Title: Comparative Safety of Smart Infusion Pumps with Standard Infusion Pumps

Transcription

1 Title: Comparative Safety of with Standard Infusion Pumps Date: October 31, 2007 Context and policy issues: General-purpose infusion pumps are widely used to accurately deliver fluids via intravenous (IV) or epidural administration for therapeutic and/or diagnostic purposes. 1 These pumps are used when greater accuracy or higher flow are needed than can be provided by manually adjusted gravity systems. 1 However, lack of standardization for dosing methods and incorrect programming have led to serious adverse drug-related events. 2 Between 1987 and March 2003, Health Canada received reports of 425 separate incidents involving infusion pumps. Of the 425 incidents, 23 resulted in death, 135 resulted in injury, and 127 could potentially have led to death or injury. Of these, 20 deaths and all 135 injuries were caused (or suspected to have been caused) by the infusion pump. Since these reports were voluntary, these figures likely underestimate the actual risk of injury or death associated with infusion pumps. 3 A national hospital survey conducted in 2003 by the Institute of Safe Medication Practices (ISMP) attempted to identify problems users have experienced with infusion pumps in Canada. 4 Seventy-five percent of responding hospitals reported infusion pump problems. Majority of the incidents were associated with incorrect flow rate (58%) free-flow errors (47%), air sensor errors (47%), and overdose errors (36%). 4 All of these problems can arise as a result of human error (e.g. in programming or improper placement of machinery) or as a result of software or hardware flaws. 4 In light of these results, Health Canada now recommends the purchase of pumps with free-flow protection and a dose error reduction system (i.e. smart technology) that safeguard against dosing and infusion rate errors. 3 A drug error reduction system is a set of software tools that check programmed doses against preset limits specific to a drug and clinical care area (e.g. ICU, surgery, obstetrics, pediatrics). 5 These systems alert clinicians to programmed doses that exceed the preset limits and either require confirmation before beginning delivery (soft limit) or not allow delivery at all (hard limit). 5 Smart infusion pumps allow for the importation of institution-specific drug libraries. 6 These libraries include drug name, diluent, drug concentration, lower and upper limits on dosage or Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 infusion rate, units (for drug, diluent, or dosing), and clinical care area. Multidisciplinary teams including pharmacists, nurses, and physicians set up and update these drug libraries based on institution-specific best practice guidelines. 7 Two-way wireless communication capabilities allow some pumps to send data to a server and receive new libraries without the need to locate and connect each pump to a computer. 5 This data can then be used to help staff address previously unrecognized medication safety issues, refine the drug library, improve compliance, and identify opportunities for best practice improvements. 8 In selecting and implementing smart pump technology, an assessment of patient harm in comparison to current technology is needed to determine potential long-term clinical and economic benefit. In 2002, the ECRI Institute began reviewing general-purpose infusion pumps based on ability to enhance patient safety. 9 This report will review evidence for the safety of Baxter Colleague smart pumps versus Baxter Flo-Gard pumps. A brief overview of other smart infusion pumps available in Canada will also be discussed. Research question: What is the evidence that the Baxter Colleague smart pump has less risk of infusion errors compared to the Baxter Flow-Gard Pump? Methods: A literature search was conducted on key health technology assessment resources, including PubMed, The Cochrane Library (Issue 3, 2007), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI s HTAIS and Health Devices Gold, EuroScan, international HTA agencies, and a focused Internet search. Results include English language publications from 2002 to date. Links to online full-text are provided when available. Bibliographies of reports were scanned to identify other relevant evidence. Summary of findings: No meta-analyses, systematic reviews, or trials were retrieved specifically addressing the safety of Baxter infusion pumps. ECRI product evaluations for general-purpose infusion pumps were retrieved in the search. 5,9,10 A detailed product comparison based on these reviews for smart pumps available in Canada as well as a useful checklist to help assess which smart infusion pump is best suited to a particular institution can be found in ECRI s latest evaluation. 5 ECRI findings show that factors that distinguish one pump from another are not performance issues, but patient safety considerations. 9 Most of the currently available pumps perform reliably and accurately when properly used. However, not all models offer the same level of protection against pump programming errors (i.e. human error) and other events that can lead to IV medication errors as a result of software or hardware design flaws. While the Baxter Flo-Gard 6201 and 6301 models both have free-flow protection, ECRI has rated them as Not Recommended for purchase because they lack a dose error reduction system. 9 Furthermore, ISMP Canada has received reports involving over-infusion with the Baxter Flo-Gard 6201 infusion pump. 11 Recently, ECRI has also rated the Baxter Colleague CX and 3CX smart pumps as Not Recommended for purchase. 10 ECRI states that the Guardian software provided with the Colleague pumps does not compare favorably with the smart technology used in other pumps. Problems encountered with setting up the drug library include a process that is not user-friendly, reduced customizability, and drug names that cannot be displayed using TALLman lettering (eg. DoBUTamine, DOPamine). 10 Not defaulting to the dose error reduction system on power-up could potentially decrease compliance with this safety 2

3 function. Lack of a dedicated log for storing programmed doses that trigger alerts or reprogramming activities hampers assessments of effectiveness or use toward improvements in clinical practice. 10 In the last few years, the Colleague CX and 3CX pumps have also been subject to several recalls and product seizures due to the potential risk for serious injury or patient death. The reason for these recalls consist of several issues encountered with these pumps including hardware and software design flaws (battery under-charging, false air detection alarms, gearbox wear, under-infusion, non-detection of upstream occlusion, battery damage), and evidence of falsified repair, test and inspection sheets A recent Health Canada advisory reports discontinued infusions encountered with Colleague triple channel infusion pumps as a result of a software irregularity. 16 The Colleague CXE and 3CXE infusion pumps were cleared for marketing in February 2007 and represent an improvement over the CX and 3CX models. Improvements include a larger drug library, a spreadsheet tool for developing drug libraries, and modifications to help prevent battery damage. 5 However, they are still rated as Not Recommended for purchase as the functionality provided by Baxter s Guardian software is still limited compared to other models. 5 The Colleague pumps also lack wireless capabilities and the keypad design could lead to inaccurate programming. 5 However, ECRI rated the Cardinal Health Alaris system as Preferred for its easy to use and comprehensive safety features (including two-way wireless communication and a bar code sanner) 5 as well as for its PCA module. 17 Furthermore, several observational prospective studies have been published documenting improvements in patient safety following successful implementation of the Alaris system. 2,18-25 Hospira s Symbiq model was rated as Acceptable for purchase due to limited implementation experience but ECRI states that this model is a good choice for hospitals that wish to use one drug error reduction system for both general-purpose and PCA pumps. 5,17 The Sigma Spectrum pump was rated as Acceptable due to good safety features but limited implementation experience. ECRI rated the B. Braun Outlook 300 and Alaris SE smart pump as Not Recommended for purchase based on the finding that the flexibility and safety features of their smart technology are inferior to other pumps. 5 Conclusions and implications for decision or policy making: Available evidence suggests that smart pumps help avert potentially serious and life-threatening medication errors. However, some smart pumps are clearly superior to the Baxter infusion pumps in terms of reliability in preventing infusion errors. An initial step in smart pump implementation is to determine the scope for smart pump use that is most appropriate for the institution s patient population, technological capabilities, and budget. 26 Supplier support for both initial implementation and ongoing system maintenance and development is an important consideration. Ideally, hospitals should choose suppliers with extensive implementation experience along with a good history of regular product upgrades and updates in response to customer feedback. 5 The establishment of multidisciplinary project teams (including pharmacy, nursing, physicians, information technology, biomedical engineering, and pharmacy and therapeutics committee) is key in programming institution-specific drug libraries according to best practice guidelines It is important to note that although smart technology is intended to improve patient safety, it may introduce new errors. Conducting a beta test (pilot study) should help identify new errors in advance and ease institution-wide adoption. 26,29 Comprehensive training is needed to prevent possible barriers with acceptance of the new technology including falsely low perceptions of risk and time pressures in clinical emergencies. 30,31 Finally, successful implementation of smart-pump technology should involve continuous collaborative efforts among all relevant disciplines. 32 Interfacing smart pumps with other systems such as the electronic medical record, computerized prescriber order entry, bar coded medication administration systems and pharmacy information systems will help realize their full potential for improving patient safety. 33 Further research is needed to confirm the impact of smart pumps on 3

4 length of hospital stay, quality of patient recovery, complications, and economic benefit over standard infusion pumps. Prepared by: Sarah Ndegwa, BScPharm, Research Officer Kelly Farrah, MLIS, Information Specialist 4

5 References: 1. ECRI Institute. Product comparison: infusion pumps, general-purpose. Plymouth Meeting (PA): ECRI; Eskew JA, Jacobi J, Buss WF, Warhurst HM, DeBord CL. Using innovative technologies to set new safety standards for the infusion of intravenous medications. Hosp Pharm 2002;37(11): Health Canada. Health risks associated with use of infusion pumps. In: MedEffect: advisories, warnings and recalls [database online]. Ottawa: Health Canada; Available: (accessed 2007 Oct 22). 4. Institute for Safe Medication Practices Canada (ISMP Canada). Infusion pump project: survey results and time for action. ISMP Canada Safety Bulletin 2004;4(1). Available: (accessed 2007 Sep 27). 5. ECRI Institute. General-purpose infusion pumps. Health Devices 2007;36(10): Snodgrass RD. Smart pump technology. Biomed Instrum Technol 2005;39(6): Beattie S. Technology today: smart IV pumps. RN 2005;68(12). Available: (accessed 2007 Sep 27). 8. Vanderveen T. Smart pumps: advanced capabilities and continuous quality improvement. Patient Safety & Quality Healthcare Newsletter Available: (accessed 2007 Sep 27). 9. General-purpose infusion pumps. Health Devices 2002;31(10): General-purpose infusion pumps: Baxter Colleague CX and 3CX infusion pumps rated not recommended for purchase. Health Devices 2005;34(12): Institute for Safe Medication Practices Canada (ISMP Canada). Alarm not activated after infusion pump tubing incorrectly loaded. ISMP Canada Safety Bulletin 2003;3(10). Available: (accessed 2007 Sep 27). 12. Baxter provides update on service documentation class I recall [web page]. In: Baxter. Deerfield (IL): Baxter; Available: service_documentation_update.html (accessed 2007 Sep 27). 5

6 13. FDA classifies baxter's voluntary recall action regarding service documentation as a class I recall [web page]. In: Baxter. Deerfield (IL): Baxter; Available: service_documentation.html (accessed 2007 Sep 27). 14. Center for Devices and Radiological Health, U.S. Food and Drug Administration. Class 1 recall: Baxter Healthcare Corp. Colleague and Colleague CX volumetric infusion pumps [web page]. In: Center for Devices and Radiological Health. Rockville (MD): FDA; Available: html (accessed 2007 Oct 22). 15. Health Canada. Colleague volumetric infusion pump. In: MedEffect: advisories, warnings and recalls [database online]. Ottawa: Health Canada; Available: (accessed 2007 Oct 22). 16. Health Canada. Colleague volumetric infusion pumps. In: MedEffect: advisories, warnings and recalls [database online]. Ottawa: Health Canada; Available: (accessed 2007 Oct 23). 17. ECRI. Patient-controlled analgesic infusion pumps. Health Devices 2006;35(1): Williams CK, Maddox RR. Implementation of an i.v. medication safety system. Am J Health Syst Pharm 2005;62(5): Hatcher I, Sullivan M, Hutchinson J, Thurman S, Gaffney FA. An intravenous medication safety system: preventing high-risk medication errors at the point of care. J Nurs Adm 2004;34(10): Malashock CM, Shull SS, Gould DA. Effect of on Medication Errors Related to Infusion Device Programming. Hosp Pharm 2004;39(5): Maddox RR, Williams CK, Oglesby H, Butler B, Colclasure B. Clinical experience with patient-controlled analgesia using continuous respiratory monitoring and a smart infusion system. Am J Health Syst Pharm 2006;63(2): Fanikos J, Fiumara K, Baroletti S, Luppi C, Saniuk C, Mehta A, et al. Impact of smart infusion technology on administration of anticoagulants (unfractionated Heparin, Argatroban, Lepirudin, and Bivalirudin). Am J Cardiol 2007;99(7): Rothschild JM, Keohane CA, Thompson S, Bates DW. Intelligent intravenous infusion pumps to improve medication administration safety. AMIA Annu Symp Proc 2003;992. Available: (accessed 2007 Oct 9). 6

7 24. Shingler RA. Correcting risk of harm from i.v. medication errors. Explore safety, financial, and community benefits. J Nurs Adm 2004;34 Suppl: Wilson K, Sullivan M. Preventing medication errors with smart infusion technology. Am J Health Syst Pharm 2004;61(2): Cohen MR, Schneider P, Neimi K. Effective Approaches to standardization and implementation of smart pump technology: a continuing education program for pharmacists and nurses. Huntingdon Valley (PA): Institute for Safe Medical Practices; Available: (accessed 2007 Sep 27). 27. Cassano AT. IV medication safety software implementation in a multihospital health system. Hosp Pharm 2006;41(2): Rohman C. Smart pump implementation: one hospital's story. Nurs Manage 2005;36(6): Wetterneck TB, Skibinski KA, Roberts TL, Kleppin SM, Schroeder ME, Enloe M, et al. Using failure mode and effects analysis to plan implementation of smart i.v. pump technology. Am J Health Syst Pharm 2006;63(16): Leape LL. "Smart" pumps: a cautionary tale of human factors engineering. Crit Care Med 2005;33(3): Rothschild JM, Keohane CA, Cook EF, Orav EJ, Burdick E, Thompson S, et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med 2005;33(3): Keohane CA, Hayes J, Saniuk C, Rothschild JM, Bates DW. Intravenous medication safety and smart infusion systems: lessons learned and future opportunities. J Infus Nurs 2005;28(5): Husch M, Sullivan C, Rooney D, Barnard C, Fotis M, Clarke J, et al. Insights from the sharp end of intravenous medication errors: implications for infusion pump technology. Qual Saf Health Care 2005;14(2):80-6. Available: (accessed 2007 Oct 5). 7