Smart Pumps, Smart Management, Safe Patients When Organizations and Clinicians Team Up, Patients Are Protected

Smart pumps, smart management, safe patients When organizations and clinicians team up, patients are protected.

By Dawn Berndt, DNP, RN, CRNI®, and Marlene Steinheiser, PhD, RN, CRNI®

MEDICATION administration errors are among the most vexing and costly events in healthcare. For the patient, errors related to therapeutic infusions can present grave consequences, including therapy disruption, over- or underdosing that reduces the therapeutic ef- fect, debilitating injury, or death. In 2020, the Institute for Safe Medication Practices (ISMP) published Guidelines for Optimizing Safe Im- plementation and Use of Smart Infusion Pumps. This resource, compiled and reviewed by clinical experts, outlines the components necessary for developing an organizational in-

Bi-directional benefits and challenges

Bi-directional smart infusion pumps raise frastructure that promotes safe patient care us- the standard of care but also present some challenges. ing smart infusion pump technology. In April 2021, The Joint Commission released a Sen- Benefits tinel Event Alert on smart infusion pumps that Bi-directional smart infusion pumps • also contains useful strategies. remove the human factor from manually Smart infusion pumps are sophisticated programming the infusion pump computer systems that communicate within a • connect the pump channel, medication order, and patient network, using software and hardware de- • promote safe medication administration signed to send the exact amount of medica- based on the provider’s order tion at a precise rate to each patient. At the in- • facilitate consistent and timely documenta- terface between the infusion pump and the tion of each infusion in the patient’s elec- nurse, critical decisions are made, presump- tronic health record. tive actions are performed, and successful or

Challenges deleterious outcomes are initiated. Bi-directional smart infusion pumps Although smart infusion pumps have re- • can be cost-prohibitive duced I.V. infusion errors, continuing lapses • are available only with select infusion pump (programming, pump setup, channel/line brands mix-ups) coupled with known smart pump • rely on a sound wireless infrastructure. technology limitations require ongoing efforts to protect patients from harm.

MyAmericanNurse.com May 2021 American Nurse Journal 17 Organizational responsibilities

Organizations must be fully engaged in • Education Organize a collaborative oversight developing infrastructure that leads and • To ensure patient safety, clinicians committee supports safe smart infusion pump use. must show competence in the use • Involve clinician end users in the of smart pump equipment, includ- evaluation of VAD and infusion Choose appropriate smart infusion ing knowledge of indications, con- products, equipment, and technolo- pumps traindications, and manufacturers’ gies, including clinical application, Use smart infusion pumps for therapies instructions. The organization performance, infection and compli- that require precise flow-control for safe should provide: cation prevention, safety, efficacy, administration. • • smart pump operation and man- acceptability, reliability, and cost. Pump selection agement education to all clinicians • Oversight committee • Base selection on the prescribed in- during orientation and before us- • Create a committee of pharmacists, fusion therapy, rate control require- ing any device in the patient care nurses, prescribers, risk managers, ments, infusion-related risks, patient setting medication safety personnel, bio- care setting, and available organiza- • ongoing training to address medical engineers, information sys- tional resources. changes in drug library entries, us- tems personnel, human factors engi- • Standardize the types of pumps ability issues, and avoiding neers/experts, and others deemed used to promote user familiarity. workarounds and to assess routine essential to ongoing oversight for • Use separate, designated pumps users and new staff members. the smart infusion pump system. for epidural infusions, enteral infu- • Assessment • Members should meet routinely to: sions, and irrigations to differenti- • Establish policies to ensure CQI data • review CQI data from infusion ate from vascular access infusions. are retrieved, analyzed, and used to pumps (good catches, overrides, • Choose devices with anti-free-flow improve patient safety. percentage of basic functions [in- protection, air-in-line detection, and • Institute regular bedside assessment fusions programmed without us- pressure and occlusion alarms. • checks to validate DERS use. ing the drug library or safety soft- Bi-directional interoperability • Care and maintenance ware]), evaluate DERS use goals, • Consider implementing infusion sys- • After each patient use, clean and dis- and take steps to improve them tems that incorporate medication infect infusion equipment (accord- • review reported I.V. medication er- orders, a drug library, EHR, barcode ing to the manufacturer’s directions) rors, including reporting medica- medication administration, and re- with products that have antimicro- tion and biologic agent adverse porting. bial activity against pathogens likely events and discrepancies to the • Smart pumps with EHR interoper- to contaminate the equipment. appropriate department and au- ability reduce manual programming • Inspect infusion equipment and thoritative reporting organiza- errors. • supplies for integrity and function tions; regularly review medication Labeling before, during, and after use. Look errors and identify and share les- • Use medication labels on the infu- for damage before use; ensure pack- sons learned; determine if an error sion reservoir and health record doc- aging is clean, dry, and intact; and requires education, drug library re- umentation that are consistent in verify the expiration date. vision, or pump hardware or wire- format and content with the smart • Remove defective pumps, associat- less network repair infusion pump drug library. ed supplies, and administration sets • review national error reports and

from patient use and label them as determine if the organization is at Establish policies and procedures such. Report the problem to the ap- risk for similar errors The use, education, assessment, and main- propriate department, the manufac- • review usability issues that inter- tenance of infusion equipment are estab- turer, and the reporting organiza- fere with safe practice and clini- lished in organizational policies, proce- tions as required. cian workflow dures, and practice guidelines. • • review infusion-associated pump Use Design infusion pump drug library recall notifications and develop a • Establish the use of smart infusion using DERS plan to manage them pumps with DERS for I.V. administra- • Initial drug library development • standardize communication tion of medications and solutions • Establish an interprofessional team processes to inform end users of (for example, continuous, intermit- to design and test the drug library. changes made to the drug library. tent, secondary infusions, PCA, and • Ongoing drug library development epidural, spinal, and nerve block in- • To avoid unnecessary alerts, update CQI = continuous quality improvement data, DERS = dose error reduction systems, EHR = electronic health fusions) throughout the acute care drug libraries regularly (to address setting, including ambulatory set- record, ISMP = Institute for Safe Medication Practices, new drugs, new drug protocols, and PCA = patient-controlled analgesia tings (perioperative/procedural/radi- drug shortages), and involve end ology care areas, emergency depart- users in the library design. Sources: Gorski et al., Institute for Safe Medication Practices ments, infusion centers). • Use a smart pump oversight team to • Set an organizational compliance assess CQI data and organizational goal for using DERS with all I.V. med- I.V. medication error reports. ications (ISMP recommends ≥ 95%).

18 American Nurse Journal Volume 16, Number 5 MyAmericanNurse.com Clinician responsibilities

Clinicians must maintain their competency and adhere to the solution level of each container (bag, glass bottle), organizational guidelines for managing smart infusion pump I.V. pole height, and pump position. planning and administration. • High-risk medications

• When high-risk medications are administered via the pri- Maintain clinical competency mary infusion system along with the primary infusion, at- • To ensure patient safety, stay current in infusion equip- tach the administration set below the smart infusion pump ment use and maintain your knowledge of indications, controlling the primary fluid flow and use a separate smart contraindications, and manufacturers’ instructions. pump to control the rate of the high-risk medication.

Adhere to organizational guidelines Use appropriate accessories • Remain current in practice, and adhere to organizational • Use only accessory devices (administration sets, syringes, policies, procedures, and guidelines. filters) that are designed to work with the smart infusion Use patient safety technology pump according to the manufacturer’s instructions for use. • Use the drug library in accordance with organizational pol- • Use only administration sets with anti-free-flow mecha- icy, and avoid manual programming and overriding drug nisms with smart infusion pumps.

library alerts. Syringe pump safety Select an appropriate infusion plan for each medication • If using syringe pumps to deliver small-volume infusions, • Identify medications that should be administered as unin- use accessory devices that offer the smallest internal vol- terrupted primary infusions (for example, rapid infusion ume (microbore tubing, shorter length) to minimize resid- and critical medications). ual volume. • Plan and prepare for each type of required infusion (prima- • Follow the manufacturer’s instructions for maintaining ry, secondary, intermittent, epidural, PCA), the associated consistent level and position of the syringe pump in rela- supplies, and the required device type (large volume, sy- tion to the patient while infusing. ringe, epidural, PCA pump). • For infants, consider using multi-connector sets to accom- • Use an appropriate separate pump for each specific admin- modate multiple continuous infusions to increase accuracy istration route (epidural, enteral, I.V.). and accommodate low flow rates.

Manage known error-prone administration applications Monitor patient during all infusions • Secondary or piggybacked medications • Routinely assess the vascular access site to detect infiltration • Know the capabilities of the smart pump for flow rate or extravasation; smart pumps don’t detect these issues.

and volume control of secondary medications. Maintain standard practice in patient care transitions • When attaching a secondary set above the smart pump, • Follow organizational policy for using flow-control devices use only a primary set that contains a back-check valve during care transitions (for example, hospital admission of or use a dedicated set with integrated mechanisms to patient with an insulin pump). prevent retrograde flow of the secondary medication in- to the primary solution container. PCA = patient-controlled analgesia

• Follow the manufacturers’ instructions for correctly posi- *Head height differential is the distance required between the secondary infusion tioning the primary and secondary solution containers container (which is hung higher to increase gravitational pressure) and the primary and the required height differences between the two con- container (which is hung lower to decrease gravitational pressure). This differential en- tainers (head-height differential). Incorrect head-height ables the secondary medication to be administered to the patient first. When it’s com- differential can lead to unintended flow rates.* pleted, the primary infusion resumes flow to the patient at the pre-programmed rate.

• Alterations in flow rate may occur due to differences in Source: Gorski et al.

Smart infusion pump design and duration for most infusion therapies. The li- Among medical devices, smart infusion pump brary is designed to accommodate each organi- technology is unique. More than an electronic zation’s specific I.V. formulary and to meet pa- mechanical device (as their predecessors were), tient population needs in multiple care areas. smart infusion pumps not only perform the me- Pharmacists and clinical experts in each chanical task of “pumping” I.V. fluids and med- organization adopt safety measures, such as ications with greater accuracy and control, they standard concentrations; high and low lim- also provide immediate, computerized, clinical its for rate, dose, and volume (for example, support for medication administration at the mg/hr, mg/kg/hr); and standard medication point of care where it can intercept human error. nomenclature as the drug library is con- Smart infusion pumps have dose error-reduc- structed. The parameters can prohibit the in- tion systems (DERS) designed to enhance safe fusion; warn the clinician of an inaccurate I.V. medication administration via a customiz- dose or rate; or accept the programmed in- able drug library that places organization-specif- fusion based on the patient care area, select- ic parameters on volume, concentration, rate, ed medication, and qualifying prescriber’s

MyAmericanNurse.com May 2021 American Nurse Journal 19 Clinician workflows

Standardized procedural steps help clinicians initiate smart • correct occlusions caused by inadvertently closed roller pump infusion therapy and maintain vigilance when monitor- clamps or vascular access device ing and transitioning patients. • observe the vascular access site and assess for patient discomfort. Patient identification • Verify the patient’s identity using at least two identifiers, Monitoring including the patient’s full name. • Monitor infusion pumps during administration to ensure safe and accurate delivery of the prescribed infusion rate Medication verification • and volume. Use barcode scanning technology when available to verify • Assess the patient and vascular access site throughout the medications before administration. infusion to detect complications or adverse effects. • Compare medications and infusion solutions with the medication order and infusion pump. Medication reconciliation • Review the medication label for the name (brand and • Perform medication reconciliation at each care transition generic), dosage and concentration, total volume, expira- (admission, transfers to different levels of care, discharge to tion date, administration route and rate, frequency, and new healthcare setting) and when new medications are or- any special instructions. dered. Verify discontinued medications to reduce the risk of medication errors, including omissions, duplications, Rights of medication administration dosing mistakes, and drug interactions. Confirm the rights of safe medication administration (right patient, drug, dose, route, time, reason) and patient allergy status. Patient handoff • At each transition to a new setting or service and as part of Infusion pump set up • the handoff process, trace all catheters, administration sets, Follow the manufacturer’s instructions for positioning the and add-on devices between the patient’s access device infusion pump in relation to the patient. • and the solution container before connecting or recon- Prime the appropriate administration set, filters, or other necting any infusion or device. add-on devices. • Load the administration set into the pump correctly. For a Patient transfer secondary infusion, ensure the setup complies with the • Ensure the patient care profile (for example, adult critical manufacturer’s instructions, and check the luer connec- care, adult general care, oncology, pediatric critical care) tions and roller clamp if applicable. selected from the drug library is appropriate for the receiv- ing unit when transferring patients from one level of care Infusion pump programming • to another. The patient care profile appears on the pump’s Scan the barcode on the patient’s identification band, programming screen and should be reviewed by each cli- medication label, and clinician identification. • nician during transfer and handoff. If barcode scanning isn’t available, manually select the • Each patient care profile contains specific medications, ap- medication from the drug library. If applicable, also select propriate drug concentrations, and specific programming the secondary infusion. • parameters with associated low and high limits for rate, Verify the correct rate, dose, concentration, and volume to dose, volume, and duration. be infused, as well as the duration. • If the patient care profile doesn’t match the patient’s Infusion pump advisories level or area of care, patient safety is compromised. For • If the smart infusion pump issues a clinical advisory alert example: after the infusion is programmed, review the warning mes- • Clinicians managing patients transferred from general sage on the pump’s user interface (programming screen).* care to critical care won’t have immediate access to • Review the programmed infusion parameters to ensure some critical care medications and concentrations in dose, rate, volume, and duration are correctly programmed the drug library. according to the provider’s order. • Patients transferred from critical care to general care • Resolve the clinical advisory alert according to the smart might be subject to infusions of higher medication infusion pump directions for use. dose and concentration than intended for general care.

High-alert medications *Each organization designs its specific drug library for the smart pump, with ex- • Implement safeguards to reduce the risk of errors with perts in the facility determining how much drug (and how fast) the pump can ad- minister. Soft-limit and hard-limit alerts occur if minimum and maximum dosages high-alert medications. are exceeded. Soft-limit alerts can be overridden by the clinician to allow the • Perform independent checks by two clinicians for high- provider and clinician some leeway to infuse a slightly larger or slightly smaller alert medications (for example, opioids, insulin, heparin, dose of medication when appropriate for the patient. When a soft-limit alert is is- chemotherapy). sued, it’s as though the pump is asking the clinician, “Is this dose correct?” Soft-limit alerts are like rumble strips on the highway that alert the driver that they’re go- Infusion activation ing outside the parameters of the lane. Hard limits are parameters built into the • After all verifications and safety steps are complete, begin smart pump drug library that prohibit the infusion from taking place as programmed. Hard limits exceed soft limits on both ends. They’re like the masonry the infusion. wall inside a road tunnel—you can’t drive over (exceed) into the other lane. • Remain at the bedside to • observe the drip chamber for active flow when applicable Source: Gorski et al.

20 American Nurse Journal Volume 16, Number 5 MyAmericanNurse.com order (infused rate, dose, and volume). patient safety depends on the dedicated, col- Some smart infusion pumps have compo- laborative efforts of the device manufacturer, nents that allow medication label barcode scan- healthcare organization, clinicians, and sup- ning, which facilitates auto-selecting medica- port professionals. Reducing I.V. medication tions from the drug library. This feature removes errors requires embracing technology ad- the need for clinicians to search the drug library vancements, standardized care imperatives, where look-alike medications or multiple con- clinician competency, continuous quality im- centration entries might lead to selection errors. provement initiatives, and sound organiza- The barcode scanning process was the precur- tional infrastructures. AN sor to smart infusion pump interoperability, Access a “good catch” story at myamericannurse.com/?p=74383. which allows bi-directional (two-way) communication between the pump channel and the The authors work at the Infusion Nurses Society in Norwood, Massa- patient’s electronic health record (EHR). Bi- chusetts. Dawn Berndt is the clinical education and publications man- directional communication technology allows ager and Marlene Steinheiser is the director of clinical education. the pump to receive the medication order direct- References ly from the EHR and for the pump to send infu- Blandford A, Dykes PC, Franklin BD, et al. Intravenous sion data (medication, rate, dose, volume) to the infusion administration: A comparative study of practices patient’s EHR infusion record. (See Bi-direction- and errors between the United States and England and al benefits and challenges.) their implications for patient safety. Drug Saf. 2019; 42(10):1157-65. doi:10.1007/s40264-019-00841-2 Organization responsibility Giuliano KK. Intravenous smart pumps: Usability issues, intravenous medication administration error, and patient Healthcare organizations must design an infra- safety. Crit Care Nurs Clin North Am. 2018;30(2):215-24. structure that supports patient safety through doi:10.1016/j.cnc.2018.02.004 procurement, implementation, application, main- Gorski LA, Hadaway L, Hagle ME, et al. Infusion therapy tenance, and continuous quality improvement standards of practice, 8th edition. J Infus Nurs. 2021;44 measures for smart infusion pump systems. This (suppl 1):S1-224. doi:10.1097/NAN.0000000000000396 requires creating a supportive environment and Institute for Safe Medication Practices. Guidelines for ensuring that standardized, facility-approved re- Optimizing Safe Implementation and Use of Smart Infu- sion Pumps. February 10, 2020. ismp.org/guidelines/ sources are readily available at the point of care. safe-implementation-and-use-smart-pumps (See Organizational responsibilities.) Kane-Gill SL, Dasta JF, Buckley MS, et al. Clinical practice guideline: Safe medication use in the ICU. Crit Care Med. Clinician responsibility 2017;45(9):e877-915. doi:10.1097/ccm.0000000000002533 According to the Infusion Nurses Society Infu- Lapkin S, Levett-Jones T, Chenoweth L, Johnson M. The sion Therapy Standards of Practice, the nurse is effectiveness of interventions designed to reduce med- responsible for ensuring patient safety through ication administration error: A synthesis of findings from systematic reviews. J Nurs Manag. 2016;24(7):845-58. competent infusion equipment use, including doi:10.1111/jonm.12390 knowledge of appropriate indications, con- Schnock KO, Dykes PC, Albert J, et al. A multi-hospital traindications, and manufacturer’s directions. before-after observational study using a point-prevalence When managing smart infusion pumps, clini- approach with an infusion safety intervention bundle to cians must maintain clinical competency, adhere reduce intravenous medication administration errors. Drug to organizational compliance goals, confidently Saf. 2018;41(6):591-602. doi:10.1007/s40264-018-0637-3 manage the I.V. medication administration The Joint Commission. Sentinel Event Alert 63: Optimiz- process, vigilantly prevent error, assess the pa- ing smart infusion pump safety with DERS. April 14, 2021. tient and monitor the pump throughout each in- U.S. Food and Drug Administration. Infusion pump risk reduction strategies for facility administrators and man- fusion, and ensure appropriate medication rec- agers. February 2, 2018. fda.gov/medical-devices/infusion- onciliation and patient handoffs and transfers pumps/infusion-pump-risk-reduction-strategies-facility- are performed. (See Clinician responsibilities.) administrators-and-managers Standardized clinical workflows will help U.S. Food and Drug Administration. Syringe pump prob- ensure routine performance of all safety meas- lems with fluid flow continuity at low infusion rates can ures and reduced risks to patient safety. (See result in serious clinical consequences: FDA safety communication. August 25, 2016. fdanews.com/ext/resources/ Clinician workflows.) files/2016/08/08-25-16-pumpsafetynotice.pdf?1480880246 Wolf ZR, Hughes RG. Best practices to decrease infu- Safety essentials sion-associated medication errors. J Infus Nurs. 2019; When using smart infusion pump technology, 42(4):183-92 doi:10.1097/NAN.0000000000000329

MyAmericanNurse.com May 2021 American Nurse Journal 21 Online

Good catch

A patient is transferred to a critical care unit for uncontrolled hyperten- sion, and the provider orders a nitroglycerin drip at 5 mcg/kg/min, which is verified by the pharmacy. The patient’s clinician, who’s new to practice, consults with two colleagues at the bedside to verify smart pump programming. When the infusion is programmed as ordered, the smart pump issues a hard-limit alert and won’t permit the infusion to begin. The clinician contacts the pharmacy to re-verify the ordered dose parameters. They’re verified as correct. The clinicians at the bedside check whether the pump is in the critical care profile portion of the library that allows access to medications and concentrations necessary in critical care units. The pump is in the profile. The clinician contacts the ordering provider again to re-verify the nitroglycerin order. The provider immediately recognizes the problem. The order should have been 5 mcg/min, not 5 mcg/kg/min. The order is corrected, the pump is programmed at the correct rate, and the patient receives a safe starting rate for the nitroglycerin infusion. The medication administration process includes four separate steps before medication reaches a patient: ordering, transcribing and verifying the order, dispensing and delivering the medication, and administering the medication. Errors can occur at any point in the process. Safety checks should be placed at each step to catch an error before it reaches the patient. In this case, the error moved undetected from one step to the next and wasn’t identified until the smart infusion pump intercepted it, protecting the patient from a significant overdose of nitroglycerin.

22 American Nurse Journal Volume 16, Number 5 MyAmericanNurse.com