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FDA Continues Efforts to Support Innovation in Medical Device Sterilization

Published

2 years ago

August 3, 2022

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

Soft Drinks Recall: Undeclared Ingredients Pose Health Hazards

https://stmdailynews.com/category/lifestyle/health-and-wellness

Author

Rod Washington

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. View all posts

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Diana Gregory Receives Lifetime Achievement Award from AmeriCorps on Behalf of President Biden

Published

1 day ago

December 19, 2024

Rod Washington, Diana Gregory

Honoring Diana Gregory

In a moment that truly embodies the essence of service and community care, Diana Gregory, the visionary founder of Diana Gregory Outreach Services, has been honored with the esteemed Lifetime Achievement Award from AmeriCorps. This award, presented on behalf of President Joe Biden, took place during a heartfelt ceremony at the VA Health Care System in Phoenix, Arizona, organized by the dedicated leadership of The Order of St. George.

Diana’s selection for this distinguished accolade highlights her extraordinary commitment to fostering positive change and improving the lives of those in her community. Over the past decade, she has passionately addressed critical issues like food insecurity and health awareness, focusing on supporting seniors and veterans. Through her organization, Diana Gregory Outreach Services, she has distributed fresh, nutritious produce to thousands, ensuring that those in need have access to healthy food options.

But Diana’s contributions extend far beyond food distribution; she has also implemented vital health education programs that empower individuals and families, helping them to embrace wellness and make informed choices about their health. This holistic approach has created a transformative impact on underserved communities, reinforcing the importance of access to both nutrition and education.

The Lifetime Achievement Award is an honorable recognition reserved for individuals who have dedicated over 4,000 hours of volunteer service. This milestone is a testament to Diana’s proactive engagement and relentless advocacy for those she serves. Her award serves not only as recognition of her achievements but also as an inspiration for others to follow in her footsteps and contribute to their communities.

The Order of St. George, a respected non-profit organization dedicated to providing humanitarian assistance to refugees, veterans, and the Boy Scouts of America, proudly presented the award. Their involvement signifies the collaborative spirit of various organizations working together to uplift and empower individuals in need, underscoring how interconnected our communities truly are.

As we celebrate Diana Gregory’s well-deserved honor, we recognize the countless lives she has touched and the paths she has paved for a brighter, healthier future. Her remarkable efforts highlight the immense power of community service and the difference every individual can make when they dedicate their time and passion to helping others.

To learn more about Diana Gregory Outreach Services and how you can get involved in her inspiring mission, please visit dianagregory.com. Together, let’s continue the legacy of compassion and service that Diana has so beautifully embodied.

Congratulations, Diana Gregory, on this remarkable achievement! Your dedication is a shining example of what it means to be a true leader and advocate for community well-being. Your work inspires us all to be better, do better, and serve better.

To learn more about Diana Gregory, visit https://dianagregory.com/

Authors

Rod Washington

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. View all posts
Diana Gregory

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Mysterious Lights Over Oregon: Pilots Report Unusual Aerial Phenomena

Published

2 days ago

December 19, 2024

Rod Washington

This past weekend, the skies of Oregon became the backdrop for an extraordinary event that has both puzzled and dazzled observers. At least four commercial pilots reported encountering unexplained bright lights displaying incredible speeds and erratic movements, renewing interest and debate about aerial phenomena.

The Encounter Details

The first report came from a pilot operating an air ambulance who described a startling experience. A bright, red light zoomed towards his Life Flight plane, only to reverse direction and head back towards the Pacific Ocean at bewildering speeds. The event left the pilot and his crew astounded by the light’s velocity and abrupt maneuvers.

Meanwhile, the pilot of a United Airlines flight over Eugene also reported seeing multiple mysterious objects. These unidentified lights moved vertically and horizontally in patterns that defied easy explanation, with no evidence of military activity in the area at the time.

Adding to the intrigue, the Life Flight pilot noted that one of the lights engaged in a corkscrew pattern, an observation that was corroborated by the aircraft’s collision avoidance system. Air traffic control, maintaining a cautious approach, authorized the pilot to maneuver as necessary to maintain safety.

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Spotted strange lights in Oregon’s skies? You’re not alone! UFO sightings are on the rise. #OregonUFOSightings #MysteriousLights 🛸✨ ♬ original sound – STMDailyNews

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Visual Evidence and Continued Sightings

Throughout these encounters, several pilots managed to capture brief video clips. These clips, although hard to discern due to the dark conditions, show glimpses of the unusual red, circular lights. Another report from two Horizon Airlines pilots further confirmed that whatever was out there wasn’t isolated to a single incident or observer.

Experts Weigh In: Possible Explanations

In the wake of these mystifying sightings, experts have been quick to offer explanations. Douglas Buettner, a scientist who has researched similar incidents, suggests that these lights could likely be flares from Starlink satellites. Starlink, a constellation designed by SpaceX to provide global broadband coverage, has been known to produce vivid optical flares when its panels reflect sunlight.

Buettner’s research, which includes previous pilot reports and observations, supports the idea that this natural reflection of sunlight could explain the phenomena observed. However, he also admits the current data is insufficient to conclusively rule out other possibilities.

Government and Public Response

Following these reports, the Federal Aviation Administration (FAA) confirmed the sighting of unidentified lights by a pilot, although they have not commented further. In a recent Senate hearing, the Pentagon’s director overseeing unidentified anomalous phenomena indicated a spike in such reports since the launch of satellite constellations like Starlink, underscoring the growing interest and concern regarding these observations.

The Broader Implications

While the most likely explanation for these mysterious lights points to satellite flares, the repeated occurrences of such phenomena continue to stir the public’s imagination and scientific curiosity. As we advance in our technological capabilities, the skies above us grow increasingly populated with human-made objects that can sometimes return to us as bewildering spectacles.

In either case, these events serve as a reminder of the vast and unexplored frontiers above us and the ever-present human quest for understanding the mysteries of our universe. Whether they turn out to be mundane or truly otherworldly, the skies over Oregon this weekend have given us all something to ponder and marvel at.

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Listening for the right radio signals could be an effective way to track small drones

Unidentified drone sightings near sensitive U.S. locations raise public concern. Challenges exist in tracking these drones, necessitating better detection methods and potential regulatory changes for airspace management.

Published

2 days ago

December 19, 2024

The Conversation

radio signal — Small drones can be hard to track at night. Kevin Carter/Getty Images

Iain Boyd, University of Colorado Boulder

The recent spate of unidentified drone sightings in the U.S., including some near sensitive locations such as airports and military installations, has caused significant public concern.

Some of this recent increase in activity may be related to a September 2023 change in U.S. Federal Aviation Administration regulations that now allow drone operators to fly at night. But most of the sightings are likely airplanes or helicopters rather than drones.

The inability of the U.S. government to definitively identify the aircraft in the recent incidents, however, has some people wondering, why can’t they?

I am an engineer who studies defense systems. I see radio frequency sensors as a promising approach to detecting, tracking and identifying drones, not least because drone detectors based on the technology are already available. But I also see challenges to using the detectors to comprehensively spot drones flying over American communities.

How drones are controlled

Operators communicate with drones from a distance using radio frequency signals. Radio frequency signals are widely used in everyday life such as in garage door openers, car key fobs and, of course, radios. Because the radio spectrum is used for so many different purposes, it is carefully regulated by the Federal Communications Commission.

Drone communications are only allowed in narrow bands around specific frequencies such as at 5 gigahertz. Each make and model of a drone uses unique communication protocols coded within the radio frequency signals to interpret instructions from an operator and to send data back to them. In this way, a drone pilot can instruct the drone to execute a flight maneuver, and the drone can inform the pilot where it is and how fast it is flying.

Identifying drones by radio signals

Radio frequency sensors can listen in to the well-known drone frequencies to detect communication protocols that are specific to each particular drone model. In a sense, these radio frequency signals represent a unique fingerprint of each type of drone.

In the best-case scenario, authorities can use the radio frequency signals to determine the drone’s location, range, speed and flight direction. These radio frequency devices are called passive sensors because they simply listen out for and receive signals without taking any active steps. The typical range limit for detecting signals is about 3 miles (4.8 kilometers) from the source.

These sensors do not represent advanced technology, and they are readily available. So, why haven’t authorities made wider use of them? https://www.youtube.com/embed/9yFzdpEqQCs?wmode=transparent&start=0 Drones were all the buzz in the Northeast at the end of 2024.

Challenges to using radio frequency sensors

While the monitoring of radio frequency signals is a promising approach to detecting and identifying drones, there are several challenges to doing so.

First, it’s only possible for a sensor to obtain detailed information on drones that the sensor knows the communication protocols for. Getting sensors that can detect a wide range of drones will require coordination between all drone manufacturers and some central registration entity.

In the absence of information that makes it possible to decode the radio frequency signals, all that can be inferred about a drone is a rough idea of its location and direction. This situation can be improved by deploying multiple sensors and coordinating their information.

Second, the detection approach works best in “quiet” radio frequency environments where there are no buildings, machinery or people. It’s not easy to confidently attribute the unique source of a radio frequency signal in urban settings and other cluttered environments. Radio frequency signals bounce off all solid surfaces, making it difficult to be sure where the original signal came from. Again, the use of multiple sensors around a particular location, and careful placement of those sensors, can help to alleviate this issue.

Third, a major part of the concern over the inability to detect and identify drones is that they may be operated by criminals or terrorists. If drone operators with malicious intent know that an area targeted for a drone operation is being monitored by radio frequency sensors, they may develop effective countermeasures. For example, they may use signal frequencies that lie outside the FCC-regulated parameters, and communication protocols that have not been registered. An even more effective countermeasure is to preprogram the flight path of a drone to completely avoid the use of any radio frequency communications between the operator and the drone.

Finally, widespread deployment of radio frequency sensors for tracking drones would be logistically complicated and financially expensive. There are likely thousands of locations in the U.S. alone that might require protection from hostile drone attacks. The cost of deploying a fully effective drone detection system would be significant.

There are other means of detecting drones, including radar systems and networks of acoustic sensors, which listen for the unique sounds drones generate. But radar systems are relatively expensive, and acoustic drone detection is a new technology.

The way forward

It was almost guaranteed that at some point the problem of unidentified drones would arise. People are operating drones more and more in regions of the airspace that have previously been very sparsely populated.

Perhaps the recent concerns over drone sightings are a wake-up call. The airspace is only going to become much more congested in the coming years as more consumers buy drones, drones are used for more commercial purposes, and air-taxis come into use. There’s only so much that drone detection technologies can do, and it might become necessary for the FAA to tighten regulation of the nation’s airspace by, for example, requiring drone operators to submit detailed flight plans.

In the meantime, don’t be too quick to assume those blinking lights you see in the night sky are drones.

Iain Boyd, Director of the Center for National Security Initiatives and Professor of Aerospace Engineering Sciences, University of Colorado Boulder

This article is republished from The Conversation under a Creative Commons license. Read the original article.