natural causes of death for both men and women in both rural and urban areas. Among women, the incidence of lung disease in remote parts of the nation grew the most when compared with rates in urban areas, followed by hepatitis. Pregnancy-related deaths also played a role, accounting for the highest rate of natural-cause mortality growth for women ages 25 to 54 in rural areas.

The negative trends for rural non-Hispanic American Indian and Alaska Native people were especially pronounced. The analysis shows Native Americans 25 to 54 years old had a 46% natural-cause mortality rate increase over those two decades. Native women had an even greater mortality rate jump, 55%, between the two studied time periods, while the rate for non-Hispanic White women went up 23%.

The rural-urban gap grew in all regions across the nation but was widest in the South.

The increased mortality rates are an indicator of worsening population health, the study authors noted, which can harm local economies and employment.

As access to and quality of health services in rural areas continue to erode, rural health experts said, the USDA findings should spur stronger policies focused on rural health.

Alan Morgan, CEO of the National Rural Health Association, said he found the report “shocking,” though, “unfortunately, not surprising.”

The disparity warrants greater attention from state and national leaders, Morgan said.

The study does not address causes for the increase in mortality rates, but the authors note that differences in health care resources could compromise the accessibility, quality, and affordability of care in rural areas. Hospitals in small and remote communities have long struggled, and continued closures or conversions limit health care services in many places. The authors note that persistently higher rates of poverty, disability, and chronic disease in rural areas, compounded by fewer physicians per capita and the closure of hospitals, affect community health.

Roach said his past job as an epidemiologist included working with social vulnerability indexes, which factor in income, race, education, and access to resources like housing to get a sense of a community’s resilience against adverse health outcomes. A map of Arizona shows that rural counties and reservations have some of the highest vulnerability rankings.

Janice C. Probst, a retired professor at the University of South Carolina whose work focused on rural health, said many current rural health efforts are focused on sustaining hospitals, which she noted are essential sources of health care. But she said that may not be the best way to address the inequities.

“We may have to take a community approach,” said Probst, who reviewed the report before its release. “Not how do we keep the hospital in the community, but how do we keep the community alive at all?”

The disparities among demographics stood out to Probst, along with something else. She said the states with the highest rates of natural-cause mortality in rural areas included South Carolina, Mississippi, Georgia, Alabama, and others that have not expanded Medicaid, the joint federal and state health insurance program for low-income people, though there are efforts to expand it in some states, particularly Mississippi.

It’s an observation the USDA researchers make as well.

“Regionally, differences in State implementation of Medicaid expansion under the 2010 Affordable Care Act could have increased implications for uninsured rural residents in States without expansions by potentially influencing the frequency of medical care for those at risk,” they wrote.

Wesley James, founding executive director of the Center for Community Research and Evaluation, at the University of Memphis, said state lawmakers could address part of the problem by advocating for Medicaid expansion in their states, which would increase access to health care in rural areas. A large group of people want it, but politicians aren’t listening to their needs, he said. James also reviewed the report before it was published.

According to KFF polling, two-thirds of people living in nonexpansion states want their state to expand the health insurance program.

Morgan added the study focused on deaths that occurred prior to the covid-19 pandemic, which had a devastating effect in rural areas.

“Covid really changed the nature of public health in rural America,” he said. “I hope that this prompts Congress to direct the CDC to look at rural-urban life expectancies during covid and since covid to get a handle on what we’re actually seeing nationwide.”

In Arizona, the leading cause of death for people 45 to 64 in 2021 in both rural and urban areas was covid, according to Roach.


Jazmin Orozco Rodriguez wrote this story for KFF Health News.


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More than 1 million people in North Carolina are diabetic and they have become increasingly worried about the national shortage of insulin.

The access problems in North Carolina are prompting some individuals to either ration their medication or switch to different brands, which can significantly complicate their diabetes management.

Jessica Lynn-Lato of Charlotte was diagnosed with Type 1 diabetes at age 28 during pregnancy. She said she has seen firsthand the challenges the insulin shortage has created.

"We typically are prescribed 10-milliliter vials," Lynn-Lato explained. "Some people were being prescribed three 3-milliliter vials. Other people were being prescribed insulin pens or altogether having the type of insulin they use changed to a different brand."

She emphasized the urgent need for transparency about the causes of the current insulin shortage and for proactive measures to ensure access to the lifesaving medication.

Lynn-Lato explained for decades, people have struggled with insulin access for a variety of reasons, primarily cost. She recounted the tragic loss of her nephew, who was forced to ration insulin when he could not afford it.

"When he was 21 years old, he went to the pharmacy to pick up his insulin and couldn't afford to pay for it," Lynn-Lato noted. "He started using less insulin, which is something many people attempt to do to make it last longer. And sadly, it caught up with him two months later."

She believes if the Affordable Care Act, and more recently, President Joe Biden's cap on insulin costs through the Inflation Reduction Act, had happened sooner, it could have saved her nephew's life.

According to Lynn-Lato, systemic reforms are needed to address the root causes of insulin shortages and improve affordability and accessibility for diabetes patients.

"I think it falls on the FDA to maybe set some standards here, when you're dealing with medications that people literally need to live," Lynn-Lato stressed.

She encouraged people to advocate for themselves by reaching out to their lawmakers and the Food and Drug Administration.

The number of avian flu cases in dairy cows is holding steady in New Mexico but experts say more testing is needed to prevent its spread and protect humans.

Technically known as H5N1, "bird flu" has been detected in eight Curry County herds, although no deaths were reported. In Texas, a man is known to have become ill with bird flu last month after contact with infected dairy cattle.

Andrew Pekosz, professor of molecular microbiology and immunology at Johns Hopkins University, said the transmission to humans is cause for concern.

"Given that dairy farms have a large number of people who come in contact with infected cows, there is an increased chance of the H5N1 virus also directly infecting humans and beginning that process of adapting to replication and spread within humans themselves," Pekosz explained.

He acknowledged the risk to the public is still very low, but argued the U.S. should improve its response to new and emerging infections in order to minimize the chance of another pandemic. The U.S. Department of Agriculture announced this week it will pay dairy farms with confirmed avian flu infections to help contain the virus' spread to people and more cows.

In Texas, the Centers for Disease Control and Prevention confirmed the virus killed a dozen cats who drank raw cow milk.

Meghan Davis, associate professor of environmental health and engineering at Johns Hopkins University, said due to extensive federal food checks prior to human consumption, she believes it is safe to eat poultry and drink milk, with one exception.

"Raw milk and raw milk products may not undergo the same processes to inactivate the virus," Davis pointed out. "I have very large concerns about the safety of raw milk."

In addition to New Mexico, last month's outbreak affected more than 33 dairy cow herds in seven other states. To date, federal officials only mandate testing for dairy cows moving between states.


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