In the summer of 2021, Philips Respironics issued a recall notification of a number of their CPAP, BiPap, and ventilators in the United States. A group of disabled people impacted by the recall organized and sent an open letter to the Head of Quality and Regulator at Philips Respironics USA on August 25, 2021. Below is a summary of a report by the Food and Drug Administration prepared by the Civil Rights and Disability Justice Clinic at New York Law School Legal Services, Inc.
Check this website or the hashtag #SuckYouPhilips on Twitter for future updates.
PLEASE NOTE: The summary is intended for educational purposes, not legal advice.
Summary of November 12, 2021 FDA Report: Update on Philips CPAP, BiPAP, and Ventilator Recall
Purpose: On June 14, 2021, Philips Respironics (Philips) recalled several models of ventilators, CPAPs, and BiPAPs due to potential health risks from the breakdown of the polyester polyurethane (PE-PUR) foam used in the devices. Between August 26, 2021, and November 9, 2021, the federal Food and Drug Administration (FDA) inspected a Philips manufacturing facility to investigate what may have caused the foam to break down in its recalled devices and to determine whether Philips followed the FDA’s quality system regulations, which outline the requirements concerning the design and manufacturing of medical devices. The observations–which are not a final FDA determination about whether Philips violated the federal Food, Drug, and Cosmetic Act or any of its implementing regulations–are summarized below. You can read the entire report here.
Observation 1: Philips’ Risk Analysis Was Inadequate.
- There is no documentation to support Philips’ reasoning for why certain foam-containing devices were included in the recall and others were not.
- On or around November 25, 2015, Philips was aware that another one of their entities had implemented a corrective action for Trilogy ventilators in response to complaints about foam breakdown, but it did not investigate potential foam breakdown issues on any Philips Sleep and Respiratory products.
- Between April 1, 2016 and January 22, 2021, there were at least 14 instances where Philips’ risk analysis was inadequate or where Philips did not conduct a risk analysis when appropriate even though it was aware of potential foam breakdown and/or Volatile Organic Compound (VOC) emission concerns in various CPAP, BiPAP, and ventilators. Some notable examples include:
- A November 25, 2016 test report that studied different types of foams found that, in contrast to PE-PUR foam, the other foams showed much better resistance to high humidity at high temperature.
- A December 10, 2020 risk assessment found that potential cell and gene toxins that may lead to cancer could result from exposure to the foam.
- After an August 24, 2021 test report showed a silicone foam-containing CPAP device (marketed outside of the U.S.) failed VOC testing, Philips did not investigate. This is important because Philips’ repair and replacement plan–which was initially approved by the FDA and implemented by Philips–replaces PE-PUR foam with silicone foam. In response, the FDA requested that Philips retain an independent laboratory to perform testing to determine whether the silicone foam poses potential safety risks.
- May 22, 2018 documentation from Philips underreported known data. A search of Philips’ consumer complaints from January 1, 2008 to the present for terms such as “contaminants, particles, foam, debris, airway, particulate, airpath, and black” resulted in over 222,000 complaints, with over 20,000 between 2008 and 2017 involving Trilogy ventilators. Moreover, in a complaint analysis Philips performed in April 2021 for confirmed complaints related to foam breakdown, there were 30 Trilogy related complaints between 2014 and 2017, and 1,254 complaints across all devices containing PE-PUR foam from 2014 to 2021.
- A health hazard evaluation (HHE) did not accurately reflect the likelihood and seriousness of harm related to foam breakdown. The HHE stated that harm was unlikely, meaning that the harm was the result of an isolated incident. However, the report states that it could not be an isolated incident because the HHE states there were 17 instances of foam breakdown.
Observation 2: Philips did not adequately establish procedures for corrective and preventive action.
- Philips did not implement any formal corrective action after receiving various complaints of foam breakdown in Trilogy ventilators. Additionally, Philips did not make sure that the corrective action they implemented that required replacement of the foam in all Trilogy 100 and 200 ventilators was effective.
- On April 12, 2018, Philips opened a formal corrective action that did not include all CPAP and BiPAP devices that contained PE-PUR foam even though it received about 80 complaints between 2014 and 2017 related to foam breakdown in non-Trilogy ventilators.
- Philips did not take any formal action in response to at least 222,000 complaints potentially related to foam breakdown (175,000 of which occurred between 2008 and 2017), before April 12, 2018.
- Starting on October 30, 2015, emails between Philips and its raw foam supplier showed that Philips was aware of the foam breakdown issues and decided not to change their device design and to continue using PE-PUR foam. Philips took no corrective action.
Observation 3: Documentation that approved the design of Trilogy 100 and 200 ventilators did not make sure the devices met user needs and intended uses.
A June 15, 2018 HHE appears to have used “typical” and “healthy” lung and bodily functions as their control group, even though many chronic ventilator users potentially lack “typical” and “healthy” lung and bodily functioning. Other risk and health hazard findings were based on an individual’s use of a humidifier and/or bacterial filter. Specifically, the documents stated that if a humidifier and bacterial filter were in place, particulates would not reach the patient, even though those components are not required for proper use of the devices.
Observation 4: Philips has not adequately established procedures for design changes.
Before Philips implemented corrective actions that required the replacement of components in Trilogy ventilators, including the foam, it did not review or validate the procedures and the replacement components.
Observation 5: Philips did not report a corrective action that called for the replacement of certain components in Trilogy 100 and 200 ventilators, including the foam, in writing to the FDA.
Observation 6: Philips has discussed PE-PUR foam breakdown issues concerning CPAPs, BiPAPs, and Trilogy ventilators at all management review meetings since 2019.
However, Philips did not implement any corrective action until April 2021, even though it was aware of the issue and has received complaints related since at least 2015 or earlier.
Observation 7: Philips has not adequately established procedures to make sure that all products and services meet specific requirements.
Philips had no documentation that detailed the quality requirements of Philips’ raw foam supplier or the specific requirements of the raw material components they supply.
Observation 8: Philips did not evaluate potential consultants or select them based on their ability to meet specific requirements, including quality requirements.
Philips also did not complete any supplier qualification forms for the consultants, as their own supplier quality procedures require.