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.
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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.
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
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.
Harkins Theatres Announces Rob Reiner Tribute Screening on December 17
Rob Reiner Tribute: Harkins Theatres will host a special $5 screening of The American President on December 17 to honor filmmaker Rob Reiner, with all proceeds benefiting the Human Rights Campaign.
Harkins Theatres Announces Rob Reiner Tribute Screening of The American President
Harkins Theatres has announced a special one-day tribute screening honoring acclaimed filmmaker Rob Reiner, celebrating his life’s work and cinematic legacy.
On December 17, select Harkins locations will screen Reiner’s 1995 political romance The American President, with all proceeds benefiting the Human Rights Campaign. Tickets are priced at $5, making the event both an accessible film experience and a charitable fundraiser.
The tribute was announced via Harkins’ official, verified social media accounts and is positioned as a legacy celebration, not a memorial.
🎥 Why The American President?
Released in 1995 and written by Aaron Sorkin, The American President stars Michael Douglas and Annette Bening and remains one of Rob Reiner’s most politically resonant films. The movie blends romance, idealism, and civic responsibility — themes that have consistently appeared throughout Reiner’s career.
The film later served as a creative blueprint for The West Wing, cementing its place in modern political storytelling.
Rob Reiner’s career spans more than five decades, including landmark films such as:
This Is Spinal Tap
Stand By Me
The Princess Bride
When Harry Met Sally…
Misery
A Few Good Men
His work is often praised for balancing entertainment, empathy, and social conscience, making tribute events like this especially meaningful to longtime audiences.
Hollywood Legend Rob Reiner and Wife Found Dead; Son in Custody
Renowned filmmaker Rob Reiner and his wife, Michele Singer Reiner, were found dead in their Los Angeles home in a reported homicide. Police have arrested their son in connection with the case, and tributes are pouring in.
Director Rob Reiner participates in a discussion following a screening of the film LBJ at the LBJ Presidential Library in Austin, Texas on Saturday October 22, 2016 On Saturday evening October 22, 2016, the LBJ Presidential Library held a sneak peek of Rob Reiner’s new filmÊLBJ, starring Woody Harrelson as the 36th president. The film, which premiered at the Toronto International Film Festival in September, chronicles the life and times of Lyndon Johnson who would inherit the presidency at one of the most fraught moments in American history. Following the screening, director Rob Reiner, actor Woody Harrelson, and writer Joey Hartstone joined LBJ Library Director Mark Updegrove on stage for a conversation about the film. LBJ Library photo by Jay Godwin 10/22/2016
Hollywood Legend Rob Reiner and Wife Found Dead; Son in Custody
December 15, 2025
Renowned filmmaker and actor Rob Reiner, 78, and his wife Michele Singer Reiner, 68, were found dead in their Brentwood, Los Angeles home on Sunday, authorities say. Emergency responders were called to the residence Sunday afternoon, where both were discovered with fatal wounds consistent with a stabbing. Police are treating the case as a double homicide.
Los Angeles police arrested the couple’s 32-year-old son, Nick Reiner, in connection with the deaths. He is being held in custody as investigators continue to piece together the circumstances surrounding the incident.
2016 SAMHSA Voice Awards
Reiner was one of Hollywood’s most influential figures, known for his work as a director, producer and actor. His career spanned decades, from early television fame to directing beloved films that shaped American cinema.
Friends, colleagues and public figures have begun sharing tributes and reactions to the news as the investigation is ongoing.
More details will be updated as they become available.
FDA’s COVID-19 Vaccine Safety Claims Lack Solid Evidence—Why Overreaction Could Harm Public Health
COVID-19 vaccine safety: The FDA’s claims about COVID-19 vaccine deaths in children lack strong evidence and could restrict vaccine access. Learn why experts say VAERS reports aren’t proof, and how overreacting may harm public health and trust in vaccines.
The death of children due to an unsafe vaccine is a serious allegation. I am a pediatric cardiologist who has studied the link between COVID-19 vaccines and heart-related side effects such as myocarditis in children. To my knowledge, studies to date have shown such side effects are rare, and severe outcomes even more so. However, I am open to new evidence that could change my mind. But without sufficient justification and solid evidence, restricting access to an approved vaccine and changing well-established procedures for testing vaccines would carry serious consequences. These moves would limit access for patients, create roadblocks for companies and worsen distrust in vaccines and public health. In my view, it’s important for people reading about these FDA actions to understand how the evidence on a vaccine’s safety is generally assessed.
Determining cause of death
The FDA memo claims that the deaths of these children were directly related to receiving a COVID-19 immunization. From my perspective as a clinician, it is awful that any child should die from a routine vaccination. However, health professionals like me owe it to the public to uphold the highest possible standards in investigating why these deaths occurred. If the FDA has evidence demonstrating something that national health agencies worldwide have missed – widespread child deaths due to myocarditis caused by the COVID-19 vaccine – I don’t doubt that even the most pro-vaccine physician will listen. So far, however, no such evidence has been presented. While a death logged in VAERS is a starting point, on its own it is insufficient to conclude whether a vaccine caused the death or other medical causes were to blame. To demonstrate a causal link, FDA staff and physicians must align the VAERS report with physicians’ assessments of the patient, as well as data from other sources for monitoring vaccine safety. These include PRISM, which logs insurance claims data, and the Vaccine Safety Datalink, which tracks safety signals in electronic medical records. It’s known that most deaths logged only in VAERS of children who recently received vaccines have been incorrectly attributed to the vaccines – either by accident or in some cases on purpose by anti-vaccine activists.
Heart-related side effects of COVID-19 vaccines
In his Substack and Twitter accounts, Prasad has said that he believes the rate of severe cardiac side effects after COVID-19 vaccination is severely underestimated and that the vaccines should be restricted far more than they currently are. In a July 2025 presentation, Prasad quoted a risk of 27 cases per million of myocarditis in young men who received the COVID-19 vaccine. A 2024 review suggested that number was a bit lower – about 20 cases out of 1 million people. But that same study found that unvaccinated people had greater risk of heart problems after a COVID-19 infection than vaccinated people. In a different study, people who got myocarditis after a COVID-19 vaccination developed fewer complications than people who got myocarditis after a COVID-19 infection. Existing vaccine safety infrastructure in the U.S. successfully identifies dangers posed by vaccines – and did so during the COVID-19 pandemic. Today, most COVID-19 vaccines in the U.S. rely on mRNA technology. But as vaccines were first emerging during the COVID-19 pandemic, two pharmaceutical companies, Janssen and AstraZeneca, rolled out a vaccine that used a different technology, called a viral vector. This type of vaccine had a very rare but genuine safety problem that was detected.A report in VAERS is at most a first step to determining whether a vaccine caused harm. VAERS, the Vaccine Safety Datalink, clinical investigators in the U.S. and their European counterparts detected that these vaccines did turn out to cause blood clotting. In April 2021, the FDA formally recommended pausing their use, and they were later pulled from the market. Death due to myocarditis from COVID-19 vaccination is exceedingly rare. Demonstrating that it occurred requires proof that the person had myocarditis, evidence that no other reasonable cause of death was present, and the absence of any additional cause of myocarditis. These factors cannot be determined from VAERS data, however – and to date, the FDA has presented no other relevant data.
A problematic vision for future vaccine approvals
Currently, vaccines are tested both by seeing how well they prevent disease and by how well they generate antibodies, which are the molecules that help your body fight viruses and bacteria. Some vaccines, such as the COVID-19 vaccine and the influenza vaccine, need to be updated based on new strains. The FDA generally approves these updates based on how well the new versions generate antibodies. Since the previous generation of vaccines was already shown to prevent infection, if the new version can generate antibodies like the previous one, researchers assume its ability to prevent infection is comparable too. Later studies can then test how well the vaccines prevent severe disease and hospitalization. The FDA memo says this approach is insufficient and instead argues for replacing such studies with many more placebo-controlled trials – not just for COVID-19 vaccines but also for widely used influenza and pneumonia vaccines. That may seem reasonable theoretically. In practice, however, it is not realistic. Today’s influenza vaccines must be changed every season to reflect mutations to the virus. If the FDA were to require new placebo-controlled trials every year, the vaccine being tested would become obsolete by the time it is approved. This would be a massive waste of time and resources.Influenza vaccines must be updated for every flu season.Jacob Wackerhausen/iStock via Getty Images Plus Also, detecting vaccine-related myocarditis at the low rate at which it occurs would have required clinical trials many times larger than the ones that were done to approve COVID-19 mRNA vaccines. This would have cost at least millions of dollars more, and the delay in rolling out vaccines would have also cost lives. Placebo-controlled trials would require comparing people who receive the updated vaccine with people who remain unvaccinated. When an older version of the vaccine is already available, this means purposefully asking people to forgo that vaccine and risk infection for the sake of the trial, a practice that is widely considered unethical. Current scientific practice is that only a brand-new vaccine may be compared against placebo. While suspected vaccine deaths should absolutely be investigated, stopping a vaccine for insufficient reasons can lead to a significant drop in public confidence. That’s why it’s essential to thoroughly and transparently investigate any claims that a vaccine causes harm.
