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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

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Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.  

“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”  

LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses. 

The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure. To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed. 

The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance. The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.  

By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available. 
 

Related Information

Source: FDA

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    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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REI Co-op to Opt Outside year-round: Co-op kicks off the summer with 300+ free classes and events across the country

Opt Outside
Nearly 6,000 people are expected to join hiking, paddling, and other programs as they prioritize time outside

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Opt Outside
Specialty outdoor retailer REI Co-op is doubling down on its bold commitment to Opt Outside by calling a time out when life feels like it is on autopilot. REI will host 300+ free classes and day tours on Saturday, June 15 to highlight how the co-op supports its members and broader outdoor community with resources, expertise and inspiration. https://www.rei.com/opt-outside REI.com/OptOutsideFreeDay

SEATTLE /PRNewswire/ — Specialty outdoor retailer REI Co-op is doubling down on its bold commitment to Opt Outside by calling a time out when life feels like it is on autopilot. REI will host 300+ free classes and day tours on Saturday, June 15 to highlight how the co-op supports its members and broader outdoor community with resources, expertise and inspiration. Registration opens today at REI.com/OptOutsideFreeDay.

REI Opt Outside: Music credit to @Drdogmusic. Specialty outdoor retailer REI Co-op is doubling down on its bold commitment to Opt Outside by calling a time out when life feels like it is on autopilot. REI will host 300+ free classes and day tours on Saturday, June 15 to highlight how the co-op supports its members and broader outdoor community with resources, expertise and inspiration. Registration at REI.com/OptOutsideFreeDay.

“Opt Outside is much bigger than one day of the year—it’s the way we live. It’s the clearest expression of what REI is all about,” says Ben Steele, REI executive vice president and chief customer officer. “Simply put, time outside is fundamental to the health and happiness of individuals and communities. Today, too many people feel like their time isn’t their own and all of us know we spend too much of our time indoors. We can make a different choice. From our incredible store staff to our professional guides and much more, the co-op is here to be a resource for everyone to have a healthy, active life outside.”

On June 15, REI will host a free curated collection of its most popular in-store workshops and local guided hiking and paddling tours with retail staff, the co-op’s experiences guides and community partners. In a single day, nearly 6,000 people will get outside and learn new outdoor skills and activities. At select stores, REI will be joined by body positivity influencer and yoga instructor Adina Crawford, Adaptive Adventures, All Bodies on Bikes, Black Girls Do Bike, Black Girls RUN!, Latino Outdoors, and The Venture Out Project.

REI’s Opt Outside landing page, REI.com/opt-outside, serves as an easy-to-access tool to learn more about virtual and in-person resources offered year-round by the co-op. For example:

  • More than 38,200 enthusiasts participated in 4,800 day experiences programs across 14 communities last year. REI teaches more people how to ride bikes every year than any other outfitter.
  • REI offers 150 adventure travel trips throughout North America, including three new itineraries launched in partnership with Outdoor Afro, Inc. that celebrate Black joy in nature. 
  • Stores regularly host introductory classes on a wide range of activities for hiking, camping, cycling and more.

REI is also amplifying its partnerships with Hipcamp and Strava to broaden awareness of meaningful ways to prioritize time outside. The world’s leading campsite booking brand and the co-op launched the “Summer of Magic Campout Series” to surprise thousands of people with free campouts during peak weekends throughout the summer. The co-op will also continue to team with Strava, the leading subscription platform at the center of connected fitness, through new challenges that will be announced in the weeks ahead.

As the co-op has done since 2015, REI will continue to pause operations on Thanksgiving and Black Friday so that all employees can spend the day outside. This holiday season marks 10 years of REI calling on the broader community to join the co-op in its action. Over the years, Opt Outside has evolved to a movement that advocates for causes important to the co-op, including environmental welfareinclusivity in the outdoor industry and responsible recreation. Since its inception, hundreds of organizations, state and local parks, and businesses have joined the co-op in opting outside on Black Friday. 

About the REI Co-op
REI is a specialty outdoor retailer, headquartered near Seattle. The nation’s largest consumer co-op, REI is a growing community of 24 million members who expect and love the best quality gear, inspiring expert classes and trips, and outstanding customer service. If you can’t visit one of our many stores, you can shop at REI.comREI Outlet or the REI shopping app. Everyone is welcome to shop REI, but members who join the co-op enjoy a range of benefits. More than a retailer, REI is a purpose-driven and values-led company dedicated to enabling life outside for all. 

SOURCE REI Co-op

https://stmdailynews.com/category/lifestyle

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Health Alert: Classic Delight Sandwiches May Pose a Risk of Contamination

Potential contamination alert: Classic Delight sandwiches recalled due to Listeria monocytogenes risk. Take necessary precautions.

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Classic Delight sandwich recall due to Listeria monocytogenes contamination risk
Fresh sub sandwich on white and wheat hoagies.(Adobe Stock)


In a recent public health alert, Classic Delight LLC, a food company based in St. Mary’s, Ohio, has announced a voluntary recall of certain individually wrapped sandwiches due to potential contamination with Listeria monocytogenes. This organism can result in severe infections, especially among vulnerable individuals. While no illness or adverse reactions have been reported thus far, the company is taking proactive measures to ensure consumer safety.

Details of the Recall:
The affected products, produced between May 11, 2023, and June 6, 2024, were distributed to several states, including Arkansas, California, Maryland, Missouri, Ohio, Pennsylvania, and Texas. These sandwiches may have made their way into food service distribution, convenience stores, and vending machines. To assist in identifying the recalled items, here is a list of the specific products:

  • 7060 Classic Delight Twin Chili Cheese Dog
  • 514713 Wakefield Charbroiled Cheeseburger
  • 311 Classic Delight Turkey Ham and Cheese Sub
  • 551697 Wakefield Ham Cheddar Pretzel Croissant
  • 314 Classic Delight Turkey Cheese Sub
  • 648899 Wakefield Chorizo Egg Ciabatta
  • 6731 Classic Delight Turkey Cheese Round
  • 806604 Wakefield Ham Egg Cheese Muffin
  • 6757 Classic Delight Twin Breaded Chicken Sliders
  • 806612 Wakefield Ham Egg Cheese Croissant
  • 7626 Classic Delight Breaded Chicken Waffle
  • 806620 Wakefield Bacon Egg and Cheese Bagel
  • 73131 Nutrisystem Turkey Sausage and Egg Muffin
  • 806638 Wakefield Sausage Egg and Cheese Biscuit
  • 176586 Wakefield Pretzel Bacon Angus Cheeseburger
  • 806646 Wakefield Sausage Egg and Cheese Muffin
  • 176594 Wakefield Southern Chicken Biscuit
  • 806653 Wakefield Bacon Cheeseburger
  • 195263 Wakefield Spicy Hawaiian Sliders
  • 806661 Wakefield Blazin Chicken
  • 514711 Wakefield Bacon Egg and Cheese Bagel
  • 806679 Wakefield Charbroiled Cheeseburger
  • 514712 Wakefield Sausage Egg and Cheese Biscuit
  • 806687 Wakefield Chicken and Cheese
  • 942821 Wakefield Sausage Egg Pancake

Reasons for Recall:
Classic Delight initiated the recall after routine environmental testing revealed the presence of Listeria monocytogenes. The company is actively collaborating with the U.S. Food & Drug Administration (FDA) to investigate the origin of the issue. As a precautionary measure, production of the affected products has been halted until the source of contamination is identified and resolved.

Action Steps for Consumers:
If you have purchased any of the recalled Classic Delight sandwiches, it is crucial to take immediate action to safeguard your health and well-being. Here’s what you need to do:

  1. Discard the affected products if they are still in your possession.
  2. For a full refund, return the recalled items to the place of purchase.
  3. Any concerns or queries can be directed to the Classic Delight Consumer Hotline at (419)-300-3202, Monday through Friday, 8:00 am to 3:00 pm Pacific Time. Alternatively, you may contact them via email at info@classicdelight.com.

Health and Safety Measures:
While there have been no reported cases of illness linked to these products thus far, it’s important to remain vigilant. Should you experience any symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, or diarrhea after consuming these sandwiches, contact your healthcare provider immediately.


Classic Delight’s voluntary recall underscores their commitment to ensuring the safety of consumers. By swiftly addressing the potential risk of Listeria monocytogenes contamination, Classic Delight is taking proactive steps to protect public health. Remember to check your refrigerators or storage areas for the listed products and follow the recommended actions to minimize any potential harm. Always prioritize your well-being and stay informed about food recalls to make educated choices about the food you consume.

Company Contact Information

Consumers:Classic Delight Consumer Hotline (419)-300-3202 info@classicdelight.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Press Release: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/classic-delight-llc-issues-public-health-alert-due-possible-health-risk

https://stmdailynews.com/category/lifestyle/health-and-wellness

About the FDA?

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health by overseeing food safety, tobacco products, caffeine products, dietary supplements, pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

The FDA primarily enforces the Federal Food, Drug, and Cosmetic Act (FD&C) but also enforces other laws like Section 361 of the Public Health Service Act. This includes regulating lasers, cellular phones, and condoms, and controlling diseases in household pets and human sperm for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President and confirmed by the Senate, reporting to the Secretary of Health and Human Services. Robert Califf is the current Commissioner as of 17 February 2022.

The FDA’s headquarters is in White Oak, Maryland, with 223 field offices and 13 laboratories across the US, including the Virgin Islands and Puerto Rico. Since 2008, the FDA has posted employees to various foreign countries like China, India, Costa Rica, Chile, Belgium, and the United Kingdom. (Wikipedia)

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Hypertrophic Cardiomyopathy 101: What every student-athlete should know

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(Family Features) You may find it difficult to wrap your mind around the idea of an energetic student-athlete with a cardiac diagnosis. Heart conditions may be more often associated with older individuals, but you might be surprised to learn hypertrophic cardiomyopathy is the most common condition responsible for sudden cardiac death in young athletes. In fact, it’s the cause of 40% of sudden cardiac death cases.

It’s estimated 1 in every 500 adults living in the United States has hypertrophic cardiomyopathy, according to the American Heart Association, but a significant percentage are undiagnosed. More than 80% of individuals who experience this condition show no signs or symptoms before sudden cardiac death. While sudden cardiac death is rare, it can occur during exercise or in its aftermath. That’s why it’s important for student-athletes and their loved ones to learn more about this condition and talk to a doctor about their risk.

With proper knowledge and the support of a skilled care team, it’s possible to manage hypertrophic cardiomyopathy with heart-healthy actions to prevent complications or worsening cardiovascular conditions like atrial fibrillation (a quivering or irregular heartbeat), stroke or heart failure. Hypertrophic cardiomyopathy awareness and education for athletes by the American Heart Association is made possible in part by a grant from the Bristol Myers Squibb Foundation.

What is hypertrophic cardiomyopathy?
Hypertrophic cardiomyopathy is the most common form of inherited heart disease and can affect people of any age. It’s defined by thickening and stiffening of the walls of the heart. The heart’s chambers cannot fill up or pump blood out adequately, so the heart is unable to function normally.

There are different types of this condition. Most people have a form of the disease in which the wall that separates the two bottom chambers of the heart (the septum) becomes enlarged and restricts blood flow out of the heart (obstructive hypertrophic cardiomyopathy).

However, sometimes hypertrophic cardiomyopathy occurs without significant blocking of blood flow (nonobstructive hypertrophic cardiomyopathy). The heart’s main pumping chamber is still thickened and may become increasingly stiff, reducing the amount of blood taken in then pumped out to the body with each heartbeat.

What are possible symptoms?
Symptoms can include:

  • shortness of breath
  • chest pain
  • heart palpitations
  • fatigue

The severity of symptoms can vary, but if you experience them or if you have a family history of hypertrophic cardiomyopathy or sudden cardiac death, it may be a good idea to speak to your doctor about whether you have this condition.

For some people, symptoms can get worse and new symptoms can appear over time, resulting in people dealing with harsher effects and a diminished ability to do the activities they love. This decrease in functions can be one of the most challenging aspects of the disease. Keeping your health care team aware of any new or changing symptoms allows them to work with you to develop a plan to manage these symptoms and reduce their impact.

How is hypertrophic cardiomyopathydiagnosed?
Medical history, family history, a physical exam and diagnostic test results all factor into a diagnosis. A common diagnostic test is an echocardiogram that assesses the thickness of the heart muscle and observes blood flow from the heart.

If anyone in your family has been diagnosed with hypertrophic cardiomyopathy, other heart diseases or has been told they had thick heart walls, you should share that information with your doctor and discuss the need for genetic testing. Because this condition is hereditary, first-degree relatives, which include siblings and parents, should be checked.

Learn more at heart.org/HCMStudentAthlete.

Photos courtesy of Shutterstock


SOURCE:
American Heart Association

https://stmdailynews.com/category/lifestyle

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