Simulator evaluation of a prototype device to reduce medication errors in anaesthesia

Transcription

1 Original Article doi: /anae Simulator evaluation of a prototype device to reduce medication errors in anaesthesia S. A. Khan, 1 S. Khan 2 and H. Kothandan 1 1 Consultant, Department of Anaesthesiology, Singapore General Hospital, Singapore 2 Senior Staff Registrar, Department of Ophthalmology, KK Women s and Children s Hospital, Singapore Summary We undertook a randomised control led trial to evaluate the effect of a prototype device which attaches to the intravenous drug administration port, and allows injection of intravenous drugs only after the user scans the barcode on the syringe label. This requires two steps: first, that the correct drug label is generated; and second, that the syringewith-label is scanned before administration. Ten anaesthetists, who were unaware of the primary outcome being measured, administered general anaesthesia for two simulated standardised cases each without and with our prototype (control and intervention, respectively). The primary outcome measured was compliance with a safe drug administration procedure (defined as a two-step procedure where, step one is scanning a drug ampoule to print a label for a syringe and step two is scanning of the labelled syringe before administering it intravenously). A total of 182 intravenous drug administrations occurred in the study (91 in each group). We found that the use of our prototype increased safe drug administration behaviour in experienced anaesthetists; 33 (36.3% [95% CI 26 47%]) vs. 91 (100% [95% CI %]) in the control and intervention groups, respectively (p = ).... Correspondence to: S. A. Khan shariq.ali.khan@sgh.com.sg Accepted: 14 June 2016 Keywords: human factors; medical device; medication error Introduction Studies suggest that medication errors occur in 1 out of every 133 anaesthetics and more than half of all anaesthetists do not always read syringe labels before drug administration [1 3]. With > 3 million inpatient surgeries performed each year in the UK alone [4], and > 200 million annually worldwide [5], it is quite apparent that medication errors from anaesthesia pose a considerable risk to patient safety. Indeed, medication errors, including those from anaesthesia, are among the top 10 causes of mortality worldwide [2, 6]. Incorrect dosing and substitution errors, defined as, drawing a drug from the wrong ampoule (ampoule swap) and/or administration of wrong drug-filled syringe (syringe swap), are responsible for up to 60% of medication errors in anaesthesia [1]. While existing anaesthesia medication safety devices (like Safe Label System SLS 500i TM (Codonics, Middleberg Heights, OH, USA) and SAFERsleep â (Safer Sleep, Auckland, New Zealand) system) address the problem of ampoule swaps, syringe swap remains a problem because these systems have been found to be unsuccessful in prompting the user to scan the drug-filled syringe before intravenous (IV) administration [7, 8]. We hypothesised that by creating a physical barrier, user behaviour can be appropriately modified The Association of Anaesthetists of Great Britain and Ireland

2 Khan et al. Simulator evaluation of prototype device to reduce drug error Anaesthesia 2016, 71, To test our hypothesis, we developed a device which attaches to the drug administration port of the patient s IV tubing, and allows injection of the drug only after the user scans the barcode on the syringe label. We tested the effect of the device on drug administration behaviour of anaesthesia specialists in a high-fidelity simulation environment. The primary outcome measured was compliance with the safe drug administration procedure. Methods Recognising the need to develop a system with effective barriers to reduce medication errors, we developed a prototype device (Figs. 1 and 2) which consists of an outer housing encasing a battery-operated, wirelesslyenabled, microcontroller operating a flow control valve on the disposable inner IV tubing. The device essentially acts like a lock and allows injection of an IV drug only after the user scans the syringe label (producing an audio visual cue consisting of drug name and concentration). Thus, when our prototype device is used in conjunction with the SLS 500i label printer, there exists two effective physical defensive barriers: first, requirement to scan an ampoule to generate a syringe label; and second, requirement to scan syringe label to allow drug injection to reduce ampoule and syringe swaps. The study was granted exemption by the Institutional Review board. After obtaining written informed consent, 10 anaesthetists from Singapore General Hospital who had > 5 years experience and who were unaware of the primary outcome being measured, were asked to participate in the study. The participants were instructed to administer a general anaesthetic (GA) for two standardised simulated cases each in the highfidelity simulation operating theatre control case and intervention case, in random order, determined by coin toss). The simulated cases were of identical scenarios except that the control case used only the SLS 500i label printer, while the intervention case had the SLS 500i label printer and our prototype device. All efforts were made to ensure uniformity and high fidelity of the simulated GA scenarios using a standardised script and actors. The primary outcome was compliance with safe drug administration procedure. This was defined as a two-step procedure where, step one is scanning a drug-ampoule to print a label for a syringe and step two is scanning of the labelled syringe before administering it intravenously. The SLS 500i, apart from (i) (ii) (iii) (iv) Figure 1 Prototype device: (i) prototype device with tablet personal computer and barcode scanner; (ii) prototype device consists of outer casing and inner disposable intravenous tubing; (iii) photograph showing site of syringe attachment; (iv) photograph of barcoded syringe label being scanned The Association of Anaesthetists of Great Britain and Ireland 1187

3 Khan et al. Simulator evaluation of prototype device to reduce drug error Step A Step B Step D Step C Figure 2 Prototype device working in conjunction with the SLS 500i label printer. Step A: scanning of drug ampoule and printing syringe label using the Codonics SLS label printer; step B: application of printed syringe labels on syringes; step C: scanning the syringe with label using our prototype device scanner followed by production of audio visual cue consisting of drug name and concentration step D: on successful completion of step C, the prototype device unlocks and allows injection of syringe into the drug administration port. printing syringe labels after scanning a drug ampoule, also has a read-back function, which means that if a syringe label is scanned by the user it read backs the contents of the label. Thus, in our study, participants in both the control and intervention groups had equal opportunity to fulfil the safe drug administration procedure (primary outcome). The study participants were asked to assign a grade between 1 and 5 (1 = strongly disagree and 5 = strongly agree) on the perceived effect of requirement to scan syringe label prior to drug administration on workload reduction and medication error prevention. Additionally, we measured syringe labelling compliance with ASA labelling standards [9]. Previous studies [7, 8] suggest a maximal 60% incidence of the primary outcome in the control group. To detect a difference of 20% in the primary outcome with a power of 80% and an alpha error of 0.05, 81 intravenous drug administrations would be required in each study group. Simulation cases were constructed such than each case had about nine intravenous drug administrations, therefore a sample size The Association of Anaesthetists of Great Britain and Ireland

4 Khan et al. Simulator evaluation of prototype device to reduce drug error Anaesthesia 2016, 71, of 20 simulated cases (10 in each group) was calculated. All data were analysed using SPSS version 20.0 (IBM, Armonk, NY, USA). Fisher s exact test was used for inter-group comparison and statistical significance was defined as p < Results Ten anaesthetists with a median of 18.5 ( [6 20]) y of experience agreed to participate in the study. Eighty percent of the participants were consultants, while the remaining 20% were senior registrars. Participants administered anaesthesia for 20 cases (10 each in the control and intervention groups). The study was conducted over two days each participant performing simulated GA cases in the control and intervention groups on the same day. A total of 182 intravenous drug administrations occurred in the study (91 each in the control and intervention groups). A total of 160 syringe labels were produced in the study (80 labels in each group), all the syringe labels were found to be compliant to ASA labelling standards (Table 1). However, compliance with step two, the scanning of the drug before administration occurred in just 33 (36.3% [95% CI 26 47%]) instances in the control group, compared with all 91 (100% [95% CI %]) of intervention cases (p = ; Table 1). There was no influence of the order in which control and intervention cases were conducted. Four participants performed the control cases after intervention (prototype) cases and only 11 out of 37 drug administrations (29.7%) were compliant with safe drug administration. Participant feedback obtained at the end of the study revealed that requirement to scan syringe label prior to drug administration was perceived to increase medication safety (median grade 4 (3 4 [2 5]), but not lead to workload reduction (median grade 2 (1 2 [1 5]). Discussion We found that the use of our prototype device significantly increased safer intravenous drug administration behaviour in the intervention group. We also found that all drug-filled syringes were labelled in compliance to ASA recommendations in the study. Several innovative devices like the SLS 500i label printer and the SAFERsleep system have been developed in response to expert opinion from safety bodies like the Anaesthesia Patient Safety Foundation (APSF) and the ASA to develop technology solutions to reduce medication errors [8, 11 14]. While the SLS 500i label printer requires the anaesthesia provider to scan a drug ampoule to print a syringe label, in the SAFERsleep system, the anaesthesia provider is presented with pre-labelled pre-filled syringes. In both these systems, the anaesthetist is required to voluntarily scan the barcode on the syringe label to receive an audio visual cue of the drug to bes delivered. Studies evaluating both the SLS 500i label printer and the SAFERsleep system have found that, in a clinical environment, only 25 62% of anaesthetists follow the rule of scanning the barcoded syringe label before drug administration [7, 8], therefore syringe swap continues to be a problem with both these systems, as studies have demonstrated that syringe swap is responsible for up to 44% of medication errors [15]. However, participants relatively strongly disagreed that the requirement to scan the syringe label before drug administration led to workload reduction. Table 1 Comparison of drug administrations compliant with safe drug administration procedure between study groups. Values are number (proportion) [95% CI]. Control group n = 91 Intervention group n = 91 p value Compliance with step 1 of the safe drug administration procedure 91 (100%) [96 100%] 91 (100%) [96 100%] 1.00 Compliance with step 2 of the safe drug administration procedure 33 (36.3%) [26 47%] 91 (100%) [96 100%] Overall compliance with safe drug administration procedure 33 (36.3%) [26 47%] 91 (100%) [96 100%] Syringe labels compliant with ASA labelling standards 80 (100%) [95 100%] 80 (100%) [95 100%] 1.00 Safe drug administration procedure is defined as two-step procedure where, step 1 is scanning drug ampoule to print a label for the syringe and step 2 is scanning of labelled-syringe before administering it intravenously The Association of Anaesthetists of Great Britain and Ireland 1189

5 Khan et al. Simulator evaluation of prototype device to reduce drug error Increased workload might itself be a safety concern (e.g. adding to exhaustion, and itself possibly a cause of policy violations), so the impact of this should be carefully assessed in future clinical studies. Our study has some limitations. First, although the study is a randomised controlled trial which was conducted in a high-fidelity simulation environment using experienced participant anaesthetists, it was not a clinical trial. Second, the device evaluated was a prototype and not the end product, primarily because this was a proof of-concept study. Therefore, the performance of the system may vary considerably in real-world conditions. Third, the participants were not blinded because it was practically impossible to do so, but instead we concealed the primary study goal to minimise bias. Importantly, we tested only failure to comply with safe drug administration practice and did not measure actual error or reduction thereof. Lastly, although we adequately powered our study for the comparison of two groups, the 95% CIs showed a potential failure-tocomply rate of ~4% for our device (almost one in 20), for the sample size we selected. However, larger sample sizes may demonstrate much tighter confidence intervals. On balance, the approach demonstrated by the prototype in promoting safe drug administration behaviour is worthy of further investigation in a clinical setting, with particular focus on perception of increased workload. Acknowledgements The authors thank the participant anaesthetists and Codonics for the use of the SLS 500i label printer. We would also like to thank the Singhealth Medical technology Office for their assistance with the project. Competing interests This study was entirely funded by the Singapore General Hospital SRG grant (ID: SRG15Jan53). All patents and rights for the prototype device are owned by our parent institution (Singhealth). No other funding or competing interests declared. References 1. Merry AF, Peck DJ. Anaesthetists, errors in drug administration and the law. New Zealand Medical Journal 1995; 108: Stelfox HT, Palmisani S, Scurlock C, Orav EJ, Bates DW. The To Err is Human report and the patient safety literature. Quality and Safety in Health Care 2006; 15: Orser BA, Chen RJ, Yee DA. Medication errors in anesthetic practice: a survey of 687 practitioners. Canadian Journal of Anesthesia 2001; 48: Sury MRJ, Palmer JHMG, Cook TM, Pandit JJ. The state of UK anaesthesia: a survey of National Health Service activity in British Journal of Anaesthesia 2014; 113: Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet 2008; 372: Glavin RJ. Drug errors: consequences, mechanisms, and avoidance. British Journal of Anaesthesia 2010; 105: Jelacic S, Bowdle A, Nair BG, Kusulos D, Bower L, Togashi K. A system for anesthesia drug administration using barcode technology: the codonics safe label system and smart anesthesia manager. Anesthesia and Analgesia 2015; 121: Merry AF, Webster CS, Hannam J, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. British Medical Journal 2011; 343: d American Society of Anesthesiologists. Statement on the labeling of Pharmaceuticals for use in Anesthesiology, resources/standards-guidelines/statement-on-labeling-ofpharmaceuticals-for-use-in-anesthesiology.pdf (accessed 05/ 04/2016). 10. Pandit JJ. If it hasn t failed, does it work? On the worst we can expect from observational trial results, with reference to airway management devices. Anaesthesia 2012; 67: Eichhorn JH. APSF hosts medication safety conference. Consensus group defines challenges and opportunities for improved practice. APSF Newsletter 2010; 25: Garnerin P, Perneger T, Chopard P, et al. Drug selection errors in relation to medication labels: a simulation study. Anaesthesia 2007; 62: Ang SB, Hing WC, Tung SY, Park T. Experience with the use of the Codonics Safe Label System to improve labelling compliance of anaesthesia drugs. Anaesthesia and Intensive Care 2014; 42: Webster CS, Larsson L, Frampton CM, et al. Clinical assessment of a new anaesthetic drug administration system: a prospective, controlled, longitudinal incident monitoring study. Anaesthesia 2010; 65: Fasting S, Gisvold SE. Adverse drug errors in anesthesia, and the impact of coloured syringe labels. Canadian Journal of Anesthesia 2000; 47: The Association of Anaesthetists of Great Britain and Ireland