We recently discussed problems associated with several of our medication safety technologies in our Patient Safety Tips of the Week for February 5, 2019 “Flaws in Our Medication Safety Technologies”, December 11, 2018 “Another NMBA Accident”, and January 1, 2019 “More on Automated Dispensing Cabinet (ADC) Safety”. However, one we did not yet discuss was smart pump infusion technologies. Smart pumps are used for administering IV medications, IV fluids, patient-controlled analgesia, parenteral nutrition, blood, and even MRI infusions. They are also used for other types of infusions, like epidural infusions, nerve blocks, and syringe infusions and enteral feedings. These devices have been used now for several decades and have a significant impact on reducing medication infusion errors. But there are still problems associated with smart infusion pumps.
A patient at a hospital in Singapore inadvertently received a dose of lignocaine (lidocaine) that was 10 times the intended dose, possibly contributing to her death (Lam 2018). A nurse had accidentally keyed in 41.7 ml/hr instead of 4.17 ml/hr. Smart infusion pumps allow you to key in under dose selection or rate selection. In this case, she should have keyed in either 41.7 mg per hour using dose selection or 4.17 ml per hour using rate selection. But she accidentally keyed in 41.7 ml in the rate selection instead. She apparently was unfamiliar with the smart pump due to her limited exposure to it, and there was no independent double check performed.
Such mistaken input of dose or dose rate instead of flow rate or vice versa (so called “wrong-field programming error”) has long been recognized as a major problem with smart pumps. ISMP (Institute for Safe Medication Practices), PPSA (Pennsylvania Patient Safety Authority), ASHP (American Society of Health-System Pharmacists), and other professional organizations have pointed out wrong-field programming errors as a danger for many years. And this problem made ECRI Institute’s Top 10 List of Health Technology Hazards for 2019 (ECRI 2019). Number 6 on the list is “Confusing Dose Rate with Flow Rate Can Lead to Infusion Pump Medication Errors”. ECRI notes that entering the intended flow rate into an infusion pump’s dose rate field can lead to dangerous medication administration errors. And ECRI notes that such wrong-field programming errors occur relatively frequently (and many go unreported).
Also, the inverse relationship between concentration and volume is counterintuitive (ISMP 2018a) That is, more concentrated drugs require less volume to deliver a specified dose, and less concentrated drugs require more volume to deliver a specified dose. So, if the programmed concentration is lower than the actual concentration in the infusion bag or syringe, the pump will deliver an overdose. If the programmed concentration is higher than the actual concentration in the bag or syringe, the pump will deliver an underdose.
Enter the need for the “hard” minimum concentration limit to prevent the overdose scenario. When pumps issue a “soft” low concentration alert that can be overridden, a nurse may override the warning, mistakenly believing the “low concentration” warning is inconsequential.
ISMP (ISMP 2018a) also highlighted a problem when using “custom” concentrations in smart pumps and stressed the importance of setting hard stops (requires reprogramming) for minimum concentration limits when programming custom concentrations. Programming a custom concentration entails selecting a drug from the library but then manually entering the concentration. The ISMP article notes that sometimes practitioners may unnecessarily select a custom concentration option, then enter the wrong concentration, even though a standard concentration option for the drug was available in the pump library. In such cases, programming errors would have resulted in a hard stop had the standard concentration pathways been employed but no hard stops appear when the custom concentration route is used.
ISMP makes the following recommendations:
· Standardize concentrations.
· Set hard minimum concentration limits.
· Educate staff.
· Distinguish custom concentrations.
· Require doses to be expressed in the metric unit.
· An order for an infusion with just the infusion rate (e.g., mL/hour) should not be accepted, even if only one standard concentration of the medication is being used hospital-wide.
· Tailor labels to MAR/pump settings.
· Verify pump programming.
· Analyze data.
See the ISMP article (ISMP 2018a) for details on each of those recommendations.
The Pennsylvania Patient Safety Authority (PPSA 2007) provides some great examples of how smart pumps prevented (or could have prevented) errors. But it also includes examples of errors that did occur with smart pumps. They categorized smart pump errors as wrong rate, wrong dose, wrong drug, wrong unit of measure, and override problems.
Examples included entering a rate for the standard drug concentration when the infusion dispensed by the pharmacy used a non-standard concentration. Also noted were cases of transposition of IV lines after temporary disconnection, resulting in infusions from two pumps being at the wrong rate. And an old nemesis, basing a dosage on the wrong weight (eg. pounds rather than kg), can also be seen with smart pumps (see our many columns on errors related to wrong weight listed at the end of today’s column).
They also had examples of using the wrong unit of measure. In once case, a drug was intended to be infused at a ml/hr rate but the smart pump’s library was set for a mg/minute rate. In another, an intended rate to be infused over 24 hours was misprogrammed to infuse over one hour.
We discussed problems with overrides in our Patient Safety Tips of the Week for December 11, 2018 “Another NMBA Accident” and January 1, 2019 “More on Automated Dispensing Cabinet (ADC) Safety”. Well, smart pumps are no different. The PPSA study gave numerous examples of errors where the smart pump libraries or alerts were overridden. They also noted the following reasons (from the literature) why practitioners bypass these safety measures:
· falsely low perceptions of risk;
· failure to make adjustments in the drug library when alerts are not credible;
· extra work to use the technology, time pressures, distractions, interruptions;
· clinical emergencies;
· a culture that inadvertently supports at-risk behaviors, including technology work-arounds
Some earlier versions of smart pumps had a problem with “key bounce” or “double bounce” where, during input, pressing a key once often led to a value entered twice. For example, a nurse thought she entered a flow rate of 36 ml/h but the second keystroke "bounced" and 366 ml/h was programmed into the pump (ISMP Canada 2006). While newer smart pumps seem to have encountered this problem less often, ISMP Canada’s recommendations are still logical:
· Use proper stance to facilitate proper depth of depression for each key
· Verify screen displays
· Listen to pump tones
· Observe the rate of infusion
· Request an independent double check for high-alert medications
· Institute dose alerts
Another problem is not specifically a problem with the pump per se but rather a problem when multiple infusion pumps are being used and the lines are temporarily disconnected during, for example, a patient transport or patient transfer to another unit. The danger here is that, when re-hooking up the lines to the pumps, the lines get transposed and the medications now get infused at the wrong rates.
A recent ISMP survey (ISMP 2018b) confirmed high usage of smart pumps in most hospitals. But bi-directional interoperability between their smart pumps and electronic health record (EHR) that facilitates pump programming and documentation of the infusion in the EHR is still not widely implemented. There is also a size/geography disparity in that and in wireless connectivity for transfering data to and from smart pumps (with lesser implementation in rural and small hospitals).
The most common types of errors reported included:
· delayed or omitted secondary infusions caused by a closed roller clamp
· secondary infusions that were administered at the wrong rate
· programming errors due to dose-rate confusion
· decimal point errors or selection of a zero instead of a decimal point
· weight-related errors
· selecting the wrong drug or dosing method in the drug library
· IV line or channel mix-ups
· tubing misconnection (eg. IV infusion hooked to an epidural site)
· hanging the wrong drug or solution
· administration of an infusion to the wrong patient
Survey respondents also noted many challenges:
· difficulty in securing agreement with prescribers regarding the drugs, standard concentrations, and dosing methods
· practitioners who routinely bypass the drug library
· difficulty with keeping the drug library up-to-date (especially during current drug shortage crises)
· smart pump technology limitations
Review of data analytics and compliance data should be part and parcel of the quality improvement program at every hospital. Of survey respondents, Of all respondents who review compliance data, review occurs monthly (33%), quarterly (35%), weekly or daily (11%), or yearly (10%). But, of concern, whereas most manager/director/administrator-level practitioners were aware of smart pump compliance rates, over half of staff-level practitioners were unaware of smart pump compliance rates.
Your quality improvement program should be tracking not only pump overrides but also looking at all alerts. Most newer smart pumps have the capability of logging all alerts. Following up on a survey of its readers, ISMP has some great recommendations on what metrics related to smart pumps should be part of your quality improvement program and how often these should be reviewed (ISMP 2018c).
One of our own most important warnings applies to any sort of infusion pump, smart or otherwise: never put a potentially lethal amount of a medication in a bag/bottle/syringe, lest some sort of error leads to infusion of the entire amount over too short a period. We have done several columns in which fatal or near-fatal overdoses of chemotherapy agents have been infused inadvertently over several hours when they had been intended to infuse over several days (see our Patient Safety Tips of the Week for September 11, 2007 “Root Cause Analysis of Chemotherapy Overdose” and April 6, 2010 “Cancer Chemotherapy Accidents” and September 15, 2015 “Another Possible Good Use of a Checklist”).
And dosing errors are not the only problems with infusion pumps. An FDA alert (FDA 2019) has just issued about problems with air-in-line alarms and the risk of air embolism with infusion pumps (the warning also applies to fluid warmers and rapid infusers). The warning notes one problem is balancing the sensitivity of the air-in-line sensor with the risk of clinically significant air embolism. It notes that, with a false alarm, the device may generate an air-in-line alarm when air is not present, or the amount of air detected is so small that it would not present a risk to the patient. When the device alarms, it stops the infusion, which may cause delays or an interruption of therapy.
It notes that some infusion devices offer different ranges or thresholds of air-in-line detection, which can be adjusted depending on the patient population. For example, an infusion pump air-in-line sensor setting used in a neonatal or pediatric patient population would likely be more sensitive than an adult patient population due to the patient size differences. In general, the setting of the air-in-line detector should be considered so that it is sensitive enough to help prevent a harmful amount of air reaching the patient, but not so sensitive that it generates false alarms too frequently.
The FDA notes that clinically significant air embolism depends on several factors including:
· the amount of air,
· how quickly the air is delivered,
· specific patient factors (for example, patient age, patient size, the overall health of the patient).
The FDA alert includes recommendations for healthcare professionals, biomedical engineers, and for those patients/families using infusion pumps at home. For healthcare professionals they note the importance of training and education on the risk of air embolism, ways to reduce the risk, and how to appropriately use infusion devices. They need to know whether the devices have an air-in-line sensor and whether they have programmable settings for air-in-line sensors that allow changing of the threshold of the sensor depending on the patient population being treated (for example, neonates, adults). Those settings should always be checked to ensure they are appropriate for the patient population using the devices.
Devices should always be inspected before use, and damaged devices should not be used. IV tubing should be free from damage such as cuts, kinks, or disconnections before and during use, as these can be a source of air in the tubing. Healthcare professionals should know what to do when an air-in-line alarm occurs so that delays of therapy do not occur. The FDA stresses the need to follow the manufacturer’s instructions for use to ensure the air is completely removed from the system when priming accessory devices (such as IV tubing).
The alert stresses that, if a patient is receiving a high-risk medication like epinephrine, you need to have a backup plan in place (for example, having spare devices and accessories readily available).
Recognition of the signs and symptoms of an air embolism (eg, a sudden onset of chest pain or tightness, difficulty breathing or shortness of breath, lightheadedness, fainting, or confusion, other neurologic symptoms) should lead to prompt intervention.
If the air-in-line sensor on your device is not working properly (for example, false alarms or failure to alarm), the device should be removed from service.
We suggest you go to the FDA alert to review the recommendations for biomedical engineers and for those patients/families using infusion pumps at home.
Back in 2010 the FDA had an initiative on infusion pump safety. We did 2 columns related to that (see our May 2010 What's New in the Patient Safety World column “FDA's Infusion Pump Safety Initiative” and our April 27, 2010 Patient Safety Tip of the Week “Infusion Pump Safety”). In the latter column we had some recommendations that still look pretty good today:
Other good resources include ISMP’s “Guidelines for Safe Implementation and Use of Smart Pumps” in 2008 (ISMP 2008). The Guidelines are currently being updated by ISMP. In the meantime, you can download the old ones here. ISMP also has a good resource “Building a Smart Infusion System Drug Library” (ISMP 2017).
Now that we’ve scared you about the potential pitfalls of smart infusion pumps, take a look at a recent study that details a successful system-wide smart pump implementation (Lehr 2019). Lehr and colleagues addressed the challenge of integrating 1327 smart pumps into clinical practice across 45 departments within an aggressive 3-month timeline. Read about the multidisciplinary structure they used for workgroups and their use of LEAN principles in guiding the project but pay special attention to how they went about building and refining their drug libraries.
Two months following implementation they achieved 100% compliance using the drug library across all 6 ICU’s. But compliance on other nursing units was not as good, with bypassing the drug library 34% of the time. Secondary infusions were often programmed outside the drug library because the staff perceived these infusions to be low risk. Some infusion limits were perceived as too restrictive so drug library dosing limits were adjusted to minimize potential alert fatigue improve compliance. That, along with ongoing education and skills training, resulted in a continual improvement in library compliance and reduction of pump alerts.
This is a very good read, not only for those organizations rolling out a smart pump program, but also for helping those with existing programs improve their compliance rates, reduce unhelpful alerts, and reduce errors.
Note, also, that we’ve not discussed problems with PCA (patient-controlled analgesia) pumps but we’ve listed below our many columns on PCA issues.
Our prior columns related to infusion pump issues:
· May 2010 “FDA's Infusion Pump Safety Initiative”
· April 27, 2010 “Infusion Pump Safety”
· August 2016 “Home Infusion Therapy Pitfalls”
Our prior columns related to chemotherapy safety:
Some of our other columns on errors related to patient weights:
March 23, 2010 “ISMP Guidelines for Standard Order Sets”
September 2010 “NPSA Alert on LMWH Dosing”
August 2, 2011 “Hazards of ePrescribing”
January 2013 “More IT Unintended Conseequences”
December 8, 2015 “Danger of Inaccurate Weights in Stroke Care”
September 2017 “Weight-Based Dosing in Children”
January 2018 “Can We Improve Barcoding?”
June 2018 “Incorrect Weights in the EMR”
Other Patient Safety Tips of the Week pertaining to PCA safety:
· January 4, 2011 “Safer Use of PCA”
· May 12, 2009 “Errors With PCA Pumps”
· September 6, 2011 “More Tips on PCA Safety”
· December 6, 2011 “Why You Need to Beware of Oxygen Therapy”
· February 12, 2013 “CDPH: Lessons Learned from PCA Incident”
Lam L. Elderly woman accidentally given 10 times prescribed drug dose at SGH. Channel NewsAsia 2018; December 19, 2018
ECRI Top 10 Health Technology Hazards for 2019
ISMP (Institute for Safe Medication Practices). Smart Pump Custom Concentrations without Hard “Low Concentration” Alerts Can Lead to Patient Harm. ISMP Medication Safety Alert! Acute Care Edition 2018; May 31, 2018
PPSA (Pennsylvania Patient Safety Authority). Smart Infusion Pump Technology: Don’t Bypass the Safety Catches. PA PSRS Patient Saf Advis 2007; 4(4): 139-143
ISMP Canada. ALERT: Potential for “Key Bounce” with Infusion Pumps. ISMP Canada Safety Bulletin 2006; 6(6): September 7, 2006
ISMP (Institute for Safe Medication Practices). Smart Pumps in Practice: Survey Results Reveal Widespread Use, but Optimization Is Challenging. ISMP Medication Safety Alert! Acute Care Edition 2018; April 5, 2018
ISMP (Institute for Safe Medication Practices). Survey Results: Smart Pump Data Analytics Pump Metrics that Should Be Monitored to Improve Safety. ISMP Medication Safety Alert! Acute Care Edition 2018; July 12, 2018
FDA (US Food and Drug Administration). Safety Communication. Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers: FDA Safety Communication. FDA January 31, 2019
ISMP (Institute for Safe Medication Practices). Smart Pumps Are Not Smart on Their Own. ISMP Medication Safety Alert! Acute Care Edition 2007; April 19, 2007
FDA (US Food and Drug Administration). Infusion Pump Risk Reduction Strategies for Patients Using Infusion Pumps at Home. FDA 2017; Last Updated: 12/13/2017
FDA (US Food and Drug Administration). Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump. FDA 2017; Last Updated: 12/17/2017
ISMP (Institute for Safe Medication Practices). Guidelines for Safe Implementation and Use of Smart Pumps . ISMP Medication Safety Alert! Acute Care Edition 2008; March 7, 2008
ISMP (Institute for Safe Medication Practices). Building a Smart Infusion System Drug Library. ISMP Medication Safety Alert! Acute Care Edition 2017; January 30, 2017
Lehr J, Vitoux RR, Evanovich Zavotsky K, et al. Achieving Outcomes With Innovative Smart Pump Technology: Partnership, Planning, and Quality Improvement. Journal of Nursing Care Quality 2019; 34(1): 9-15, January/March 2019
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