Friday, February 19, 2010

IV infusion devices move from "smart" to "intelligent"

INTELLIGENT INNOVATIONS: From left, Clapp, Kinnealy, Sims and Hampton

In the late 1990s, the MGH transformed patient intravenous (IV) medication safety by conceptualizing and developing the "smart" drug infusion pump -- an invention that was first deployed at the MGH and has since proven highly useful in clinical care worldwide.

Motivated by an awareness of continuing tragic events involving the complexity of drug dosing calculation errors and misprogrammed drug infusion pumps at hospitals, a multidisciplinary Partners HealthCare team, including five senior members from the MGH, has created a roadmap for further advancing IV medication safety. A highlight of this plan is a proposal to pilot closed-loop IV medication administration at the MGH using software that compares data from a patient's drug infusion pump with the specific order in the pharmacy profile and generates alerts if necessary.

"The original smart pump technology was considered revolutionary because it housed customized clinical decision support within FDA-regulated patient care devices," says Nathaniel Sims, MD, anesthesiologist and innovator at the MGH Department of Biomedical Engineering, who led the research that resulted in patented inventions owned by the MGH on the original smart pump prototype.

As the next step in smart pump enhancement, Sims and Margaret Clapp, MGH Pharmacy director; Rick Hampton, Partners Wireless Communications manager; M. Ellen Kinnealey, BSN, RN, Advanced Infusion Systems specialist; and Luis Melendez, assistant director of Partners Biomedical Engineering Medical Device Integration and Informatics, recently authored an in-depth report outlining the transition of technology from stand-alone smart infusion pumps to networked Intelligent Infusion Pumps (IIDs).

"The new IIDs are wirelessly networked and can be associated with a particular patient, based on a scan of the pump's front-panel barcode by a bedside caregiver," says Kinnealey. "Since all MGH drug pumps will soon have capable radios, they will be constantly 'tweeting' drug name, concentration and dose-rate settings to a pump server."

With this in place, the team proposed that MGH-written software could provide a nearly-real-time comparison between what's happening at the bedside and what should be happening, and look for variances.

"This is a critical next step," says Gregg Meyer, MD, senior vice president of the MGH/MGPO Center for Quality and Safety. "It amounts to a second safety check of the pump's programming against an actual medication order, augmenting our vision of 'making the right thing easier to do.'"

The team considered multiple complex issues during the year-long effort, which included visits to hospitals piloting prototypes of automated pump programming directly from pharmacy information systems.

"We took a hard look at several tough requirement issues," says Hampton. "These include Partners' high standards for authentication and the security of medical devices on wireless networks."

Adds Melendez, "The team realized that the new software module will likely permit closing the loop in a way that is consistent with proposed new regulations. It'll take time and resources to move a successful software module from a controlled setting, such as a lab, to the bedside. Many challenging issues about medical device connectivity and interoperability will remain, as the all-electronic inpatient medical record -- with numerous connected patient care devices -- moves closer to reality at the MGH."

Learn more about the transition of smart pumps to intelligent pumps

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