The use of smart pumps in a paediatric intensive care unit improved patient safety by intercepting infusion-related programming errors from reaching patients
Silvia Manrique-Rodriguez PharmD PhD
Clinical Hospital Pharmacist,
Paediatric Intensive Care Unit,
Hospital General Universitario Gregorio Marañón,
Patient safety is a major concern that involves every healthcare professional. As the use of medications becomes increasingly complex, there are ever-growing levels of risk that can result in errors at all stages of the process, from initial prescription through to administration of the drug.(1,2)
The likelihood of an injury occurring when there is a medication error is enhanced when there are concomitant factors, such as intravenous administration and the use of high-risk drugs.(3) Patient characteristics also play a role: the younger and more critically ill the patient, the more susceptible he/she is to suffer from a medication error.(4–6) Safeguarding the paediatric patient in the intensive care unit (PICU) is therefore a priority for the healthcare system.
Making drug administration ‘smarter’
Nowadays, emerging technologies such as smart pumps can diminish medication errors as well as standardising and improving clinical practice with the subsequent benefits for patients. Smart infusion pumps incorporate drug libraries that define concentration and maximum and minimum infusion rates for each drug. Based on these values, ‘hard’ and ‘soft’ programming limits can be established, with the aim of preventing under- and over-dosing.
Therefore, if a user exceeds the defined rate for a soft limit due to a programming error, an alarm is triggered, warning the user that the dose or infusion rate may not be adequate for a determined patient, but allowing the infusion to continue. By constrast, accidentally exceeding a hard limit will sound an alarm that cannot be ignored, leading the user either to cancel the infusion or reprogram the administration.
Organisations are increasingly recognising the benefits offered by smart pump technology and are gradually replacing conventional systems with these new systems.
Assessing the impact in the PICU
We carried out an initial comparative study between the Alaris (CareFusion) and MedNet® (Hospira) systems for smart pump selection,(7) as well as a prospective and intervention study with analytical components of implementing the smart pump technology, at the PICU of Gregorio Marañón General and Teaching Hospital.(8)
The 11-bed PICU serves approximately 500 patients each year, with an average length of stay for patient of 6.25 days. The hospital operates computerised physician order entry associated with 18 automatic dispensing systems. A multidisciplinary team including clinical pharmacists, intensive care paediatricians and PICU nurses was developed, and pharmacists played a very important role in designing and coordinating the different phases of the study and also acted as a link among all health professionals involved in the project.
Shortly before the smart infusion systems were implemented, an observational pilot study carried out within the PICU for two weeks revealed a medication error rate of 26.5 errors per 100 doses administered.(9)
Initial comparative study and pump selection
The first version of the drug library was developed from June to December
2009 and was developed by the multidisciplinary team through weekly meetings during the first four months and fortnightly during the last trimester of this phase. The drugs most commonly used in the PICU, intravenous drugs, high-risk drugs, as well as those that could cause problems in administration due to lack of experience, were included. For each drug, concentration and recommended infusion rates were determined according to the sources of information most used by the PICU and the pharmacy service. Drugs were distributed into profiles according to their therapeutic group.
A comparative, prospective, descriptive study was performed from January to June 2010. The infusion pumps compared were volumetric and syringe, Alaris Guardrails® (CareFusion) with safety software, available at the hospital at the time of the study, and Plum A+® (Hospira) volumetric pumps with MedNet® safety software, of interest owing to some technological advantages offered regarding connectivity, compared with other systems on the market. The trial period was intended to be three months for each system.
During the first infusion programmed with the Hospira system, air bubbles were detected in the distal extreme of the infusion line, which posed a risk of gaseous embolism to the patient.7 The three-month trial period was therefore terminated. Infusion tests showed that bubbles appeared where the flow rate under 5ml/h was programmed and disappeared on incorporating a 0.2-μm filter in the infusion line, a measure proposed as a solution for continuing the study. Systematic use of filters for administering drug concentrations <5μg/ml is not recommended; it is not recommended when the amount to administer over 24 h is <5mg, due to risk of under-dosage if part of the drug were to remain in the filter membrane; also, it is not recommended to infuse oily mixtures because of a risk of emulsion breaking.10 Because many of the drugs administered in the PICU comprise some of these characteristics, and infusion flows in paediatrics tend to be under 5ml/h, CareFusion systems were chosen to continue the implementation project.
The intervention study of implementing smart pump technology was performed at the IV drug administration phase in all infusions in the 11-bed PICU over a period of 17 months (during 2010–2011).
CareFusion provided full technical programming and user support for nursing staff before the study commenced.
Systematic analysis of the information stored on the devices during their routine clinical use was carried out.
These findings, enabled the identification of enhancements to guide the development of different versions of the drug library that were incorporated through regular updates and to contribute to overall improvements of the technology.(11,12) Some of these updates were related to the inclusion of new drugs, new standard concentrations to better suit patients’ infusion requirements, and changes in limits to allow for dose rounding and to minimise unnecessary alerts.
By doing so, the percent compliance with the drug library (defined as the number of infusions programmed through the safety software per 100 infusions started) was determined in order to estimate the impact of the technology.
The number of programming errors prevented (based on the alerts detected by the safety software) was determined. Once the intercepted errors were identified after the implementation of the smart pump technology, they were classified according to the potential severity of the consequences had the errors reached the patients. The severity of the interceptions were independently classified by four clinical pharmacists and four intensive care paediatricians; analyses of intragroup and intergroup agreement in perceptions of severity were then carried out.(8)
Compliance with the drug library
During the study period, 624,252 infusions were started, of which 486,875 were programmed through the drug library, indicating a rate of user compliance with the safety software of 78%.(8)
The use of smart pumps resulted in the interception of 92 programming errors, 84% of which involved analgesics, anti-infectives, inotropes, and sedatives. Approximately 97% of the errors resulted from user programming of doses or infusion rates above the hard limits defined in the smart pump drug library. The potential consequences of the intercepted errors were considered to be of moderate, serious, or catastrophic severity by the multidisciplinary team in 49% of cases.(8)
The main limitation of our study was the retrospective design of the analysis, which did not allow follow-up analysis of the infusions cancelled immediately after the alarm sounded. Future wireless connectivity developments might enable the prospective analysis of such information as well as real-time data access.(8)
The study results presented here may act as a basis for extending this technology to other units of our hospital.
The use of smart pumps in our PICU improved patient safety by enabling the interception of infusion programming errors that posed the potential for severe injury to paediatric patients. A multidisciplinary approach with collaboration between healthcare professionals (doctors, pharmacists, and nursing staff) and information technology teams is essential to help ensure that this technology is easy to use and optimally effective in preventing errors.
- Leape LL, Bates DW, Cullen DJ et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA 1995;274:35–43.
- Pepper GA. Errors in drug administration by nurses. Am J Health-Syst Pharm 1995;52:390–5.
- Hadaway LC. Managing i.v. therapy: ‘high-alert’ drugs keep nurse managers ever watchful. Nurs Manage 2000;31(10):38–40.
- Verklan MT. Malpractice and the neonatal intensive-care nurse. J Obstet Gynecol Neonatal Nurs 2004;33:116–23.
- Sullivan JE, Buchino JJ. Medication errors in pediatrics – the octopus evadingdefeat. J Surg Oncol 2004;88:182–8.
- Fernández-Llamazares CM et al. Impact of clinical pharmacist interventions in reducing paediatric prescribing errors. Arch Dis Child 2012;97:564–8.
- Manrique-Rodríguez S et al. Implementation of smart pump technology in a paediatric intensive care unit . Health Informatics J 2014;Feb 4 [epub ahead of print].
- Manrique-Rodríguez S et al. Impact of implementing smart infusion pumps in a pediatric intensive care unit. Am J Health-Syst Pharm 2013;70:1897–906.
- Echarri L et al. Evaluación de los errors de administración de medicamentos en una unidad de cuidados intensivos pediátricos. In: Libro de ponencias: I jornada de investigación del Instituto de Investigación Sanitaria Hospital Gregorio Marañón. Madrid: Hospital General Universitario Gregorio Marañón; 2011:66 [In Spanish].
- Ball PA. Intravenous in-line filters: filtering the evidence. Curr Opin Clin Nutr Metab Care 2003;6(3):319–25.
- Manrique-Rodríguez S et al. Developing a drug library for smart pumps in a pediatric intensive care unit. Artif Intell Med 2012;54(3):155–61.
- Manrique-Rodríguez S et al. Smart pump alerts: all that glitters is not gold. Int J Med Inform 2012;81:344–50.