The U.S. Food and Drug Administration (FDA) is announcing a virtual public workshop Understanding Risk with Medical Devices. This 2-hour workshop will expand on the basics of risk associated with medical device use by featuring Risk Basics for Medical Devices and Application of Risk Management Principles for Medical Devices. The presentations will be followed by a live question-and-answer session with stakeholders and a panel of CDRH leaders.
Risk Basics for Medical Devices (Joseph Tartal, Deputy Director Division of Industry and Consumer Education)
Understanding risk is a necessity to bring and keep a medical device on the market. These basic concepts will start you on the journey to determine the risk of your medical device, which will increase predictability, aid in appropriate design and manufacturing, and provide clearer premarket submission regulatory expectations. This session will discuss the basics of risk and use a generic example to help establish a fundamental understanding of risk.
Application of Risk Management Principles for Medical Devices (Tonya Wilbon, Branch Chief, Postmarket and Consumer Branch, Division of Industry and Consumer Education)
Medical device manufacturers are required to make risk-based decisions and conduct risk management activities as a part of the design, manufacture, and production of medical devices or in general as part of the quality system. In addition, the regulation of medical devices incorporates risk-based decisions to assure devices are safe and effective. This session will provide an understanding of the application of risk management principles and review of risk information for medical devices.
Each session will include a presentation, followed by a moderated live question-and-answer session with a panel of CDRH leaders. Audience participants are encouraged to email or call with questions during each session.
Participants may choose one or both sessions. Each session will begin at the scheduled time.
1:00 – 2:00 PM ET: Risk Basics for Medical Devices
2:00 – 3:00 PM ET: Application of Risk Management Principles for Medical Devices
AUBURN GRESHAM — Carlos Nelson used to drive past the “lifeless” building at 839 W. 79th St. almost every day for years.
Home to a drab public aid office in the 1970s, city officials bricked over the 18-by-18-foot windows on the ground floor and boarded up the second and third floor windows when the office closed. The nearly 100-year-old terra cotta building sat vacant for decades — but Nelson saw potential for revival.
After seven years of work, Nelson looked on Friday as Auburn Gresham’s four-story Healthy Lifestyle Hub welcomed dozens of neighbors with a Hollywood red carpet, live music and healthy food.
Community leaders and local officials cut the ribbon in October but Friday’s extravaganza was for neighbors to roam the halls for the first time, said Nelson, executive director at the Greater Auburn Gresham Development Corporation.
A “dark and dismal” sight in Auburn Gresham is now a beacon of light offering medical care, nutritious food, community space and other services steps away from neighbors’ homes, Nelson said.
“I used to see this building and the boarded-up windows, and it hurt to think of what others thought about our people,” Nelson said. “When I visualized the Healthy Hub, I wanted to be able to bring life into this building. We wanted to light up 79th Street, literally and figuratively. Today is a day of excitement.”
Credit: Atavia Reed/Block Club ChicagoThe UIC Neighborhood Center features a mural commissioned by artist Dorian Sylvain featuring the “faces” of Auburn Gresham.
‘You’ll See The Light Emanating From This Building’
The Healthy Lifestyle Hub will replenish a neighborhood long denied necessities and amenities, Nelson said. The 79th and Halsted intersection alone has lost a Save A Lot grocery store, a CVS pharmacy and a Bank of America branch.
A UI Health Clinic and Urgent Care Center on the second floor can provide medical, dental and mental health services to more than 30,000 patients per year, Nelson said. Nearly 500 patients have come in even without any advertising for the clinic, Nelson said.
The third floor is home to Heartland Alliance and the UIC Neighborhood Center, with tutoring services and small business workshops provided by the university.
Bank of America will soon open on the first floor, years after closing the nearby location. A high-tech kitchen and training center on the same floor, sponsored by a $600,000 donation from the Chicago Bears, will give local cooks a space to perfect their healthy recipes, Nelson said.
Big Brothers Big Sisters of Metropolitan Chicago, Serenity Home Health Care, Mikkey’s Retro Grill and a pharmacy will also soon open at the hub, Nelson said.
“It’ll be like you’re in Downtown Chicago,” Nelson said. “We’ll have restaurants, businesses, and a bank in one space, and when you walk by, you’ll see the light emanating from this building.”
Credit: Atavia Reed/Block Club ChicagoAntonio “Tone” Barnes poses with his wife, Syntyche “Syn” Barnes. The duo own Juiced by Shic.
Antonio “Tone” Barnes, co-founder of Juiced by Shic, handed out free samples of his healthy, blended smoothies while guests toured the space.
The Black-owned business, operated by a husband-and-wife duo, is the newest tenant in the healthy living center.
Growing up on the South Side, Barnes didn’t have many stores in his neighborhood that offered fresh fruits and vegetables, he said. Juiced By Shic in Auburn Gresham will be the change he always wanted to see, he said.
“We are bringing an option of fresh fruits and vegetables into the community and exposing our people to different kinds of healthy ingredients,” Barnes said. “You are what you eat. I feel that food is medicine, and the healthier you eat, the healthier you’ll be.”
Enid Johnson, a former Auburn Gresham resident, came back to the neighborhood Friday to witness “something fantastic,” she said.
Healthy food options like Juiced by Shic and the UI Health Center are some of her favorite additions, she said.
“I plan on coming here and taking advantage of all the services they offer,” Johnson said. “I want to support community organizations as much as possible. We’ve gotten away from that on the South Side in our communities, so this is wonderful. I’m excited about all the things that are going to happen here.”
Credit: Atavia Reed/Block Club ChicagoA giant model of former Chicago Bears football player Devin Hester.
For Charles Perry, visiting the Healthy Hub Friday was the start of building a legacy.
With his small children in tow, his family ate healthy tacos, toured the many resources available in the hub and danced to beats spun by DJ Farley “Jackmaster” Funk, Perry said.
When his children reflect on Friday’s celebration in later years, he hopes the eventful day will be the catalyst that inspired them to dream big, Perry said.
“I wanted them to see what’s possible if you have a vision,” Perry said. “Life is bigger than the 3-by-3 blocks that they live on. The world is so much bigger, and I want them to explore it. Right now, it might not mean anything to them, but 20 years from now, they’ll remember the way we danced. That’s what we have to do as a community. We have to give our children experiences so they can go and create their experiences.
I’m envisioning my children telling me to come out because they’re having a grand opening at a building twice as big as this.”
The Healthy Lifestyle is proof if you give a neighborhood the proper resources, “we can make great things happen,” Nelson said.
The South Side development corporation received $4 million from Mayor Lori Lightfoot’s Invest South/West program in 2020 to create the lifestyle hub. Months later, the project won the first ever Pritzker Traubert Foundation’s $10 million Chicago Prize to bring the vision closer to reality.
Now, the healthy living center will encourage others to see the greatness that thrives in the neighborhood, Nelson said.
“The Healthy Lifestyle Hub lets neighbors know that Auburn Gresham is a place where they need to grow their roots, reinvest and raise their families,” Nelson said. “I want people to tell their kids and grandkids about this so people can look at Auburn Gresham, see a beautiful brick bungalow community, and say, ‘Alright, let’s invest here. Let’s grow our families and build wealth here.’”
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A free 7-day, flexible weight loss meal plan including breakfast, lunch and dinner ideas and a shopping list. All recipes include macros and links to WW recipe builder to get your personal points.
7 Day Healthy Meal Plan
Thanksgiving! If you have been watching my Instagram stories you know I have been planning and prepping for the big day! Check out some of my favorite recipes for this holiday like my Dry Brine Turkey that I will start this Sunday (it’s a 4-day brine), Chicken Sausage and Herb Stuffing, and for dessert my and for dessert my No Bake Pumpkin Cheesecake! I hope you all have a day filled with love, family, friends and good food!
With grocery prices soaring, many of us are having to adjust, scale back and/or get more creative with our meals. One of the absolute BEST ways to stay within a budget and maintain healthy eating habits is to MEAL PLAN. You can get more 5-day Budget Friendly Meal Plans by signing up for Relish+ (get a 14-day free trial here!)
Ultimate Skinnytaste Meal Planner
I’m also excited to share the Skinnytaste Ultimate Meal Planner is now available! The 52 week spiral bound meal planner has weekly meal planning grids you can tear out and put on your fridge if you wish, a 12-week meal plan, 30 (15 new) recipes, and tear-out grocery lists. I love starting my week with gratitude, affirmations and intentions, so I included a space for that as well. I hope you will love this as much as I do!
Buy the meal planner here:
A note about WW Personal Points:
I no longer provide points since they vary on the new Weight Watchers plans but I do provide links to WW Personal points recipe builder for all recipes. Look for the orange button in the recipe card says my WW personal points. Click on that and it takes you to the Weight Watchers website where you can see the WW points and add it to your day (US only, you must be logged into your account). All cookbook recipes in the cookbook index are also updated!
About The Meal Plan
If you’re new to my meal plans, I’ve been sharing these free, 7-day flexible healthy meal plans (you can see my previous meal plans here) that are meant as a guide, with plenty of wiggle room for you to add more food, coffee, beverages, fruits, snacks, dessert, wine, etc. or swap recipes out for meals you prefer, you can search for recipes by course in the index. Depending on your goals, you should aim for at least 1500 calories* per day. There’s no one size fits all, this will range by your goals, your age, weight, etc.
There’s also a precise, organized grocery list that will make grocery shopping so much easier and much less stressful. Save you money and time. You’ll dine out less often, waste less food and you’ll have everything you need on hand to help keep you on track.
Lastly, if you’re on Facebook join my Skinnytaste Facebook Community where everyone’s sharing photos of recipes they are making, you can join here. I’m loving all the ideas everyone’s sharing! If you wish to get on the email list, you can subscribe here so you never miss a meal plan!
Meal Plan:
Breakfast and lunch Monday-Friday, are designed to serve 1 while dinners and all meals on Saturday and Sunday are designed to serve a family of 4. Some recipes make enough leftovers for two nights or lunch the next day. The grocery list is comprehensive and includes everything you need to make all meals on the plan.
MONDAY (11/21) B: 1 egg plus ½ cup egg white scrambled with 1 thin slice whole grain toast and ½ a grapefruit L: Asian Chicken Chopped Salad D: Creamy Roasted Acorn Squash Soup with Kale Salad with Quinoa and Cranberries
Total Calories: 984*
TUESDAY (11/22) B: 1 egg plus ½ cup egg white scrambled with 1 thin slice whole grain toast and ½ a grapefruit L: LEFTOVER Asian Chicken Chopped Salad D: Cheesy Rotisserie Enchilada Skillet
Total Calories: 1,075*
WEDNESDAY (11/23) B: High-Protein Enchilada Scrambled Eggs L: LEFTOVER Asian Chicken Chopped Salad D: One-Pot Spaghetti and Meat Sauce with 2 cups arugula, ½ ounce shaved parmesan and 1 tablespoon light balsamic vinaigrette
Total Calories: 1,067*
THURSDAY (11/24) B: Savory Cottage Cheese Bowl L: Mini Greek Spinach Pies and Stuffed Mushrooms with Broccoli Rabe and Sausage D: Herb and Salt-Rubbed Dry Brine Turkey, Roasted Green Beans with Caramelized Onions, Chicken Sausage and Herb Stuffing, Instant Pot Mashed Potatoes, Cranberry Pear Sauce and Vanilla Sweet Potato Casserole with Praline Topping
Total Calories: 1,325*
FRIDAY (11/25) B: Savory Cottage Cheese Bowl L: Leftover Turkey Harvest Cobb Salad (recipe x 2) D: Turkey Pot Pie Soup with a whole grain roll
Total Calories: 969*
SATURDAY (11/26) B: Leftover Turkey and Sweet Potato Frittata L: Navel Orange Salad with Avocado with 3 ounces cooked shrimp D: DINNER OUT
Total Calories: 533*
SUNDAY (11/27) B: Instant Pot Steel Cut Oats L: Open Faced Turkey Melts with 8 baby carrots D: Seattle Asian Salmon Bowls
Total Calories: 921*
*This is just a guide, women should aim for around 1500 calories per day. Here’s a helpful calculator to estimate your calorie needs. I’ve left plenty of wiggle room for you to add more food such as coffee, beverages, fruits, snacks, dessert, wine, etc.
1 small bunch/container fresh dill (can sub 1 tablespoon oregano in Mini Spinach Pies, if desired)
1 small bunch/container fresh basil
1 small bunch/container fresh thyme
1 small bunch/container fresh sage
1 small bunch/container fresh oregano1 small bunch/container fresh rosemary
1 medium bunch fresh Italian parsley
1 small bunch fresh cilantro
1 medium head Boston/Bibb lettuce
1 small head Romaine lettuce
1 medium bunch Lacinato kale
1 medium bunch/bag broccoli rabe (rapini)
1 (1-pound) bag/clamshell baby arugula
1 (1-pound) bag/clamshell mixed greens
1 (5-ounce) bag/clamshell baby spinach
1 dry pint grape or cherry tomatoes
2 medium plum tomatoes
3 medium red onions
2 large Vidalia onions
1 small PLUS 4 medium yellow onions
Meat, Poultry and Fish
¾ pound cooked peeled, deveined shrimp (can buy 1 pound raw and cook yourself, if desired)
1 pound (4) wild salmon filets
1 (16-pound) turkey (adjust size/weight of turkey based on how many you are serving. You will need about 2 ¾ pounds leftover cooked turkey to make everything in this meal plan.)
A new Global Oral Health Status Report published today by the World Health Organization (WHO) provides the first-ever comprehensive picture of oral disease burden with data profiles for 194 countries, giving unique insights into key areas and markers of oral health that are relevant for decision-makers.
The report shows that almost half of the world’s population (45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} or 3.5 billion people) suffer from oral diseases, with 3 out of every 4 affected people living in low- and middle-income countries. Global cases of oral diseases have increased by 1 billion over the last 30 years—a clear indication that many people do not have access to prevention and treatment of oral diseases.
“Oral health has long been neglected in global health, but many oral diseases can be prevented and treated with the cost-effective measures outlined in this report,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “WHO is committed to providing guidance and support to countries so that all people, wherever they live and whatever their income, have the knowledge and tools needed to look after their teeth and mouths, and to access services for prevention and care when they need them.”
Rapid increase of oral diseases
The most common oral diseases are dental caries (tooth decay), severe gum disease, tooth loss and oral cancers. Untreated dental caries is the single most common condition globally, affecting an estimated 2.5 billion people. Severe gum disease ̶ a major cause of total tooth loss ̶ is estimated to affect 1 billion people worldwide. About 380 000 new cases of oral cancers are diagnosed every year.
The report underscores the glaring inequalities in access to oral health services, with a huge burden of oral diseases and conditions affecting the most vulnerable and disadvantaged populations. People on low incomes, people living with disabilities, older people living alone or in care homes, those living in remote and rural communities and people from minority groups carry a higher burden of oral diseases.
This pattern of inequalities is similar to other noncommunicable diseases such as cancers, cardiovascular diseases, diabetes, and mental disorders. Risk factors common to noncommunicable diseases such as high sugar intake, all forms of tobacco use, and harmful use of alcohol all contribute to the global oral health crisis.
Barriers to delivering oral health services
Only a small percentage of the global population is covered by essential oral health services, and those with the greatest need often have the least access to services. The key barriers to delivering access to oral health services for all include:
Oral health care requires high out-of-pocket expenditures. This often leads to catastrophic costs and significant financial burden for families and communities.
The provision of oral health services largely relies on highly specialized providers using expensive high-tech equipment and materials, and these services are not well integrated with primary health care models.
Poor information and surveillance systems, combined with low priority for public oral health research are major bottlenecks to developing more effective oral health interventions and policies.
Opportunities to improve global oral health
The report showcases many promising opportunities to improve the state of global oral health including:
adopting a public health approach by addressing common risk factors through promoting a well-balanced diet low in sugars, stopping use of all forms of tobacco, reducing alcohol consumption and improving access to effective and affordable fluoride toothpaste.
planning oral health services as part of national health and improving integration of oral health services in primary health care as part of universal health coverage.
redefining oral health workforce models to respond to population needs and expanding competencies of non-dental healthcare workers to expand oral health service coverage; and
strengthening information systems by collecting and integrating oral health data into national health monitoring systems.
“Placing people at the heart of oral health services is critical if we are to achieve the vision of universal health coverage for all individuals and communities by 2030,” said Dr Bente Mikkelsen, WHO Director for Noncommunicable Diseases.
She added: “This report acts as a starting point by providing baseline information to help countries monitor progress of implementation, while also providing timely and relevant feedback to decision-makers at the national level. Together, we can change the current situation of oral health neglect.”
The Global Oral Health Status Report uses the latest available data from the Global Burden of Disease (GBD) project, the International Agency for Research on Cancer (IARC) and global WHO surveys. The report is directed at policymakers, practitioners, researchers, development agencies and members of the private sector and civil society.
In 2022, the World Health Assembly adopted a global strategy on oral health with a vision of universal health coverage for oral health for all individuals and communities by 2030. A detailed action plan is under development to help countries translate the global strategy into practice. This includes a monitoring framework for tracking progress, with measurable targets to be achieved by 2030.
“You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in the Division of Industry and Consumer Education, who presented during the agencies virtual public workshop Understanding Risk with Medical Devices, Tuesday.
To start, it helps to understand the terminology.
While “risk” has no formal across-the-board definition in FDA documents, Tartal describes risk as looking at the harm that the device can cause patients and users and their environment. That includes harm from medical device failures.
Risk in this realm does not mean financial risk, he said.
The combination of the probability of occurrence of harm and severity of that harm go into determining the risk of a medical device.
But it’s not only risk that comes into play in risk management. Benefit is new to FDA’s definition of risk when it comes to medical devices, according to Tartal.
Here too there is no formal definition for benefit, but Tartal describes the benefit as “… the positive impact or desired outcome of the use of a medical device on the health of an individual or a positive impact on patient management or public health.”
Analyzing medical device risk
To analyze risk, systematically use available information to identify hazards and estimate risk. There are different approaches for this. Tartal suggested starting here: identify possible hazards, including user error; calculate or estimate risk in normal and fault conditions; determine risk acceptability; reduce risk to an acceptable level; and evaluate changes to make sure you’re not introducing new hazards.
It is up to the manufacturers to identify possible hazards and risk associated to reduce the risk to acceptable levels, according to workshop speaker Tonya Wilbon, branch chief, Postmarket and Consumer Branch, Division of Industry and Consumer Education at FDA.
Risk occurs throughout a device’s lifecycle, she said.
FDA uses risk-based decisions for medical devices, too
FDA classifies medical devices based on risk, with class 1 medical devices being the lowest risk and class 3 being the highest, Tartal noted.
“The Office of Regulatory Affairs uses risk to schedule medical device inspections. Recall classifications are based on risk, as are enforcement actions,” Tartal said. “We even use risk analysis tools such as health hazard evaluations and health risk assessments when determining a recall’s classification.”
The International Organization for Standardization (ISO) 14971 2019 “Medical Devices Application of Risk Management to Medical Devices” is the international standard for medical devices accepted around the world and is recognized by the FDA to establish a risk management process.
Risk management technique examples
Tartal talked about three commonly use risk analysis techniques: Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), a top-down approach; and Failure Mode and Effects Analysis (FMEA), which looks at risk according to individual line items, single component, or single processes.
Preliminary Hazard Analysis, usually done early in a device’s development, helps identify and prioritize hazards, hazardous situations and events that can cause harm, according to Wilbon.
“For each hazard identified, you identify and document the hazardous situation, the possible harm, the severity of the harm, and the probability of the hazard and hazardous situation leading to harm,” she said.
The Preliminary Hazard Analysis also includes identifying possible risk control measures, according to Wilbon.
Those doing risk analyses might use the Fault Tree Analysis to analyze identified hazards, estimating their probability and identifying situations when they might occur.
And Failure Mode and Effects Analysis identifies and evaluates individual fault or failure modes and is a bottom-up method that starts with cause and works toward effect or how it affects device use. This technique analyzes not only device failure but also failures in manufacturing and component assembly, Wilbon said.
Enter benefit-risk analysis
Once manufacturers have made all risk reduction measures and only acceptable residual risk remains, FDA conducts a benefit-risk analysis. FDA’s benefit-risk analysis considers many factors when determining benefits and risk for Premarket Approval Application (PMA) and de Novo classification; substantial equivalence in Premarket Notifications (501(k)); Investigational Device Exemption (IDE); and product availability, compliance, and enforcement decisions, according to Wilbon.
The factors that FDA considers in each of these areas often differ. For example, medical necessity is a factor FDA considers only when doing benefit-risk analysis for availability, compliance, and enforcement decisions, while “magnitude of benefit” applies in all four categories.
“… severity of risk or harm is considered during premarket review process and when making product availability, compliance and enforcement decisions,” she said.
Wilbon used the example of a benefit-risk analysis in product availability, compliance, and enforcement for a human chorionic gonadotropin (hCG) device—essentially, an over-the-counter pregnancy test that detects hCG in urine.
She said a healthcare provider noticed a higher rate of positive results, but the positive results were not confirmed in blood samples. So, the device yielded a higher rate of false positives than expected by the manufacturer. The manufacturer identified the problem in specific lots and disclosed that the end user is not able to detect this malfunction.
FDA considered that there are other such devices on the market that don’t have the same risk and reduced the benefit due to the test’s potential inaccuracy. Considering these and other factors, FDA decided there was no need for the product to continue to be available, and FDA and the manufacturer decided to recall the device, classifying it as a class 2 recall, according to Wilbon.
“… risk management activities are essential throughout the product lifecycle and not just required during design validation,” Wilbon said. “… manufacturers should use more than one risk management technique in their risk management process.”
Kelly DePadro started her YouTube channel with the motivation of teaching people to make great, healthy recipes for dinner without spending too much time preparing and cooking the food.
ATLANTA, Nov. 18, 2022 /PRNewswire-PRWeb/ — The “Healthy Dinner Recipes and Ideas with Kelly” YouTube channel hopes to inspire and equip home chefs with a more intentional, creative and enjoyable cooking experience. Kelly DePadro’s main goal is to help others serve meals that the entire family will enjoy and prepare food the way God intended it to be. As a devout Christian, Kelly believes that we need to be intentional with the food we consume to take care of our health. In the world today, it is not always easy with many temptations for fast, premade meals with preservatives and other unhealthy additives that offer a lack of nutrients. She believes that nuts, vegetables, fruits and grains that are organic in nature are what the body needs to stay in prime condition. Her helpful videos show how simple it is to follow her meal plans from start to finish. Some of her delicious, easy-to-prep dinner recipes she demonstrates include one pot creamy Italian chicken pasta, chicken tortilla soup, Italian meatballs and sauce, baked rice and sweet treats, such as homemade cinnamon swirl bread and coconut chia seed pudding. The recipes shared on the “Healthy Dinner Recipes and Ideas with Kelly” channel use only the healthiest of ingredients and her step-by-step demonstrations are simple for anyone to follow.
“The purpose of the “Healthy Dinner Recipes and Ideas with Kelly” channel is to help families achieve physical, mental and spiritual health, through wholesome, fast and low prep meals,” says Kelly DePadro.
More about Kelly DePadro: As a busy mother of three, Kelly DePadro, discovered a way to make dishes that all of her family members love by developing easy, quick and healthy recipes. Friends and family kept asking for her culinary secrets, so she started her “Healthy Dinner Recipes and Ideas with Kelly” YouTube channel. She hopes to help others dine on tasty, nourishing meals with little effort involved and just a few ingredients.
Media Contact
Kelly DePadro, Healthy Dinner Recipes and Ideas with Kelly, 678-595-2877, kellydepadro@gmail.com
SOURCE Healthy Dinner Recipes and Ideas with Kelly
