Regenstrief launches hospital research community to improve infusion pump drug-delivery system

July 16, 2012  

Cindy Gaston and Jim Young

Cindy Gaston, at right, senior clinical pharmacist for the University of Wisconsin Hospital & Clinics in Madison, discusses the importance of safety standards for the use of infusion pumps at a meeting of the Infusion Pump Informatics Community, while Jim Young, quality assurance/process improvement pharmacist at Wishard in Indianapolis, listens. (Purdue University photo/Phillip Fiorini)

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WEST LAFAYETTE, Ind. - A Purdue University research center is working with major Midwestern hospitals to establish safety standards for infusion pumps, which have become commonplace in the past decade for administering drugs to patients.

The Regenstrief Center for Healthcare Engineering, a Discovery Park center focused on improving health-care delivery, has partnered with hospitals in Indiana, Iowa, Illinois, Nebraska and Wisconsin to launch the Infusion Pump Informatics Community at Purdue. Through its Web-based tool, users can easily share analysis, data reporting and best practices for what are known as "smart pumps."

Participating hospitals are Community Health Network, Franciscan St. Francis Health, Wishard Health Services, Indiana University Health and St. Vincent Health, the Roudebush Veterans Medical Center, and St. Vincent Health, all based in Indianapolis; Witham Health Services, based in Lebanon, Ind.; University of Iowa Hospitals and Clinics in Iowa City; University of Wisconsin Health & Clinics in Madison; and Nebraska Medical Center in Omaha.

"Infusion pumps present benefits and risks. They have allowed for a greater level of control, accuracy and precision in drug delivery, thereby reducing medication errors and contributing to improvements in patient care," says Steve Witz, director of the Regenstrief Center for Healthcare Engineering at Purdue.

"At the same time, infusion pumps have been associated with safety problems. We believe that Purdue's Regenstrief Center can help bring together key players in hospitals to address this national concern by putting research into practice."

Bill Malloy

Cindy Gaston, at right, senior clinical pharmacist for the University of Wisconsin Hospital & Clinics in Madison, discusses the importance of safety standards for the use of infusion pumps at a meeting of the Infusion Pump Informatics Community, while Jim Young, quality assurance/process improvement pharmacist at Wishard in Indianapolis, listens. (Purdue University photo/Phillip Fiorini)

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Infusion pumps offer a variety of designs to intravenously deliver nutrition, fluids and drugs like pain medications, insulin and cancer treatments. Today, an estimated 2 million infusion pumps are in hospitals and clinics and thousands more are used by patients in their homes.

The pumps come with a programmable computer to control the rate and volume of medication flow, which can vary depending on the patient's illness, weight, age and other factors. A doctor, nurse or other health-care worker enters information on the infusion pump's keypad.

Despite their advantages, the FDA reports that infusion pumps were linked to more than 56,000 adverse event reports from 2005-2009, including at least 500 deaths.

Cindy Gaston, senior clinical pharmacist for the University of Wisconsin Hospital & Clinics in Madison, says the Purdue-led community has been helpful in sparking discussion from hospital personnel in different environments who have diverse experiences and different vantage points.

"We're all human, and we make mistakes," Gaston says. "When we're programming numbers into a pump, we can make an error. Many times, those errors won't cause patient harm, but it can be one or two times that it does cause severe patient harm, ultimately resulting in death.

"If we can prevent those deaths and improve our use of infusion pumps, it's a very worthwhile project that Purdue is leading."

In 2010 the U.S. Food and Drug Administration released guidelines designed to improve safety as part of its Infusion Pump Improvement Initiative, which proposed stricter regulation of pumps and cited software defects, user interface issues and mechanical or electrical failures as main causes of adverse events.

Infusion pump manufacturers say most problems stem from a nurse or health-care worker accidentally entering the wrong data. But the FDA and hospital officials say the deaths and injuries were because of engineering and design defects of the devices.

That was the driving force behind Regenstrief's efforts to create the group to examine the problems with smart pumps and find solutions.

Beverly Vermace, parental infusion device coordinator and a registered nurse at the University of Iowa Hospitals and Clinics, says the Purdue network has allowed her hospital system to work through existing hurdles encountered with the use of smart pumps while being proactive in avoiding potential hurdles learned from other hospitals.

"With all health-care technology, we cannot remove the human element," Vermace says. "Technology needs to be designed to allow the clinician to do safe patient care. When that happens, patient outcomes will improve."

A team led by Ann Christine Catlin, a research scientist in Purdue's Rosen Center for Advanced Computing, developed the Web-based tool called the Infusion Pump Informatics System.

The initiative uses Purdue's innovative HUBzero website platform to host the tool, tutorials, Q&A forums, and other educational and research resources, all accessible via a Web page.

Jim Young, quality assurance/process improvement pharmacist at Wishard, says that through the group led by Purdue, hospitals can share individual processes for getting a better understanding about how to set guidelines and limits for dosages and concentrations of medication.

Young, whose hospital system began using wireless infusion pumps in 2010, says pharmacists can learn a lot about their proper use by talking to the nurses and vice versa.

"The interaction with this community is helping us improve that communication process to make sure we can give our patients the best possible care," he says. "We're writing the textbook here through the interactions with this community of hospitals."

Vermace at the University of Iowa Hospitals and Clinics says the community also provides a form of encouragement for hospital administrators and staff who know other hospitals have similar issues and are committed to find solutions.

"We get good ideas such as what has worked from the lessons learned, why pharmacists and nurses must work together more effectively," she says. "Another advantage is the rapid response to questions asked and immediate contact with people with a shared experience."

Kathy Rapala is now vice president of clinical risk management at Aurora Health Care in Wisconsin. She first began looking into ways to address the infusion pump problem for hospital staff while pursuing her doctorate of nursing practice at Purdue in 2008.

Through the Indianapolis Coalition for Patient Safety, she submitted a grant to Cardinal Health with the vision of linking the smart pump databases of the Indianapolis hospitals. 

"It's exciting when an idea takes off," Rapala says. "To work with data on one platform with diverse organizations is a great step forward in understanding a device and the interaction with the care environment. The learning environment that Purdue has created around the data platform will further that understanding and research."

Community participants say they are convinced a continued focus on this national patient safety issue, building on the research and data collection under way at Purdue, will give hospitals the necessary tools to improve use of infusion pumps, spark ideas to improve the use of guardrails on the devices, minimize alerts and grow their acceptance.

"The stakes are high," Wishard's Young says. "This community established by Purdue's Regenstrief Center and involving these many hospitals is helping us improve our patient safety measures and saving lives."

The Indianapolis-based Regenstrief Foundation provided $3 million to launch the Regenstrief Center in 2005 and awarded an additional $11 million grant in April 2008 to expand and extend its partnership. The foundation's work supports the legacy of Sam Regenstrief's vision: The continued improvement of the health-care delivery system.

Writer: Phillip Fiorini, 765-496-3133,

Sources: Steve Witz, 765-496-8303,

Cindy Gaston, 608-265-8161,

Jim Young, 317-630-6019,

Beverly Vermace, 319-356-4527,     

Kathy Rapala, 414-299-1652,

Ann Christine Catlin, 765-494-4465,

Related website:

FDA Infusion Pump Improvement Initiative

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