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Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing



Today, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak. 

“Since the beginning of the monkeypox outbreak, the agency has used the full breadth of its authorities to work quickly and proactively to ensure the availability of medical countermeasures, including diagnostics, to prevent the spread of the disease,” said FDA Commissioner Robert M. Califf, M.D. “We will continue to engage federal public health partners like the Centers for Disease Control and Prevention, laboratories, commercial manufacturers, health care professionals, and consumers to facilitate the availability of monkeypox tests to people and communities who need them.”

Since the first case of monkeypox was detected in the U.S., the FDA has been: 

  • working with the CDC to increase production and distribution of the FDA-cleared CDC non-variola orthopoxvirus test; 
  • clearing the use of additional reagents and automation to increase the testing capacity of laboratories using the CDC test;  
  • proactively engaging with commercial manufacturers on the development and validation of both lab-based molecular diagnostic tests and rapid molecular or antigen tests for use at the point-of-care (such as clinics) or at home;
  • facilitating the development and availability of test components to help high-complexity CLIA-certified laboratories develop tests for monkeypox; and
  • monitoring tests that have been developed and used since the start of the outbreak. For example, on July 15, the FDA issued a safety communication recommending the use of lesion swabs to avoid false results.

New Guidance to Facilitate Development of Additional Tests

Today, the FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. These templates include recommendations – not requirements – for how a developer could validate a test to help ensure it is appropriately accurate and reliable. The FDA intends to update its recommendations, as needed, in response to the developing emergency.  

This guidance follows a declaration by the Secretary of the Department of Health and Human Services justifying the emergency use of in vitro diagnostics for detection and/or diagnosis of the monkeypox virus or non-variola orthopoxviruses. Under the declaration, the FDA may issue an EUA to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics. 

“Today’s important actions further aid the monkeypox response by working toward expanding vital testing capacity and facilitating the detection of cases nationwide in an effort to stem the spread of the virus,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The policy announced today is intended to support the development of more validated monkeypox tests and expand access to testing.”

As explained in the guidance, the FDA does not intend to enforce requirements for certain tests developed by laboratories that are used without submission of an EUA request where they are appropriately validated and the laboratories notify the FDA within 30 days, among other things. The agency’s intent is to facilitate the development of additional tests to address local availability and accessibility concerns not addressed by current testing capabilities. The FDA will monitor the situation and may adjust its policies as appropriate to address testing needs. The FDA also may decide, on a case-by-case basis, not to object to individual labs offering tests using different specimen types or technologies to address patient care needs. 

Commercial manufacturers who intend to make a diagnostic test for monkeypox and want to seek authorization through the more streamlined EUA process should inform the FDA of their plans within 30 days, as well. 

It is important that all tests be appropriately validated prior to use, as false results can have a negative impact on both the individual patient and the public health broadly. Currently, only lesion swabs have been shown to be an appropriate specimen type for diagnosing monkeypox. If and when other specimen types are validated, the FDA will inform the developer community and the public. Test developers are encouraged to discuss alternative specimen types, technologies, and approaches to validating their test with the agency.

FDA Authorizes Quest Diagnostics Monkeypox Virus Real-Time PCR Test

In addition to the FDA’s guidance, the agency issued the first EUA for a monkeypox in vitro diagnostic. The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens. Quest Diagnostics submitted data demonstrating that its test for distribution to other laboratories met the standards for issuance of an EUA.

Related Information

Source: FDA


Grey Tsumani is coming – seniors 65+ to make up 1/4 of the population by 2030. Northern Ontario’s Canadore College is leading the way to healthier aging.



NORTH BAY, ON /CNW/ – The metaphor “grey tsunami” refers to the demographic shift being caused by the growing number of older adults in society, led by the baby boomer generation. Canadore College recognizes seniors need to age better and healthier, be more productive and engaged with their community, and it’s using The Village to help make that a reality.

Students from Canadore College receive experiential learning working with older adults on campus (CNW Group/Canadore College)

Seniors aging better, and healthier thanks to The Village at Canadore College.

The only model of its kind in Canada, The Village is focused on collaborative, interprofessional education and the integration of Indigenous, Eastern, and Western healing and wellness practices.  A world-class health, wellness, and education facility located at Canadore College in North Bay, Ontario, it is home to the College’s schools of Indigenous Studies, Human Care, Health Science and Social Services, and Sport and Recreation. Students learn in The Village’s comprehensive suite of student-run clinics, modern classrooms, and cultural spaces.

“This model is about leveraging learning to benefit the community and the community supporting our learners,” said Micheline Demers, The Village Collective Impact Project Manager. “Canadore College is a place the community feels they belong. In turn, the community is invested in and supports every aspect of the students’ learning. Together, we are solving issues facing our country by coming together inter-generationally, inter-professionally, and inter-culturally. The lessons learned on our campuses are brought to the workplace. This improves the lives of seniors and supports healthy aging.”

“As a student, the Village provides a learning experience like no other by giving us an opportunity to work directly alongside members of the community within a setting that we are already familiar with,” said Jenna Faulkner, a student in the Occupational Therapist Assistant/Physical Therapist Assistant Intensive program. “I value these experiences as the interaction and feedback from community members allows me to develop interpersonal skills that are not otherwise developed in a standard classroom setting. The experience gained through my participation in student-led programs in The Village will prepare me well for my career.”

The Village Collective Impact Project (CIP) is funded in part by the Government of Canada’s New Horizons for Seniors Program.  In 2019, the CIP received nearly $2 million dollars in funding to distribute to seniors’ organizations to get programming up and running. The project is making a difference in the lives of adults aged 60 and older in the districts of Nipissing and Parry Sound in Northern Ontario. Its offerings include daily exercise classes and walking groups, digital literacy seminars, and a weekly pickleball game. The CIP’s goal is to reduce the risk of social isolation and increase social participation among adults 60+. The project is working collaboratively with seniors, including Indigenous seniors, their caregivers and families, stakeholders, regional community organizations, and agencies, to develop models of healthy aging and inclusion to improve the health outcomes of seniors living in the Nipissing-Parry Sound districts.

“Research has shown us social isolation can be as harmful to one’s health as smoking up to 15 cigarettes a day, and Canadore wants to provide better care for the older adults in the communities we serve,” said George Burton President and CEO. “We saw a need to bring seniors together to stay healthy and enjoy their lives, and we have done that through The Village Collective Impact Project.”

The Village CIP is hitting its targets, and the data is impressive. It has created a network of 87 organizations across Nipissing and Parry Sound. The most recent statistics, from Fall 2023, for the 50 partner organizations that have received CIP funding, support more than 30,000 seniors from Nipissing and Parry Sound. Canadore College, through The Village programming, has supported more than 5300 seniors since launching in 2019, 750 participants came through the program every month last fall. That is more than the CIP projected when it launched four years ago.

Since the inception of the project, almost 1600 students have provided more than 87,000 hours of on-campus support.

Canadore College is planning for the expansion of The Village into intergenerational living opportunities for seniors and more hands-on learning experiences for the students.  The long-term care facility will provide healthcare, assisted living, respite care, transitional beds, and affordable housing options.

SOURCE Canadore College

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How to Prepare Your Body for Daylight Saving Time



(Family Features) Millions of Americans will soon get extra sunlight in the evenings when daylight saving time (DST) – observed by every state except Arizona and Hawaii – begins on the second Sunday in March and clocks are set ahead by one hour at 2 a.m.

While the extra daylight is a welcome change for most, failing to prepare for DST can have consequences. In fact, research from the Sleep Foundation has found a lack of sleep caused by the time change can affect thinking, decision-making and productivity. The change can alter your circadian rhythm, the body’s internal clock that helps control sleep and other biological processes, which may cause mood fluctuations, and the transition has been associated with short-term risk of heart attack, stroke and traffic accidents.

However, making small adjustments ahead of DST can help reduce its impact on your sleep and minimize negative effects. Consider these tips to help navigate the time change.

Reset Your Internal Clock
As you get ready to “spring forward,” gradually adjust your sleep schedule throughout the week leading up to the time change, which can help prevent unnecessary shock to your system. The American Academy of Sleep recommends going to bed 15-20 minutes earlier each day than normal, and other daily activities like mealtimes and exercise can also be moved up slightly to help acclimate to the change. Awakening earlier and getting extra light exposure in the morning can also help adjust your circadian rhythm.

Upgrade Your Sleep Environment
Creating a bedroom environment that is conducive to sleep can help ensure you get a good night’s rest, which is especially important leading up to the time change when you effectively lose an hour of sleep. Start optimizing your sleep space comfort by choosing a supportive mattress and comfortable bedding then block out unwanted light with blackout curtains and dampen unwanted noises using a fan or soothing white noise machine.

To help regulate temperature, set the thermostat to 60-70 F – a cooler thermostat setting helps maintain a lower core temperature – then adjust if too hot or too cold by adding or removing blankets or changing your pajamas. Lavender essential oils, or another fragrance like peppermint or heliotropin, can also help improve relaxation and sleep quality.

Avoid Screens Before Bed
In the days leading up to DST, experts recommend turning off electronics, including televisions, computers, smartphones and tablets, at least 1 hour before bedtime as the blue light from screens can suppress production of melatonin, the substance that signals the body it’s time for bed. If necessary, cut back on screentime in smaller increments leading up to the time change or swap evening screen usage for other activities like crossword puzzles, meditation or reading a book.

Phase Out Caffeine in the Evenings
While avoiding caffeine later in the day can help you fall asleep easier at night, experts suggest limiting and slowly reducing your caffeine intake in the days prior to DST. Choosing half-caffeinated coffee, mixing regular and decaf or cutting out 1-2 caffeinated drinks during the week can help sleep patterns ahead of the change. However, be wary that giving up caffeine “cold turkey” can sometimes lead to headaches.

Find more tips for healthy living all year at eLivingtoday.com.

Photo courtesy of Unsplash


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HSS Orthopedics with Stamford Health Establishes Premier Spine Center in Connecticut

Multidisciplinary Spine Center Offers Back and Neck Pain Solutions to Southern New Englanders



STAMFORD, Conn. /PRNewswire/ — Back pain is a complex, widespread issue across the United States, with the Centers for Disease Control and Prevention estimating that 65 million Americans are affected. Common reasons include arthritis, disc and nerve injury, muscle strain, and other underlying health conditions such as osteoporosis and scoliosis. Responding to the urgent need for increased access to high quality spine care in Connecticut, a specialist center was created last year as an extension of the collaboration between Hospital for Special Surgery (HSS) and Stamford Health.

Specialized in musculoskeletal health since 1863 and ranked No. 1 for Orthopedics worldwide and nationwide, HSS treats more people with back and neck conditions than any other hospital in the U.S. The HSS Spine Center with Stamford Health led by co-medical directors Steven J. McAnany, MD, spine surgeon at HSS, and Andrea F. Douglas, MD, FAANS, FACS, chief of Neurosurgery at Stamford Health, builds on a successful collaboration started in 2016. It provides patients aged 12 and older with timely access to highly trained specialists in physical therapy, physiatry, pain management, neurology, neuro-interventional radiology, neurosurgery and spine surgery. Most patients are treated non-surgically.

“Improved care options for neck and spine conditions is one of the fastest-growing needs we see among patients of all ages today,” says HSS spine surgeon Harvinder S. Sandhu, MD, MBA, and Stamford Hospital Orthopedic Department Chair. “This program integrates our personalized approach to diagnosing and developing treatment plans to help us achieve the best possible patient outcomes.”

“Acute and chronic spinal conditions affect many patients in our community and beyond, with wide ranging quality of life impact,” remarks Dr. Douglas. “The Spine Center offers clinical expertise from multidisciplinary teams and facilitates seamless access for our patients closer to home.”

Spine patient successes include long-time Danbury-based soccer coach Tony Elmore. Tony experienced back and sciatic pain that quickly escalated to the loss of feeling in his right foot. Last April, HSS spine surgeon Evan D. Sheha, MD, determined Tony’s L5 nerve was being crushed by bone and a herniated disc. Dr. Sheha decompressed Tony’s nerve root and performed a robotic-assisted fusion that same month.

Soon thereafter, his disc above herniated, causing recurrent nerve pain. In August, Dr. Sheha performed a successful lumbar microdiscectomy and, together with physical therapy, helped Tony regain 80 percent of the feeling in his right foot. “HSS Orthopedics with Stamford Health literally saved my life,” he explains. “Dr. Sheha was fantastic. I’m hard on myself physically and the fact that I can do what I’m doing after two surgeries is remarkable.”

Darien, Connecticut, resident Diane Barston underwent surgery elsewhere for prior spine-related issues. When her scoliosis became significantly worse, she chose to see her surgeon, Dr. Sandhu, who performed minimally invasive lumbar decompression spinal fusion with robotics.

One week after surgery, Diane could walk a mile without pain and has since increased her mileage. She danced at her son’s wedding in October and has returned to higher-impact cardio, tennis, hiking and pickleball. “I knew right away after meeting Dr. Sandhu that he was the best choice,” she recalls. “He knew exactly what was wrong with me and how to treat it. I feel like night and day before versus after my surgery.”

“The HSS Spine Center with Stamford Health harnesses the expertise of our respective institutions to bring world-class patient care to the communities we serve,” said Kathleen Silard, president and CEO at Stamford Health. “Over the past year, hundreds of patients with back and neck conditions have benefitted from the exceptional capabilities and proven expertise we offer through the HSS Spine Center with Stamford Health.”

For more information about the program or to schedule an appointment, please visit: https://www.hss.edu/hss-spine-center-stamford.asp.

About HSS

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 14th consecutive year), No. 2 in rheumatology by U.S. News & World Report (2023-2024), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fourth consecutive year (2023). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

About Stamford Health
Stamford Health is a non-profit independent health care system with more than 3,900 employees committed to caring for the community through a wide range of high-quality health and wellness services. Patients and their families receive expert, compassionate care through the system’s 305-bed Stamford Hospital; Stamford Health Medical Group, with more than 40 offices in lower Fairfield County offering primary and specialty care; a growing number of ambulatory locations across the region; and support through the Stamford Hospital Foundation.

Stamford Health is known for its expert, person-centered care through its many recognitions and partnerships. U.S. News & World Report has recognized Stamford Hospital as a High-Performing Hospital. The Leapfrog Group awarded Stamford Hospital an “A” for patient safety. The American Nurses Credentialing Center has granted Stamford Hospital Magnet Status, which recognizes superior patient care with the highest level of safety, quality, and patient satisfaction. Stamford Health is Planetree Gold-Certified for Excellence in Person-Centered Care and is a Certified™ Great Place to Work.

Stamford Health is a major teaching affiliate of the Columbia University Vagelos College of Physicians and Surgeons and offers treatment and expertise from Columbia University Irving Medical Center’s nationally recognized heart and neurosurgeons. Stamford Health and Hospital for Special Surgery (HSS) have created a premier center for specialty orthopedic care right in Stamford, Connecticut. Stamford Health’s Carl & Dorothy Bennett Cancer Center has a robust collaboration with Dana-Farber Brigham Cancer Center.

Dedicated to being the community’s most trusted health care partner, Stamford Health puts patients first to build long-lasting relationships. For more information, visit StamfordHealth.org. Like us on Facebook and follow us on XInstagramYouTube, and LinkedIn.

SOURCE Hospital for Special Surgery

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