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The death toll linked to Phillips’ respiratory device recall reached 364 back in April 2021, Philips first began publicizing its issues with its bilevel positive airway pressure machines (BiPAP ) and continuous positive airway pressure machines (CPAP) when concerns were raised over the degrading foam in its DreamStation CPAP machines. Before that point, Philips had only sent 30 medical device reports (MDRs) to the FDA regarding the breakdown of PE-PUR foam in the last decade, now however, there are approximately 99,000 MDRs filed against the devices. Just over the past year, 21,000 MDRs have been filed against the recalled devices with complaints peaking from May to July 2022. Since then, although the rate of complaints has reduced, there has been a rise in the death toll.  Datasets produced by the Food and Drug Administration (FDA) have listed 123 deaths overall in the first year of the recall; between the months of  May to July of that year, the agency listed 45 deaths. The figure for August to October was initially out at 91 but has now gone up to 96 after the company’s review of the MDRs. These are the figures that have been reached after consulting Philips's review of the reports. Since the recall began in the summer of 2021, the rate of deaths per month has only risen each month and as of now, a total of 364 deaths reports have been received. In the final two months of last year alone, 82 deaths have been linked to Phillips’ respiratory device recall. These deaths were reported among the over 800 MDRs that the FDA received between November and December. The most recent figure is yet to be adjusted in light of the firm’s own review, but it is expected that it will be the highest death rate in the dataset. The number of deaths per month has been on the rise. For the last 3 reporting periods, figures rose from 15 to 41. Both Phillips and the FDA, however, have clarified that all the MDRs cannot be linked to the recall. Phillips, in fact, shared the results of its safety tests from last December that covered the majority of the recalled devices and it revealed that the disintegrating foam in the tested recalled devices was unlikely to have been the cause of harm for any patient. The volatile organic compounds released from the foam were not identified as an active threat to patients’ health. “The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury,” Philips said. “Philips Respironics investigates all allegations of technical malfunction serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.” Despite the fact that companies are still rolling out, Philips has continued to work on its repair-and-replace program for its 5.5 million recalled respiratory devices.  In a recent update, the company shared that the production required for the delivery of the replacement device was almost 90% done and that the remediation program will likely finish within this year.  To read more about this topic, click here. 
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Death toll linked to Phillips’ respiratory device recall reaches 364

Editorial Team
  • February 20, 2023
  • 3 min read
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Bioactives from hemp support gut function preclinical data from U.S-based bioactive company, Brightspeed has recently published its findings that two compounds found in hemp hulls, N-trans feruloyl tyramine (NFT) &N-trans caffeoyl-tyramine (NCT), potentially support gut health and improve its function.  The overall health of the human body is impacted by gut health, particularly the immune system and gut-brain axis. Overall gut health is influenced by the gut barrier which allows the absorption of nutrients and provides protection against toxins and pathogens. In fact, it is hypothesized that Increased permeability of the intestinal epithelium (leaky gut) is connected to impaired gut health.  Bioactives are known as the “dark matter” of nutrition and are compounds produced by microbes, plants, and fungi. They are particularly known for growing in adverse conditions and have been known to be used as active ingredients in medicines in the past. The company is in te field of artificial intelligence and biosciences, especially for the purpose of using it to restore human health, Data from the in vitro study was published in the Journal of Food Bioactives, a peer-reviewed journal, and revealed that the two bioactive, NCT and NFT could improve gut barrier function in human primary intestinal epithelial cell culture using RepliGut. When said bioactive interacted with inflamed cells, significant improvement was observed in transepithelial electrical resistance (TEER) and intestinal permeability. The HNF4ɑ protein in the gut is associated with decreased gut barrier integrity and poor intestinal health, while the two bioactive compounds have been known to act as antagonists to the protein and hinder these developments.  Jim Flatt, CEO and co-founder of Brightseed stated "These insights into how NCT and NFT can support gut function, and specifically gut barrier strength by restoring a healthy epithelium barrier, provide a strong foundation for the clinical research that is underway to substantiate the benefits of natural ingredients for personalized and proactive health solutions." It was due to Brightseed’s AI platform Forager that the company was able to find a source for NCT and NFT in hemp hulls. The propriety AI has been known to accelerate biological validation, ingredient formulation, and bioactive discovery not only in gut health but last year the 2 bioactive compounds were also revealed to help clear fat from the liver. This may possibly influence our ability to manage non-alcoholic fatty liver disease (NAFLD) and combatting obesity.  The company also launched Brightseed Bio 01 last year. The project worked to produce and upcycled hemp-based dietary fiber ingredients that could not only optimize the amount of NCT and NFT but also had a similar nutritional profile as the hemp hull.  According to Sofia Elizondo, COO of Brightseed, the company’s experience in advanced metabolomics and computational bioactive discovery will enable it to help the food, beverage, and supplement industry to discover the full scope of bioactive in human health. NCT and NFT have already been observed to effectively supplement the health gains from cereals, granolas, and nutrition bars. To read updated news on Health click here
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Bioactives from hemp support gut function

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  • February 18, 2023
  • 3 min read
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