Breas Medical has initiated a corrective action for over 8,000 of its Vivo 45 LS ventilators following the discovery of a risk associated with formaldehyde exposure, according to information provided by the Food and Drug Administration (FDA). The company, which reported no injuries related to this issue, conducted internal tests on these devices, revealing the possibility of short-term exposure to increased levels of formaldehyde under certain conditions.
The identified risk has triggered a broader concern regarding ventilators, as formaldehyde is known to be potentially harmful to the lungs and nervous system. This is not an isolated incident in the medical equipment sector; similar precautions have been taken by other companies, including GE Healthcare, in the past two years to address concerns related to formaldehyde emission from medical devices such as ventilators.
In response to the findings, Breas has implemented significant changes to ensure patient safety. The company has adjusted the maximum allowable room air temperature setting on the affected ventilators, decreasing it from 104 degrees Fahrenheit (40 degrees Celsius) to 86 degrees Fahrenheit (30 degrees Celsius). Additionally, Breas has revised the instructions for use of these devices. Going forward, newly manufactured devices from the period of February 2021 to July 2024 will come with updated guidelines.
Breas has also taken a further precautionary step for devices that will be shipped through July 24, requiring these units to be operated for a 14-day period before they are used on patients. This measure is intended to further reduce any risk of formaldehyde exposure. This approach follows similar actions by GE Healthcare, which also reduced the operating temperatures of its ventilators and implemented a run-in period before clinical use.
As of August 5, Breas started the correction across the nation for a total of 8,186 Vivo 45 LS ventilator devices. These are specifically designed to be small and portable for ease of use but have now been found to have the potential to emit formaldehyde, which can cause reversible airway irritation or inflammation. The danger is especially pronounced in children, where such exposure could exacerbate or lead to conditions such as asthma, thereby necessitating additional medical treatment to manage these effects.
Breas has not yet received any reports of injuries linked to this newly discovered issue, suggesting that the problem was identified through the company’s vigilance before any incidents occurred. This proactive approach by Breas, aimed at mitigating risks and ensuring the safety of ventilator users, underscores the importance of constant monitoring and updating of equipment guidelines based on latest available data and testing outcomes.
Overall, the correction of these ventilators is a part of ongoing efforts by both manufacturers and health authorities like the FDA to ensure medical devices are safe for patients. These measures reflect an industry-wide commitment to patient safety and are critical in maintaining trust in medical technologies that are vital for treating numerous health conditions.
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