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Are smart pumps smart enough?

Giuliano, Karen K. PhD, MBA, RN, FAAN; Ruppel, Halley MS, RN, CCRN

doi: 10.1097/01.NURSE.0000512888.75246.88
Department: INFUSION THERAPY
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Karen K. Giuliano is a nurse scientist at Hallmark Health System in Medford, Mass., and was a Postdoctoral Fellow at Yale School of Nursing when this article was written. Halley Ruppel is a Ph.D. student at Yale School of Nursing in Orange, Conn.

The authors have disclosed no financial relationships related to this article.

THE INTRODUCTION of smart pumps, sometimes called smart infusion pumps or intelligent infusion devices, represents a significant advancement in I.V. medication administration safety.1 Numerous examples in the literature attribute I.V. medication error reduction to their use. Still, end-user smart pump workarounds and I.V.-related medication errors remain common. As the primary end users of smart pumps, nurses need to be aware of potential safety issues and play an active role in improving the technology. This article discusses what smart pumps can—and can't—do and how nurses can avoid common safety pitfalls associated with their use.

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Historical perspective

Smart pumps were conceptualized in 1992 at Massachusetts General Hospital (MGH) when Dr. Nat Sims and his team conceived the idea of using drug libraries with dose-error reduction systems (DERSs) to assist clinicians with the administration of highly complex I.V. medication infusions.2 Clinical use of smart pumps began at MGH in 1996. Since that time, smart pumps have become a widespread standard of care.

In the 2016 Infusion Nurses Society (INS) Infusion Therapy Standards of Practice, a smart pump is defined as an “electronic infusion device with imbedded computer software aimed at reducing drug dosing errors through the presence and use of a drug library.”3 The built-in drug library and DERS are intended to ensure safe medication administration. The user chooses the desired medication from an approved list and inputs the required patient information. The smart pump then calculates the infusion rate. Drug libraries are often customized by the institution to reflect its patient populations and to meet the needs of specific units.1

Drug libraries contain the most commonly used I.V. medications, and DERSs alert the user if the calculated infusion rate exceeds normally acceptable dosing limits. These limits can be expressed as either hard stop alerts (which indicate that the dose is outside safe limits and can't be bypassed by users at the pump, preventing users from starting the programmed infusion) or soft stop alerts (which warn that a dose isn't within anticipated limits, but still allow users to start the infusion as programmed once the limits have been acknowledged).1

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Design innovation stagnation

Although smart pump safety features are conceptually advanced, innovation and improvement in clinical ease-of-use has been slow. Most smart pumps in current clinical use are outdated in their design and don't take advantage of new technologies, such as touchscreens. Current user interfaces are too complicated and not intuitive for contemporary clinical users.4 For example, in one of the most widely used smart pumps, the shortest way to turn on the pump and program sodium nitroprusside at 10 mcg/kg/min requires 23 steps and 3 nonactionable alert bypasses.

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Sources of error

Although the use of smart pumps can reduce the incidence of medication errors, research has shown that errors still occur in 60% or more of I.V. medication administrations.5-8

Potential sources of error include overriding dose error alerts and manually bypassing drug libraries or the DERS completely.7-9 Nurses have cited the complexity of the device-user interface and incomplete drug libraries as reasons they bypass drug libraries and the DERS.2,9

Incorrect smart pump programming is one of the most common causes of I.V. adverse drug events.10 Clinicians report that pump programming is frequently rushed and alerts are overridden because of time constraints, competing work demands, and patient acuity.9,10 Recent data support that nurses perceive current smart pumps as cognitively demanding.11 (See Smart pump limitations.)

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Safety initiatives

The ubiquity of smart pumps along with a sense of urgency to address I.V. medication safety has garnered the attention of several organizations focused on patient safety.

  • In 2009, the Institute for Safe Medication Practices released guidelines for implementation and use of smart pumps, developed out of a multi-stakeholder summit focused on the use of smart pumps.1
  • The FDA launched new safety requirements for I.V. pump manufacturers in 2010. The Association for the Advancement of Medical Instrumentation (AAMI) and the FDA cosponsored a summit in 2010 to prioritize patient safety related to I.V. infusions as a national concern.1
  • The National Quality Forum conducted an environmental analysis that resulted in 13 recommendations to improve safety of I.V. infusion devices.10
  • In 2015, AAMI initiated a multiyear national coalition to address I.V. infusion device safety.
  • The 2016 INS Infusion Therapy Standards of Practice include important patient safety strategies and recommend the use of DERSs.3
  • The number one Health Technology Hazard for 2017, identified by the ECRI Institute, is infusion errors caused by missed safety steps.13
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How nurses can help

By understanding the limitations of smart pumps, nurses can take appropriate steps toward avoiding medication errors. First, nurses should be aware that smart pumps can identify errors related to rate and dose only, and that bypassing the drug library eliminates the possibility that the smart pump will identify programming errors.7 Smart pumps can't verify the accuracy of information like patient weight, which relies entirely on correct programming by the nurse.1 Nurses still need to use clinical judgment and confirm medication rights, such as right patient, drug, dose, time, route, and indication. Medication verification practices are delineated in the INS 2016 Infusion Therapy Standards of Practice, and should include independent double checks of high-alert medications by two clinicians, and the use of barcode technology to improve accuracy of verification if available.3 When barcode scanning is used in conjunction with smart pumps, more sources of medication error can be prevented.9 Nurses should avoid workarounds when using these safety technologies.

Data from smart pumps can be retrieved to identify areas of the drug library that cause unnecessary alerts or overrides, and routine assessment of these data can lead to updates to the library.3,14 Nurses should report problems or inappropriate drug library settings, and should be involved in updating smart pump drug libraries. Simple steps, such as ensuring roller clamps are in the correct position and checking the drip chambers for unexpected flow, must also remain standard of practice.3

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Final thoughts

Smart pumps have considerably advanced medication administration practices and patient safety. Nurses can help continue this advancement by identifying problems with the technologies that are disruptive to patient care and advocating for change. Nurses should seek to work closely with clinical engineers, vendors, and patient safety organizations to understand smart pump functionality and make suggestions for how to improve the technology. As end users of smart pumps, nurses are uniquely positioned to drive future innovations to enhance patient safety.

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Smart pump limitations

The following is a list of suggestions for addressing the limitations of current smart pumps. We compiled this list based on issues identified by the National Quality Forum report on patient safety and I.V. infusion devices, the AAMI and FDA Infusion Device Summit, and our own clinical experience in both adult and pediatric critical care.10,12

User interface

  • In most cases, users can easily bypass the drug library and DERS safety features and instead manually enter the infusion rate and volume, which increases the risk of error.
  • Smart pumps can't detect a dosing error for a patient that occurs inside of the standard dosing limits.
  • Users have very limited ability to review data stored in the pumps. Most pumps don't allow a reviewer to identify which patients or users were involved with an error.
  • Manually updating and maintaining drug libraries is time-consuming without the benefit of a reliable wireless network. This often results in different versions of drug libraries on different pumps in the same institution, which can be a serious safety issue.
  • Soft stop alerts can be easily overridden, generally with one key stroke.
  • If hard stop alerts aren't set appropriately, they force users to engage in workarounds in order to administer the medication.
  • Alarms, alerts, or the status of infusions generally appear only on the pump screen in the room and aren't communicated to nurses in real time through a secondary notification system; the nurse must be at the pump to see the message.
  • Smart pump screens often don't make clear which units of measurement the user is expected to enter. For example, a user may enter a patient's weight in pounds when the pump uses kilograms to calculate doses.
  • Warning messages are often unclear, causing users to ignore them, and warning messages are displayed so often that users develop alarm fatigue.
  • Infusion pump screens can be difficult to read due to small screen size, scrolling letters, poor backlighting, and the need to look for information across multiple screens.
  • Software error messages are often displayed in ways that are meaningless to the end user, contributing to unnecessary pump downtime.

Physical design

  • Most pumps are too heavy and too large, making patient ambulation and transport difficult and contributing to patient and staff injuries.
  • Current pumps aren't designed to withstand normal daily wear-and-tear, resulting in downtime and expensive repairs.
  • Pumps can inadvertently shut off due to battery depletion, and this can easily go unnoticed.
  • Pumps don't communicate with one another, making it easy for nurses to infuse incompatible medications or inadvertently administer a double dose.
  • Current designs make it difficult to keep track of which medications are going through which pumps.
  • Most pumps still require the user to change the bag height of a primary infusion in order for the secondary medication to infuse. This feature contributes to numerous delays and errors during secondary medication infusion.
  • Very few pumps are “location aware,” so pumps are often lost in hospitals.
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REFERENCES

1. Institute for Safe Medication Practices. Proceedings from the ISMP summit on the use of smart infusion pumps: guidelines for safe implementation and use. 2009. http://www.ismp.org/Tools/guidelines/smartpumps/default.asp.
2. Massachusetts General Hospital (MGH). Smart tech revolution. 2010. https://giving.massgeneral.org/smart-pump-smart-tech-revolution.
3. Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D. Infusion therapy standards of practice. J Infus Nurs. 2016;39(suppl 1):S1–S159.
4. Giuliano KK. IV smart pumps: the impact of a simplified user interface on clinical use. Biomed Instrum Technol. 2015;suppl:13–21.
5. Husch M, Sullivan C, Rooney D, et al Insights from the sharp end of intravenous medication errors: implications for infusion pump technology. Qual Saf Health Care. 2005;14(2):80–86.
6. Maddox RR, Danello S, Williams CK, Fields M. Intravenous infusion safety initiative: collaboration, evidence-based best practices, and “smart” technology help avert high-risk adverse drug events and improve patient outcomes. In: Henriksen K, Battles JB, Keyes MA, Grady ML, eds. SourceAdvances in Patient Safety: New Directions and Alternative Approaches. Rockville, MD: Agency for Healthcare Research and Quality; 2008.
    7. Ohashi K, Dalleur O, Dykes PC, Bates DW. Benefits and risks of using smart pumps to reduce medication error rates: a systematic review. Drug Saf. 2014;37(12):1011–1020.
    8. Schnock KO, Dykes PC, Albert J, et al The frequency of intravenous medication administration errors related to smart infusion pumps: a multihospital observational study. BMJ Qual Saf. 2017;26(2):131–140.
    9. McAlearney AS, Vrontos J Jr, Schneider PJ, Curran CR, Czerwinski BS, Pedersen CA. Strategic work-arounds to accommodate new technology: the case of smart pumps in hospital care. J Patient Saf. 2007;3(2):75–81.
    10. National Quality Forum (NQF). Critical paths for creating data platforms: intravenous infusion pump devices. 2012. http://www.qualityforum.org/Publications/2012/10/Critical_Paths_for_Creating_Data_Platforms__Patient_Safety__Intravenous_Infusion_Pump_Devices.aspx.
    11. Perrigino MB, Dunford BB, Berndt D, Gaston CL. Taking another view: how nurses perceive infusion pumps as demanding for both themselves and their patients. J Infus Nurs. 2016;39(4):225–234.
    12. AAMI. Infusing patients safely: priority issues from the AAMI/FDA Infusion Device Summit. 2010:1–48.
    13. ECRI Institute. Executive brief: top 10 health technology hazards for 2017. Health Devices. 2016:1–13.
    14. Skledar SJ, Niccolai CS, Schilling D, et al Quality-improvement analytics for intravenous infusion pumps. Am J Health Syst Pharm. 2013;70(8):680–686.
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