Shortly after arriving as medical director at Philips four years ago, Hisham Elzayat faced an internal crisis that threatened one of the world’s largest makers of breathing machines. The longtime heart surgeon had pored over a spate of complaints about the company's best-selling devices, which were filled with an industrial foam capable of breaking down into tiny particles and fumes. When inhaled, the toxic material could move through the nose and sinus cavity and into the lungs, a stealth intruder that threatened incalculable harm. After meeting with a top Philips biosafety engineer who also expressed concerns, the 46-year-old doctor said he had seen enough. In June 2020, he pushed to stop all shipping of the devices from the company's factories near Pittsburgh and pressed to meet with one of the company's most powerful executives to take on what he called an unfolding emergency. "I have made my safety concerns known," he recalled in an internal complaint. But the company turned down his request to halt the deliveries and instead ratcheted up sales of its CPAPs and ventilators during the throes of the pandemic while Philips took in hundreds of millions of dollars in revenue. Dr. Elzayat’s internal battle to pull the machines off the shelves is detailed in hundreds of pages of company emails, text messages and reports that have been turned over to federal prosecutors as part of a criminal investigation of the leadership of the company, according to sources with direct knowledge of the probe. The confidential documents, which have been obtained by the Post-Gazette, show for the first time the surgeon was among nearly a dozen Philips engineers and others who pushed the company to warn patients about the dangers of the foam before Philips removed millions of the devices from the market in a recall in June 2021 and to later stop the company from downplaying the risks.
Pittsburgh Post-Gazette’s Post
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Philips: How fast can things go wrong? If you are working in the medical device field, you might be familiar with the significant device recall by Philips impacting millions of ventilator devices in recent years. But how can a product be in the market for an extended period without major issues, only to suddenly pose significant risks leading to injuries and fatalities that prompt a mass recall? In today's video, we delve into a timeline of events culminating in the class action lawsuits in US, Canada, and the EU! #Philips #MedicalDevices #DeviceRecall #Ventilators #HealthcareSafety #MedicalDeviceField #ProductSafety #ClassActionLawsuits #Healthcare #PatientSafety #MedicalTechnology #DeviceRegulation #HealthTech #RegulatoryAffairs #ProductRecall #HealthcareIndustry
What happened during the infamous Philips recall?
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Healthcare Product Compliance Professional | Regulatory Affairs & Quality Assurance | R&D Enthusiast | Software Fanatic
No. of #DeviceProblems reported: ~116,000 No. of #deaths caused: ~561 No. of #CPAP, #BiPAP and other #ventilator devices recalled: ~15 million... Initial estimated #settlements to be paid by Philips: ~$4.5 billion... Dutch MedTech colossus Philips arrives at a $1.1 billion deal to settle lawsuits (personal injury claims) and a $613 million deal to settle economic losses in the US relating to potentially faulty breathing devices. Philips said it did NOT “admit any fault or #liability, or that any #injuries were caused" by the devices. However, the company said in a statement that the settlement was made to "end the uncertainty associated with litigation in the US." ProPublica and the Pittsburgh Post-Gazette Advertising conducted an investigation in 2023, revealing that Phillips had kept #complaints about the foam concealed for more than #ten years prior to issuing a warning to customers. Furthermore, the FDA has accused Philips of failing to adequately address the risks associated with the deteriorating #foam in its CPAP and ventilator devices, despite being aware of these #risks as early as 2015. Concurrently, the FDA has clarified that further #investigation is necessary to substantially prove that Philips' devices caused the injuries/deaths. Sales of Philips' popular #DreamStation and other respiratory units in the U.S. are presently #suspended. The company has stated its intention to recommence sales once it fulfils the requirements outlined in a #ConsentDecree with the Government of USA. Checkout the #timeline of the events that unfolded here: https://lnkd.in/gXM3QKAe Honestly, it's a challenge for an unbiased interpretation. Who is liable? Did the patients suffer injuries/die from unrelated causes? Philips Respironics to be blamed? Design and Development failure? QMS breakdown? Ineffective CAPA? Philips in denial? Why did a re-recall happen, despite Philips performing "sufficient" data analysis? End users at fault? What is the plan of action for faulty devices sold outside US? Nevertheless, patients who suspect they own or use one of the affected devices should look up Philips' recall page; it offers ways to check serial numbers and register a product: https://lnkd.in/gsn9C5nE
Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices
usa.philips.com
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Chuck Ventura thank you for sharing. A few thoughts come to mind. 1. Generally speaking, we are not using appropriate statistical techniques for early signal detection in our industry. “Trending and monitoring” is not sufficient for detecting low frequency signals with a high potential severity. 2. We seem to be not monitoring adverse events data on similar competitive products. Knowledge of adverse events with similar devices can help us to activley identify new risks and and take preventive action. Further we need to be updating our risk files when such information becomes available. 3. We seem to be missing a lot of information posted on social media that could be considered a complaint. 4. Post market surveillance is not a check the box activity. It should be treated as a business process that continually evaluates emerging risk to facilitate timely action. 5. Finally discontinuing a profitable product is not an easy decision. Seems to me that the senior executives could not see a way out of this situation. I don’t really buy the official reason related to supply chain challenges. To me it seems that it was too late for them to turn the public opinion and regulatory scrutiny around. 6. That is why post market surveillance has to be an ACTIVE process. I am pretty sure if they could foresee these issues much before the Philips story escalated in public, they might be able to take preventive action. =============================== Like this post? Follow me Naveen Agarwal, Ph.D. Agarwal, Ph.D. and hit the 🔔 so you don't miss my posts.
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🤔 Are We Doing Enough to Address Hidden Risks in Our Medical Devices? In light of recent developments with Drive DeVilbiss Healthcare's discontinuation of its popular sleep apnea devices, it's good to revisit the importance of robust risk management practices in the medical device industry, mainly through the lens of ISO 14971. ISO 14971 provides a framework for manufacturers to identify hazards associated with medical devices, including those related to materials and components, to estimate and evaluate associated risks, to control these risks, and to monitor the effectiveness of the controls. The situation with Drive DeVilbiss, similar to the earlier Philips Respironics recall, underscores the critical need for ongoing risk analysis and management throughout a product's lifecycle. Both instances involved the degradation of polyester-based polyurethane foam, which could potentially release harmful particles and gases, posing a significant risk to patients. These cases highlight the importance of thorough material selection, continuous monitoring for any signs of material degradation, and timely and transparent communication with regulators and the public. For medical device manufacturers, ISO 14971 offers a systematic approach to managing these risks, emphasizing the need for a dynamic risk management process that doesn't just end post-market but continues as long as the product is in use. It serves as a reminder that patient safety must always be the paramount concern and that robust risk management is not just a regulatory requirement but a moral imperative. As industry professionals, let's take this as a learning opportunity to reinforce our commitment to upholding the highest safety standards, ensuring that our practices align with ISO 14971 to manage and mitigate risks effectively, and to maintain the trust of the patients and healthcare providers we serve. Navigating risk management for medical devices is difficult, but can we enhance our processes to better identify and mitigate these complex "silent" risks? Your insights are invaluable, so please share your thoughts in the comments below! Link to full article here 👉 https://lnkd.in/g6v2uaE9 #MedicalDevices #RiskManagement #ISO14971 #PatientSafety #designcontrol #combinationproducts #medicaldevice #medicaldevices
Safety concerns emerge over breathing machines at another Pennsylvania medical device maker
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All tweets are my personal opinion and do not represent any of the various companies or agencies.
Federal law requires medical devise makers, within 30 days, to investigate all reports of patient injuries, deaths & malfunctions that have the potential to cause harm & to submit these reports to the FDA, which oversees medical devices. Instead, Philips kept complaints about its top selling Continuous Positive Airway Pressure (CPAP) breathing machines secret while stock prices soared to their highest levels in decades. A ProPublica & Pittsburgh Post-Gazette analysis of tens of 1000s of reports shows that Philips withheld from the FDA more than 3,700 complaints received over 11 years. The company did not launch a formal investigation of the problem until 2019–9 years after the first wave of complaints—& 3 years after the company’s first known tests found that the device’s noise silencing foam was degrading. These tainted CPAP machines & ventilators went to children, the elderly & at least 700k veterans despite the company’s internal warnings said the devices posed an “unacceptable” risk. The complaints just piled up in company files while Philips waged aggressive global marketing campaigns to not only sell more of the machines at issue, but to even add new models fitted with the same hazardous foam. https://lnkd.in/eQfii-2J
Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared — ProPublica
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𝗪𝗵𝗮𝘁 𝗮 𝘄𝗮𝘀𝘁𝗲 𝗼𝗳 𝗴𝗿𝗲𝗮𝘁 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹…🙄 For way too long, the Philips Brightview XCT has been in our stock. All bored and wasting its capabilities. Instead it should be in someone's clinic or hospital ensuring a high patient throughput. 😍 Some of the benefits you’ll experience with this system is: ⚙️ 𝗖𝗿𝘆𝘀𝘁𝗮𝗹-𝗖𝗹𝗲𝗮𝗿 𝗜𝗺𝗮𝗴𝗲𝘀, 𝗟𝗼𝘄𝗲𝗿 𝗗𝗼𝘀𝗲: you can get unparalleled image quality at minimal radiation doses. ⚙️ 𝗦𝘁𝗿𝗲𝘀𝘀-𝗙𝗿𝗲𝗲 𝗖𝗮𝗿𝗱𝗶𝗮𝗰 𝗦𝗰𝗮𝗻𝘀: this system allows your patients to breathe easy with no-hold while having a full-heart scan in a single rotation. ⚙️ 𝗦𝗽𝗮𝗰𝗲-𝗦𝗮𝘃𝗶𝗻𝗴 𝗗𝗲𝘀𝗶𝗴𝗻: it makes it easy to upgrade to advanced CT without the need for a big space or major remodels. It fits into fairly small rooms. Reach out to our team at sales@lbnmedical.com: "sales [at] lbnmedical [dot] com" for more information on this system.😊 #xct #excellence #imagingequipment #lbnmedical
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Hey connections!! I recently had the opportunity to use the Audiometer, and I wanted to share my experience with this innovative device. 🔊 Sound Quality & Precision The Audiometer excels in delivering accurate and precise measurements. Its high-quality sound calibration ensures that the results are reliable, which is crucial for both diagnostic and screening purposes. 🖥️ User Interface The user interface is intuitive and user-friendly. The touch screen display is responsive, and the layout makes it easy to navigate through different tests and settings. ⚙️ Features & Functionality With its wide range of test options and customizable settings, the Audiometer meets the needs of various clinical and research applications. The device also supports multiple languages, which is a big plus for international use. 🔋 Portability & Battery Life The compact design and long battery life make it a perfect choice for mobile clinics and on-the-go audiometric testing. It’s lightweight and easy to carry around. 🛠️ Support & Training The customer support team is responsive and knowledgeable. The training materials provided are comprehensive, making it easy for new users to get up to speed quickly. 📊 Data Management The integration with electronic health records (EHR) systems is seamless, allowing for efficient data management and patient record keeping. Overall, the ABC Audiometer is a top-tier choice for audiologists and hearing professionals looking for accuracy, reliability, and ease of use. I highly recommend it! #Audiology #HearingHealth #MedicalDevices #ProductReview #HealthcareTechnology #Nimhans
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In this video Dr. Lieven Vergote, Head of Emergency Medical Services, shares about the challenges he faces with pulse oximetry finger sensors. And Mr. Kristoff Coleman, Head Nurse of the Emergency Department, shares why he relies on our Nasal Alar SpO2 Sensor to obtain and maintain an SpO2 reading for even his most severely hypothermic patients. Their insights into the overall value of our device for the patients & clinical staff are eye-opening. Algemeen Stedelijk Ziekenhuis Aalst Philips #philips https://lnkd.in/ezHePBCX
Philips Nasal Alar SpO2 Customer Testimonial
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🔴 Head of CURIS DESIGN 🔴 Design Agency | Medical & laboratory products 🔸 Former Design Lead at PHILIPS Design | Medical 🔸 15 Design Awards 🔸 20+ years of experience in medical design 🔸
🔴 PHILIPS - Improve peoples life vs. increase profits 🔴 An excellent article by journalists from the Pittsburgh Post-Gazette and NRC, which describes all details that lead to recall of millions of respiratory devices from PHILIPS. It is a 10 min read with a lot of details how this case was and still is handled internally over the last 10 years. The article tries to explain how the focus on patient safety and patient experience more and more shifted towards maximising the profit. The article from the NRC can be found here https://lnkd.in/e_pdyVsw #Philips #medicaldevice #respiratorycare #patientsafety
Philips kept warnings about dangerous CPAP machines secret while profits soared
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Taking in the air for an active life Inhale and exhale. The process of breathing is taken for granted. Most people hardly think about it. But now, thanks to the Loeisa device, this also applies to ventilator patients. Our innovation is particularly mobile, compact and lightweight. The device works in a horizontal or vertical position and can be flexibly attached to a wheelchair or bed. At a glance: Battery life up to 18 hours 10 inch touch screen Horizontal or vertical position Simple: Without adapter, intuitive operation With a battery life of up to 18 hours, the device expands the user's range of movement and provides him with a positive feeling of additional security. It is easy to operate the Louiza device via the 10-inch touch screen. Menu navigation is easy and intuitive while other features simplify everyday use. Loeiza brings air to an active, mobile lifestyle – and opens up entirely new horizons for its users. Louisa's new respirator won a design award German, iF Award and Red Dot Award. Azeermed Medical Company Löwenstein Medical #homecare #respiratorycare ##research #respiratorytherapist
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☠ FDA classifies Philips Respironics’ Trilogy Evo ventilator recall as Class I According to the FDA, using these devices without the necessary software update may result in serious injuries or death. The recall, initiated on 19 March 2024, involves Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators distributed from 20 March 2019 to 16 February 2024. These devices, which use a microprocessor-controlled blower to provide various forms of breathing support, are essential for individuals requiring continuous or intermittent assistance. They are used in medical, home, and non-emergency transport settings, such as wheelchairs, personal vehicles, or ambulances. The recall is classified as a correction rather than a product removal. Philips Respironics is addressing the issue by providing a software update for the affected devices. Customers have been instructed to upgrade to software version 1.05.06.00 to resolve the malfunction. The issue arises from a software problem that causes the ventilators to issue a “Battery Depleted” or “Loss of Power” alarm even when sufficient power is available, potentially leading to a sudden loss of ventilation. This malfunction affects all Trilogy Evo ventilators except those with the updated software installed. Read more online: https://lnkd.in/gT4rp9ch 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing
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