The irregular marketing of medical ventilators
In the context of a class action filed against the Philips corporation for deaths and illnesses linked to defective ventilators during the health contingency, the head of the Secretariat of Anti-Corruption and Good Government, Raquel Buenrostro, revealed compelling evidence. The federal official stated that the company continued to market these respiratory assistance devices without having the corresponding health authorizations from the Federal Commission for the Protection against Health Risks (Cofepris), even after the emergency period due to the pandemic ended.
Regulatory background and emergency situation
During the morning conference chaired by President Claudia Sheinbaum Pardo this Friday, October 24 at the National Palace, Buenrostro meticulously explained the chronology of the events. He explained that initially a “special permit” was granted for the emergency use of this medical equipment, but that it subsequently had to be withdrawn from the market once the critical phase of the pandemic had passed. The investigation documents that in June 2021, the United States Food and Drug Administration (FDA) issued a specific risk alert against these ventilators, identifying the problematic models E30, V60, V680, TRILOGY and EV300 in Mexico.
The head of the secretariat indicated that Cofepris immediately activated the corresponding security protocols through an official health alert directed at these specific models. “It is imperative to remember that, during the pandemic crisis, numerous ventilation devices were enabled globally due to critical equipment shortages,” Buenrostro explained precisely. “These ventilators, which were essentially newly implemented, did not have conventional health registration. They were exclusively granted a special health registration for emergency use, so all of this equipment had to be kept under strict regulatory surveillance.”
Post-emergency non-compliance and corrective actions
“At the end of the pandemic contingency period, the health registry for emergency use was automatically extinguished,” the official continued explaining. “What legal implications does this situation entail? That automatically, by legal provision, all distributors were obliged to immediately withdraw these fans from the market, since they lacked regulatory validity for their ordinary commercialization. However, the investigation identified that the company continued to carry out commercial activities with these devices, even using digital sales platforms.”
Buenrostro mentioned that Cofepris maintains an active investigation into this case of regulatory non-compliance. “Currently, these products are no longer available on digital platforms,” he stated, referring to the fact that the authorities verified their elimination from online marketing channels. He added that supervision operations are being maintained to verify that all the fans subject to the alert have been effectively removed from circulation.
The federal official emphasized that the removal of the devices constitutes an independent measure of compensation for damages and losses caused to those affected: “The manufacturing company has the legal obligation to respond for the equipment that did not work correctly or that did not comply with all the established technical and safety requirements.” This distinction is crucial from the perspective of corporate responsibility, establishing that withdrawal from the market does not exempt the company from the legal consequences for the damage caused.
The analysis of this case reveals the regulatory complexities that emerged during the global health crisis, where the urgent need for medical equipment collided with established safety and efficacy protocols. The situation exposes vulnerabilities in post-emergency control mechanisms and underscores the importance of maintaining robust surveillance systems that prevent the commercialization of medical devices without proper authorization, particularly when they have been associated with documented risks to the health of patients.
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