News
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
Transportation
FAA Nationwide Ground Stop Disrupts Thousands of Flights, Exposes Aging Air Traffic Control Infrastructure
FAA nationwide ground stop on November 13, 2026, disrupts U.S. flights and raises concerns about aging air traffic control infrastructure.
Last Updated on November 14, 2026 by Daily News Staff
Major communications and radar disruptions temporarily halted departures across the United States on Friday, raising fresh concerns about the reliability of the nation’s aviation infrastructure.
A major technical failure involving the Federal Aviation Administration’s (FAA) air traffic control systems triggered a nationwide ground stop on Friday, November 13, 2026, disrupting thousands of flights and leaving travelers stranded at airports across the United States.
The FAA temporarily suspended aircraft departures as technicians worked to address communications and radar system problems that threatened the reliability of air traffic control operations.
The nationwide ground stop reportedly began at approximately 3:54 p.m. Eastern Time and was lifted around 8:15 p.m., lasting more than four hours.
Aging Technology Raises Safety Concerns
According to reports, the disruption involved aging telecommunications equipment within the nation’s air traffic control infrastructure.
Transportation Secretary Sean Duffy indicated that older equipment experienced problems as newer technology was integrated into the network, resulting in intermittent communications and radar information failures.
Officials reported no evidence that the outage resulted from a cyberattack.
The incident highlights ongoing concerns about the FAA’s aging infrastructure and the challenges of modernizing critical aviation systems while maintaining safe and reliable operations.
Phoenix Airports Among Those Affected
The disruption also affected air travel throughout Arizona, including Phoenix Sky Harbor International Airport, Phoenix Deer Valley Airport, Phoenix-Mesa Gateway Airport, and Scottsdale Airport.
At Phoenix Sky Harbor, local reports indicated approximately 338 flight delays and 155 cancellations by Friday evening.
Nationwide, early reports indicated more than 10,000 delayed flights and over 4,000 cancellations, with an estimated 1.5 million passengers affected.
Airlines continued working to restore normal schedules after the FAA lifted the ground stop.
Questions Remain About System Reliability
The incident has renewed attention on efforts to replace outdated air traffic control equipment and strengthen the resilience of the national aviation network.
Although departures resumed Friday evening, the disruption raised important questions about whether the FAA’s existing infrastructure can adequately support growing air traffic demands.
Federal aviation officials are expected to continue evaluating the failure and measures needed to prevent similar nationwide disruptions.
For travelers, the incident serves as a reminder that a technical problem affecting the nation’s aviation network can quickly create widespread delays, cancellations, and travel uncertainty.
STM Daily News — News You Can Use This Moment!
Sources and Further Information
Last Updated on November 13, 2026 by Daily News Staff
STM Daily News | November 12, 2026
Graffiti Cleanup Transforms Oceanwide Plaza
LOS ANGELES — The unfinished skyscrapers known as downtown Los Angeles’ “Graffiti Towers” have reached a visible milestone: most of the exterior tagging has been removed, although completing the long-stalled Oceanwide Plaza development remains a separate challenge.
City officials celebrated the cleanup November 12. According to the mayor’s office, crews cleared graffiti from roughly 250 balconies across the three-tower complex opposite Crypto.com Arena and near the Los Angeles Convention Center. Remaining work has included touch-ups on windows and other exterior areas.
Oceanwide Plaza was envisioned as a mixed-use destination with residences, a luxury hotel, shops and restaurants. Construction stopped in 2019 after Beijing-based developer Oceanwide Holdings could no longer finance the project.
In early 2024, trespassers covered the unfinished towers with graffiti, turning them into an internationally recognized sight. The property also attracted dangerous stunts and heightened concerns about security.
The development entered bankruptcy in February 2024. This July, a bankruptcy court approved a purchase arrangement involving KPC Square, a joint venture between KPC Group and Lendlease. Graffiti removal began while the acquisition was still pending.
What Comes Next for LA’s Graffiti Towers?
The partnership is targeting a January 2027 closing, according to the Los Angeles Business Journal. Financing, a construction contract and required approvals remain important steps before the development can be completed.
For downtown residents and businesses, the cleanup marks tangible progress at a prominent property. However, it does not mean the towers are ready to open, and no firm opening date has been announced.
Sources
- Los Angeles Mayor’s Office, November 12, 2026: https://mayor.lacity.gov/news/mayor-bass-celebrates-graffiti-removal-oceanwide-plaza-clearing-way-full-restoration-and
- Los Angeles Business Journal, November 9, 2026: https://labusinessjournal.com/real-estate/cleaning-up-oceanwide/
- City News Service / MyNewsLA, November 12, 2026: https://mynewsla.com/life/2026/11/12/graffiti-cleanup-milestone-marked-at-oceanwide-plaza-in-downtown-la/
Forgotten Genius Fridays
David Crosthwait: The Engineer Behind Indoor Comfort
David Crosthwait helped solve the challenges of heating large buildings, including Radio City Music Hall. Explore his inventions and lasting engineering legacy.
Forgotten Genius | STM Daily News
When audiences enter New York’s Radio City Music Hall, they notice the stage, the lights, and the sweeping auditorium. The engineering that keeps the building comfortable rarely receives applause.
One of the people behind that comfort was David Nelson Crosthwait Jr., a Black engineer and inventor whose work helped advance heating, ventilation, and temperature control in large buildings.
His career offers a reminder that some of the most useful inventions work quietly around us.
Solving the Problem of Heating Large Buildings
Heating a large building takes more than producing enough heat. Different areas can have different needs: one side may face bitter wind while another receives warming sunlight. Delivering the right amount of heat throughout the building requires careful control.
Crosthwait devoted much of his career to those challenges. A Purdue University engineering graduate, he worked for the C.A. Dunham Company, developing equipment and systems for heating and ventilation.
His inventions included improvements to boilers, thermostat controls, and vacuum pumps. These components helped engineers manage the movement and regulation of heat in larger buildings.
One example appears in U.S. Patent No. 1,727,965, granted in 1929. The patent describes a vacuum steam-heating system designed to serve different sections of a building at different steam pressures. That allowed the system to address varying heating needs while using a shared steam source.
Behind the technical drawing was a practical question: How could one building provide comfortable conditions in spaces that needed different amounts of heat?
His Connection to Radio City Music Hall
Crosthwait’s best-known projects included designing the steam-heating system for Radio City Music Hall at Rockefeller Center.
It was a fitting assignment for an engineer whose expertise centered on the demands of large buildings. While performers entertained audiences, the systems behind the scenes helped make the experience comfortable.
His contributions extended across a substantial body of work. The National Inventors Hall of Fame credits him with 39 U.S. patents and 80 international patents, spanning heating, refrigeration, controls, and other technologies.
Sharing Knowledge and Breaking Barriers
Crosthwait also helped other engineers learn. He wrote technical material, contributed to engineering guides, and later taught steam-heating theory and control systems at Purdue.
In 1971, he became the first Black Fellow of the American Society of Heating, Refrigerating and Air-Conditioning Engineers. Purdue awarded him an honorary doctorate in 1975, and the National Inventors Hall of Fame inducted him in 2014.
His legacy rests in the practical details of engineering: controlling pressure, improving equipment, and making complicated systems work together.
The next time you settle into a comfortable auditorium on a cold evening, consider the ingenuity behind that warmth. David Crosthwait helped make indoor comfort an engineering achievement worth remembering.
Discover more inventors and innovators through the Forgotten Genius series in The Knowledge at STM Daily News.
Related Links
- National Inventors Hall of Fame: David Crosthwait — Biography covering his inventions, patent totals, Radio City Music Hall work, teaching, and professional honors.
- Rockefeller Center: A Rock Center Innovator — Highlights his role in designing Radio City Music Hall’s steam-heating system.
- Original 1929 Patent: U.S. Patent No. 1,727,965 — Technical drawings and Crosthwait’s description of a steam-heating system serving different building sections at different pressures.
- Purdue University Libraries: Historical Timeline — Documents his 1913 graduation and contributions to heating, ventilation, and air conditioning.
Sources: National Inventors Hall of Fame, Rockefeller Center, Purdue University Libraries, and U.S. Patent No. 1,727,965.
