FDA Lifts Import Ban on Hospira’s Costa Rica Device Manufacturing Facility
Hospira, a provider of injectable drugs and infusion technologies, provided an update on its global device strategy. The global device strategy, initiated in 2013, establishes a streamlined and modernized device portfolio and positions the company for future innovation and growth while supporting continued advancement of device remediation, including quality-improvement efforts. The company reported on the lifting of the import alert on the company’s portfolio of infusion devices by the US Food and Drug Administration (FDA), the introduction of next-generation pumps, and details on future technology development.
Hospira reported that on January 5, 2015, the FDA notified the company that the agency lifted the import alert that previously prohibited US importation of infusion pump devices manufactured in Hospira’s Costa Rica device manufacturing facility, including Hospira’s Plum A+â„¢ and LifeCare PCAâ„¢ infusion pumps. Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates and will resume the importation of these devices into the United States immediately.
In 2015, Hospira expects to offer new next-generation pump technology, including: SapphirePlus; Hospira’s partner Q Core Medical recently received FDA clearance on this Hospira MedNet-ready general-infusion device, which features wireless capability and a touch screen to help improve the safety and efficiency of IV medication administration. Hospira is also awaiting FDA clearance on a new infusion system, Plum 360, which builds on air-management and concurrent delivery features while expanding its drug library and wireless capability. Also, the latest update to the Hospira MedNet safety software enables MedNet to operate with all Hospira pump platforms. The anticipated launches of these new pumps is expected in 2015. Hospira and partner Q Core Medical recently enhanced their collaboration to develop a next-generation platform of pumps, building on both the Sapphire and Plum cassette technologies.