Vapotherm reintroduces humidifier

Vapotherm (Stevensville, Maryland), a manufacturer of respiratory care devices for hospitals and home care, reported that its 2000i High Flow Humidification Device has been reintroduced to the market after agreement by the FDA that the company can begin shipping the devices to customers. The company is notifying its hospital and homecare customers to arrange for shipment of devices beginning this week.

The devices are being returned to customers with new instructions for use, including the recommendation to utilize only sterile water in the system.

The company reported last January that it was initiating a recall (Medical Device Daily, Jan. 30, 2006). The company said some of its devices had been found to contain the Ralstonia species of bacteria. As with any gram-negative organism, Vapotherm said Ralstonia may cause infection, sepsis and in severe cases be life-threatening.

The device is used in both the home and in healthcare institutions for warming and humidifying breathing gases, such as oxygen, delivered by nasal cannula.

Vapotherm said there have been "numerous" reports of Ralstonia colonization, including three reports of infection. It said 26 hospitals in 16 states have reported positive cultures of Ralstonia species from the Vapotherm 2000i device.