Anesth Pain Med.  2016 Jan;11(1):36-41. 10.17085/apm.2016.11.1.36.

A comparative clinical study on the accuracy and efficacy of Accumate(R) 1100, an infusion pump for patient-controlled analgesia

Affiliations
  • 1Department of Anesthesiology and Pain Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea.
  • 2Departments of Anesthesiology and Pain Medicine, Clinical Pharmacology, Seoul Asan Hospital, Seoul, Korea. nohgj@amc.seoul.kr

Abstract

BACKGROUND
The accuracy and efficacy of patient-controlled analgesia (PCA) devices are crucial because malfunction of the devices may lead to fatal outcomes. The aim of this study is to evaluate the accuracy and efficacy of Accumate(R) 1100, an electronic PCA pump, in comparison with GemStar(R) infusion system.
METHODS
Fifty patients scheduled for gastrectomy or colon resection were assigned to the Accumate or GemStar group (n = 25 in each group). Intraoperatively, backflow, siphonage, autoclamp function, and lockout time were tested. Postoperatively, PCA using either Accumate(R) 1100 or GemStar(R) infusion system according to the assigned group was maintained for 48 hours. For PCA, fentanyl 1,500 ug and ketorolac 180 mg in 100 ml were used (demand bolus 1 ml, background infusion 1 ml/h, lockout time 15 minutes). The accuracy of the total infused dose and the level of satisfaction of the patients and users were assessed. The results were compared between the two groups.
RESULTS
Although backflow and auto-clamp backflow were less with GemStar(R) infusion system, their extent was negligible in both groups. Siphonage was not different between both pumps. Autoclamp and lockout time worked without abnormalities. The relative error of total infused volume over 48 hours was -0.26 +/- 1.20% and -0.34 +/- 0.48% in the Accumate group and GemStar group, respectively. The Accumate group showed a higher level of satisfaction in terms of the ease of priming (P < 0.05).
CONCLUSIONS
The accuracy and clinical efficacy of Accumate(R) 1100 were comparable to those of GemStar(R) infusion system.

Keyword

Equipment safety; Infusion pumps; Patient-controlled analgesia

MeSH Terms

Analgesia, Patient-Controlled*
Colon
Equipment Safety
Fatal Outcome
Fentanyl
Gastrectomy
Humans
Infusion Pumps*
Ketorolac
Passive Cutaneous Anaphylaxis
Fentanyl
Ketorolac

Reference

1. Grass JA. Patient-controlled analgesia. Anesth Analg. 2005; 101(5 Suppl):S44–61. DOI: 10.1213/01.ANE.0000177102.11682.20. PMID: 16334492.
Article
2. Kang DH, Kim DS, Kim JD, Kim JW. A comparison of fentanyl and morphine for patient controlled analgesia after laparoscopic cholecystectomy. Anesth Pain Med. 2013; 8:21–5.
3. Lee GW. A prospective observational cohort study on postoperative intravenous patient-controlled analgesia in surgeries. Anesth Pain Med. 2015; 10:21–6. DOI: 10.17085/apm.2015.10.1.21.
Article
4. McNicol ED, Ferguson MC, Hudcova J. Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. Cochrane Database Syst Rev. 2015; 6:CD003348. DOI: 10.1002/14651858.cd003348.pub3.
Article
5. White PF. PCA: Past, present and future. Intravenous Anesthesia. 1997; 1:340–4.
6. Grey TC, Sweeney ES. Patient-controlled analgesia. JAMA. 1988; 259:2240. DOI: 10.1001/jama.1988.03720150022027.
Article
7. Thomas DW, Owen H. Patient-controlled analgesia--the need for caution. A case report and review of adverse incidents. Anaesthesia. 1988; 43:770–2. DOI: 10.1111/j.1365-2044.1988.tb05753.x. PMID: 3052160.
8. Christie L, Cranfield KA. A dangerous fault with a PCA pump. Anaesthesia. 1998; 53:827. DOI: 10.1046/j.1365-2044.1998.0584h.x. PMID: 9797536.
Article
9. Schein JR, Hicks RW, Nelson WW, Sikirica V, Doyle DJ. Patient-controlled analgesia-related medication errors in the postoperative period: causes and prevention. Drug Saf. 2009; 32:549–59. DOI: 10.2165/00002018-200932070-00002. PMID: 19530742.
10. Notcutt WG, Knowles P, Kaldas R. Overdose of opioid from patient-controlled analgesia pumps. Br J Anaesth. 1992; 69:95–7. DOI: 10.1093/bja/69.1.95. PMID: 1637612.
Article
11. Doyle DJ, Vicente KJ. Electrical short circuit as a possible cause of death in patients on PCA machines: report on an opiate overdose and a possible preventive remedy. Anesthesiology. 2001; 94:940. DOI: 10.1097/00000542-200105000-00050.
12. Jeong YB, Lee MS, Choi BM, Chin JH, Noh GJ. A clinical study to evaluate the safety and efficacy of a patient-controlled analgesia pump in post-surgical patients. Korean J Anesthesiol. 2007; 52:161–5. DOI: 10.4097/kjae.2007.52.2.161.
Article
13. Sinha A, Paech M, Ledger R, McDonnell N, Nathan E. A clinical evaluation of the GemStar® and the AmbIT® pumps for patient-controlled epidural analgesia. Anesth Pain Med. 2012; 2:66–71. DOI: 10.5812/aapm.7513. PMID: 24223340. PMCID: PMC3821112.
14. Skryabina EA, Dunn TS. Disposable infusion pumps. Am J Health Syst Pharm. 2006; 63:1260–8. DOI: 10.2146/ajhp050408. PMID: 16790578.
Article
15. Hankin CS, Schein J, Clark JA, Panchal S. Adverse events involving intravenous patient-controlled analgesia. Am J Health Syst Pharm. 2007; 64:1492–9. DOI: 10.2146/ajhp060220. PMID: 17617499.
Article
16. Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. J Diabetes Sci Technol. 2010; 4:98–103. DOI: 10.1177/193229681000400112. PMID: 20167172. PMCID: PMC2825629.
Article
17. Kern H, Kuring A, Redlich U, Dopfmer UR, Sims NM, Spies CD, et al. Downward movement of syringe pumps reduces syringe output. Br J Anaesth. 2001; 86:828–31. DOI: 10.1093/bja/86.6.828. PMID: 11573591.
Article
18. Yoon JS, Kim HJ, Kim JY, Park SG. Accuracy and continuity of infusion devices with volumetric analyzer. Korean J Anesthesiol. 1995; 28:611–7.
Article
19. U.S. Food and Drug Administration Medical Devices, 2013 Medical Device Recalls [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; Hospira Inc., GemStar Infusion System - Damage from Battery Leakage;issued 2013 May 01; updated 2015 Jul 8; cited 2015 Sep 02. Available from: www.fda.gov/medicaldevices/safety/listofrecalls/ucm350397.htm.
20. U.S. Food and Drug Administration Medical Devices, 2013 Medical Device Recalls [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift;issued 2013 Nov 25; updated 2015 Jul 09; cited 2015 Sep 02. Available from: http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm376641.htm.
21. U.S. Food and Drug Administration Medical Devices, 2013 Medical Device Recalls [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; Hospira Inc., GemStar Infusion System, Lithium Battery - Low Voltage;issued 2013 Apr 29; updated 2015 Jul 08; cited 2015 Sep 02. Available from: www.fda.gov/medicaldevices/safety/listofrecalls/ucm349866.htm.
Full Text Links
  • APM
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr