Health
FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply
Last Updated on February 2, 2023 by Daily News Staff
The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.
These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
Under the new proposed guidance:
- The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
- The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
- All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
- Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Other considerations in the guidance include:
- No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
- Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
- Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
- Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
- Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
- Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.
- The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
The agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood. However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood. The FDA will continue to track the latest data relevant to PrEP and blood donation.
“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
To inform these draft recommendations, the FDA carefully reviewed numerous data sources, including data from the United Kingdom and Canada, countries with similar HIV epidemiology that have implemented this gender-inclusive, individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, and the performance characteristics of nucleic acid testing for HIV. Additionally, the agency funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCEExternal Link Disclaimer) study. This study examined several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants.
As part of the FDA’s established process, today’s proposal will be open for public comment for 60 days. The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.
Related Information
- Keeping Blood Transfusions Safe: FDA’s Multi-layered Protections for Donated Blood
- Blood & Blood Products
Consumer Corner
Cold cities are the most ready for winter, with one exception. See where your city ranks
Cold cities? Every neighborhood has a mix of homeowners who approach seasonal home maintenance differently – there are the people who stay on schedule, and on the other end, the procrastinators. There are the dedicated DIYers, and those who have their favorite maintenance pro saved as a favorite contact in their phone. As it turns out, cities are no different. Some metropolitan areas keep their neighborhoods in tip-top shape, while others are a little more slow-going.
Cold cities are the most ready for winter, with one exception. See where your city ranks
(Sheeka Sanahori) Every neighborhood has a mix of homeowners who approach seasonal home maintenance differently – there are the people who stay on schedule, and on the other end, the procrastinators. There are the dedicated DIYers, and those who have their favorite maintenance pro saved as a favorite contact in their phone. As it turns out, cities are no different. Some metropolitan areas keep their neighborhoods in tip-top shape, while others are a little more slow-going.
New data from home services company Angi, covering fall maintenance activity in August, reveals which U.S. metropolitan areas are the most proactive with fall maintenance. Washington, D.C., tops the ranking with the strongest demand for fall maintenance in the country, followed by Columbus, Ohio, and Milwaukee, Wisconsin. Northern cities dominate the rest of the list.
Cleveland, Ohio, and Albany-Schenectady-Troy, New York, round out the top five. Cold-weather markets dominate the ranking, accounting for eight of the 10 most-prepared metros. Rochester, New York; Charlotte, North Carolina; Chicago; Indianapolis; and Pittsburgh complete the top 10.
Least fall-ready metros
Fewer than 1 in 5 American cities is prepping for fall at an above-average rate. Among the 66 metros that recorded at least 100 fall maintenance service requests during the analysis period, Los Angeles had the lowest level of per-capita activity, followed by Oklahoma City and Riverside, California. California accounts for four of the bottom 10 markets, with Los Angeles, Riverside, San Diego and San Francisco all appearing on the list. These metros historically don’t experience the colder winter climates of the Northeast and Midwest, making fall maintenance less of an imperative.
Grand Rapids, Michigan, stands out as the only clearly cold-weather metro among the 10 least-prepared large metros. The New York City metro, which includes Newark and Jersey City, ranked just outside the 10 least-prepared large metros, coming in at number 11. Other New York state metros, including Syracuse, Rochester and the Albany metro area, were on the most prepared list.
Homeowners are choosing upkeep over upgrades
Sixty-three percent of homeowners who have recently hired a professional completed maintenance work, and 58% completed repairs. Although they may be waiting to do that dream kitchen or bath renovation, they’re focusing for now on the maintenance that keeps their homes in order.
The most common fall maintenance projects focus on outdoor upkeep. Nationally, tree trimming was the most popular, followed by lawn and yard waste cleanup and shrub care.
What homeowners should do now
When tackling a home maintenance list, start at the top of the home by inspecting the roof and gutters. Look for loose or damaged shingles, and make sure gutters are debris-free. It’s also a good idea to ensure downspouts direct water far away from the foundation. Homeowners should inspect these areas from the ground or hire a professional if the work requires climbing or feels unsafe.
Next, check for drafts around the windows and doors. Replacing worn weatherstripping and damaged caulk in the fall can prevent warm air from escaping once the heat comes back on. Homeowners should also inspect their HVAC filters and have the heating system checked before the temperatures drop.
Every home’s maintenance needs will vary, depending on the age and condition of the house and where it’s located. Whether homeowners hire a professional or safely address small issues, making the fixes can prevent larger and more expensive problems later.
The ranking: Metros from most to least prepared
America’s 10 Most Fall-Prepared Metros
1. Washington, D.C.
2. Columbus, Ohio
3. Milwaukee, Wisconsin
4. Cleveland, Ohio
5. Albany-Schenectady-Troy, New York
6. Rochester, New York
7. Charlotte, North Carolina
8. Chicago, Illinois
9. Indianapolis, Indiana
10. Pittsburgh, Pennsylvania
10 Metros With the Most Opportunity to Get Fall-Ready
1. Los Angeles, California
2. Oklahoma City, Oklahoma
3. Riverside, California
4. Miami, Florida
5. San Diego, California
6. Houston, Texas
7. Grand Rapids, Michigan
8. San Francisco, California
9. Austin, Texas
10. Memphis, Tennessee
Methodology
The rankings are based on fall maintenance activity recorded on Angi during August 2026. Projects included yard cleanup, winterization, roofing and gutters, heating systems, water and drainage, outdoor plumbing, fireplaces and chimneys, pest prevention, and snow and storm preparation. U.S. metropolitan areas were ranked by activity per 100,000 residents using 2020 U.S. Census population data. To qualify for the least-prepared ranking, metros were required to have at least five service requests or jobs during the analysis period. The rankings reflect activity on Angi’s platform and are not a complete measure of all home-maintenance activity within each metro. These rankings reflect activity observed on Angi’s platform and should not be interpreted as a complete measure of all home-maintenance behavior within a metro area.
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Angi
Health
Type 2 Diabetes Doesn’t Have to Be Your Future: Medicare Has a Benefit That Can Help
Left unchecked, prediabetes can progress to type 2 diabetes. However, with the right support, prediabetes can often be managed or even reversed. If you have Medicare, you may qualify for a Medicare-covered program that can help you lower your chances of developing type 2 diabetes – at no cost to you.
(Feature Impact) Nearly 1 in 2 people age 65 and older has prediabetes – a condition where blood sugar (glucose) levels run higher than normal. Left unchecked, prediabetes can progress to type 2 diabetes. However, with the right support, prediabetes can often be managed or even reversed. If you have Medicare, you may qualify for a Medicare-covered program that can help you lower your chances of developing type 2 diabetes – at no cost to you.
The Medicare Diabetes Prevention Program is a covered Medicare benefit that gives you practical tools, personalized support, and proven strategies to make healthy lifestyle changes. Learn how to eat better, exercise more, and build healthy habits that stick while guided by a certified coach who helps you every step of the way.
Research shows the program works. People with prediabetes who complete the program result in weight loss, which ultimately leads to reduced risk of type 2 diabetes onset.
What can you expect?
Prevention does not mean you have to make big changes all at once. This program helps you take small, realistic steps that can add up to lasting results. It includes 16 core sessions where you can learn how to reduce your diabetes risk by making healthier meals, moving more, and building healthy habits.
The core sessions are followed by six months of monthly maintenance sessions to help you keep your momentum.
You can choose the class format that works for you
You can enroll in these services from approved Medicare Diabetes Prevention Program suppliers and participate in the way most convenient for you:
- In-Person: Attend sessions in a community location.
- Live-Distance Learning: Join interactive group sessions from home.
- Self-Paced Online: This new option allows you to access online content and learn on your own schedule.
Visit www.medicare.gov/PreventDiabetes to find a class that’s right for you.
Who is eligible?
You may qualify if you are enrolled in Medicare Part B and meet these criteria:
- Have had one of the following test results within the past 12 months:
- Hemoglobin A1c between 5.7% and 6.4%
- Fasting plasma glucose between 110 and 125 mg/dL
- Two-hour plasma glucose between 140 and 199 mg/dL after an oral glucose tolerance test
- Have a body mass index (BMI) of 25 or higher (or 23 or higher if you self-report as Asian descent).
- Have never been diagnosed with type 1 or type 2 diabetes or end-stage renal disease (ESRD).
What does it cost?
If you have Medicare Part B and qualify for the program, you pay nothing to participate. If you are in a Medicare Advantage Plan, you may have to go to an in-network provider to get these services. Contact your plan for more information.
Ready to get started on your healthier future?
Take control of your health on your own terms, schedule, and pace that fits into your life. Check with your doctor to find out if you have prediabetes or are at risk for developing type 2 diabetes. If you’re eligible for the Medicare Diabetes Prevention Program, your doctor can refer you, or you can enroll on your own.
If you’re ready to get started today, find the class that’s right for you at: www.medicare.gov/PreventDiabetes.
Information provided by the U.S. Department of Health and Human Services
Photos courtesy of Shutterstock
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Centers for Medicare & Medicaid Services
health and wellness
The Oral and Cardiovascular Health Connection: 4 Tips to Protect Your Teeth, Gums and Heart
People often think of dentists and doctors as totally separate healthcare professionals: one cares for your teeth and mouth while the other handles the rest of the body. In reality, the different systems in the human body are closely interconnected and oral health is no exception, making dentists a vital part of your healthcare team. Care for your teeth, gums and heart all at once using these tips.
(Feature Impact) People often think of dentists and doctors as totally separate healthcare professionals: one cares for your teeth and mouth while the other handles the rest of the body. In reality, the different systems in the human body are closely interconnected and oral health is no exception, making dentists a vital part of your healthcare team.
Oral health and heart health have a particularly close connection, with inflammation at the core of it. When your gums are inflamed, the resulting bacteria can make their way from your mouth through your bloodstream, potentially contributing to your blood vessels constricting or becoming blocked. This, in turn, may force your heart to work harder and raise your blood pressure, putting you at risk of heart disease and stroke. More than 46% of adults in the U.S. have high blood pressure, and more than 40% of adults age 30 and older are affected by periodontal (gum) disease.
To help address these issues, the American Heart Association’s Healthy Smiles, Healthy Hearts initiative, in collaboration with Delta Dental of California, is encouraging dental teams to take a total-body perspective with their patients. Simple steps like blood pressure screenings during checkups can give a more complete picture of a person’s overall health. If a member of your dental care team pulls out a blood pressure cuff at your next appointment, it’s a good sign.
“The mouth is a gateway to the body and can often reveal more about your total body health than you may think,” said Daniel Croley, D.M.D., chief dental officer at Delta Dental of California and Affiliates. “Oral health professionals have a powerful opportunity to integrate more into their patients’ collective health care team beyond protecting their patients’ teeth By connecting oral health and heart health, this initiative helps dentists identify risks early and guide patients toward care that can improve and even save lives.”
Care for your teeth, gums and heart all at once using these tips from experts at the American Heart Association.
Follow a Brushing and Flossing Schedule
Good dental health starts with a daily routine. If you don’t want to sheepishly cringe next time the dentist inquires about yours, brush at least twice a day and floss at least once a day to disrupt plaque-forming bacteria. Dentists recommend using toothpaste with fluoride and brushing your teeth and gums thoroughly yet gently, as applying too much pressure can wear away enamel and cause gum recession.
Eat a Healthy Diet and Limit Sugar
Most kids are used to hearing sugar will rot their teeth – and that’s not just a parental scare tactic to get their little hands out of the candy jar. Sugar feeds harmful bacteria in your mouth, producing acid that can cause cavities and gum disease. For a diet your heart and teeth will both appreciate, prioritize vegetables, lean proteins, complex carbohydrates and healthy fats, while limiting added sugars and refined carbohydrates.
Avoid Smoking and Tobacco Products
The connection between smoking and oral disease is well established: smokers face significantly higher risks of developing periodontal disease, losing teeth or being diagnosed with oral cancer. Cigarettes aren’t the only form of tobacco to worry about, either. Vaping, dipping and chewing tobacco can also harm your dental health by drying out your mouth and restricting blood flow to the gums. Since these products are also harmful to heart health, quitting or avoiding them offers plenty of worthwhile benefits. Seek support if you need help to kick the habit.
Communicate with Your Healthcare Team
Since your body’s systems are connected to each other, it’s helpful to talk to your dentist about your blood pressure and to your doctor about your oral health. Start thinking of your dentist as a key member of your integrated healthcare team. Don’t be afraid to share your medical history, discuss the side effects of any medications you’re taking and ask for personalized recommendations on caring for your teeth, gums and overall health.
To learn more about how to improve your oral and cardiovascular health, visit Heart.org/OralHealth.
Photos courtesy of Shutterstock
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