<i>What's the Prognosis?</i> Making Infusion Systems Safer

The AAMI/FDA Infusion Device Summit in October of 2010 has proven to be a catalyst for healthcare professionals who care about one of the most important safety issues of our time—infusing patients safely. Two years out, the ripple effects from the summit and the events that prompted it are only increasing in magnitude and impact. Today, more people are talking, working together, and committing to making the system of delivering intravenous (IV) therapy safer.What's different now? Here's a look at some of the progress to date:Champions of infusion safety are taking into account the entire technological, medical, institutional, and human system in which infusion devices are used, rather than focusing narrowly on pumps alone. That's a sea change in defining and working through the problem comprehensively—and with a clear recognition of its complexity.“Infusion pumps are only part of the problem, and IV infusions require a system, of which pumps are a part,” says Tim Vanderveen, PharmD, vice president of The Center for and a member of the AAMI Board of Directors. “For the most part, when errors do occur, it is a system issue and not a singular event.” By way of example, Vanderveen compared infusion pumps to automobiles. “Accidents are not typically [due to] the car, but more the driver, the conditions, the maintenance, and so on.”Tony Easty, senior scientist at the University Health Network in Toronto, agrees. “I see more of a systems approach being taken,” says Easty, who is also team leader of the Health Technology Safety Research Team at the Centre for Global eHealth Innovation. Scientists there are conducting groundbreaking research on multiple line management. “Manufacturers are more aware of the difficulties that occur in implementation and clinical use, and healthcare organizations and clinical engineers are looking at infusion safety in a more comprehensive way than before.”Easty doesn't minimize the effort and practices required for systems thinking, but he's encouraged by the increasing exchanges of information and collaboration. “I think many institutions are trying hard to make an integrated plan for the various components of a medication safety system, but this is not easy to do,” he says.“It is time-consuming and requires a multidisciplinary approach. I think we have come to realize just how much effort is required to develop and implement a truly effective medication safety system. Also, there is a large commitment required for ongoing analysis and feedback. Staff need to be given time to focus on quality and safety assessment, so this is definitely an additional load for institutions to bear.”Manufacturers, healthcare organizations, pharmacists, clinical engineers, nurses, and other patient safety specialists are working together much more actively and collaboratively to improve the system.Pat Baird, systems engineer at Baxter Healthcare Corporation and chair of the AAMI Infusion Systems Steering Committee (ISSC), says “many manufacturers” are involved in standards work as it relates to infusion pumps and are also active in developing other solution-focused resources. “People have asked the team, ‘Aren't they your competitors? Why are you working together? Isn't it in your best interest to have an advantage over another company?’ Our response has always been, ‘We won't compete on basic safety,’” Baird says.Easty says he sees a new mindset and approach at work among the various players. “There is a growing realization that to achieve improvements in infusion safety, technology needs to be combined with careful planning and implementation,” he says. “We also know that we still have a long way to go in this regard. There are major challenges in standardizing drug ordering practices, compliance with pre-programmed drug libraries, and other patterns of use that bypass some of the safety features built into modern smart infusion pumps. These behaviors are often based on the pressure of work faced by nurses in busy clinical units, and so we need to understand these pressures better and work with them to design systems that are safer and more convenient to use.”Still, there are advances on the pharmaceutical front. Bona Benjamin, director of Medication-Use Quality Improvement at the American Society of Health-System Pharmacists and a member of the AAMI ISSC, reports “significant progress” in standardizing the nomenclature for medication administration via infusion devices, as well as recommendations for standardized concentrations for high-risk, high-volume medications. “Once we achieve consensus on the final formulary, we will develop tools and resources that help users apply this information to safely configure drug libraries for smart pumps,” she says.Healthcare professionals who had been laboring in the wilderness to improve infusion safety have more company and support now. “There is now much more awareness of the complexity of these processes, and I find when I talk to people that they are better informed of the challenges involved in improving medication safety, so focusing on this issue has certainly raised its profile,” Easty says.Pete Doyle, a human factors engineer at The Johns Hopkins Hospital in Baltimore, MD, describes a “cross-fertilization of ideas between stakeholders to include clinicians, clinical engineers, human factors engineers, pharmacists, regulatory and R&amp;D personnel, and others.”Moreover, infusion device safety is now on the radar screen of institutional leaders, thanks to key stakeholders emboldened to take action, which is creating an environment that is more conducive to change.For example, Benjamin says, pharmacists in hospitals and elsewhere “have become integral” in initiatives aimed at medication-related technology challenges. “By involving users of infusion devices in policy and clinical decision-making, applying their clinical knowledge and systems thinking skills, and leveraging support from technology vendors, pharmacists can help ensure that a safe medication use process is planned and implemented,” Benjamin says.The unprecedented AAMI/FDA Infusion Device Summit produced a focused agenda that highlighted both the extraordinary challenges facing the entire healthcare community and best practices by leading organizations.Framed by expert presentations, summit participants built consensus on 13 priority issues that they believe are crucial to improving patient safety. Shortly after the summit, AAMI's Infusion Device Standards Committee grouped the 13 priority actions into five clarion themes, which serve as a call to action.Indeed, the summit turnout—which included physicians, nurses, pharmacists, clinical engineers, biomedical technology professionals, human factors engineers, manufacturers, academicians, regulators, and organizations that represent them—underscored an overarching key message of the event: It would take a comprehensive, collaborative, and multidisciplinary effort to improve infusion device safety.At the end of 2010, AAMI published Infusing Patients Safely, a report of the summit's clarion themes, priority issues, best practice presentations, and expert perspectives. The report was widely distributed to healthcare organizations and stakeholders.“Perhaps what made the summit most remarkable was the overwhelming commitment of attendees that, as a community, they would continue to work together on the development and implementation of action plans based on the agreed-upon priorities,” says AAMI President Mary Logan.Moreover, the clarion themes continue to resonate, according to professionals who are deeply involved in improving the state of practice. “As a comprehensive set, they provide an excellent basis for developing strategies to address the issues of pump safety,” Doyle says.“Yes, the themes from the summit remain,” says the FDA's Anthony Watson, director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Evaluation at the Office of Device Evaluation at the Center for Devices and Radiological Health (CDRH). “The infusion pump team at the FDA is still highly motivated and recognizes change takes time.”Alan Lipschultz, president of Healthcare Technology Consulting LLC in Wilmington, DE, attended the summit and sees its impact. “The summit was the start of something,” he says. “The conversation has changed because the document is a door opener to get some of the issues on the table and talk about the bigger picture within institutions, within which clinical engineers function.”The summit report served that purpose for Glenn Scales, who put it in the hands of leaders who make strategic decisions and set priorities on behalf of Duke University Health System in North Carolina. Scales, who serves on the ISSC, recently retired as a patient safety specialist with Duke's Department of Clinical Engineering. To get the attention of people who have “hundreds of priorities that are priority number one,” Scales distributed handfuls of copies of the report and follow-up publications. He also forwarded e-mails and electronic information related to infusion devices to keep the issues on the radar screen of institutional leaders and key staff members, such as the chief nursing officer and patient safety officer.“It helped people to understand that they needed to get a little more galvanized at looking at this institutionally, rather than just being reactive when a problem occurs,” Scales says. “The good news is that in this institution and in many others, you've got people who know the right people and have the right kinds of influence to help them see the bigger picture and understand how our developmental practices need to change and evolve.”In practice, that has meant changes in business as usual in the two years since the summit, with more thoughtful, multidisciplinary approaches to improving the use of infusion systems. “We're doing things differently now,” Scales says. “We're collaborating better. Committees that are beginning to look at how we make errors and how we can improve our processes and drug libraries and settings are much more multidisciplinary than they used to be. It used to be that it would just be pharmacists and maybe a few nurses. Now it's a much broader cross-section of people across the institution. Some of the work product from the summit is helping us think about different ways of how to use the tools that we have more effectively.”The recall two years ago has had manufacturers scrambling to supply new infusion pumps to replace the 200,000 recalled devices. Baxter turned to SIGMA, a small firm in Medina, NY, and others to supply replacement pumps. At the time, Baxter had a 40 percent ownership stake in SIGMA; this year, Baxter completed its acquisition of the company.SIGMA and other firms had to ramp up production quickly and dramatically. There have been bumps along the way, including additional recalls of the replacement pumps. Still, the industry and healthcare institutions seem to have risen to this immediate challenge.“A concern among clinical engineers was that overly rapid, FDA-mandated implementation of 200,000 new smart pumps in hundreds of hospitals, together with user training and all the necessary support systems, could create inherent dangers,” says Nathaniel Sims, an anesthesiologist, medical device inventor, and physician advisor to Biomedical Engineering at Massachusetts General Hospital (MGH) in Boston. “Happily, to the best of our knowledge, the rapid replacement of the recalled systems, has significantly improved the patient safety net and did not create unintended consequences of change.” Sims also serves on the ISSC, which is part of the AAMI Foundation's Healthcare Technology Safety Institute.At the same time, manufacturers had to learn how to follow the new FDA regulatory process with infusion pumps. That includes the new safety assurance cases and design controls. In addition, pump manufacturers and healthcare institutions recognize that the advent of electronic medical records, computerized physician order entry (CPOE), and other technologies requires their attention as well. They're working on new partnerships with information technology (IT) companies that specialize in healthcare IT to connect infusion systems with other IT systems. In short, manufacturers have a lot on their plates. “Even if we have all the answers, change takes time,” Baird says. “I think people in the industry realize this.”But the new forums in place for collaborative efforts to improve practices are easing the way. “I see that the concept of a cross-functional safety council like the ISSC can work to improve areas where medical device safety overlaps with medical practice safety,” Baird says.The shift toward integrated systems is impacting healthcare institutions as well. At Duke University Health System, for example, “the very best of the IT talent has been taken away from their day-to-day operations to focus on new IT projects such as CPOE and integrated electronic medical record systems and the things that MDDS [the FDA Medical Device Data Systems rule] is beginning to mandate that we do,” Scales says. Eventually these new integrated systems will incorporate data from infusion devices, which Scales believes will be the beginning of safer medication delivery at bedside.Scales is concerned that U.S. manufacturers have been so overwhelmed meeting production demands—and uncertain about FDA requirements— that the next generation of infusion systems is in jeopardy. “Fortunately, at this point the infusion devices we are using are meeting our current needs,” he says. “But we also know that if we decided that we wanted to replace this fleet, we have about a 30-month timeline ahead of us. We don't see any truly innovative, earth-shattering device development in the near future that's worthy of our attention. We're just seeing little, incremental changes in the equipment base that we already have.”With these challenges, however, come opportunities for innovation. Sims believes the next wave of innovation could come from abroad, as manufacturers everywhere work toward new infusion platforms with global reach. “I'm convinced that the next innovative leaps will come from sourcing best clinical practices, engineering insight, and business models from around the world” says Sims.Still, foreign manufacturers must go through the FDA approval process as well—and that's unfamiliar territory for them. And they have to tailor their products to American user expectations. That could pose hurdles not just in device development and approval, but also in medical practice. For example, Lipshultz says, many non-U.S. manufacturers base their technology on syringe pumps, rather than the large-volume infusion pumps that are used in most U.S.clinical settings.The summit showcased a handful of leading organizations and individuals whose research and innovative practices inspired summit participants and continue to serve as exemplars to the healthcare community. Since then, there has been more progress, which is laying a foundation for broader improvements in infusion device design, human factors, evaluation, manufacturing, and use.For example, in the case of device design and usability, The Johns Hopkins University Applied Physics Laboratory and Johns Hopkins Medicine have collected more than 900 candidate usability solutions and other comments from a diverse set of pump experts. “We are in the process of reducing these to identify the most helpful and most feasible solutions for later prototype evaluation in a simulation setting,” says Doyle, whose team includes Alan Ravitz, program manager, biomedical systems, at the Applied Physics Lab and Julius Pham, MD, of Johns Hopkins Medicine. The prototype capabilities will enable a degree of flexibility for test activities—and they will be made available for others to use once the project is completed.A three-year grant from the U.S. Department of Health and Human Services Agency for Healthcare Research and Quality is funding some of this work.“Research conducted on human factors issues related to pumps continues at a good pace,” Doyle says. “What is really beneficial, I believe, is that now there is more dialogue between human factors specialists and others in the pump community. This helps to point human factors research better to feed design activities. While progress may seem incremental, one must acknowledge both the complexity of this challenge and the need for a discerning scientific approach. It should be recognized that the unprecedented cooperation of stakeholders is proving most advantageous in providing guidance and direction.”On another research front, the Health Technology Safety Research Team at the University Health Network in Toronto, in collaboration with the Institute for Safe Medication Practices Canada, has unearthed a number of risks and challenges in what recently had been an multiple IV This research has and the and time pressures where many patients multiple IV with some IV infusions to research team themes that are of with issues that can to patient related to these themes of of multiple IV the project is still way, of the ISSC are with the research to which takes into account factors related not just to healthcare but also factors at the and the project is from research to best practice by making recommendations for improvements to infusion and clinical best practice and work practices required to the Scales and other biomedical technology professionals, the that need a working knowledge of the of infusion how and the devices like the you a of the pressure that it on the pump and on the patient is he says. “The more the the is a lot of the is for a lot of any than it has to be to clear the of the a to the and the to put the at an after it to get through the the the Scales says. they don't understand pressure and it's the better if it's they don't make the effort to make the he of the of infusion and the risks of multiple IV are not and in nursing according to the they are in clinical nurses typically learn how to use infusion devices in and training by the are and it's to learn these on the got a of time and they just the Scales says. what I call do I need to to get the right “I at how much progress has been made on the issue of multiple line safety, progress, not just people around about I also at the of things just around the There is that's still AAMI quickly up on the infusion summit, as well as the AAMI Medical Device Summit of by the Healthcare Technology Safety Institute has infusion device safety as its priority and now an Infusion Systems Safety by the multidisciplinary this leading serves as a and of all stakeholders in infusion device safety. The stakeholders together to progress, identify and and partnerships to research and best the of was a grant by the to a three-year on key issues the administration of IV medication using smart pumps. The of this to be by and Hospital in is to the of errors that may occur when using smart pumps to IV and what can be about errors are the most of in hospitals, and IV says MD, the who has smart pumps is senior vice president for quality and safety at and medication errors represent one of the most safety and for hospitals, and have that many of these errors are Vanderveen says. “The of smart IV pumps has a of new information that has helped us understand the degree of in the IV medication This will more to best practices in IV therapy and help better technology to errors and improve patient will smart pump at hospitals across the team of two at will the medication the administration of using smart pumps to find any In the year, the team will the and develop safety solutions to help future solutions are will IV medication errors at the to The research team will the of the and best practices for smart pump progress made by more by the healthcare community in than two years is says. “I'm of the that the and of the summit, that a of thoughtful, can change the it is the only that our work and can we go and now? Our work will not be we achieve our that should be by a drug

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