Reflections on the Current State of Infusion Therapy

AAMI Foundation is very grateful to its premiere industry Reflections on the Current partners and wishes to thank them for making the work of the foundation possible: National Coalition for Alarm State of Infusion Therapy Management Safety; National Coalition to Promote the Continuous Monitoring of Patients on Opioids; and the Matthew B. Weinger and Andrew Kline National Coalition for Infusion Therapy Safety.

Diamond Sponsors: This article reviews the current state of A Brief History of Infusion Therapy About the Authors intravenous (IV) infusion technology and IV infusion therapy has a long and remarkable Matthew B. delineates aspects that would benefit from history. The first recorded attempt to give an Weinger, MD, improved design and development. It infusion was in 1492,4 when physicians tried to is professor and provides context for the current landscape of transfuse Pope Innocent VIII via vein-to-vein vice chair of infusion technology by briefly describing the anastomosis from three young boys—both the anesthesiology history of infusion therapy and highlighting Pope and his donors died. The first working and professor of biomedical key events and innovations that have shaped infusion device was created in 1658 by Sir informatics and medical education modern infusion. Building on previous Christopher Wren who attached a quill to a at the Vanderbilt University School reports that focused on medication errors pig’s bladder to instill a mixture of alcohol and of Medicine in Nashville, TN; director and patient safety,1,2 the current work concen- morphine into the veins of sick dogs.5 Learning of the Center for Research and trates on the limitations of existing of Wren’s success, Richard Lower, a London Innovation in Systems Safety at the Vanderbilt University Medical Center technology and related workflows that cardiologist, infused a man named Arthur Coga and staff physician in the Geriatric constrain clinical efficiency and overall value. with sheep blood to calm him, inciting a Research Education and Clinical Platinum Sponsors: Future innovations that could advance “benign form of insanity.”6 Dr. Lower used Center at the VA Tennessee Valley infusion system safety, efficacy, usability, primitive versions of the same elements of Healthcare System in Nashville, TN. efficiency, and overall value to clinicians and modern-day syringes, needles, and catheters. Email: [email protected] the healthcare system also are discussed. Of As experimentation continued, the proliferation Andrew Kline, note, this article focuses on volumetric of adverse events led both the British Royal BA, is program infusion pumps used in clinical settings. Society and the Vatican to ban transfusions in coordinator in Beyond reducing medication errors, an the late 1660s, and infusion science was put on the Center for important potential benefit of optimal design hold for more than a century.6 Research and Innovation in of infusion technology is the prospect of In 1795, the American physician Philip Syng Systems Safety considerable cost savings. Each preventable Physick once again advocated for human-to- at Vanderbilt University Medical adverse drug event (ADE) has been reported human blood transfusions. However, it was Center in Nashville, TN. Email: Gold Sponsors: to cost nearly $9,000.3 Through built-in not until the 1820s that James Blundell, an [email protected] designs and adherence to the “five rights of English physician and obstetrician, performed medication administration,” smart pumps can the first documented successful transfusion.4 help decrease the incidence of ADEs. Indeed, Blundell also developed two mechanical not only is avoidable patient harm wrong, it infusion devices: the gravitator, which used also has proven to be expensive. Moreover, gravity to deliver fluids in a regulated stream, care process inefficiencies add increased costs and the impellor, which infused fluids under to a healthcare system that is already far too pressure. These devices sound eerily similar costly for the quality of care offered. to current technologies.

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Infusion science accelerated in the 1830s pump also included an early version of dose during London’s cholera epidemic. Dr. error reduction software (DERS) that alerted William O’Shaughnessy reported in The the user to potential problems with their Lancet in 1832 that cholera victims lost a high on-pump programming. Mike Cohen and concentration of their saline and alkali.6 In Tim Vanderveen were the first to describe the response, Dr. Thomas Latta performed the smart pump in a 2002 issue of the Institute first nonblood IV infusions of sodium for Safe Medication Practices newsletter.8 In chloride and bicarbonate and was able to save 2010, Sims noted that “since infusion pumps eight of the 25 victims he treated.6 In the are used in so many settings in almost every mid- to late 1800s, numerous clinicians hospital bed, many changes will no doubt be initiated and advocated for IV medication forthcoming in the next few months or administration. The most common IV years.”3 Smart pumps can now be found in medications were narcotic substances, most major hospitals worldwide and have including opium and cocaine. undoubtedly prevented many serious infusion IV medication administration, as well as errors. However, as currently implemented, fluid and transfusion therapy, became part of they only prevent a portion of all infusion- routine military medicine during the Second related harm, leaving many unresolved safety World War.5 The first civilian infusion service and quality issues with IV therapy. may have occurred in 1940 at Massachusetts General Hospital (MGH), where one nurse Cost of Drug Errors served as the infusion “operator.” Clinicians The Society for Actuaries suggested that the returning to civilian practice helped to financial cost of medical errors was nearly $1 proliferate modern IV therapy. While trillion per year when including both the mechanical peristaltic pumps (e.g., for direct and the indirect (e.g., morbidity, cardiopulmonary bypass and dialysis applica- decreased patient quality of life) costs.9 tions) were introduced earlier, and the first Considering the impact of the Institute of ambulatory pump was marketed in the late Medicine’s likely conservative 2001 estimate 1950s, the first modern electromechanical of nearly 100,000 medical error–related infusion pumps became commercially deaths annually, researchers and policy available in the 1960s. An important early experts have called these errors “America’s innovation was the use of an electronic drip most important public health issue.”10 What detector that allowed feedback control to a might seem like a small error can snowball, microprocessor to improve flow accuracy. As producing exponential effects on patients and the market matured, competitors introduced their cost of treatment. Without a systemwide further innovations, including the first focus on quality of care, the moral and “volumetric” infusion pump, whereby the financial burden of avoidable injury and volume being pumped was directly measured death will continue to plague healthcare and recorded (within constraints to be systems worldwide. Technology has a role in discussed later); “air-in-line” and downstream reducing injury and cost, but only if it is (distal) occlusion alarms; and the use of a designed and implemented correctly. Ample proprietary disposable. opportunities exist for infusion technology to So-called “smart” pumps were first con- improve substantially the overall value of ceived by Dr. Nathaniel Sims and his team at healthcare processes. MGH in 1992, then implemented in 1997.7 The first permutation of the team’s fully Drug Library Creation operational smart pump showed the promise and Maintenance of interoperability by connecting the pump to A key finding of a recent survey was that a computer library of infusion medications. hospitals using smart pumps typically Their most important innovation was the adopted this technology due to “inventory age incorporation of a hospital-proctored drug and failure” rather than as part of an over- library into the pump’s software, thereby arching “safety strategy.”11 Moreover, these allowing the user to select specific drugs, hospitals were unable to integrate their new concentrations, doses, and rates. The MGH pumps with other medication management

254 Biomedical Instrumentation & Technology July/August 2016 © Copyright AAMI 2016. Single user license only. Copying, networking, and distribution prohibited. Features technologies (i.e., computerized provider infusions.2,13 Redesigned infusion technolo- order entry, bar-coded medication adminis- gies must consider and address these tration), thereby limiting the ability of their inefficiencies. Given the high cost of nursing pumps to fully address the “five rights.” As care in most facilities, efforts to reduce these one indication of the limitations of DERS, low-value tasks will improve nurses’ job only about one-half of the hospitals surveyed satisfaction and yield substantial cost savings implemented hard limits on their pumps. for the organization. Below, we discuss Further, a major reason for DERS noncom- specific opportunities for improvements in pliance was incomplete or outdated hospital infusion therapy design and workflow. drug libraries. For smart pumps to attain their safety Pump and Tubing Management for improvement potential, drug libraries must Multiple Infusions be maintained and trusted by the staff. Many When administering multiple infusions to a installed infusion pumps still do not have single patient, pump and tubing management wireless functionality; these pumps need to is currently a frustrating, time-consuming, have their libraries uploaded manually—a and error-prone task.14 As a worst-case time-consuming (and therefore expensive) example, imagine a cardiac surgery patient burden on the organization’s healthcare (either in the operating room [OR] during technology management staff. In most surgery or the intensive care unit [ICU] hospitals, pharmacists typically are responsi- immediately afterwards) who is on a dozen or ble for the ongoing management of the drug more infusions of vasopressors, inotropes, libraries. Given hospital pharmacists’ current sedatives, analgesics, muscle relaxants, workload and the rapidly changing landscape antibiotics, procoagulants, antiarrhythmics, of available pharmaceuticals, it can be electrolyte replacements, and blood products, extremely challenging to keep drug libraries each with its own pharmaceutical constraints up-to-date. To the extent that newly available (e.g., drug-drug interactions and incompat- medication safety information has not been ibilities, flow rate limits). These infusions, as implemented in a drug library, preventable well as carrier and volume replacement fluids, harm may reach the patient. Another risk of are infusing through multiple peripheral and an out-of-date drug library is that clinician central lines. You can see how difficult it can users will not find a desired drug in the be for the clinician to maintain an accurate library and then bypass the DERS safety mental model of what drugs are administer- features through “basic” unlabeled milliliter ing into what catheters. Current infusion per hour infusions. systems do little to support this critical management task. The clinician is constantly Workflow Issues fighting with (and sometimes tripping over) Much of inpatient nurses’ time is consumed equipment and tubing. Errors are common by “low-value” tasks (bundled into what is and adverse consequences have been well often called “indirect patient care tasks”).12 documented.15,16 Infusion pumps are a major contributor to The effective coordination of concurrent these care process inefficiencies. According therapy is important. Two medications being to modern quality improvement practices infused by different pumps may be contrain- such as Lean or Six Sigma, tasks that do not dicated to be infused through the same IV generate real value for the organization or the line. The concurrent infusion of two drugs, customer (i.e., the patients) should be one acidic and the other alkaline, can pro- minimized if not eliminated. In the case of duce an insoluble salt that occludes the IV. infusion therapy, lower-value time-consum- Alternatively, one drug running through the ing nursing tasks may include searching for same line may inactivate the other. Drug- available pumps, priming tubing (including drug incompatibilities can also occur when air elimination), manual pump program- drugs are infused through different IV sites. ming, responding to false or unnecessary For example, the effects of one drug can alter pump alarms, and managing tubing spa- the effects of a second. There are reports of ghetti (i.e., tangled plumbing) and secondary inadvertent double dosing, where one

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clinician starts an infusion, fails to notify not need IV fluids) is on a regular IV drug another clinician (or the electronic health regimen (e.g., intermittent IV antibiotics), it record [EHR] system fails to do so), and then is still common to administer a low rate of IV a second clinician gives a second dose of the fluids to maintain vein patency and to flush same drug. A more subtle adverse conse- through the drug doses after they are com- quence of numerous infusions in the same plete. Thus, nurses often administer patient is fluid overload. In the patient on secondary or “piggyback” infusions in which fluid restriction (e.g., someone with heart the drug dose is attached to an already active failure or brain injury) neither the pharma- IV fluid infusion at a Y-site above the infu- cist nor the bedside nurse may be aware that sion pump inlet. To ensure preferential flow the myriad infusions of IV medications of the secondary infusion, that IV bag must accumulate to a total fluid volume that be hung higher than the primary fluid bag. exceeds the desired level of hydration. Thus, These secondary infusion sets use a backflow when one patient has multiple infusions, the (or check) valve to prevent retrograde flow pumps should communicate with each other, from the primary to the secondary fluid thereby enabling appropriate bedside deci- sources. The desired dose of drug from the sion support related to drug-drug secondary source is then programmed into interactions, drug incompatibilities, and total the infusion pump. fluid therapy goals. However, this very common bedside For the typical ward patient on just one or “plumbing” arrangement is prone to medica- two infusions, the total space (or volume) and tion errors. A 2012 report17 described how, weight consumed by one or two infusion without proper set up, secondary infusions pumps, tubing, and an IV pole usually are can be delivered at uncontrolled and often manageable, though the risks of physical incorrect rates. Disturbingly, these incorrect harm during transport is well described. flow rate errors can be insidious, without However, consider our cardiac surgical patient detection by the pump or the user. Therefore, who now may have as many as 16 pumps at secondary infusions should never include the head of the bed (along with monitors, continuous high-alert medications. Smart ventilators, and other supportive technology). pumps should be designed to eliminate the The total weight and bulk of pumps, fluid risks of secondary infusion errors and, sources, and tubing can present an impedi- further, should reduce the complexity ment to easy patient access. Further, current currently associated with administering more multiple-line infusion pumps have numerous than one drug or fluid to a patient through bags of drugs and fluids hanging above them. the same IV site. Use errors are commonly reported related to the difficulties clinicians have trying to figure Flow Continuity out which drug/fluid source is associated with Drugs administered by infusion pumps at a which pump or pump channel. Thus, better specified rate are generally assumed to infuse methods of organizing, handling, and trans- continuously at the set rate within the porting pumps and their associated drug/fluid infusion pump standard (specified as ±5% sources and tubing need to be developed and level of flow accuracy). Instead, under some promulgated. In addition to smaller, lighter, circumstances, current infusion pumps easier-to-use pumps, greater effort must be administer fluids at highly discontinuous invested in tubing management systems and rates, including long periods of little or no to new ways for clinicians to organize fluid/ infusion into the patient. Such flow disconti- drug sources in different ways. nuity occurs most commonly at low infusion rates, especially when there is appreciable Secondary Infusions fluid volume between the pump and the Most patients only have one IV, and the most patient in higher-compliance tubing (e.g., common use of that IV is for hydration larger bore or softer tubing walls) and the IV administered as a milliliter per hour infusion access site has higher flow resistance (e.g., of a crystalloid solution. Even when a patient small-bore catheters). In such situations, who is able to take oral fluids (and thus does long periods of time (tens of minutes or

256 Biomedical Instrumentation & Technology July/August 2016 © Copyright AAMI 2016. Single user license only. Copying, networking, and distribution prohibited. Features longer) can elapse after a flow rate change doxically, because large-bore central venous before the change actually reaches the lines have more dead space, infusions patient. While a careful analysis of interna- through them can have greater delays before tional infusion pump standards (e.g., IEC physiological effects are seen. A delayed 60601-2-24:2012) and infusion pump refer- onset of effect can lead clinicians to increase ence manuals is beyond the scope of this the infusion to an excessive rate due to article, suffice it to say that 5% accuracy is perceived inadequate dosage. Thus, “clini- only guaranteed for specified (albeit typical) cians wishing to optimize therapy of conditions. Thus, in low-flow, high–distal complicated patients … may fail to recognize resistance applications, a syringe pump may [the long time for a drug to reach its target at be preferred. the desired concentration] and inadvertently Downstream plumbing can have a tremen- set drug delivery rates to harmful levels by dous influence on flow continuity. overly rapid adjustments of infusion pump Downstream occlusion alarms signal that an settings.”19 The higher initial rate and time increase in downstream pressure has required to attain a new steady state may be reached a threshold and, after the occlusion especially pronounced in pediatric (and is released, the infusion can resume. How- especially neonatal) patients.20 ever, release of the occlusion may result in a Infusion pump technology could mitigate postocclusion bolus to the patient due to the the effects of dead space to attain prompter pent-up pressure. This is particularly relevant and safer transitions between infusions. in neonates, in whom the smallest bolus can Because patients often receive multiple have clinical significance. Next-generation infusions, especially in critical care areas, it infusion technology must reduce flow rate will be important for future designs to account fluctuations where possible and, more for “dead space” and for clinicians to remain importantly, make the actual dynamic flow mindful of rate disparities and limitations. profile more transparent to the user. Battery Power and Pump Management Dead Space Patients rarely stay in the same place for very A drug will only start having an effect when long. Even very ill patients can require it enters the patient’s bloodstream, yet transportation to imaging tests or proce- pumps record a drug as being given after it dures. In fact, based on better outcomes in leaves the pump. An appreciable delay can recent studies,21 critically ill patients are now occur between when a drug leaves the pump being routinely ambulated. Picture a patient and when it enters the patient’s vascular with multiple life-threatening conditions system. This delay will vary for every infu- receiving multiple infusions via pumps, on a sion, with the most critical factors being the mechanical ventilator, etc., walking (with nature (e.g., compliance) and amount of assistance) the halls of the ICU (an increas- tubing (i.e., fluid volume) between the pump ingly standard practice!). The increasing and the patient, the type (i.e., size, length) of emphasis on patient ambulation argues for IV catheter used, and the programmed flow next-generation pumps to be smaller, lighter, rate. The volume of fluid between the pump and more portable. Further, during transport, infusion mechanism and the IV catheter hub electromechanical technology must be on is known as the “dead space” or “dead battery power. Although hospital-based volume.” For a continuous unchanging pumps have battery power (typically allowing infusion, the delayed effect due to dead space at least four and up to eight hours off AC is only relevant upon the initiation of the main power with a full battery), unlike infusion. However, every time a dosage dedicated ambulatory pumps, extended change occurs, the effects of the change will battery life has not been a design priority. be subject to the same delay. Studies show that due to dead space and Locating Missing Pumps pump start-up performance, it can take It has been reported that as many as one in between 0 and 40 minutes for correct five infusion pumps in a hospital are “lost” at flow-rate continuity to be achieved.18 Para- any one time, thereby requiring hospitals to

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have far more pumps than are clinically Automated Programming and Documentation required.22 These “lost” pumps are typically If the existing HIT already contains the found abandoned in remote parts of the essential patient-specific medication therapy facility (a corner in recreation therapy) or information, why isn’t this information hidden (e.g., hoarded), for example, in a routinely and automatically sent to and closet on a unit for “just-in-case” use. Some available on the appropriate infusion pump hospitals have begun to use a location (i.e., electronic data input)? Why don’t pumps management technology such as active radio routinely and automatically send their frequency identification (RFID) to keep infusion information to the existing HIT for better track of their pump inventory.23,24 therapy verification, clinical documentation, Because current pumps do not typically have and other purposes like decision support appropriate built-in technology, this feature (i.e., electronic data output)? These notions becomes an expensive add on. Next- are not new, and the impediments are not generation pumps should include primarily technological.24 In fact, some pump “location-aware” technology. This would vendors are already doing one or both with facilitate asset tracking, as well as improve selected HIT vendors in selected clinical adherence to the “five rights” by facilitating sites. However, appreciable impediments to the ability to associate specific pumps with ubiquitous bidirectional data sharing specific patients. between pumps and HIT remain, with the same being true for other bedside devices Health Information Technology (e.g., physiological monitors). The sidebar Integration titled “Example Case: The Future of Infusion The American healthcare system, like those Therapy” describes a clinical scenario that in other developed nations, has begun to demonstrates the potential value of a fully aggressively embrace health information integrated approach. technology (HIT) as a panacea for improving value (i.e., benefit/cost ratio), safety, effi- Patient-Specific Therapy ciency, and even patient satisfaction. In fact, To date, infusion pumps have accommodated the scientific evidence supporting the patient identification as well as weight and widespread belief in this “technology elixir” height, but these have had to be entered by is limited,25,26 and examples of false starts and the bedside provider manually. In addition, abject failures are numerous.27 Nonetheless, other patient-specific attributes influencing HIT is here to stay and does provide opportu- therapy effectiveness or safety have not been nities to improve the safety and efficiency of available at the pump. For example, if an infusion management. In this section, we infused drug to which the patient is allergic discuss the potential for automated pump is inadvertently ordered, administration is programming and administration documen- the last chance to catch the error and prevent tation, as well as opportunities for more harm. If the pump “knew” a patient’s patient-tailored therapy. medication allergies, it could generate an alert during pump programming. Few clinicians are willing to enter patient allergies Example Impediments to Ubiquitous Data Transfer or other patient-specific data manually on an Insufficiently specified and/or adopted national/international standards for data infusion pump (and manual entry is prob- terminology and connectivity lematic due to potential data input errors). Legacy device and software database architecture and other technological These factors underscore the value of a constraints that do not allow or facilitate data exchange robust HIT system that is interconnected to Lack of incentives for health information technology and infusion pump vendors to the infusion system software. “play with each other” Many drug effects are influenced by Food and Drug Administration constraints and concerns numerous pharmacokinetic (PK; the relation- Proprietary data formats and/or communication protocols ship between administered dose and blood levels) and pharmacodynamic (PD; the Concerns about data integrity and accuracy (when received from an outside source) relationship between blood levels and both Cybersecurity concerns desired and undesired effects) factors. Patient

258 Biomedical Instrumentation & Technology July/August 2016 © Copyright AAMI 2016. Single user license only. Copying, networking, and distribution prohibited. Features age is perhaps the single most important bedside. Such integrated task management factor affecting both PK and PD, with technology can also reside as a web app on a reduced dosing generally warranted (all other cell phone to provide the nurse with a things being equal) at both extremes of continually updated to-do list. Further, young and old age. An elderly patient may be dashboards can help keep track of the pump much more sensitive to both the effects and fleet on a unit, facilitate acquisition of an potential side effects of a drug. Other impor- unused pump, and avoid pump hoarding. tant PK factors include patient gender, renal, With a different dashboard, pharmacists can and liver function. Other PD factors include monitor a unit’s pump fleet to identify when heart, lung, and brain function and the new infusions need to be mixed and deliv- concomitant use of other drugs acting on ered to the unit. Similarly, the pharmacist can those major organs. When two drugs acting identify any pumps that have not been on the same effect site are coadministered, the result is often more than additive (i.e., synergistic). If age and other PK-PD information was available in the infusion software, EXAMPLE CASE: THE FUTURE then appropriate dosing guidance (e.g., during titration of a potent medication) or OF INFUSION THERAPY alerts/reminders could be appropriately activated and displayed on the pump. Access Nurse Jim Smith receives a text message on his cell phone that an to information at the time of programming IV gentamycin dose is due on his patient Gilda Jones (who was about patient-specific dosing adjustments admitted to the hospital with a pneumonia requiring IV antibiot- (i.e., effects on PK and PD) could substan- ics). Jim goes to the medication dispensing station and types in tially improve drug efficacy and safety while Gilda Jones’ name. Because it is due in a few minutes, the genta- reducing unwanted side effects. mycin order is presented at the top of the list of all of Mrs. Jones’ medication orders. Electronic Dashboards After Jim reviews and selects the gentamycin, the correct unit Additional HIT integration benefits are dose is dispensed in an IV bag that also contains an RFID tag. Jim beginning to be realized through the develop- takes the bag into the patient room and assesses Mrs. Jones. Jim ment and use of electronic displays of then logs into the IV pump (currently administering maintenance infusion therapy status. These displays, fluid therapy) with his fingerprint after the pump automatically sometimes called dashboards, can be syn- recognizes him from the RFID tag on his hospital name badge. chronized via wireless with all pumps in a The pump then asks Jim to confirm the patient’s name and unit. Such dashboards have the capacity to medical record number. He does this with a secure custom strengthen clinical workflow by highlighting application on his cell phone, linked by Bluetooth to the pump, issues and events as they occur and thereby that reads the RFID tag on Mrs. Jones wristband and transmits it allowing for intermediary action. For exam- to the pump. The pump then presents a list of pending orders for ple, a dashboard on a tablet computer carried Mrs. Jones, where the gentamycin order appears first (because by a ward nurse who is covering eight there were no overdue orders and it is the most current). Jim selects the gentamycin order, confirms all of the “five rights” on patients can inform her of an ongoing the screen, connects the distal end of the gentamycin bag’s tubing occlusion alarm in one room or a fluid into the pump’s secondary inlet port, and hits “start infusion.” infusion that has run dry. Similarly, an infusion dashboard at the central nursing The time at which the infusion began and its other attributes are station can highlight an air-in-line alarm in automatically sent to the EHR, as well as to the pharmacy’s one room or a new medication ordered to be computer system. During the infusion, the pump monitors administered to another patient. Nurses can downstream pressure and flow characteristics and uses advanced thereby monitor multiple active pumps from software algorithms to identify potential changes, such as pend- a single screen, increasing efficiency, and ing infiltration. Concurrently, Jim can monitor the infusion’s status more readily coordinating timely care with from an infusion status display on his smart phone. Further, in other clinicians on their team. Thus, with near real time, the amount of drug infused is sent to Mrs. Jones’ this technology, a fleet of pumps can be electronic medical record so that her physician can see the progress of the prescribed treatment. viewable and managed contemporaneously as they are being handled intelligently at the

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upgraded to the latest version of the institu- Some normally running infusion pumps tion’s drug library. Another dashboard can make mechanical noise (estimated range of allow healthcare technology managers to be 73–78 dBA, depending on the rate of infu- able to monitor an entire hospital’s pump sion).29 Imagine the cumulative sound of 12 fleet for maintenance issues (e.g., need for to 16 pumps running in an ICU patient’s battery replacement) or software upgrades. room. Even with all of the room lights off, if Design Recommendations Much like the smart pump user interface, the pump screens are all on, the patient’s for More Efficient Use these dashboards need to provide usable, room will be illuminated at a level not and Usability useful, and actionable information and be conducive to normal sleep. • Cost-reduction support. more widely available. Why can’t infusion pumps be as environ- Next-generation infusion mentally aware as are our phones? An pumps and their associated Future Innovations to Improve ambient light sensor could allow the pump drug library software need Infusion Therapy screen to dim to a level that is the minimum to better support modern necessary to be visible to the nurse when healthcare’s emphasis Even if all of the above issues were ade- on cost reduction and quately addressed with contemporary checking on a sleeping patient at night. In value-based care through technology, major hurdles remain to fully contrast, the screen could be brightened in a features that minimize adopting and integrating available technolo- plugged-in pump in the OR, where the waste, provide low-cost gies. Substantial opportunities exist for ambient light levels are extremely high. alternatives, and decrease future innovations to enhance medication Similarly, with an ambient microphone, OR drug errors. delivery efficiency, effectiveness, safety, and pumps could adjust alarm volumes to be • Greater healthcare user satisfaction. heard effectively regardless of room noise. In worker efficiency. Infusion contrast, pumps in a sleeping patient’s room technology must eliminate Custom Drug Packaging could enunciate in-room alarms at much associated work process Although many medications are packaged in lower levels while still being heard. (Of note, inefficiencies for nurses, bags or bottles, thereby allowing direct pump alarm notifications should be sent to a pharmacists, healthcare infusion via an administration set, a surpris- central station or to a wearable device carried technology managers, and ing number of routinely used parenteral by the nurse when a clinician is not readily in anesthesia professionals. Pump fleets must be easier medications must be repackaged into a audible range.) RFID detection of a clinician to locate, update, deploy, different container before they can be infused in the room could trigger a local versus and monitor. Individual via a pump. Further, in the OR, anesthesia remote notification. pumps and sets must be professionals still draw up from vials or An orientation and/or motion sensor on easier to prime and program. bottles and infuse most if not all of their IV the pump could facilitate the detection of the Secondary infusions medications. To attain desired levels of connected patient being transported, thereby must be easier to fit into patient safety, many more medications must facilitating appropriate adjustment of alarms, daily workflow, less time be delivered from the original manufacturer displays, and other parameters. consuming to use, and safer. or an authorized batch repackager to the • Better pumps. Next- point of care in a form that can be immedi- Drug and Dose Recognition generation pumps must ately used in the pump. Further, the Automated pump programming (via HIT be more accurate, provide point-of-care medication packaging should interconnectivity) offers appreciable effi- better flow continuity, and include machine-readable (preferably ciency and safety benefits: based on be smaller, lighter, and more wireless and automatic) drug and concentra- electronic recognition of the patient, the portable. tion identification. medication to be administered can be loaded • HIT integration. Infusion in the pump, and the associated physician- pumps should do more Environmental Impact prescribed orders can be loaded in the pump. to communicate with Infusion technology can adversely influence However, going a step further, why couldn’t healthcare providers in real- the patient’s care environment; it can be loud, the pump automatically recognize the time at the bedside and at bright, and bulky. There is a high incidence medication with which it has been loaded? the systems level to promote safety and clinical efficiency. of sleep deprivation in hospitalized patients New technology is emerging to facilitate (especially those in intensive care).28 These electronic detection of IV medications at the sleep disturbances contribute to slower time of delivery. Yet, the best parenteral recovery as well as “ICU delirium,” which has medication safety solution would be technol- been clearly associated with worse patient ogy that could identify at the catheter what is outcomes and long-term psychiatric effects. actually infusing into the patient. Modern drug

260 Biomedical Instrumentation & Technology July/August 2016 © Copyright AAMI 2016. Single user license only. Copying, networking, and distribution prohibited. Features detection (e.g., mass spectrometry) and Disclosure sensor (e.g., lab on a chip) technologies are The authors received consulting income from capable of doing this, but the technical Ivenix, Inc., which supported an initial draft of challenge remains being able to do so this document but had no substantive input on accurately, reliably, and cost effectively in its content or ultimate form. Dr. Weinger has near real time. Again, entrepreneurs are an equity interest in Ivenix, Inc. actively attempting to develop such technologies, and we envision success in the References not-too-distant future. 1. Weinger MB, Kline AK. Improving intravenous therapy: opportunities for designing the next Infiltration Prevention and Recognition generation infusion system. Part 1: supporting Many believe that the “holy grail” of infusion medication safety. Available at: www.ivenix.com/ therapy is the elimination of IV infiltrations. wp-content/uploads/2015/05/Ivenix_White_Paper_ Infiltration remains a critical safety and Supporting_Medication_Safety.pdf. Accessed May efficacy issue in infusion therapy, not to 25, 2015. mention a major contributor to patient and 2. Weinger MB, Kline AK. Improving intravenous clinician dissatisfaction. Paradoxically, many therapy: opportunities for designing the next bedside clinicians mistakenly believe that generation infusion system. Part 2: infusion pump pump downstream pressure sensors will alarms management. Available at: www.ivenix. “detect” infiltration. Numerous entrepre- com/wp-content/uploads/2015/05/Ivenix_White_ neurs and infusion pump companies have Paper_Infusion_Pump_Alarms_Management.pdf. attempted to develop technologies to reliably Accessed May 25, 2015. detect infiltration, thus far without apparent 3. Brady JL. First, do no harm: making infusion success. The real innovation will be when pumps safer. Biomed Instrum Technol. infusion technology can prevent infiltrations. 2010;44(5):372–80.

Conclusion 4. Millam D. The history of intravenous therapy. J Smart pumps have become the norm in Intraven Nurs. 1996;19(1):5–14. hospitals throughout the developed world. 5. Barsoum N, Kleeman C. Now and then, the history Although many advances in their technology of parenteral fluid administration.Am J Nephrol. and safety have occurred, much of their true 2002;22(2-3):284–9. potential has not yet been realized. We have attempted to identify areas requiring further 6. Rivera AM, Strauss KW, van Zundert A, Mortier improvement. Smart pumps are still univer- E. The history of peripheral intravenous catheters: sally regarded by clinicians as being clunky, how little plastic tubes revolutionized medicine. difficult and inconvenient to use, and fre- Acta Anaesthesiol Belg. 2005;56(3):271–82. quently an impediment to high-quality care. 7. Kinnealey E, Fishman G, Sims N, et al. Infusion Addressing these issues will require a deliber- pumps with “drug libraries” at the point of ate and rigorous application of user-centered care: a solution for safer drug delivery. Available design approaches that have been refined in at: http://c.ymcdn.com/sites/www.npsf.org/ the field of human factors over the last resource/collection/ABAB3CA8-4E0A-41C5- half-century. With these investments, infusion A480-6DE8B793536C/Kinnealey2003_NPSF.pdf. pumps can become the exemplar for other Accessed May 25, 2015. medical devices in terms of true partnership 8. Institute for Safe Medical Practices. “Smart” with their clinician users to attain the safety, infusion pumps join CPOE and bar coding as effectiveness, and efficiency required of important ways to prevent medication errors. healthcare delivery in the coming decades. n Available at: www.ismp.org/newsletters/acutecare/ articles/20020207.asp. Accessed June 14, 2016. Acknowledgments To Tim Vanderveen for reviewing and comment- 9. Andel C, Davidow SL, Hollander M, Moreno DA. ing on the section, “A Brief History of Infusion The economics of health care quality and medical Therapy.” The innovative insights of Jeff Carlisle errors. J Health Care Finance. 2012;39(1):39–50. were an inspiration for this work.

10. James JT. A new, evidence-based estimate of patient 19. Lovich MA, Peterfreund GL, Sims NM, Peterfreund harms associated with hospital care. J Pat Safe. RA. Central venous catheter infusions: a laboratory 2013;9(3):122–8. model shows large differences in drug delivery dynamics related to catheter dead volume. Crit Care Practical Advice for Cost-Effective 11. Trbovich PL, Cafazzo JA, Easty AC. Med. 2007;35(12):2792–8. Implementation and optimization of smart infusion systems: are we reaping the safety 20. Ma H, Lovich MA, Peterfreund RA. Quantitative Compliance and Safety benefits?J Healthc Qual. 2013;35(2):33–40. analysis of continuous intravenous infusions in pediatric anesthesia: safety implications of dead 12. Wong DH, Gallegos Y, Weinger MB, et al. Changes volume, flow rates, and fluid delivery.Paediatr in intensive care unit nurse task activity after Anaesth. 2011;21(1):78–86. installation of a third-generation intensive care unit information system. Crit Care Med. 2003;31:2488– 21. Kress JP. Clinical trials of early mobilization of 94. critically ill patients. Crit Care Med. 2009;37(10 suppl):S442–7. 13. Fraind DB, Slagle JM, Tubbesing VA, et al. Reengineering intravenous drug and fluid 22. Kemper B, Koopmans M, Does R. Quality administration processes in the operating room: quandaries: the availability of infusion pumps in a step one: task analysis of existing processes. hospital. Quality Engineering. 2009;21(4):471–7. Anesthesiology. 2002;97(1):139–47. 23. Swedberg C. PAR-level RTLS solution saves costs Electrical 14. Rayo M, Smith P, Weinger MB, Slagle JS. Assessing at Oregon hospital. Available at: www.rfidjournal. medication safety technology in the Intensive Care com/articles/view?9234. Accessed May 20, 2016. Unit. Available at: www.mc.vanderbilt.edu/criss/ Safety 24. Vanderveen T. Intravenous infusion medication publications/Rayo%20Assessing%20med%20 safety: the vision becomes reality. Patient Safety & Electrical Safety Manual safety%20tech.pdf. Accessed June 14, 2016. Quality Healthcare. 2013;10(3):24–30. Manual 2015 Edition 15. Cassano-Piché A, Fan M, Sabovitch S, et al. 25. DesRoches CM, Campbell EG, Vogeli C, et al. Multiple intravenous infusions phase 1b: practice Electronic health records’ limited successes suggest 2015 Revised and expanded for the first and training scan. Ont Health Technol Assess Ser. more targeted issues. Health Aff (Millwood). 2012;12(16):1–132. time in six years, this manual pulls 2010;29(4):639–46. 16. Patient Safety Authority. Aligning the lines: an relevant material together from a 26. McCullough JS, Casey M, Moscovice I, Prasad S. analysis of IV line errors. Available at: http:// The effect of health information technology on patientsafetyauthority.org/ADVISORIES/ wide range of codes, standards, quality in U.S. hospitals. Health Aff (Millwood). AdvisoryLibrary/2014/Mar;11%281%29/Pages/01. 2010;29(4):647–54. and regulations, and offers practical aspx. Accessed May 25, 2016. 27. Karsh BT, Weinger MB, Abbott PA, Wears RL. advice for cost-effective compliance. 17. Ontario Health Technology Advisory Committee. Health information technology: fallacies and sober Mitigating the risks associated with multiple IV realities. J Am Med Inform Assoc. 2010;17(6):617–23. A Comprehensive Guide to infusions: recommendations based on a field Electrical Safety Standards Order code: ESM4 or ESM4-PDF study of twelve Ontario hospitals. Available 28. Pandharipande P, Girard T, Jackson J, et al. Long- List $198 / AAMI member $120 at: www.aami.org/htsi/infusion/wg/multiple/ term cognitive impairment after critical illness. New For Healthcare Facilities MultipleIVInfusions_Phase1bSummary_ Engl J Med. 2013;369(14):1306–16. Recommendations and Rationale_June 2012.pdf. Accessed Sept. 17, 2014. 29. Lawson N, Thompson K, Saunders G, et al. Sound intensity and noise evaluation in a critical care unit. Matthew F. Baretich, PE, PhD 18. Bartels K, Moss DR, Peterfreund RA. An analysis Am J Crit Care. 2010;19(6):e88–98. of drug delivery dynamics via a pediatric central venous infusion system: quantification of delays in achieving intended doses. Anesth Analg. 2009;109(4):1156–61.

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Practical Advice for Cost-Effective Compliance and Safety

Electrical Safety Electrical Safety Manual Manual 2015 Edition 2015 Revised and expanded for the first time in six years, this manual pulls relevant material together from a wide range of codes, standards, and regulations, and offers practical advice for cost-effective compliance. A Comprehensive Guide to Electrical Safety Standards Order code: ESM4 or ESM4-PDF For Healthcare Facilities List $198 / AAMI member $120

Matthew F. Baretich, PE, PhD

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