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Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices

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Agency remains committed to updating public about Philips recalled devices

Today, the U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. More than 17 million masks are impacted by this recall. BiPAP and CPAP machines help people with obstructive sleep apnea, respiratory insufficiency or respiratory failure — health conditions that cause pauses in breathing during sleep. 

What you need to know: 

  • The recalled masks are worn by a person when using a BiPAP or CPAP machine and have magnets that connect the mask components to hold the device in place. 
  • The magnets can potentially affect the functioning of or cause movement of certain implanted metallic medical devices, which could result in injury or death to the mask user or people near the patient wearing the recalled mask, such as a bed partner, who have such devices. Medical devices that could potentially be affected by these magnets include brain stents, aneurysm clips, pacemakers, implantable cardioverter defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants or any metallic implanted medical device affected by magnets. 
  • The magnets could also affect mask users who have metallic objects in their body, such as shrapnel or splinters in their eyes, including people near the patient wearing the affected mask, such as a bed partner.
  • Five mask types are affected by this recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks.
  • To date, Philips reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to use of the recalled masks. The FDA is providing recommendations in a safety communication for patients, caregivers and health care providers concerning use of the recalled masks with magnets, which patients may be using with Philips BiPAP and CPAP machines or those of other manufacturers.

“This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We strongly encourage providers and at-risk patients to review this important safety information and follow our recommended actions to reduce the potential for harm from these products.” 

This recall is not associated with the polyester-based polyurethane (PE-PUR) foam issue for certain ventilators, BiPAP machines and CPAP machines recalled in June 2021. However, this recall affects masks used with some of the devices that were recalled in June 2021.

The FDA is committed to ensuring the public is kept informed of any additional issues regarding these recalled masks and other developments involving the prior recalls of Philips ventilators, CPAP and BiPAP machines. The agency will continue to provide updates when available.

Related Information

Source: FDA

Rod is a blogger, writer, filmmaker, photographer, daydreamer who likes to cook. Rod produces and directs the web series, CUPIC: Diary of an Investigator. He is also the editor, producer and administrator of TNC Network.

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Health

Observing World Cancer Day

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World Cancer Day is an international day marked on 4 February to raise awareness of cancer and to encourage its preventiondetection, and treatment. World Cancer Day is led by the Union for International Cancer Control (UICC) to support the goals of the World Cancer Declaration, written in 2008. The primary goal of World Cancer Day is to significantly reduce illness and death caused by cancer and is an opportunity to rally the international community to end the injustice of preventable suffering from cancer. The day is observed by the United Nations.

World Cancer Day targets misinformation, raises awareness, and reduces stigma. Multiple initiatives are run on World Cancer Day to show support for those affected by cancer. One of these movements are #NoHairSelfie, a global movement to have “hairticipants” shave their heads either physically or virtually to show a symbol of courage for those undergoing cancer treatment. Images of participants are then shared all over social media. Hundreds of events around the world also take place. (wikipedia)

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

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FDA CDC News

Food Safety Tips for Game Day

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/PRNewswire/ — Super Bowl Sunday is coming up and you may be planning a party with friends and family. These parties often involve finger foods, communal dishes, and treats that are left out for long periods of time—which can lead to foodborne illness (also known as food poisoning).  Don’t let foodborne illness ruin the fun. Check out these tips from the U.S. Food and Drug Administration and learn how you can keep your food safe.

Food Safety Tips for Game Day

CLEAN

  • Wash your hands with warm water and soap for at least 20 seconds before and after handling food and after using the bathroom, changing diapers, and handling pets.
  • Wash your cutting boards, dishes, utensils, and counter tops with hot soapy water after preparing each food item.
  • Rinse fresh fruits and vegetables under running tap water, including those with skins and rinds that are not eaten. Scrub firm produce with a clean produce brush.

SEPERATE

  • Separate raw meat, poultry, seafood, and eggs from other foods in your shopping cart, grocery bags, and refrigerator.
  • Use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
  • Never place cooked food on a plate that previously held raw meat, poultry, seafood, or eggs unless the plate has been washed in hot, soapy water.
  • Don’t reuse marinades used on raw foods unless you bring them to a boil first.
  • If baking, make sure that no raw flour is on surfaces that contact other foods.

COOK

  • Use a food thermometer to ensure the safety of meat, poultry, seafood, and egg products. These foods must be cooked to a safe minimum internal temperature to destroy any harmful bacteria.
  • When cooking in a microwave oven, cover food, stir, and rotate for even cooking. If there is no turntable, rotate the dish by hand once or twice during cooking. Always allow standing time, which completes the cooking, before checking the internal temperature with a food thermometer.

CHILL

  • Refrigerate or freeze meat, poultry, eggs, seafood, and other perishables within 2 hours of cooking or purchasing. Refrigerate within 1 hour if the temperature outside is above 90° F.
  • Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator.

SERVE

  • Keep cold foods chilled to 40 °F or below and hot foods heated to 140 °F or above.
  • If you’re planning a buffet and aren’t sure how quickly the food will be eaten, keep serving portions small. Prepare a number of small platters and dishes ahead of time and replace the serving dishes with the fresh ones throughout the party.
  • Don’t add new food to an already filled serving dish. Instead, replace nearly empty serving dishes with freshly filled ones.
  • Watch the clock with leftovers. Whether you’re sending “doggie bags” home with guests or are saving them for yourself, leftovers should be refrigerated as soon as guests arrive home and/or within 2 hours!

Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm328131.htm

SOURCE U.S. Food and Drug Administration

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FDA CDC News

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

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Statement From:Janet Woodcock, M.D.
Principal Deputy Commissioner – Office of the Commissioner

January 26, 2023

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.  

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. 

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

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The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. 

The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literatureinformation submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. 

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

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