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FDA Continues Efforts to Support Innovation in Medical Device Sterilization
Last Updated on June 26, 2024 by Daily News Staff
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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The Long Track Back
Why Downtown Los Angeles Feels Small Compared to Other Cities
Downtown Los Angeles often feels “small” compared to other U.S. cities, but that’s only part of the story. With some of the tallest buildings west of the Mississippi and skyline clusters spread across the region, LA’s downtown reflects the city’s unique polycentric identity—one that, if combined, could form a true mega downtown.
Last Updated on February 18, 2026 by Daily News Staff
Panorama of Los Angeles from Mount Hollywood – California, United States
When people think of major American cities, they often imagine a bustling, concentrated downtown core filled with skyscrapers. New York has Manhattan, Chicago has the Loop, San Francisco has its Financial District. Los Angeles, by contrast, often leaves visitors surprised: “Is this really downtown?”
The answer is yes—and no.
Downtown LA in Context
Compared to other major cities, Downtown Los Angeles (DTLA) is relatively small as a central business district. For much of the 20th century, strict height restrictions capped most buildings under 150 feet, while cities like Chicago and New York were erecting early skyscrapers. LA’s skyline didn’t really begin to climb until the late 1960s.
But history alone doesn’t explain why DTLA feels different. The real story lies in how Los Angeles grew: not as one unified city center, but as a collection of many hubs.
Downtown Los Angeles
A Polycentric City
Los Angeles is famously decentralized. Hollywood developed around the film industry. Century City rose on former studio land as a business hub. Burbank became a studio and aerospace center. Long Beach grew around the port. The Wilshire Corridor filled with office towers and condos.
Unlike other cities where downtown is the place for work, culture, and finance, Los Angeles spread its energy outward. Freeways and car culture made it easy for businesses and residents to operate outside of downtown. The result is a polycentric metropolis, with multiple “downtowns” rather than one dominant core.
A Resident’s Perspective
As someone who lived in Los Angeles for 28 years, I see DTLA differently. While some outsiders describe it as “small,” the reality is that Downtown Los Angeles is still significant. It has some of the tallest buildings west of the Mississippi River, including the Wilshire Grand Center and the U.S. Bank Tower. Over the last two decades, adaptive reuse projects have transformed old office buildings into lofts, while developments like LA Live, Crypto.com Arena, and the Broad Museum have revitalized the area.
In other words, DTLA is large enough—it just plays a different role than downtowns in other American cities.
View of Westwood, Century City, Beverly Hills, and the Wilshire Corridor.
The “Mega Downtown” That Isn’t
A friend once put it to me with a bit of imagination: “If you could magically pick up all of LA’s skyline clusters—Downtown, Century City, Hollywood, the Wilshire Corridor—and drop them together in one spot, you’d have a mega downtown.”
He’s right. Los Angeles doesn’t lack tall buildings or urban energy—it just spreads them out over a vast area, reflecting the city’s unique history, geography, and culture.
A Downtown That Fits Its City
So, is Downtown LA “small”? Compared to Manhattan or Chicago’s Loop, yes. But judged on its own terms, DTLA is a vibrant hub within a much larger, decentralized metropolis. It’s a downtown that reflects Los Angeles itself: sprawling, diverse, and impossible to fit neatly into the mold of other American cities.
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Century City: From Hollywood Backlot to Business Hub
Century City, originally part of 20th Century Fox’s backlot, transformed into a prominent business district in Los Angeles during the 1950s amid the decline of cinema. Developer William Zeckendorf envisioned a mixed-use urban center, leading to iconic skyscrapers and establishing the area as a hub for law, finance, and media, blending Hollywood history with modern business.
Before Century City became one of Los Angeles’ premier business districts, it was part of 20th Century Fox’s sprawling backlot, used for filming movies and housing studio operations. By the 1950s, as television rose and movie attendance declined, 20th Century Fox faced financial challenges and decided to sell a portion of its land.
Developer William Zeckendorf envisioned a “city within a city”—a modern, mixed-use urban center with office towers, hotels, and entertainment facilities. Branded Century City, the name paid homage to its studio roots while symbolizing LA’s vision for the future.
The first skyscrapers, including the Gateway West Building, set the tone for the district’s sleek, futuristic skyline. Architects like Welton Becket and Minoru Yamasaki helped shape Century City’s iconic look. Over time, it evolved from Hollywood’s backlot to a corporate and legal hub, attracting law firms, financial institutions, and media companies.
Today, Century City stands as a testament to Los Angeles’ postwar optimism, westward expansion, and multi-centered urban growth—a unique blend of Hollywood history and modern business.
Related STM Daily News Links:
- The Evolution of Los Angeles Public Transportation
- Why Los Angeles Grew Into a Sprawling City
- Downtown Los Angeles: Past, Present, and Future
Dive into “The Knowledge,” where curiosity meets clarity. This playlist, in collaboration with STMDailyNews.com, is designed for viewers who value historical accuracy and insightful learning. Our short videos, ranging from 30 seconds to a minute and a half, make complex subjects easy to grasp in no time. Covering everything from historical events to contemporary processes and entertainment, “The Knowledge” bridges the past with the present. In a world where information is abundant yet often misused, our series aims to guide you through the noise, preserving vital knowledge and truths that shape our lives today. Perfect for curious minds eager to discover the ‘why’ and ‘how’ of everything around us. Subscribe and join in as we explore the facts that matter. https://stmdailynews.com/the-knowledge/
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Local governments provide proof that polarization is not inevitable
Local politics help mitigate national polarization by focusing on concrete issues like infrastructure and community needs rather than divisive symbolic debates. A survey indicates that local officials experience less partisanship, as interpersonal connections foster recognition of shared interests. This suggests that reducing polarization is possible through collaboration and changes in election laws.
Lauren Hall, Rochester Institute of Technology
When it comes to national politics, Americans are fiercely divided across a range of issues, including gun control, election security and vaccines. It’s not new for Republicans and Democrats to be at odds over issues, but things have reached a point where even the idea of compromising appears to be anathema, making it more difficult to solve thorny problems.
But things are much less heated at the local level. A survey of more than 1,400 local officials by the Carnegie Corporation and CivicPulse found that local governments are “largely insulated from the harshest effects of polarization.” Communities with fewer than 50,000 residents proved especially resilient to partisan dysfunction.
Why this difference? As a political scientist, I believe that lessons from the local level not only open a window onto how polarization works but also the dynamics and tools that can help reduce it.
Problems are more concrete
Local governments deal with concrete issues – sometimes literally, when it comes to paving roads and fixing potholes. In general, cities and counties handle day-to-day functions, such as garbage pickup, running schools and enforcing zoning rules. Addressing tangible needs keeps local leaders’ attention fixed on specific problems that call out for specific solutions, not lengthy ideological debates.
By contrast, a lot of national political conflict in the U.S. involves symbolic issues, such as debates about identity and values on topics such as race, abortion and transgender rights. These battles are often divisive, even more so than purely ideological disagreements, because they can activate tribal differences and prove more resistant to compromise.
Such arguments at the national level, or on social media, can lead to wildly inaccurate stereotypes about people with opposing views. Today’s partisans often perceive their opponents as far more extreme than they actually are, or they may stereotype them – imagining that all Republicans are wealthy, evangelical culture warriors, for instance, or conversely being convinced that all Democrats are radical urban activists. In terms of ideology, the median members of both parties, in fact, look similar.
These kinds of misperceptions can fuel hostility.
Local officials, however, live among the human beings they represent, whose complexity defies caricature. Living and interacting in the same communities leads to greater recognition of shared interests and values, according to the Carnegie/CivicPulse survey.
Meaningful interaction with others, including partisans of the opposing party, reduces prejudice about them. Local government provides a natural space where identities overlap.
People are complicated
In national U.S. politics today, large groups of individuals are divided not only by party but a variety of other factors, including race, religion, geography and social networks. When these differences align with ideology, political disagreement can feel like an existential threat.
Such differences are not always as pronounced at the local level. A neighbor who disagrees about property taxes could be the coach of your child’s soccer team. Your fellow school board member might share your concerns about curriculum but vote differently in presidential elections.
These cross-cutting connections remind us that political opponents are not a monolithic enemy but complex individuals. When people discover they have commonalities outside of politics with others holding opposing views, polarization can decrease significantly.
Finally, most local elections are technically nonpartisan. Keeping party labels off ballots allows voters to judge candidates as individuals and not merely as Republicans or Democrats.
National implications
None of this means local politics are utopian.
Like water, polarization tends to run downhill, from the national level to local contests, particularly in major cities where candidates for mayor and other office are more likely to run as partisans. Local governments also see culture war debates, notably in the area of public school instruction.
Nevertheless, the relative partisan calm of local governance suggests that polarization is not inevitable. It emerges from specific conditions that can be altered.
Polarization might be reduced by creating more opportunities for cross-partisan collaboration around concrete problems. Philanthropists and even states might invest in local journalism that covers pragmatic governance rather than partisan conflict. More cities and counties could adopt changes in election law that would de-emphasize party labels where they add little information for voters.
Aside from structural changes, individual Americans can strive to recognize that their neighbors are not the cardboard cutouts they might imagine when thinking about “the other side.” Instead, Americans can recognize that even political opponents are navigating similar landscapes of community, personal challenges and time constraints, with often similar desires to see their roads paved and their children well educated.
The conditions shaping our interactions matter enormously. If conditions change, perhaps less partisan rancor will be the result.
Lauren Hall, Associate professor of Political Science, Rochester Institute of Technology
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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