Charles Sternberg, Associate Editor12.21.22
Royal Philips has provided an update on the test and research program of its subsidiary Philips Respironics, following the voluntary recall notification/field safety notice to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices.
Additional test results and assessments have now been completed for the first-generation DreamStation devices.
Philips says the test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.
These assessments have been done in response to lawsuits filed against Philips alleging that the polyester-based polyurethane (PE-PUR) sound abatement foam in recalled Philips CPAP, BiPAP and ventilator devices may cause cancer and serious respiratory problems.
1. The new results indicate that exposure to particulate matter (PM) emissions from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
New, lab-aged and used devices were tested and all were compliant with ISO 18562-21 allowable limits for PM emissions. Testing was performed on devices with varying degrees of degradation (i.e., from no degradation to severe degradation), including 61 new devices, 96 used devices, and 24 devices with lab-aged foam that intentionally had been exposed to significantly elevated temperatures (≥80 oC) and humidity (≥75% RH) to accelerate degradation.
Further tested PM emissions of used devices with degradation were not statistically different than PM emissions of used devices without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.
Biocompatibility testing, including the chemical evaluation and toxicological risk assessment in accordance with ISO 109932, is now complete for the foam in first-generation DreamStation devices. Even with the very conservative and theoretical assumption of exposure to all of the degraded PE-PUR foam within the device, the third-party risk assessment concluded that exposure to particulates from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
2. The results further indicate that the exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients.
Expanded testing and toxicological risk assessments on multiple devices with new, used, and lab-aged foam have shown no appreciable harm to health for the VOCs detected. Therefore, exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not anticipated to result in long-term health consequences for patients based on ISO 18562-33 testing and evaluation of new, lab-aged and used devices. This is consistent with the results presented in December 2021. Similar to the PM testing described above, VOC testing was performed on new, lab-aged and used devices with varying degrees of degradation.
3. Prevalence of visible foam degradation in inspected returned devices was found to be low.
Based on the visual inspection of the foam in returned first-generation DreamStation devices, the prevalence of visible foam degradation was found to be low. 164 out of 36,341 (0.5%) returned devices from the US and Canada were inspected and showed significant visible foam degradation. These devices were self-reported as not using ozone cleaning. Only 1 out of 2,469 (0.04%) inspected devices returned from multiple countries in Europe showed significant visible foam degradation. This included devices from the Netherlands, the UK, Italy, and Spain, ranged in age up to around 6 years. None of the 1,964 (0%) inspected returned devices from Japan showed significant visible degradation. This is consistent with the results presented in June 2022.
Visual inspection can only identify visible foam degradation and cannot measure volatile organic compounds generation or quantify particulate loss, therefore additional testing and analyses were performed as described above and in the complete update.
“Our first priority is the health and well-being of patients, both in terms of safety and providing replacement devices,” said Roy Jakobs, CEO of Royal Philips. “Over the past 18 months, we have focused on gaining more clarity about the safety of the devices affected by the June 2021 field safety notice, and providing replacement devices to patients as fast as we can.
“The comprehensive test and research program has yielded extensive data and results for the first-generation DreamStation devices, as published today and presented in the press release, and we now have a better understanding of the potential health risks compared to the limited insights that we had in early 2021. I would like to stress that we are very sorry that it has taken this much time, but the testing involved long throughput times, and needed to be done thoroughly. We deeply regret the concern and uncertainty felt by patients, their physicians, and customers, and continue to work hard to address their needs. By year-end we have ramped up our production such that we have produced almost 90% of all devices that are needed for the remediation program.”
Mr. Jakobs continued: “The relevant competent authorities globally, including the FDA, are still reviewing the extensive data and assessments that we have provided. We share the same objective to ensure patient safety and quality in the delivery of healthcare. We are therefore committed to working closely with these agencies, as we continue to complete the test and research program, and the remediation of the affected devices.”
“This PR spin masquerading as research lacks any credibility and is yet another shameless attempt by Philips to cast blame for the dangers found in its now-recalled breathing devices that pumped degraded foam and chemicals into patients. Despite their previous acknowledgements to the FDA of how detrimental the foam degradation is, Philips continues to desperately try to downplay the issue and the health risks consumers face as a result. The FDA has criticized prior studies completed by Philips as ‘not adequately performed to identify or detect quality problems’; this new data suffers from the same flaws and bias.
“In an official notice to Philips, the FDA rejected the claim that ozone cleaners are responsible for foam degradation issues, concluding that ‘the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents,’ and ’patients and providers cannot readily mitigate the unreasonable risk associated with the recalled devices.
“Philips knew as far back as 2015 that the foam it used in the recalled devices would degrade, creating an unreasonable health hazard to patients, but waited until June 2021 to issue a recall or notify health regulators. Today, thousands of patients who put their trust in Philips are suffering from cancer and respiratory illnesses, while millions more are forced to rely on the company’s dangerously defective devices while waiting for a replacement. We look forward to holding Philips fully accountable for its misconduct.”
Additional test results and assessments have now been completed for the first-generation DreamStation devices.
Philips says the test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.
These assessments have been done in response to lawsuits filed against Philips alleging that the polyester-based polyurethane (PE-PUR) sound abatement foam in recalled Philips CPAP, BiPAP and ventilator devices may cause cancer and serious respiratory problems.
Philips’ Findings
The complete update on the PE-PUR testing results and conclusions available to date can be found here, and the overall findings for the first-generation DreamStation devices have been summarized below:1. The new results indicate that exposure to particulate matter (PM) emissions from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
New, lab-aged and used devices were tested and all were compliant with ISO 18562-21 allowable limits for PM emissions. Testing was performed on devices with varying degrees of degradation (i.e., from no degradation to severe degradation), including 61 new devices, 96 used devices, and 24 devices with lab-aged foam that intentionally had been exposed to significantly elevated temperatures (≥80 oC) and humidity (≥75% RH) to accelerate degradation.
Further tested PM emissions of used devices with degradation were not statistically different than PM emissions of used devices without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.
Biocompatibility testing, including the chemical evaluation and toxicological risk assessment in accordance with ISO 109932, is now complete for the foam in first-generation DreamStation devices. Even with the very conservative and theoretical assumption of exposure to all of the degraded PE-PUR foam within the device, the third-party risk assessment concluded that exposure to particulates from degraded foam in DreamStation devices, including potential respirable and non-respirable particulates, is unlikely to result in an appreciable harm to health in patients.
2. The results further indicate that the exposure to volatile organic compound emissions (VOCs) is not anticipated to result in long-term health consequences for patients.
Expanded testing and toxicological risk assessments on multiple devices with new, used, and lab-aged foam have shown no appreciable harm to health for the VOCs detected. Therefore, exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not anticipated to result in long-term health consequences for patients based on ISO 18562-33 testing and evaluation of new, lab-aged and used devices. This is consistent with the results presented in December 2021. Similar to the PM testing described above, VOC testing was performed on new, lab-aged and used devices with varying degrees of degradation.
3. Prevalence of visible foam degradation in inspected returned devices was found to be low.
Based on the visual inspection of the foam in returned first-generation DreamStation devices, the prevalence of visible foam degradation was found to be low. 164 out of 36,341 (0.5%) returned devices from the US and Canada were inspected and showed significant visible foam degradation. These devices were self-reported as not using ozone cleaning. Only 1 out of 2,469 (0.04%) inspected devices returned from multiple countries in Europe showed significant visible foam degradation. This included devices from the Netherlands, the UK, Italy, and Spain, ranged in age up to around 6 years. None of the 1,964 (0%) inspected returned devices from Japan showed significant visible degradation. This is consistent with the results presented in June 2022.
Visual inspection can only identify visible foam degradation and cannot measure volatile organic compounds generation or quantify particulate loss, therefore additional testing and analyses were performed as described above and in the complete update.
“Our first priority is the health and well-being of patients, both in terms of safety and providing replacement devices,” said Roy Jakobs, CEO of Royal Philips. “Over the past 18 months, we have focused on gaining more clarity about the safety of the devices affected by the June 2021 field safety notice, and providing replacement devices to patients as fast as we can.
“The comprehensive test and research program has yielded extensive data and results for the first-generation DreamStation devices, as published today and presented in the press release, and we now have a better understanding of the potential health risks compared to the limited insights that we had in early 2021. I would like to stress that we are very sorry that it has taken this much time, but the testing involved long throughput times, and needed to be done thoroughly. We deeply regret the concern and uncertainty felt by patients, their physicians, and customers, and continue to work hard to address their needs. By year-end we have ramped up our production such that we have produced almost 90% of all devices that are needed for the remediation program.”
Mr. Jakobs continued: “The relevant competent authorities globally, including the FDA, are still reviewing the extensive data and assessments that we have provided. We share the same objective to ensure patient safety and quality in the delivery of healthcare. We are therefore committed to working closely with these agencies, as we continue to complete the test and research program, and the remediation of the affected devices.”
Response from Attorneys Leading Litigation on Behalf of Patients
The following is a statement from Plaintiffs’ Co-Lead Counsel in the Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation (Sandra L. Duggan of Levin Sedran & Berman LLP, Kelly K. Iverson of Lynch Carpenter LLP, Christopher A. Seeger of Seeger Weiss LLP, and Steven A. Schwartz of Chimicles Schwartz Kriner & Donaldson-Smith LLP) regarding Philips’ newly released testing results:“This PR spin masquerading as research lacks any credibility and is yet another shameless attempt by Philips to cast blame for the dangers found in its now-recalled breathing devices that pumped degraded foam and chemicals into patients. Despite their previous acknowledgements to the FDA of how detrimental the foam degradation is, Philips continues to desperately try to downplay the issue and the health risks consumers face as a result. The FDA has criticized prior studies completed by Philips as ‘not adequately performed to identify or detect quality problems’; this new data suffers from the same flaws and bias.
“In an official notice to Philips, the FDA rejected the claim that ozone cleaners are responsible for foam degradation issues, concluding that ‘the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents,’ and ’patients and providers cannot readily mitigate the unreasonable risk associated with the recalled devices.
“Philips knew as far back as 2015 that the foam it used in the recalled devices would degrade, creating an unreasonable health hazard to patients, but waited until June 2021 to issue a recall or notify health regulators. Today, thousands of patients who put their trust in Philips are suffering from cancer and respiratory illnesses, while millions more are forced to rely on the company’s dangerously defective devices while waiting for a replacement. We look forward to holding Philips fully accountable for its misconduct.”