Bunnell Inc., 436 Lawndale Drive, a company producing ventilator equipment for critically ill infants, has received permission from the Food and Drug Administration to resume normal distribution of its Life Pulse High Frequency Jet Ventilator.
The federal agency had limited Bunnell's operations solely to providing its current customers with supplies and shipping additional ventilators for emergencies only.J. Bert Bunnell, president and chief executive officer, was expected to announce the lifting of the restrictions Wednesday at Snowbird during the 10th annual High Frequency Ventilation of Infants Conference at Snowbird, a conference he co-founded.
The conference usually attracts 200 doctors, nurses and respiratory therapists for discussion and presentation of papers related to infant ventilation technology.
The FDA started its restrictive action against Bunnell on July 30, 1992, and the agency ordered the company to instruct its 200 client hospitals to stop using the ventilator. An informal hearing ended in a modified order that allowed hospitals to continue using the ventilator while Bunnell upgraded its documentation and reporting practices.
Bunnell said the impact of the FDA action has been mixed. "We have sustained heavy losses in personnel and sales, but our customer base has remained largely intact. Our commitment to helping our customers save their critically ill infant patients has resulted in a great outpouring of support," he said.
He said improvements in customer support and manufacturing will undoubtedly help the company in the long run.
Founded in 1980, Bunnell developed the ventilator that delivers hundreds of tiny spurts of oxygen per minute. The device is used in the United States and Canada, primarily in neonatal critical care, to provide improved oxygenation and ventilation at pressures and rates specifically calibrated for small and delicate lungs.