Breas Medical addresses formaldehyde in ventilators

Breas Medical, a leading innovator in respiratory care, has announced a significant nationwide correction involving 8,186 Vivo 45 LS ventilator units. This decision comes after internal testing revealed the potential for short-term elevated formaldehyde exposure levels under specific conditions. This proactive measure underscores Breas Medical’s commitment to patient safety and product integrity.

The devices in question were manufactured between February 4, 2021, and July 1, 2024, and distributed from February 12, 2021, to July 24, 2024. Breas Medical has not received any reports of patient injury or adverse effects of formaldehyde exposure from these devices despite the potential risks identified. The correction is a precautionary step to mitigate any potential health risks and ensure the highest safety standards for users.

Formaldehyde exposure, even at short-term elevated levels, can lead to adverse pulmonary or neurological effects. These effects include transient and reversible airway irritation or inflammation. In vulnerable populations, such as small pediatric patients, this could exacerbate conditions like asthma, necessitating additional medical interventions. Such interventions might include bronchodilator administration, ventilator setting adjustments, or increased ventilatory and oxygen support.

The affected Vivo 45 LS ventilators can be identified by the model name on the front panel and specific model and serial numbers on the back panel. These devices have been distributed nationwide to Durable Medical Equipment providers, distributors, and healthcare facilities, emphasizing the widespread importance of this correction.

To address the issue, Breas Medical has implemented several corrective measures. The maximum room air temperature for operating the Vivo 45 LS has been reduced from 40°C (104°F) to 30°C (86°F). Additionally, new devices shipped up to July 24, 2024, are required to undergo a pre-run period of 14 days before being used by patients. These changes aim to minimize the potential for formaldehyde emissions and enhance device performance and safety.

Communication is a critical component of this correction process. Breas Medical is actively contacting its distributors and commercial customers in the United States via email and phone to inform them of the necessary actions. Existing end users will receive updated Instructions for Use detailing the corrective measures and ensuring they have the information needed to operate their devices safely.

End users and other recipients of the Vivo 45 LS should contact the company that provided the device or Breas Medical directly for further information regarding the necessary corrective measures. Breas Medical has established a dedicated support line to assist with any questions or concerns.

Breas Medical also encourages users to report any adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or by fax.