Health Letter, December 2023
By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
The Philips Respironics (Philips) recall of ventilators and positive airway pressure machines, initiated in June 2021, is one of the largest recalls of medical devices in history, involving more than 10 million devices in the United States and 15 million devices worldwide. The devices that were recalled (about 20 models of ventilators and positive airway pressure machines) used a polyester-based polyurethane sound abatement foam that can degrade and harm patients who breathe in toxic particles and emissions. The Food and Drug Administration (FDA) classified the recall as Class 1 (the most severe category) because of the reasonable probability that use of the devices can cause serious health issues or death.
An ongoing investigation by the Pittsburgh Post-Gazette and ProPublica has demonstrated in detail how Philips kept secret more than 3,700 complaints about the faulty devices over an 11-year period before initiating the recall. The complaints were withheld from the FDA, and the company did not launch its own formal investigation until 2019—nine years after the first complaints and three years after known tests for the company found that the foam was degrading. Indeed, Philips continued to sell more machines, including new models that contained the hazardous foam. The health problems for people using the Philips machines have included “vomiting, dizziness, and headaches, along with newly diagnosed cancers of the lungs, throat, sinuses, and esophagus.”
When presented with a summary of the investigation’s findings, Dr. Sidney M. Wolfe, Public Citizen’s Health Research Group founder and senior adviser, called the situation “one of the two or three worst things I have ever seen…It was unacceptable to sell those machines.”
One of the articles quotes from the complaints received by the company; these include descriptions of “‘black particles’ or ‘dirt and dust’ inside machines” that pump air into the lungs of patients with preexisting breathing difficulties. The article also includes descriptions of “black shavings in the chamber” and of contamination “with unknown sticky substance.”
A follow-up article, published in October 2023, highlighted the very disturbing decision by the company to halt shipments of the defective devices from its factories near Pittsburgh in April 2021 (two months before the recall), yet approved the continued sale of the same devices by distributors.
In a statement, Philips took issue with “the characterizations made in these articles,” adding that it “regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this.”
The Philips recall is a public health crisis, because of both the harm to patients and the breakdowns in medical device surveillance and regulation that the recall has exposed. Lawsuits against the company are ongoing in federal court. Sen. Richard Blumenthal (D-Connecticut) has called on the FDA and the Department of Justice to investigate the “allegations thoroughly, taking the strongest enforcement action possible, including criminal charges, if the allegations are substantiated.” As the current post-market surveillance system for medical devices in the United States relies in large part on voluntary action by companies, the FDA also requires greater oversight authority. Reforms are needed to ensure that manufacturers of moderate and high-risk medical devices are required to track individual devices through unique device identifiers and the use of product registries and other systems. Medicare must also include the unique device identifiers on claim forms.