Adverse drug events are known to be the single leading cause of medical injuries.1 Medication errors related to intravenous (IV) infusion present the greatest potential for harm. In a study of pediatric inpatients, IV medications were associated with 54% of potential adverse drug events (ADEs).2 Of serious and life-threatening errors, 60% were associated with IV therapy, according to a communication with D.W. Bates in October 2001. In a United Kingdom study, IV medications were associated with 56% of medication errors.3 It is generally accepted that ADEs associated with IV infusion devices are usually a result of incorrect programming.4
Now, a new generation of infusion devices—so-called “smart pumps”—can reduce medication errors, improve workflow, and provide a new source of data for continuous quality improvement (CQI). This article reviews the need for more sophisticated infusion technology, key capabilities of the new smart pumps, initial findings, and sources for further information, including an independent evaluation of infusion devices.
IV Medication Errors
Infusion pumps were first introduced over 30 years ago. What began as limited rate/volume devices used primarily for nutrition and cardiovascular drugs has evolved into very sophisticated, therapy-specific devices. Pumps for IV and epidural pain control, syringe pumps for anesthesia and ICU use, and multichannel general-purpose pumps are used to administer IV medications and fluids.
One common characteristic of all of these devices is a wide range of acceptable programming parameters. For example, the general-purpose IV pumps have a 10,000-fold rate or dose range. They can deliver a drop or two over 1 hour, or they can be programmed to deliver 1 liter or more in an hour.4 Similarly, the volumes that can be delivered range from 0.1 to 9999 mL—a full 100,000-fold difference from the lowest to the highest settings.4
Unlike drugs, which are ordered and dispensed in amounts that are adjusted for the patient and the intended use, infusion pumps are set up to have maximum flexibility, so they can be used anywhere. Consequently, a pump used today for a 200-kg patient in the adult ICU may be used next on a 600-gm premature infant. Errors of 10-, 100-, or even 1000-times the intended dose can easily be programmed, since there are no limits in devices. In short, the IV pumps rely on human intelligence and depend on error-free programming.
Examples of fatal errors taken from published reports or professional meetings include a case in which morphine was entered as 90 mg/hr instead of 9.0 mg/hr, causing delivery of 10-times the intended dose. In a neonatal ICU, an infusion rate was reprogrammed from 3.2 to 304 ml/hr, when the intention was 3.4 ml/hr. Nitroglycerin ordered to be administered in mcg/min was inadvertently programmed as mcg/kg/min, resulting in administration of 60 times the intended dose. Many of the tragic errors with patient-controlled analgesia (PCA) pumps have resulted from incorrect programming of the drug concentration, leading to a factor of 10 overdose. In terms of rate, a bag of heparin intended to be administered over 24 hours can easily be misprogrammed to be infused in 1 hour. The common denominator in each of these cases was a single wrong entry or button press.
Fortunately, the next generation of infusion devices, referred to as a “smart pump” by the Institute for Safe Medication Practices (ISMP), is setting a new standard of safety for IV medication administration, with demonstrated ability to avert such errors. These commercially available infusion systems perform a “test of reasonableness” to check that programming is within pre-established institutional limits before infusion can begin.
To avoid medication errors, the new technology incorporates multiple comprehensive libraries of drugs, usual concentrations, dosing units (e.g., mcg/kg/min, units/hr) and dose limits. Both continuous and bolus infusions can be programmed with the expanded drug dose calculator. The libraries are set up and managed by the hospital pharmacy department with input from the pharmacy and therapeutics committee, as well as patient care areas. When the device is turned on, the clinician designates a particular area of use (e.g., adult ICU, NICU), and the device is automatically configured to meet the needs of that area. The clinician then selects the drug and concentration from the appropriate predetermined list and completes the programming. Safeguards built into the device include not allowing the patient’s weight to be used if the drug is not dosed according to weight, identifying whether the drug is already infusing on another channel, and alerting the user if the dose exceeds the institution-established, predetermined limit. Limits can be set as either “soft” (can be overridden) or “hard” (cannot be overridden).
With this new technology, the errors cited above would have resulted in alerts to the clinician before infusion could begin. A high rate in the NICU would result in a “high rate” alert. The 10-fold morphine and 24-fold heparin programming errors would result in “high dose” alerts. For drugs where weight is not used in the calculation, the calculator would not allow a weight entry.
An additional feature of these new smart pumps is their ability to log all alerts. This allows a hospital to track programming errors, or “near misses,” that have been averted and could have resulted in patient harm. Continuous quality improvement (CQI) data also provide a new source of information to assist in assessing infusion practices and identifying opportunities for process improvements.4
IV error-prevention data published to date are shown in Table 1.4 Since no study has ever documented the actual frequency of IV medication errors with infusion devices, this information is the first indication of the actual frequency of programming that is outside of the hospital’s best practice guidelines. Projecting the data over 1 year, a 1400-bed hospital indicates that there would be over 1 million programmings, approximately 18,500 alerts, and 4,000 programming changes.4
The National Patient Safety Foundation (NPSF) recently granted its annual Solutions Award to Ellen Kinnealey, BSN, a bedside technology specialist from the Department of Biomedical Engineering at Massachusetts General Hospital.1 Her study, “Infusion Pumps with ‘Drug Libraries’ at the Point of Care: A Solution for Safer Drug Delivery,” examined the use of an electronic drug library, which was clinician designed, hospital sanctioned, and customizable to different settings. This solution was implemented in the Intensive Care Unit and Operating Room environments at Massachusetts General Hospital, and has thus far resulted in at least a 50% reduction in the number of drug administration errors involving syringe pumps, as indicated by clinician reports.1
The use of smart technology contributes to the building of a high reliability organization. A clinician no longer has to rely on memory to determine correct dosing, or on keystroke accuracy to ensure correct programming. Instead, a clinician can rely on a smart pump that is programmed according to institution-established best practices. The effective implementation of smart technology thus changes the role of the clinician from that of a “hunter-gatherer” of data and rules to that of a clinical decision-maker who tests the reasonableness of the rules and implements them as appropriate. The clinician remains the central figure in the use of innovative technology to deliver more effective care.5
Some “smart pumps” are available with an anesthesia option that automatically reconfigures a general-purpose infusion device to an “anesthesia-friendly” device. Designed to meet the special needs of OR use, the selection of the anesthesia mode provides access to a unique set of drugs and modifies the nature of the alarms and dose alerts. For drug infusions that are to be continued in the PACU or ICU, simply unplugging the power cord automatically converts the smart pump back to a nurse-friendly device. This seamless conversion provides a safer patient transfer while also providing more cost-effective drug therapy.
An independent analysis of commercially available “smart pumps” was published by the Emergency Care Research Institute (ECRI) in Health Devices.6 In the newly adopted rating for infusion pumps, devices without dose limits are now considered “Not Recommended” for purchase. Only 5 out of 26 devices tested meet this new criterion. Now that the bar has been raised for IV medication safety, other manufacturers may seek to add this new safety capability.
Currently, an estimated 70% of the anesthesia departments use infusion pumps for cardiovascular drugs and other medications that will be used in the OR. Indeed effective patient care, whether in the OR, during or after the transition to the ICU, requires accurate administration of IV drugs, either by anesthesiologists, nurse anesthetists, or by nurses carrying out physician’s orders. While the full impact of the new “smart pumps” on the reduction of IV medication errors has yet to be measured, the preliminary data are very encouraging. We predict that the widespread adoption of smart pumps will significantly reduce IV medication errors.
Dr. Reves is Dean of the College of Medicine and Vice President for Academic Affairs at the University of South Carolina.
- Press release. National Patient Safety Foundation announces solutions winner for Janssen Elder Care Award. NPSF January 6, 2003.
- Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114-2120.
- Ross LM, Wallace J, Paton JY. Medication errors in a paediatric teaching hospital in the UK: five years operational experience. Arch Dis Child 2000;83:492-497.
- Eskew JA, Jacobi J, Buss WF, Warhurst HM, DeBord CL. Using innovative technologies to set new safety standards for the infusion of intravenous medication. Hosp Pharm 2002;37:1179-1189.
- Kremsdorf R, Five Rights Consulting. Using innovative technology to enhance patient care delivery. Presentation at American Academy of Nursing, Washington, D.C., July 12-14, 2002.
- Evaluation: General-Purpose Infusion Pumps. Health Devices. ECRI, Plymouth Meeting, PA. October 2002;31(10),352-384.