ANNAPOLIS, Md. - A new hip or knee joint can give Marylanders a new lease on enjoying the state's outdoor life, but there's a dark side to surgically-implanted medical devices, according to Consumers Union. The group says those devices are subject to almost no government regulation, testing or monitoring.

Lisa McGiffert, who directs the Consumers Union "Safe Patient Project," says seniors are especially at risk, since complications connected to artificial joints or heart stents can be more serious at that stage of 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."

She says Congress should reauthorize the Medical Device User Fee and Modernization 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 that they report incidents in which a medical device contributed to a death or serious injury.

In addition to medical device testing, another concern is the use of surgical mesh, which McGiffert says has been known to cause problems after surgery - and she says it's being used more often to replace stitches.

"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 says 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.

Details about the Medical Device User Fee and Modernization Act are at 1.usa.gov/ACDxbv.




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September is Self-Care Awareness Month and the American Heart Association in Missouri is urging caregivers to take some much-needed time for themselves.

Missouri has around 600,000 family caregivers, many of whom provide unpaid care to loved ones with heart disease, cardiac events and other debilitating illnesses. The emotional and physical toll can be severe, with 21% of caregivers reporting their own health has declined.

Dr. Ravi Johar, chief medical officer for UnitedHealthcare and a member of the American Heart Association of St. Louis, wants caregivers to understand proper self-care is not selfish.

"It's really important that after an acute event, whenever you've had a chance to kind of catch your breath, sit down and think about exactly what they need and exactly what you need and how much you can give," Johar recommended. "That's not being selfish. That's not, not taking care of them. That's doing the right thing for both of you."

According to the American Heart Association, it is important for caregivers to have someone they can confide in about their fears and doubts; a person who can offer reassurance and emotional support.

A 2023 AARP survey showed nearly 40% of family caregivers spend more than 20 hours a week assisting their loved ones from driving to appointments to providing direct care, many while also working and raising children. Johar stressed the importance of caregivers using time off from work wisely, which includes new mothers with babies in neonatal intensive care.

"The baby's getting the best care in the hospital and there's nothing you can do to help," Johar pointed out. "Go ahead and go back to work. Save that time, go in every evening. Spend all night or as much time as you want with the baby. But save your time off, because when this baby comes home, then you're really going to need to be there."

Doctors also emphasized the critical role of regular exercise, like brisk walks and the need for caregivers of all ages to maintain a heart-healthy diet. The habits help manage stress and boost energy levels.

Self-measuring blood pressure sites are coming to the Northwest, starting with a community organization in Portland.

The American Heart Association and Providence Health Plan have launched a program to bring self-monitoring blood pressure equipment to 20 clinics and community organizations in Oregon and Washington. The first was introduced at the Portland Opportunities and Industrialization Center, a training center serving more than 3,000 students age 17-65.

Michael Hale, a health navigator at the center, said some people get "white coat syndrome" when they visit the doctor, causing inaccurate blood pressure numbers.

"The beauty of this program is to be able to have our staff use the blood pressure monitors at home or in their office when they're regulated, before they drink their coffee," Hale explained. "Then they'll be able to log it throughout the week and then use that information, take it to the doctor."

Hale pointed out people can then discuss with their doctors whether it's time for blood pressure medication or lifestyle changes, depending on the readings. The program will loan out blood pressure monitoring equipment to students, families and staff at the center.

Blood pressure is an important indicator of health. Left untreated, high blood pressure can lead to heart attack, stroke and other health issues.

Meredith Collett, executive director of the American Heart Association of Oregon and southwest Washington, said the program is designed to bring monitoring to people who may not have access.

"Our hope with our collaboration with Providence Health Plan is to remove those barriers to health care access by setting up these self-measured blood pressure cuffs with POIC for at-risk communities," Collett noted. "They can really track and understand their numbers."

The initiative to bring self-measuring blood pressure equipment to clinics and organizations in the Northwest is expected to expand to 20 over the next three years.

Nonprofits across Texas are coming together to address disparities in health care for the Latinx community. A report by the Commonwealth Fund shows some factors that lead to the differences in health care include high poverty rates, elevated levels of pollution and crime and a lack of green spaces.

Paulina Sosa, Latinx Voces founder, said many in the Latinx community lack access to vital resources that could improve their overall health.

"Lack of physical access to a clinic or a doctor, the lack of information on how to go about accessing those health care services, and of course, it could be related to the lack of linguistics, otherwise known as information in Spanish," she said.

She added health disparities that had been in existence for years were brought to light during the COVID-19 pandemic when Hispanics experienced some of the highest death rates.

Edgar Carmona, president of the nonprofit Alliance for Progress in Dallas, which works to reduce health-care disparities among vulnerable populations, said some in the Latinx community don't seek medical care because they don't trust caregivers from other races.

"We just don't see the medical community being able to represent the community that it serves. We, as a society, are perhaps not creating the opportunities needed, or the encouragement for our youth to go into this field," he continued.

Both Sosa and Carmona said collaborations can help improve health outcomes for the Latinx community. Sosa added that during and after the pandemic, community partners, small businesses and faith-based organizations worked together to improve the lives of those most vulnerable.

"How do we ensure that the momentum, around addressing these disparities - particularly for Latino and Spanish-speaking communities - how do we ensure that the momentum continues? That is one of the biggest questions we're trying to tackle. We really believe that partnership is at the center of that solution," Sosa said.


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