In 2010, the fda ordered a recall of all baxter colleague volumetric infusion pumps due to the companys longstanding failure to correct the numerous problems with the pumps. Operating in ma for the last 25years, i am familiar with the nuances of oems and the flavor of the medical community. The aamifda infusion device summit opened with this quote from margaret mead. Pumps and problems according to the fdas white paper on the initiative, between 2005 and 2009, the fda received approximately 56,000 reports of adverse events. The cqi analyticsplus program organizes your data into actionable reports that enable your staff to readily analyze infusion pump activity and help make quality improvement decisions. Food and drug administration has announced a new initiative to address what fdas center for devices and radiological health cdrh has referred to as rampant safety issues associated with the technology utilized by external infusion pumps. Since the scoring system was implemented at intermountain healthcare, the overall infusion pump safety score for the 22 hospitals has improved from 6. Achieving outcomes with innovative smart pump technology. An external infusion pump is a medical device used to deliver fluids into a patients body in a controlled manner.
In 2010, the fda undertook the infusion pump improvement initiative to support. Advameds support for efforts to improve infusion pumps while minimizing risks, advameds infusion pump working group developed the infusion pump assurance case ipac report template which is discussed in more detail below. Qualityimprovement analytics for intravenous infusion pumps. Through the infusion pump improvement initiative, fda will work to establish additional requirements for infusion pump manufacturers, proactively facilitate device improvements, and increase user. Prepare nurses for the cultural shift of having to think in terms of dose rate. In 201112, in accordance with a nationwide, standardized approach, kaiser permanente replaced approximately 17,000 largevolume pumps with smart infusion pumps, which offered more robust safety features, the promise of wireless connectivity, and the ability to gather continuous quality improvement.
With this aggressive and farreaching initiative, the fda is also driving the industry toward improved software development and veri. An infusion pump infuses fluids, medication or nutrients into a patients circulatory system. We sought to improve medication safety by implementing a 2person verification system before medication administration. The frequency of hospital settings in which medication pumps are being used are increasing. Food and drug administration fda has launched a comprehensive initiative to improve their safety, called the infusion pump improvement initiative. Change in competitive bid program could jeopardize.
Collaboration fuels success of infusion management interoperability initiative lynn razzano, angie box, karen corrick, james mcdowell, and rachel r. Collaboration, evidencebased best practices, and smart. Infusion pumps are only part of the prob lem, and iv. A free powerpoint ppt presentation displayed as a flash slide show on id. A brief 2person verification approach can reduce medication errors due to inaccurate infusion pump programming. Standard drug concentrations and smartpump technology. Request pdf quality improvement analytics for intravenous infusion pumps purpose. Our quality improvement initiative took place in an anesthesia radiology. Fda infusion pump improvement initiative infusion nurse blog. The infusion data captured and stored from the sigma spectrum infusion system can provide insights into infusion pump practices.
To determine if combining standard drug concentrations with smart pump technology reduces reported medication infusion errors. The implementation of a smart pump continuous quality improvement cqi program across a. A 242bed universityaffiliated tertiary pediatric hospital. The efforts of this group culminated with the infusion pump improvement initiative of april 2010. Our quality improvement initiative took place in an.
In 2010, the fdas center for devices and radiological health issued an infusion pump improvement initiative. Nhia will post updates on the website and listserv as both the home use devices initiative and infusion pump improvement initiative move forward. Introduction there are various types of infusion pump designed with a view to serve different purpose of therapy but it is important that the pumps selected can deliver the fluids at desired rate and volume. Errors associated with the use of infusion pumps can cause serious harm or death in hospitalized patients and increased costs to the health care system. In response to the recent report from the fda titled infusion pump improvement initiative, nurse assist, inc. Ppt infusion pumps powerpoint presentation free to. The idea that an infusion pump could identify doses that were out of range was well received, and in simulation testing the using data to improve smart intravenous infusion pumps. Innovative health care safety initiatives earn awards ihi npsf lucian leape institute recognizes improvement teams from purdue university and. To that end, the infusion pump requirement for all ambulance services stipulates that a transportation rated infusion pump be used in the out of hospital setting in the off chance that an ems patient requires norepi. At a 644bed, tertiarycare, magnet system, intravenous iv infusion medication errors were determined to present the greatest risk of harm. Development of an infusion pump safety score american.
The summit focused on infrastructure, the drug library, continuous quality improvement data, clinical workflow, and bidirectional smart infusion pump interoperability with the ehr. Infusion pump improvement initiative to establish requirements for pump manufacturers and proactively facilitate device improvements. However, simultaneous implementation of all these technologies is rarely feasible. Fda infusion pump improvement initiative june 20, 2012 the fda cdrh center for devices and radiologic health is embarking on an initiative to reduce adverse events from external infusion pumps. Infusion pump improvement initiative, fda will work to establish additional requirements for infusion pump manufacturers, proactively facilitate device improvements, and increase user awareness. Advamed continues to support fdas infusion pump improvement initiative to support the benefits of infusion pumps while minimizing the risks. Infusion pump problems have been observed across multiple manufacturers and pump types. Through analysis of pump related adverse event reports and device recalls, fda has concluded that many of these problems appear to be related to deficiencies in device design and engineering. Think competencies, not hours, when planning your next education initiative. Continuous quality improvement cqi data capabilities.
The clinical engineering, logistics, and infusion systems teams were. Pdf safetyassured development of the gpca infusion pump. Errors continue to plague smart pumps healthcare it news. The purchase and implementation of smart infusion pump. Using data to improve smart intravenous infusion pumps. This guidance, is provided by ucl and its partners as is, without any representation or endorsement made and without warranty of any kind whether express or implied, including but. Institutions need to pay attention to pre and postsmart pump implementation recommendations. Lessons learned at a multihospital system deborah christopher, bsn, rn, six sigma black belt.
Implementing smart infusion pumps at kaiser permanente. Pump manufacturers and home infusion providers alike are encouraged to submit comments and suggestions to nancy. The second national ismp smart infusion pump summit was convened in march, 2018. Never doubt that a group of thoughtful, committed citizens can change the world. In this article, we describe the need to improve iv infusion medication safety at the.
Draft guidelines for optimizing safe implementation and use of smart infusion pumps. It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used infusion pumps can administer fluids in ways that would be impractically expensive or unreliable if performed manually by nursing staff. Safetyassured development of the gpca infusion pump software. The agency found that many problems related to infusion pumps were related to deficiencies in device design and engineering. Safetyassured development of the gpca infusion pump. Cdrh director jeffrey shuren has called this a first for the agency, exercising its authority over an. However, the fda has identified problems that can compromise. Infusion pumps improvement initiative, including that pharmacists confirm that settings on a pump are correct before giving it to a patient or clinician, and that pharmacists work with a multidisciplinary team to monitor any pump incidents. Infusion pump standards guide epsrc programme grant epg0590631 disclaimer. Wireless infusion pumps, by using standardsbased commercially available technologies and industry best practices to help hdos strengthen the security of the wireless infusion pump ecosystem within healthcare facilities. A constantforce spring within the device provides mechanical energy to depress the.
The usfda launches initiative to reduce infusion pump. This improvement was achieved with the use of plandostudyact cycles. Infusion pumps provide a high level of control, accuracy, and precision in drug delivery, thereby reducing medication errors and contributing to improvements. Infusion pump project gutenberg selfpublishing ebooks. Many highrisk infusion medications eg, propofol, dexmedetomidine. Bcma, and smart pumps computerized iv infusion safety systems are all essential. Quality improvement outcomes included 100% drug library compliance across all 6. Students were assessed on knowledge, simulation performance, and confidence. The fda has launched the infusion pump improvement initiative. An iv infusion safety initiative focused on multidisciplinary collaboration, standardization of iv dosing, and medication safety technology. Previous article video monitoring a simulationbased quality improvement program in bihar. Infusion status data sent from the pump to the emr. Infusion pump improvement initiative, april 2010, center for devices and radiological health, u. This nist cybersecurity publication provides best practices and detailed guidance on how to manage.
Infusion pumps basic infusion system flow by gravity flow controlled by roller clamp difficult to set and control infusion rate infusion pumps what are they. Food and drug administration fda is taking steps to address problems through its infusion pump improvement initiative. For more information on fdas progress in completing these steps see the infusion pump improvement initiative page. Known as the remedi collaborative, it is a free, online resource for clinicians, manufacturers, researchers, and medication safety organizations. Errors made in the administration of intravenous medication can lead to catastrophic harm. Smart pump app for infusion pump training clinical. A modular iv infusion safety system was determined to provide the greatest speed to impact in. Fda hasnt published final infusion pump guidance yet after industry feedback on 510k recommendations, fda decided to use their infusion pump experience as a pilot study to evaluate safety assurance cases in 510ks although fda is studying improvement initiatives for other device types e. For these reasons, including infusion pumps in the dmepos competitive. There are many different types of infusion pumps, which are used for a variety. This project played a key role, as part of a larger initiative within the department of anesthesia, in reducing medication errors. Preintervention and postintervention comparison of reported medication errors related to infusion therapies during the calendar years 2002 and 2003.
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