Raquel Buenrostro revealed that Philips continued to sell defective ventilators even after the pandemic ended and it no longer had the provisional permits derived from the COVID-19 pandemic.
Mexico City, October 24 (However).- The Anti-Corruption and Good Government Secretary, Raquel Buenrostro Sánchezrevealed that the company Philips continued marketing E30 fans even after the health emergency ended due to COVID-19 and despite the fact that these teams – which already had an international risk health alert – only had a permit for provisional and emergency use. For this reason, he said that the Federal Commission for the Protection against Health Risks (Cofepris) in Mexico is already investigating.
“As a result of the comments that were made in the morning, the focus was placed again (on the Philips issue) and it was identified that the company continued to market even using platforms. That is an investigation that Cofepris is opening,” said the official in the morning conference of President Claudia Sheinbaum.
The origin of Philips ventilators dates back to 2020, when the pandemic led governments around the world to relax production standards to meet the urgent demand for ventilators. In this context, Philips began manufacturing and distributing the E30 model, designed for temporary use during the emergency.
During the morning conference, Buenrostro recalled that precisely when the pandemic was declared on March 30, 2020, there was a shortage of ventilators and “everyone was looking for ventilators, and Philips is starting to sell all over the world,” the official said. Faced with this situation, she explained, two thousand Philips ventilators were donated to different public institutions, through FONSALUD, in addition to those that the Government itself acquired, some of which the official revealed.
Shortly after, in June 2021, the United States Food and Drug Administration (FDA)—equivalent to Cofepris in Mexico—issued a health alert due to risks associated with E30 ventilators.
“The FDA sets an alert and gives contraindications: it says in which cases they should not be used and which should be kept under technological observation. And since all health agencies are in communication in the world, Mexico was no exception,” he explained.
On June 30, 2021, the FDA classified the recall as Class I, the most serious category, for the risk of severe injury or death. Since then, the agency has issued at least 13 additional communications between 2021 and 2024 and ordered the recall or repair of different Philips models, including the E30, DreamStation, Trilogy 100, Trilogy 200, and BiPAP A30/A40. Consequently, Cofepris also issued an alert to warn about the risks of the equipment.
In Mexico, ventilators did not have a permanent health record, but rather a temporary emergency authorization, and regulatory agencies around the world agreed that their use should cease at the end of the pandemic, Buenrostro said.
“Once the pandemic ends, the emergency use permit ends. That means that automatically, all the ventilators had to be removed throughout the world, because they no longer had health registration,” he highlighted.
However, once the pandemic ended on May 10, 2023, Philips continued to sell them, at least on digital platforms, as revealed by Buenrostro who added that, after the issue was made public, the company removed the sales information from digital platforms.
On the other hand, the official indicated that at least in public hospitals all equipment has already been removed, and that the Secretariat collaborates with health institutions to physically verify it.
“What we have detected is that they are all retired. Some have even been returned and withdrawn by the company,” he added.