Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation

Alan F Merry, Craig S Webster, Jacqueline Hannam, Simon J Mitchell, Robert Henderson, Papaarangi Reid, Kylie-Ellen Edwards, Anisoara Jardim, Nick Pak, Jeremy Cooper, Lara Hopley, Chris Frampton, Timothy G Short, Alan F Merry, Craig S Webster, Jacqueline Hannam, Simon J Mitchell, Robert Henderson, Papaarangi Reid, Kylie-Ellen Edwards, Anisoara Jardim, Nick Pak, Jeremy Cooper, Lara Hopley, Chris Frampton, Timothy G Short

Abstract

Objective: To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia.

Design: Prospective randomised open label clinical trial.

Setting: Five designated operating theatres in a major tertiary referral hospital.

Participants: Eighty nine consenting anaesthetists managing 1075 cases in which there were 10,764 drug administrations.

Intervention: Use of the new system (which includes customised drug trays and purpose designed drug trolley drawers to promote a well organised anaesthetic workspace and aseptic technique; pre-filled syringes for commonly used anaesthetic drugs; large legible colour coded drug labels; a barcode reader linked to a computer, speakers, and touch screen to provide automatic auditory and visual verification of selected drugs immediately before each administration; automatic compilation of an anaesthetic record; an on-screen and audible warning if an antibiotic has not been administered within 15 minutes of the start of anaesthesia; and certain procedural rules-notably, scanning the label before each drug administration) versus conventional practice in drug administration with a manually compiled anaesthetic record.

Main outcome measures: Primary: composite of errors in the recording and administration of intravenous drugs detected by direct observation and by detailed reconciliation of the contents of used drug vials against recorded administrations; and lapses in responding to an intermittent visual stimulus (vigilance latency task). Secondary: outcomes in patients; analyses of anaesthetists' tasks and assessments of workload; evaluation of the legibility of anaesthetic records; evaluation of compliance with the procedural rules of the new system; and questionnaire based ratings of the respective systems by participants.

Results: The overall mean rate of drug errors per 100 administrations was 9.1 (95% confidence interval 6.9 to 11.4) with the new system (one in 11 administrations) and 11.6 (9.3 to 13.9) with conventional methods (one in nine administrations) (P = 0.045 for difference). Most were recording errors, and, though fewer drug administration errors occurred with the new system, the comparison with conventional methods did not reach significance. Rates of errors in drug administration were lower when anaesthetists consistently applied two key principles of the new system (scanning the drug barcode before administering each drug and keeping the voice prompt active) than when they did not: mean 6.0 (3.1 to 8.8) errors per 100 administrations v 9.7 (8.4 to 11.1) respectively (P = 0.004). Lapses in the vigilance latency task occurred in 12% (58/471) of cases with the new system and 9% (40/473) with conventional methods (P = 0.052). The records generated by the new system were more legible, and anaesthetists preferred the new system, particularly in relation to long, complex, and emergency cases. There were no differences between new and conventional systems in respect of outcomes in patients or anaesthetists' workload.

Conclusions: The new system was associated with a reduction in errors in the recording and administration of drugs in anaesthesia, attributable mainly to a reduction in recording errors. Automatic compilation of the anaesthetic record increased legibility but also increased lapses in a vigilance latency task and decreased time spent watching monitors. Trial registration Australian New Zealand Clinical Trials Registry No 12608000068369.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that AFM, TGS, JC, and CSW are shareholders in Safer Sleep. AFM is a director of Safer Sleep, holds about 9% of its shares, and advises the company on the design of its products. TGS, JC, and CSW are minor shareholders. The intellectual property of the new system is owned by Safer Sleep, although some patents are in the name of AFM (as inventor). AFM and CSW have been authors on several previous publications evaluating the new system.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4788159/bin/mera824532.f1_default.jpg
Flow of cases (patients undergoing anaesthesia for surgery) through trial; five operating theatres randomly allocated by week to one or other method for 83 study weeks

References

    1. Department of Health. An organisation with a memory—report of an expert group on learning from adverse events in the NHS. Stationery Office, 2000.
    1. Institute of Medicine. To err is human: building a safer health system. National Academy Press, 2000.
    1. Webster CS, Merry AF, Larsson L, McGrath KA, Weller J. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care 2001;29:494-500.
    1. Abeysekera A, Bergman IJ, Kluger MT, Short TG. Drug error in anaesthetic practice: a review of 896 reports from the Australian incident monitoring study database. Anaesthesia 2005;60:220-7.
    1. Merry AF, Peck DJ. Anaesthetists, errors in drug administration and the law. N Z Med J 1995;108:185-7.
    1. Merry AF, Weller JM, Robinson BJ, Warman GR, Davies E, Shaw J, et al. A simulation design for research evaluating safety innovations in anaesthesia. Anaesthesia 2008;63:1349-57.
    1. Webster CS. The iatrogenic-harm cost equation and new technology. Anaesthesia 2005;60:843-6.
    1. Orser BA, Byrick R. Anesthesia-related medication error: time to take action. Can J Anaesth 2004;51:756-60.
    1. Merry AF, Webster CS. Medication error in New Zealand—time to act. N Z Med J 2008;121:6-9.
    1. Eichhorn J. APSF hosts medication safety conference: consensus group defines challenges and opportunities for improved practice. APSF Newsletter 2010;25:1-7.
    1. Stewart M, Purdy J, Kennedy N, Burns A. An interprofessional approach to improving paediatric medication safety. BMC Med Educ 2010;10:19.
    1. Poon EG, Keohane CA, Yoon CS, Ditmore M, Bane A, Levtzion-Korach O, et al. Effect of bar-code technology on the safety of medication administration. N Engl J Med 2010;362:1698-707.
    1. DeYoung JL, Vanderkooi ME, Barletta JF. Effect of bar-code-assisted medication administration on medication error rates in an adult medical intensive care unit. Am J Health Syst Pharm 2009;66:1110-5.
    1. Helmons PJ, Wargel LN, Daniels CE. Effect of bar-code-assisted medication administration on medication administration errors and accuracy in multiple patient care areas. Am J Health Syst Pharm 2009;66:1202-10.
    1. Kennedy PJ, Feingold A, Wiener EL, Hosek RS. Analysis of tasks and human factors in anesthesia for coronary-artery bypass. Anesth Analg 1976;55:374-7.
    1. McDonald JS, Dzwonczyk RR. A time and motion study of the anaesthetist’s intraoperative time. Br J Anaesth 1988;61:738-42.
    1. Gibbs RF. The present and future medicolegal importance of record keeping in anesthesia and intensive care: the case for automation. J Clin Monit 1989;5:251-5.
    1. Rowe L, Galletly DC, Henderson RS. Accuracy of text entries within a manually compiled anaesthetic record. Br J Anaesth 1992;68:381-7.
    1. Leape LL, Berwick DM. Five years after to err is human: what have we learned? JAMA 2005;293:2384-90.
    1. Merry AF, Webster CS, Mathew DJ. A new, safety-oriented, integrated drug administration and automated anesthesia record system. Anesth Analg 2001;93:385-90.
    1. Webster CS, Merry AF, Gander PH, Mann NK. A prospective, randomised clinical evaluation of a new safety-orientated injectable drug administration system in comparison with conventional methods. Anaesthesia 2004;59:80-7.
    1. Webster CS, Larsson L, Frampton CM, Weller J, McKenzie A, Cumin D, et al. Clinical assessment of a new anaesthetic drug administration system: a prospective, controlled, longitudinal incident monitoring study. Anaesthesia 2010;65:490-9.
    1. Merry AF, Webster CS, Weller J, Henderson S, Robinson B. Evaluation in an anaesthetic simulator of a prototype of a new drug administration system designed to reduce error. Anaesthesia 2002;57:256-63.
    1. Block FE Jr. Automatic anesthesia record keeping. J Clin Monit 1989;5:284-6.
    1. Reich DL, Wood RK Jr., Mattar R, Krol M, Adams DC, Hossain S, et al. Arterial blood pressure and heart rate discrepancies between handwritten and computerized anesthesia records. Anesth Analg 2000;91:612-6.
    1. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med 2010;362:1066-9.
    1. Runciman B, Merry A, Walton M. Safety and ethics in healthcare: a guide to getting it right. Ashgate, 2007.
    1. Tenner EW. Why things bite back—technology and the revenge of unintended consequences. Vintage Books, 1997.
    1. Weinger MB. The impact of health care reform on anesthesiologists and their patients in the United States: an ergonomic perspective. Acta Anaesthesiol Sin 1996;34:27-32.
    1. Standard specification for user applied drug labels in anesthesiology (D4774-94). American Society for Testing and Materials, 1995.
    1. User-applied labels for use on syringes containing drugs used during anaesthesia (AS/NZS 4375:1996). Standards New Zealand, 1996.
    1. Standard for user-applied drug labels in anaesthesia and critical care (Z264.3-98). Canadian Standards Association, 1998.
    1. Anaesthetic and respiratory equipment. User-applied labels for syringes containing drugs used during anaesthesia. Colours, design and performance (ISO 26825:2008). International Organization for Standardization, 2008.
    1. Dripps RD, Eckenhoff JE, Vandam LD, Longnecker DE, Murphy FL. Introduction to anesthesia. 9th ed. Saunders, 1997.
    1. Weinger MB, Reddy SB, Slagle JM. Multiple measures of anesthesia workload during teaching and nonteaching cases. Anesth Analg 2004;98:1419-25.
    1. Weinger MB, Herndon OW, Zornow MH, Paulus MP, Gaba DM, Dallen LT. An objective methodology for task analysis and workload assessment in anesthesia providers. Anesthesiology 1994;80:77-92.
    1. Borg G, ed. Simple rating methods of perceived exertion. Permagon Press, 1977.
    1. Australian and New Zealand College of Anaesthetists. Recommendations on the recording of an episode of anesthesia care (the anaesthesia record) (Policy document Review PS 6). Australian and New Zealand College of Anaesthetists, 2001.
    1. Smedley BD, Stith AY, Nelson AR, eds. Unequal treatment—confronting racial and ethnic disparities in health care. National Academy Press, 2003.
    1. Davis P, Lay-Yee R, Dyall L, Briant R, Sporle A, Brunt D, et al. Quality of hospital care for Māori patients in New Zealand: retrospective cross-sectional assessment. Lancet 2006;367:1920-5.
    1. Currie M, Mackay P, Morgan C, Runciman WB, Russell WJ, Sellen A, et al. The “wrong drug” problem in anaesthesia: an analysis of 2000 incident reports. Anaesth Intensive Care 1993;21:596-601.
    1. Zollinger RM Jr, Kreul JF, Schneider AJ. Man-made versus computer-generated anesthesia records. J Surg Res 1977;22:419-24.
    1. Weinger MB, Herndon OW, Gaba DM. The effect of electronic record keeping and transesophageal echocardiography on task distribution, workload, and vigilance during cardiac anesthesia. Anesthesiology 1997;87:144-55.
    1. Storr JA, Engineer C, Allan V. Save lives: clean your hands: a WHO patient safety initiative for 2009. World Hosp Health Serv 2009;45:23-5.
    1. Orser BA, Oxorn DC. An anaesthetic drug error: minimizing the risk. Can J Anaesth 1994;41:120-4.
    1. Parsons HM. What happened at Hawthorne? Science 1974;183:922-32.
    1. De Amici D, Klersy C, Ramajoli F, Brustia L. More about the Hawthorne effect. Anesth Analg 2000;91:1043.
    1. Evley R, Russell J, Mathew D, Hall R, Gemmell L, Mahajan RP. Confirming the drugs administered during anaesthesia: a feasibility study in the pilot National Health Service sites, UK. Br J Anaesth 2010;105:289-96.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅