Baxter’s next-generation SIGMA Spectrum infusion pump obtains FDA clearance

9 May 2014 (Last Updated May 9th, 2014 01:00)

Baxter International has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation SIGMA Spectrum infusion pump with master drug library.

Baxter International has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation SIGMA Spectrum infusion pump with master drug library.

The new improvements to the next-generation infusion pump include increased drug library capacity and device tracking services.

The master drug library helps hospitals maintain a customised in-house database of facility-defined dosing parameters for infusions to minimise the drug errors during the care process.

"The master drug library helps hospitals maintain a customised in-house database of facility-defined dosing parameters for infusions to minimise the drug errors during the care process."

In addition, the new device tracking services would allow hospitals to effectively locate, manage and deploy SIGMA Spectrum inventory.

The master drug library also offers an option for wireless connectivity to integrate data into a hospital's electronic medical record (EMR) system, to facilitate the transfer of data to and from the system for updating drug libraries, and create continuous quality improvement reports.

With the master drug library, the infusion pump provides multiple safety features, including dose error reduction software (DERS) and an automatic default to use of the drug safety library at the initial start of dose programming.

Baxter's Hospital Products business president Brik Eyre said clinicians are looking for integrated systems that are efficient and cost-effective, and allow hospital staff to focus on providing quality care for patients.

''We are excited to bring the next-generation of Baxter's SIGMA Spectrum Infusion Pump with master drug library and its advanced, patient-centered safety technology to the US marketplace,'' Eyre said.

In general, infusion pumps are used across hospitals and other acute and chronic care settings to deliver fluids and medications that save and sustain lives.

The company anticipates launching the next-generation SIGMA Spectrum with select healthcare facilities beginning in mid-2014.