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FDA Continues Efforts to Support Innovation in Medical Device Sterilization
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
- Sterilization for Medical Devices
- Resilient Supply Chain Program for Medical Devices
- FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies
- FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions
Source: FDA
https://stmdailynews.com/category/lifestyle/health-and-wellness
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Hey there, pickleball fans and community members! Welcome back to Sleeve’s Senior Pickleball Report, where we keep you in the loop about all things pickleball. Today, we’re serving up a controversial topic that’s making waves over at El Quito Park in Saratoga, California. Grab your paddles and a snack as we dive into the noise — and not just the joyful sound of pickleball!
The Pickleball Factor
Thanks to a booming interest during the pandemic, Saratoga recently added two brand-spankin’-new pickleball courts to great fanfare. But what started as a way to enjoy the game has quickly turned into a cacophony that has some locals reconsidering their living arrangements. As reported by Isha Trivedi in the East Bay Times, the sound from the courts has led to complaints from nearby residents about what they describe as a “bombardment of noise.” Even long-time locals like Zack Petersen, who’s enjoyed three decades in the area, are expressing their frustrations. Zack went as far as to say the noise sounds like “shotguns” — yikes!
Check out the article: https://www.mercurynews.com/2024/09/16/pickleballs-bombardment-of-noise-rule-breakers-and-fence-climbers-at-saratoga-courts-lead-to-100000-soundproofing-and-lock-costs-after-neighbor-complaints/
It’s not just the noise that’s causing concern. With no installed lights on the courts, players often bring their own lighting, keeping matches going late into the night, sometimes past midnight. With the city struggling to enforce playtime limits, it’s clear why some residents are feeling overwhelmed.
In response to the uproar, Saratoga’s City Council has earmarked a whopping $100,000 to install soundproofing panels and a new magnetic locking system to keep the courts quieter and more organized. But here’s the catch — Zack fears this might just be a “band-aid” on the real issue. He’s observed that dedicated players have been known to climb over fences to keep the games alive even after the gates are locked. A real pickle indeed!
Despite the pushback from some neighbors, not all pickleball players are brushing off the complaints. Local pickleball ambassador Jason Tseng recognizes the need for soundproofing that works for both players and residents. He pointed out that how the city implements these sound-dampening measures could actually create an echo chamber within the courts, enhancing the noise inside rather than reducing it outside. Double yikes!
So, where does that leave us? With pickleball’s rising popularity, it’s clear something needs to be done to keep the spirit of the game alive while respecting the local community. We’re eager to hear your thoughts!
Do you think pickleball noise is a real issue for local neighborhoods, or is it just part of the game’s charm? Should the city invest in soundproofing and locking systems, or is that a waste of funds? We invite you to share your opinions and experiences in the comments below. Let’s keep the conversation going and work towards solutions that benefit everyone involved!
Until next time, keep it friendly on the courts and consider your volume levels — your neighbors will thank you! And don’t forget… Let’s Pickle!
—Sleeves
Get the latest updates and information on the rapidly growing sport of pickleball, specifically designed for the senior community aged 50+. Check out Sleeve’s Senior Pickleball Report on YouTube to stay informed and up-to-date with the ever-changing world of pickleball. Join the community and stay ahead of the game. https://stmdailynews.com/sleeves-senior-pickleball-report/
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What is an Atlantic Niña? How La Niña’s smaller cousin could affect hurricane season
In August 2024, both La Niña and the lesser-known Atlantic Niña seem to be developing. This rare combination may impact Atlantic hurricane season, potentially reducing risk despite global warming’s influence.
Annalisa Bracco, Georgia Institute of Technology and Zachary Handlos, Georgia Institute of Technology
The North Atlantic Ocean has been running a fever for months, with surface temperatures at or near record highs. But cooling along the equator in both the Atlantic and eastern Pacific may finally be starting to bring some relief, particularly for vulnerable coral reef ecosystems.
This cooling is related to two climate phenomena with similar names: La Niña, which forms in the tropical Pacific, and the less well-known Atlantic Niña.
Both can affect the Atlantic hurricane season. While La Niña tends to bring conditions ideal for Atlantic hurricanes, the less powerful Atlantic Niña has the potential to reduce some of the hurricane risk.
We’re ocean and atmospheric scientists who study this type of climate phenomenon. It’s rare to see both Niñas at the same time, yet in August 2024, both appeared to be developing. Let’s take a closer look at what that means.
La Niña and its cousin, Atlantic Niña
La Niña is part of the El Niño–Southern Oscillation, a well-known climate phenomenon that has widespread effects on climate and weather around the world.
During La Niña, sea surface temperatures in the tropical Pacific dip below normal. Easterly trade winds then strengthen, allowing more cool water to well up along the equator off South America. That cooling affects the atmosphere in ways that reverberate across the planet. Some areas become stormier and others drier during La Niña, and the wind shear that can tear apart Atlantic hurricanes tends to weaken.
La Niña and its warmer opposite, El Niño, oscillate every three to four years or so. https://www.youtube.com/embed/wVlfyhs64IY?wmode=transparent&start=0 La Niña and its opposite, El Niño, explained. NOAA.
A similar climate phenomenon, Atlantic Niña, occurs in the Atlantic Ocean but at a much smaller scale and amplitude. It typically peaks around July or August and tends to have a shorter duration than its Pacific cousin, and much more modest and local impacts. Atlantic Niñas generally have the opposite effect of Atlantic Niños, which tend to reduce rainfall over Africa’s Sahel region and increase rainfall in Brazil and the countries that surround the Gulf of Guinea, such as Ghana, Nigeria and Cameroon.
While much weaker than their Pacific counterpart, Atlantic Niñas can, however, partially counteract La Niñas by weakening summer winds that help drive the upwelling that cools the eastern Pacific.
Why might both happen now?
In July and August 2024, meteorologists noted cooling that suggested an Atlantic Niña might be developing along the equator. The winds at the ocean surface had been weak through most of the summer, and sea surface temperatures there were quite warm until early June, so signs an Atlantic Niña might be emerging were a surprise.
At the same time, waters along the equator in the eastern Pacific were also cooling, with La Niña conditions expected there around October or November.
Getting a Pacific-Atlantic Niña combination is rare but not impossible. It’s like finding two different pendulums that are weakly coupled to swing in opposite directions moving together in time. The combinations of La Niña and Atlantic Niño, or El Niño and Atlantic Niña are more common.
Good news or bad for hurricane season?
An Atlantic Niña may initially suggest good news for those living in hurricane-prone areas.
Cooler than average waters off the coast of Africa can suppress the formation of African easterly waves. These are clusters of thunderstorm activity that can form into tropical disturbances and eventually tropical storms or hurricanes.
Tropical storms draw energy from the process of evaporating water associated with warm sea surface temperatures. So, cooling in the tropical Atlantic could weaken this process. That would leave less energy for thunderstorms, which would reduce the probability of a tropical cyclone forming.
However, NOAA takes all factors into account when it updates its Atlantic hurricane season outlook, released in early August, and it still anticipates an extremely active 2024 season. Tropical storm season typically peaks in early to mid-September.
https://datawrapper.dwcdn.net/lcaEc/2
Two reasons are behind the busy forecast: The near record-breaking warm sea surface temperatures in much of the North Atlantic can strengthen hurricanes. And the expected development of a La Niña in the Pacific tends to weaken wind shear – the change in wind speed with height that can tear apart hurricanes. La Niña’s much stronger effects can override any impacts associated with the Atlantic Niña.
Exacerbating the problem: Global warming
The past two years have seen exceptionally high ocean temperatures in the Atlantic and around much of the world’s oceans. The two Niñas are likely to contribute some cooling relief for certain regions, but it may not last long.
In addition to these cycles, the global warming trend caused by rising greenhouse gas emissions is raising the baseline temperatures and can fuel major hurricanes.
Annalisa Bracco, Professor of Ocean and Climate Dynamics, Georgia Institute of Technology and Zachary Handlos, Atmospheric Science Educator, Georgia Institute of Technology
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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Senior Pickleball Report
Serve & Sip: Dallas’s Largest Pickleball Entertainment Destination Brings Sport, Social, and Style Together
Alex Menzel announces Serve & Sip Pickleball Club in Dallas for 2025, blending sport, hospitality, and community in a unique venue.
DALLAS, Sept. 12, 2024 /PRNewswire/ — Alex Menzel, a community-focused entrepreneur, developer, and SMU alumnus is pleased to announce the upcoming launch of Serve & Sip Pickleball Club, the largest indoor-outdoor pickleball entertainment venue in the heart of Dallas. Scheduled to open in 2025, Serve & Sip is designed to offer a premium, bespoke blend of sport and hospitality, all within a vibrant and meticulously designed environment.
A New Standard in Pickleball and Social Entertainment
Serve & Sip will be a venue where community, connection, and unforgettable experiences come together. Featuring spacious, professional-grade courts, a lively outdoor patio, and an inviting dining experience, Serve & Sip will offer a personalized, high-quality environment where guests can compete on the court, savor handcrafted cocktails, or simply unwind with friends. Our commitment to experiential hospitality will ensure that every visit is exceptional, whether you are a seasoned player or simply looking to enjoy a great time in a welcoming atmosphere.
Built for Today and Designed for Tomorrow
Easily accessible off I-75 (Royal exit) and also nestled at the intersection of three of Dallas’s beloved trails—Serve & Sip is more than just a pickleball venue; it is a destination. Whether you are walking along the White Rock Creek Trail, biking down Cottonwood Creek Trail, or taking in the scenic views from the Northaven Trail Bridge, all roads lead to Serve & Sip.
This unique location positions Serve & Sip as a natural gathering point for patrons, offering a welcoming space where everyone can find something to enjoy. From fun pickleball activities to leisurely gatherings on the outdoor patio, to social events in our thoughtfully designed indoor spaces, Serve & Sip is crafted to cater to a diverse range of interests. Where some venues might focus on simply filling a space with as many courts as possible, Serve & Sip takes a different approach. We believe that the best pickleball experience is about more than just the game—it is about creating a welcoming atmosphere, nurturing a strong sense of community, and fostering a deep sense of belonging through tailored hospitality. Our venue is designed with both today’s needs and tomorrow’s growth in mind, ensuring that Serve & Sip remains a vibrant, inclusive social hub for years to come.
A Vision for Community Impact
Serve & Sip will capitalize on the booming popularity of pickleball, the fastest growing sport in the U.S. with 13.6 million players nationwide and a 33% compound annual growth rate over the last 5 years. Serve & Sip is set to become a vibrant gathering place for the Dallas community, promoting active lifestyles and fostering social connections. The venue’s location along these key trails offers a natural meeting point for community members to gather, play, and relax in an upscale setting. By easing demand for publicly accessible courts and providing a space where people can enjoy both physical activity and social interaction, Serve & Sip is poised to make a lasting impact on the community.
Collaborative Excellence and Strategic Partnerships
The development of Serve & Sip has been driven by collaboration with the city of Dallas, our capital and private investment partners, and award-winning, renowned hospitality designers, ensuring that every detail of the venue contributes to a highly enjoyable experience. As we approach our grand opening in 2025, we continue to engage with like-minded partners who share our vision for creating vibrant community spaces that stand out in today’s entertainment landscape.
About Serve & Sip
Serve & Sip will become Dallas’s premier indoor-outdoor pickleball entertainment venue, offering a unique blend of sport, social engagement, and experiential hospitality. Opening in 2025, the venue will feature professional-grade courts, and a vibrant social atmosphere, making it the ultimate destination for both pickleball enthusiasts and social seekers alike.
SOURCE Serve & Sip Pickleball Club
Get the latest updates and information on the rapidly growing sport of pickleball, specifically designed for the senior community aged 50+. Check out Sleeve’s Senior Pickleball Report on YouTube to stay informed and up-to-date with the ever-changing world of pickleball. Join the community and stay ahead of the game. https://stmdailynews.com/sleeves-senior-pickleball-report/
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