With this aggressive and farreaching initiative, the fda is also driving the industry toward improved software development and veri. Smart pump app for infusion pump training clinical. 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. Innovative health care safety initiatives earn awards ihi npsf lucian leape institute recognizes improvement teams from purdue university and. However, simultaneous implementation of all these technologies is rarely feasible. Infusion pump project gutenberg selfpublishing ebooks. Our quality improvement initiative took place in an anesthesia radiology.
Collaboration fuels success of infusion management interoperability initiative lynn razzano, angie box, karen corrick, james mcdowell, and rachel r. Cdrh director jeffrey shuren has called this a first for the agency, exercising its authority over an. 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. 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. 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 made in the administration of intravenous medication can lead to catastrophic harm. 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. Continuous quality improvement cqi data capabilities. Quality improvement outcomes included 100% drug library compliance across all 6. Think competencies, not hours, when planning your next education initiative. Infusion pumps provide a high level of control, accuracy, and precision in drug delivery, thereby reducing medication errors and contributing to improvements. Achieving outcomes with innovative smart pump technology.
In 2010, the fda undertook the infusion pump improvement initiative to support. Ppt infusion pumps powerpoint presentation free to. Errors continue to plague smart pumps healthcare it news. 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. Nhia will post updates on the website and listserv as both the home use devices initiative and infusion pump improvement initiative move forward. We sought to improve medication safety by implementing a 2person verification system before medication administration.
In 2010, the fdas center for devices and radiological health issued an infusion pump improvement initiative. 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. This article describes the design and evaluation of autosyp, a lowcost, lowpower syringe pump intended to deliver intravenous iv infusions in lowresource hospitals. 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. Lessons learned at a multihospital system deborah christopher, bsn, rn, six sigma black belt. The aamifda infusion device summit opened with this quote from margaret mead. Many highrisk infusion medications eg, propofol, dexmedetomidine.
Implementing smart infusion pumps at kaiser permanente. 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. A 242bed universityaffiliated tertiary pediatric hospital. The efforts of this group culminated with the infusion pump improvement initiative of april 2010. Infusion status data sent from the pump to the emr. A modular iv infusion safety system was determined to provide the greatest speed to impact in. 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. Collaboration, evidencebased best practices, and smart. Development of an infusion pump safety score american.
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. Change in competitive bid program could jeopardize. Qualityimprovement analytics for intravenous infusion pumps. Fda infusion pump improvement initiative infusion nurse blog.
Operating in ma for the last 25years, i am familiar with the nuances of oems and the flavor of the medical community. Standard drug concentrations and smartpump technology. Infusion pumps are only part of the prob lem, and iv. A free powerpoint ppt presentation displayed as a flash slide show on id. 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. However, the fda has identified problems that can compromise. Safetyassured development of the gpca infusion pump. Infusion pump improvement initiative to establish requirements for pump manufacturers and proactively facilitate device improvements.
Draft guidelines for optimizing safe implementation and use of smart infusion pumps. Advamed continues to support fdas infusion pump improvement initiative to support the benefits of infusion pumps while minimizing the risks. External infusion pumps hereinafter infusion pumps are medical devices that deliver fluids, including nutrients and medications, into a patients body in a. An external infusion pump is a medical device used to deliver fluids into a patients body in a controlled manner. 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. Known as the remedi collaborative, it is a free, online resource for clinicians, manufacturers, researchers, and medication safety organizations. Through the infusion pump improvement initiative, fda will work to establish additional requirements for infusion pump manufacturers, proactively facilitate device improvements, and increase user. Pdf safetyassured development of the gpca infusion pump.
An infusion pump infuses fluids, medication or nutrients into a patients circulatory system. 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. Infusion pumps provide a high level of control, accuracy, and precision in drug delivery, thereby reducing medication errors and contributing to. In this article, we describe the need to improve iv infusion medication safety at the. At a 644bed, tertiarycare, magnet system, intravenous iv infusion medication errors were determined to present the greatest risk of harm.
To determine if combining standard drug concentrations with smart pump technology reduces reported medication infusion errors. Bcma, and smart pumps computerized iv infusion safety systems are all essential. For these reasons, including infusion pumps in the dmepos competitive. Using data to improve smart intravenous infusion pumps. Students were assessed on knowledge, simulation performance, and confidence. Infusion pump problems have been observed across multiple manufacturers and pump types. 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 infusion data captured and stored from the sigma spectrum infusion system can provide insights into infusion pump practices. A constantforce spring within the device provides mechanical energy to depress the. Request pdf quality improvement analytics for intravenous infusion pumps purpose.
The summit focused on infrastructure, the drug library, continuous quality improvement data, clinical workflow, and bidirectional smart infusion pump interoperability with the ehr. Fda2010d0194 draft guidance for industry and fda staff. Institutions need to pay attention to pre and postsmart pump implementation recommendations. In response to the recent report from the fda titled infusion pump improvement initiative, nurse assist, inc. Food and drug administration fda is taking steps to address problems through its infusion pump improvement initiative. 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. Infusion pump improvement initiative, fda will work to establish additional requirements for infusion pump manufacturers, proactively facilitate device improvements, and increase user awareness. This improvement was achieved with the use of plandostudyact cycles.
The implementation of a smart pump continuous quality improvement cqi program across a. Collaboration, evidencebased best practices, and smart technology help avert highrisk adverse drug events and improve. Infusion pump improvement initiative, april 2010, center for devices and radiological health, u. Food and drug administration fda has launched a comprehensive initiative to improve their safety, called the infusion pump improvement initiative. These errors were an impetus for this quality improvement qi project. The fda has launched the infusion pump improvement initiative. 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.
Pump manufacturers and home infusion providers alike are encouraged to submit comments and suggestions to nancy. Pdf 474kb aami and fda summit on infusion devices, oct 56, 2010. Since the scoring system was implemented at intermountain healthcare, the overall infusion pump safety score for the 22 hospitals has improved from 6. A brief 2person verification approach can reduce medication errors due to inaccurate infusion pump programming. An iv infusion safety initiative focused on multidisciplinary collaboration, standardization of iv dosing, and medication safety technology. Infusion pump standards guide epsrc programme grant epg0590631 disclaimer. Prepare nurses for the cultural shift of having to think in terms of dose rate. 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. This project played a key role, as part of a larger initiative within the department of anesthesia, in reducing medication errors. The frequency of hospital settings in which medication pumps are being used are increasing. Preintervention and postintervention comparison of reported medication errors related to infusion therapies during the calendar years 2002 and 2003. For more information on fdas progress in completing these steps see the infusion pump improvement initiative page. 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. Infusion pumps fda approved for ground ambulance use.
The clinical engineering, logistics, and infusion systems teams were. This nist cybersecurity publication provides best practices and detailed guidance on how to manage. The purchase and implementation of smart infusion pump. 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. There are many different types of infusion pumps, which are used for a variety. Our quality improvement initiative took place in an. The usfda launches initiative to reduce infusion pump.
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