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FDA Continues Efforts to Support Innovation in Medical Device Sterilization

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The sterilization of medical devices is a vital process for helping to prevent serious infections. The U.S. Food and Drug Administration continually works to oversee sterilization methods for these devices to ensure they are effective and used in amounts that are safe for the patients and health care professionals who use them.

Ethylene oxide, or EtO, is a gas used during manufacturing processes to sterilize a variety of both medical and non-medical products. Use of ethylene oxide is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing and causing infections without degrading the product, unlike some other sterilization methods. It is currently the most commonly used method in the U.S. to sterilize medical devices and is widely used by medical device manufacturers and contract sterilizers worldwide. 

In fact, more than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for approximately 50% of devices that require sterilization. These devices range from wound dressings to more specialized devices, such as stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made from different materials. Inadequate sterilization can lead to life-threatening infections in patients undergoing a wide range of medical procedures.

Today, the Environmental Protection Agency, which regulates industrial facilities to ensure unsafe emissions levels are not released into the environment, announced plans to propose an air pollution rule later this year to address emissions of ethylene oxide at commercial sterilizers. As part of its proposal, the EPA has conducted a risk assessment which identified 23 commercial sterilizers in several states that were found to emit high levels of ethylene oxide. 

The FDA shares concerns about the release of ethylene oxide at unsafe levels into the environment. We have been proactively working with medical device sterilizers to reduce the amount of EtO they use while still effectively sterilizing products to help ensure they meet the EPA’s standards for ethylene oxide emission levels. In addition, we have been working with companies on the development of novel sterilization methods to replace the use of ethylene oxide.

Over the past few years, we have prioritized reducing the use of ethylene oxide and several actions to develop programs and initiatives to support innovation in medical device sterilization.  

For example, we launched the EtO Sterilization Master File Pilot Program for premarket approval (PMA) holders of high-risk devices that enables certain changes between sterilization processes and facilities that reduces the amount of ethylene oxide concentrations used to sterilize medical devices without compromising safety and effectiveness. To date, 11 sites and 28 class III devices are included in the pilot. Multiple organizations have also expressed interest in our recently announced 510(k) master file pilot program, which exponentially expands the number of medical devices that are eligible for pilot participation. 

The Innovation Challenges we launched have also shown encouraging progress with new strategies to reduce EtO emissions. Early observations suggest that some facilities have cut emissions ranging from 20-35%, with the potential to impact millions of devices. In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range. In addition to reducing emissions by lowering the EtO cycle concentration, Challenge participants are also exploring the potential for using alternative sterilization methods, such as vaporized hydrogen peroxide, supercritical carbon dioxide and nitrogen dioxide for certain types of medical devices. In some cases, device manufacturers are working collaboratively with contract sterilizers to validate new or different sterilization methods as well as the feasibility for scale up.

Collectively, these programs encourage new ways to sterilize medical devices that reduce the potential impact of ethylene oxide on the environment and public health, and we are committed to continuing to prioritize these efforts.   

While signs of innovation are promising, other methods of sterilization cannot currently replace the use of EtO for many devices. To that end, we are equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations. Our supply chain program is ready to work with industry to help prevent and mitigate potential shortages due to reduced supply of certain ethylene oxide sterilized medical devices.

The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon.

Related Information

Source: FDA

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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health and wellness

ELVIE PUTS MATERNAL SUPPORT UNDER A MICROSCOPE WITH NEW REPORT

Leading FemTech Pioneer’s “The Motherload: The weight of limited postpartum support” Survey Shows That Women Face a Trio of Serious Pregnancy & Postpartum Challenges

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NEW YORK /PRNewswire/ — Today, Elvie, the disruptive global FemTech health and wellness brand, releases “The Motherload: The weight of limited postpartum support,” their first-ever report, in partnership with Mother.ly, putting the state of maternal health under the microscope. The study of over 1,000 women with children has uncovered a trio of serious pregnancy and postpartum challenges that mothers currently face. 

Elvie: State of Maternal Health Report

As a female-founded and female-grounded company, Elvie has worked tirelessly to empower women through radical female-first technology that harnesses their incredible biology. The brand is taking this one step further with their newest report, partnering with Mother.ly to unveil research detailing the challenges mothers face when it comes to the fourth trimester, breastfeeding, pelvic floor health and mental health and the intersection between those and technology.

Based on the survey Elvie conducted in February 2024, mothers are finding that they can successfully turn to both family and technology to ease their challenges, but are often left wanting by doctors, employers and their political policy landscape. Findings from the study also uncover that while mothers expect postpartum challenges to occur, they’re often complicated by a lack of strong support and poor maternity leave policies.

“With this new research, we’re demonstrating something those mothers already know: postpartum care in the US is simply not good enough.” says Tania Boler, Founder & President of Elvie. “While they rely on and are comfortable with technology, whether it be a pump, ovulation tracker or pregnancy app, there’s an increase in frustration surrounding unexpected challenges and unknowns when it comes to their maternal health.

“Women are looking to feel as sure in their doctors as they are in their trusted technology. But today’s current maternal health issues – from lack of education and paid leave to physical and mental challenges – are having a tremendous impact on how women navigate both the pre- and post-natal landscape. Better medical, social, and governmental aid are crucial to empower the women raising the next generation.”

Enlisting one of the brand’s largest innovative marketing strategies, Elvie is unveiling their first-ever billboard in Times Square timed to the release of the report, doubling down on its commitment to women and postpartum challenges they face. The billboard’s creative will include an animation flipping through a variety of words relating to challenges that the majority of women in the report faced such as “Baby Blues,” “Bleeding,” “Loneliness,” “Breastfeeding,” and more, to bring to life the often undiscussed issues discussed in the report.

The billboard, as well as additional marketing channels, will lead back to a landing page for the maternal health report featuring different modules of the survey’s findings with a call to action for consumers to download the report and “mama’s game plan,” which includes educational content surrounding fourth trimester challenges.

CHALLENGING SURPRISES – WITH LIMITED SUPPORT

Majority of new moms feel more prepared to use postpartum technology than to deal with lack of sleep, finding breastfeeding to be the biggest postpartum challenge, alongside untreated pelvic floor issues and compounded mental health & physical health challenges.

Boobie Trapped

  • 83% report breastfeeding for at least 1 month.
  • Breastfeeding or pumping (74%) is the most common need in the postpartum health journey after sleep (82%).
  • The single biggest misconception about postpartum care: thinking breastfeeding would be easier (48%).
  • 84% of moms experienced at least mild breast feeding complications after giving birth; 27% had severe complications.
  • Almost as many mothers stop breastfeeding due to the challenges of breastfeeding than due to natural reasons. 42% stop because of return to work constraints, lack of support, difficulty balancing breastfeeding with other duties, sleep issues, mental health issues, or pain/discomfort. 56% stop because of insufficient supply, a transition to solids, or the baby deciding it’s time.

Let’s (Not) Talk About Pelvic Floor

  • A 56% majority did kegels or pelvic floor exercises before having a baby, but 79% still experienced at least mild pelvic floor issues after giving birth.
  • Only 31% were satisfied with the level of pelvic floor treatment offered after giving birth.
  • Just 19% spoke about their pelvic floor health often with their healthcare provider during their postpartum phase.

Mental vs. Physical

  • 77% of moms experienced at least mild mental health complications after giving birth.
  • Of these, 20% had severe mental health complications.
  • Only 28% say they had good mental health during the postpartum period, but only 31% had professional mental health support.

It’s All About Family

  • 94% felt supported by their partner during their pregnancy experience, and 90% felt supported by their partner during the postpartum experience.
  • 83% considered their partners/family to be supportive to their mental health during their experience.
  • By contrast, only 14% said they felt partner/family support was needed but missing.

WE GET TECHNOLOGY, BUT WHAT ARE THE RULES?

Most women understand and rely on technology for postpartum recovery support more than the support from their doctors, but are confused by and lack awareness of postpartum policy solutions.

Technology is Queen

  • 97% relied on technology to support their postpartum recovery. Electric breast pumps (72%) are the most common technology mothers turned to after baby monitors (75%)
  • 75% relied on technology to support their prenatal phase. Smartphone apps (57%) are the most commonly-used technology.
  • 81% say tech products and services made their motherhood journey easier.
  • 68% agree that the tech products/services they used for prenatal and postnatal care played an important role in supporting them. 67% say their tech products were always reliable and 74% say they were well-designed.
  • 26% say the access they had to smart technology, products and services was the most valuable support they received, statistically tied with professional healthcare support (28%).
  • 82% of moms who had access to high tech breastfeeding products say they were effective. By contrast, 77% of those who used a lactation consultant rate the service as effective.
  • 58% felt prepared to take advantage of available tech solutions after their pregnancy, significantly more than the level of preparation for breastfeeding, sleep challenges, childcare and relationship challenges.

What Are The Rules?

  • Only 21% are very familiar with their state’s maternity rights.
  • Only 30% know what the “Pump Act” covers.
  • Most mothers recognize breastfeeding rights, including:
    • 89% the right to a private space (not a bathroom) at work.
    • 84% the right to a break at work long enough to pump.
    • 81% the right to breastfeed in public.
    • 67% believe they have a right to a free electric breast pump.

UNSUPPORTIVE COMPLICATIONS

While mothers understand that postpartum challenges are guaranteed, they’re often complicated by a lack of strong structural support and poor paid maternity leave policies. 

Time Out & Time Off

  • Only 16% expected an easy/quick recovery in the postpartum period, and only 25% felt prepared for this phase as a result of their prenatal care.
  • Only 25% of moms who experienced severe complications predicted they would have significant physical or emotional difficulties in the postpartum period.
  • Only 23% felt very supported by their doctor, midwife, or other healthcare provider.
  • Postpartum challenges were exacerbated by lack of paid maternity leave, which was only available to 59% of moms (64% of those who work full time and 24% who do not)
    • 60% took less than 2 months of paid maternity leave
    • 72% of moms with severe complications were still back to work within 6 months

About Elvie
Elvie is a disruptive global women’s health and wellness brand which uses smart technology to create superior products for women. Founded in 2013 by Tania Boler, Elvie brings together a team of world-class engineers, designers and business minds to develop extraordinary products that improve women’s lives — revolutionizing categories which had been overlooked for many years, including breastfeeding and pelvic floor health.

The first to launch, Elvie Trainer, is an award-winning Kegel trainer and connected app that allows women to take charge of their pelvic floor with expert-designed care from home. Elvie’s second product, Elvie Pump, is the smallest, quietest and smartest (and only Piezo-Powered™) wearable breast pump. Slipping discreetly in-bra, moms can pump, hands-free, whenever and wherever they want.

Elvie now has six products on the market, and continues to expand its product line and innovate new solutions for more women to have access to products that work smarter and harder for their bodies.

In 2021, Elvie launched Elvie Stride, a hands-free, hospital-grade electric pump that allows mothers to express on-the-go without compromising on pumping performance. Stride Plus launched six months later, featuring the award-winning Elvie Stride breast pump, along with a 3-in-1 Carry Bag that includes a wet bag for mess-free travel, and a cool bag and ice pack to keep breast milk fresh. Elvie Curve and Elvie Catch both work to enhance the Elvie breastfeeding range – Elvie Curve is a manual, silicone in-bra breast pump that uses natural suction to optimize milk output, and Elvie Catch is a set of two secure milk collection cups that replace the need for single-use breast pads.

For more information visit www.elvie.com.

SOURCE Elvie

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Health

Mill Creek’s Frontier Dermatology Is First in Washington to Offer Nonsurgical Treatment for Common Skin Cancer Using Image-Guided Superficial Radiation Therapy

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BURR RIDGE, Ill. /PRNewswire/ — SkinCure Oncology, the world leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT), a nonsurgical treatment with the highest cure rate for common skin cancers, today announced its availability in Washington at an event at Frontier Dermatology in Mill Creek. This is the first medical practice in the state to offer this GentleCure™ treatment experience.

Image-Guided SRT is the only treatment for nonmelanoma skin cancer (basal and squamous cell carcinoma) that uses ultrasound imaging to help clinicians direct low-level x-rays to targeted areas of the skin, killing cancer cells without bleeding, pain, surgical scarring or need for reconstructive surgery. A study published in the journal Oncology and Therapy showed that Image-Guided SRT produces a 99.3 percent cure rate for early stage nonmelanoma, making it just as effective as traditional surgical treatment.

Dieter Schmidt, M.D., FAAD, FACMS, of Frontier Dermatology, noted, “More than 68,000 Washingtonians are expected to be diagnosed with nonmelanoma skin cancer this year alone. It is essential for them to have information on all available treatment options, both surgical and nonsurgical, so they can make informed decisions about their care. Image-Guided SRT is one of the most exciting technological innovations in dermatology today. We call it the GentleCure experience, and we are proud to be the first in Washington to offer it.”

Joining Dr. Schmidt at the event was Mill Creek Mayor Brian Holtzclaw, who said, “We are a community of nature lovers and outdoor enthusiasts here in Mill Creek, and whether you’re swinging a driver at Mill Creek Country Club, a paddle on the pickleball courts at Heron or Highlands Park, or simply just taking in the scenery on one of our many nature trails and community parks, it’s critical that we take the necessary steps to protect ourselves from the sun’s rays. In those cases where exposure to the sun or other factors leads to a cancer diagnosis, patients now have more treatment options, including the new, nonsurgical standard of care called GentleCure. I want to thank Dr. Schmidt and Frontier Dermatology for bringing GentleCure to our city and state. It’s a proud moment for us all.”

“We at SkinCure Oncology are delighted to partner with Frontier Dermatology to offer this highly effective, noninvasive treatment option for their patients,” said Kerwin Brandt, Chief Executive Officer of the Chicago-based company. “Patients everywhere should have the choice of curing their nonmelanoma skin cancer without surgery.”

About SkinCure Oncology
SkinCure Oncology is the world leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT), the most advanced nonsurgical treatment for common skin cancer. The company partners with quality-focused dermatologists, Mohs surgeons and other physicians to bring cancer center-level radiation therapy treatment to private practices. Presented to patients as the GentleCure™ experience, Image-Guided SRT is available from some 500 physicians nationwide, with more than 75,000 patients having been treated. Learn more about the company at SkinCureOncology.com, and visit GentleCure.com for helpful consumer and patient information.

SOURCE SkinCure Oncology

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fitness

Mejore su salud caminando

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(Family Features) Una caminata no solo es buena para el cuerpo, sino también para el alma. La actividad física, como caminar, es una de las mejores formas de reducir el estrés y mejorar su estado de ánimo. Sin embargo, los informes revelan que las tasas de caminatas están disminuyendo constantemente en los Estados Unidos.

En promedio, uno de cada cuatro adultos estadounidenses permanece sentado durante más de ocho horas al día, según la investigación de los Centros para el Control y la Prevención de Enfermedades (CDC). Esto puede tener consecuencias negativas para la salud física y mental. El ejercicio regular mejora el estado de ánimo, aumenta la energía e incluso puede ayudarle a dormir mejor. Estar activo es una de las mejores maneras de mantener la mente y el cuerpo sanos.

Tome esta recomendación de la American Heart Association (la Asociación Americana del Corazón), que ha trabajado durante décadas para promover políticas y estrategias que faciliten que las comunidades estén y se mantengan activas. Un ejemplo es el Día Nacional para Caminar, que lo estableció la organización para incentivar a las personas a moverse más a lo largo del día. para que puedan pensar, dormir, vivir y sentirse mejor.

De hecho, moverse más puede beneficiar a su cuerpo y a su mente de numerosas maneras, como por ejemplo las siguientes:

Reducir el riesgo de sufrir enfermedades. Realizar la cantidad recomendada de actividad física (al menos 150 minutos de actividad moderada, 75 minutos de actividad intensa o una combinación de esas actividades por semana) está relacionado con un menor riesgo de sufrir enfermedades, tener huesos y músculos más fuertes, una mejor salud mental y función cognitiva, y menor riesgo de depresión, según el Departamento de Salud y Servicios Humanos de los EE. UU.

Estar más al sol. El ejercicio al aire libre es un manera fácil de mantenerse en movimiento y estar al sol, lo que puede mejorar el estado de ánimo, aumentar la inmunidad y ayudarle a obtener un poco de vitamina D. Pasar tiempo al aire libre es una opción que no tiene costo y se ha demostrado que reduce el estrés, promueve el sentido de pertenencia y mejora el estado de ánimo.

Mejorar la función cognitiva y mental. La actividad física mantiene la mente alerta ahora y en el futuro. Los estudios muestran que niveles más altos de condición física están relacionados con una mejor atención, aprendizaje, memoria de trabajo y resolución de problemas. Es más, un estudio publicado en el “British Journal of Sports Medicine” demuestra que las personas que realizan la cantidad recomendada de actividad física tienen menos probabilidades de desarrollar depresión.

Vivir una vida más larga. La esperanza de vida saludable puede verse afectada positivamente por el aumento de la actividad. Según una investigación publicada en el “American Journal of Epidemiology”, cambiar solo 30 minutos de estar sentado por actividad física de baja intensidad reducía el riesgo de muerte en un 17 %.

Manténgase en movimiento para reducir el estrés y mejorar su salud. Amplía la información en heart.org/movemore.

Inspírese para mantenerse en movimiento

Un poco de creatividad puede ser de gran ayuda para que su caminata sea más divertida. Es posible que piense que caminar es una actividad en solitario, pero hacerlo con compañía la hace aún más placentera. Pida a compañeros de trabajo, amigos o familiares que le acompañen.

Una caminata es una excusa perfecta para tomar un descanso después de un largo día sentado en el escritorio. Si trabaja de forma remota, realice una conferencia telefónica mientras se mueve o considere que la caminata es su recompensa por completar un proyecto.

Utilice su caminata como una oportunidad para escuchar un nuevo audiolibro sin culpa o cree una lista de reproducción con su música favorita para salir a caminar.

Experimente con recorridos alternativas. Intente tomar nuevas rutas para hacer sus caminatas más interesantes. Esto también le ayuda a evitar que se aburra si va por el mismo camino de siempre.

Si hay algo más que puede incentivarle a mantenerse en movimiento es sin dudas una mascota. Su mascota puede ayudarle a ponerse en forma. Quienes tienen un perro tienen más probabilidades de alcanzar sus objetivos de acondicionamiento físico respecto de aquellos que no lo tienen. De hecho, según el “Journal of Physical Activity & Health”, las personas que tienen perros tienen un 34 % más de probabilidades de caminar 150 minutos a la semana respecto de quienes no tienen un perro. Las mascotas también pueden ayudar a reducir el estrés, la presión arterial, el colesterol y el azúcar en sangre y a aumentar su felicidad y bienestar general.

Fotos cortesía de Shutterstock


SOURCE:
American Heart Association

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