Development of a RAMA Gallbladder Retrieval Bag for Improved Patient Safety: A Nursing Innovation
Keywords:
Equipment design, Gallbladder, Laparoscopic cholecystectomy, Medical device, Patient safety, RAMA retrieval bagAbstract
One of the major problems in laparoscopic cholecystectomy is the bile and stone spillage into the abdominal cavity, which results in contamination. Thus a retrieval bag is used to prevent this problem. This study aims to describe the further development of an existing retrieval bag for improved patient safety and the evaluation of the effectivenes of the new version of RAMA retrieval bag. The study was conducted in two phases: design and development of the new retrieval bag and evaluation of its efficacy. For the efficacy evaluation, data regarding problems in using the retrieval bag were collected from surgeons on 110 laparoscopic cholecystectomy procedures from January to April 2017, and the surgeons’ opinions regarding use of the retrieval bag. Descriptive statistics were used to analyze the data.
The results showed that after the surgical procedure was completed for all patients, no problems occurred during gallbladder removal and no bags were broken. Bag closure was somewhat difficult in three cases (2.7%). According to the 12 surgeons’ opinions, the overall effectiveness of RAMA retrieval bag was highly rated with both high safety and function. The redesigned retrieval bag is easy to open and prevent the specimen leaving from the bag, resulting in patient safety. The cost of the new version is much less than the cost of other retrieval bags. This bag is convenient and require less time for the nurses in preparation instruments during surgery.
References
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29. Knudson L. Management Connections: Ensuring safe use of medical devices. AORN J. 2013;98(1):C1-C10. DOI: https://doi.org/10.1016/S0001-2092(13)00606-6
30. Kao CC, Cha TL, Sun GH, Yu DS, Chen HI, Chang SY, et al. Cost-effective homemade specimen retrieval bag for use in laparoscopic surgery: Experience at a single center. Asian J Surg. 2012;35(4):140-3. DOI: https://dx.doi.org/ 10.1016/j.asjsur.2012.04.025
31. Richardson DB, Chesney TR, Englesakis M, Govindarajan A, Cleary SP, Swallow CJ. Trends in port-site metastasis after laparoscopic resection of incidental gallbladder cancer: A systematic review. Surgery. 2017;161:618-27. DOI: https://dx.doi.org/10.1016/j.surg.2016.08.007
32. Jin K, Lan H, Zhu T, He K, Teng L. Gallbladder carcinoma incidentally encountered during laparoscopic cholecystectomy: How to deal with it. Clin Transl Oncol. 2011;13(1):25-33. DOI: https://dx.doi.org/10.1007/ s12094-011-0613-1
33. Siddiqui NA, Azami R, Murtaza G, Nasim S. Postoperative port-site pain after gall bladder retrieval from epigastric vs. umbilical port in laparoscopic cholecystectomy: A randomized controlled trial. Int J Surg. 2012;10(4):213- 6. DOI: https://dx.doi.org/10.1016/j.ijsu.2012.03.008
34. Tracey MW. Design and development research: A model validation case. Education Tech Research Dev. 2009; 57:553–71. DOI: https://dx.doi.org/10.1007/s1142 3-007-9075-0
2. Stavroulis A, Memtsa M, Yoong W. Methods for specimen removal from the peritoneal cavity after laparoscopic excision. TOG. 2013;15:26-30. DOI: https://dx.doi. org/10.1111/j.1744-4667.2012.00148.x
3. Singh SP, Singh U, Singh CP, Chaturvedi J, Shekhar C. Laparoscopic cholecystectomy v/s open cholecystectomy: A comparative study at LLRM Medical College & Hospital, Meerut. IJPHRD. 2012;3(1):72-4.
4. Faour R, Sultan D, Houry R, Faour M, Ghazal A. Gallstone-related abdominal cystic mass presenting 6 years after laparoscopic cholecystectomy: A case report. Int J Surg Case Rep. 2017;32:70-2. DOI: https://dx.doi. org/10.1016/j.ijscr.2017.01.059
5. Zehetner J, Shamiyeh A, Wayand W. Lost gallstones in laparoscopic cholecystectomy: All possible complications. Am J Surg. 2007;193:73–8. DOI: https://dx.doi. org/10.1016/j.amjsurg.2006.05.015
6. Endo catch™ gold disposable specimen pouch [Internet]. Covidien company. 2012 [cited April, 2017]. Available from: https://www.covidien.com/imageServer.aspx? contentID=38627&contenttype=application/pdf.
7. Majid MH, Meshkat B, Kohar H, El Masry S. Specimen retrieval during elective laparoscopic cholecystectomy: Is it safe not to use a retrieval bag? BMC Surg. 2016;16(1): 64. DOI: https://dx.doi.org/10.1186/s12893-016-0181-y
8. Shyam DC, Baruah AJ, Topno N. Cheap retrieval bag for laparoscopic cholecystectomy. East Cent Afr J surg. 2012;17(2):110-1. https://www.ajol.info/index.php/ ecajs/article/view/84259/74268
9. Stavrou G, Fotiadis K, Panagiotou D, Faitatzidou A, Kotzampassi K. Homemade specimen retrieval bag for laparoscopic cholecystectomy: A solution in the time of fiscal crisis. Asian J Endosc Surg. 2015;8(2):223-5. DOI: https:// dx.doi.org/10.1111/ases.12165
10. Bergmann JHM, Noble A, Thompson M. Why is designing for developing countries more challenging? modelling the product design domain for medical devices. Procedia Manuf. 2015;3:5693-8. DOI: https://doi.org/10.1016 /j.promfg.2015.07.792
11. Crook C. Advocacy: How far would you go to protect your patients? AORN J. 2016;103(5):522-6. DOI: https:// doi.org/10.1016/j.aorn.2016.03.009
12. Bhumisirikul P, Kongdan Y, Pongchairerks P. Low-priced specimen retrieval sac for laparoscopic cholecystectomy. ELSA. 1999;3(3):47-9.
13. Bhumisirikul P. Ramathibodi bag version 2 : The newly designed gallbladder retrieval sac for laparoscopic cholecystectomy. Rama Nurs J 2005;2(11):77-83.
14. Bunting DM. Port-site hernia following laparoscopic cholecystectomy. JSLS. 2010;14(4):490-7. DOI: http: //dx.doi.org/10.4293/108680810X1292446600 7728
15. Sharma R, Mehta D, Goyal M, Gupta S. The earliest presenting umbilical port site hernia following laparoscopic cholecystectomy: A case report. J Clin Diagn Res. 2016;10(7):PD18-PD9. DOI: https://dx.doi.org/10. 7860/JCDR/2016/20460.8205
16. Mattox E. Patient Safety. Medical devices and patient safety. Crit Care Nurse. 2012;32(4):60-8. DOI: https:// dx.doi.org/10.4037/ccn2012925
17. Blandford A, Furniss D, Vincent C. Patient safety and interactive medical devices: Realigning work as imagined and work as done. Clin Risk. 2014;27(5):107-10. DOI: https://dx.doi.org/10.1177/1356262214556550
18. Castner J, Sullivan SS, Titus AH, Klingman KJ. Strengthening the role of nurses in medical device development. J Prof Nurs. 2016;32(4):300-5. DOI: 10.1016/j.profnurs. 2016.01.002
19. McClelland M, Kleinke D. Improving lives using multidisciplinary education: partnering to benefit community, innovation, health, and technology. J Nurs Educ. 2013; 52(7):406-9. DOI: 10.3928/0148483420130610-01
20. Swayze SC, Rich SE. Promoting Safe Use of Medical Devices. Online J Issues Nurs. 2012;17(1):11-9.
21. Fairbanks RJ, Wears RL. Hazards with medical devices: The role of design. Ann Emerg Med. 2008;52(5):519-21. DOI: https://dx.doi.org/10.1016/j.annemergmed.2008. 07.008
22. Design for patient safety: User testing in the development of medical devices [Internet]. 2010 [cited January 10, 2018]. Available from: file:///C:/Users/NSA/Downloads/1184_ User%20testing%20of%20medical%20devices_access.pdf.
23. Fiedler BA. Evaluating new medical devices purchases. In: Fiedler BA, editor. Managing Medical Devices within a Regulatory Framework. New York: Elsevier; 2016. p. 179-201.
24. Richey RC, Klein JD. Design and development research: Methods, strategies, and issues. 1st ed. Mahwah, New Jersey: Lawrence Erlbaum; 2007.
25. Sullivan GM, Jr ARA. Analyzing and interpreting data from Likert-Type scales. J Grad Med Educ. 2013;5(4): 541-2. DOI: https://dx.doi.org/10.4300/JGME-5-4-18
26. Joshi A, Kale S, Chandel S, Pal DK. Likert scale: Explored and explained. Br J Appl Sci Technol 2015;7(4):396- 403. DOI: https://dx.doi.org/10.9734/BJAST/2015 /14975
27. Martin JL, Norris BJ, Murphy E, Crowe JA. Medical device development: The challenge for ergonomics. Appl Ergon. 2008;39(3):271-83. DOI: https://dx.doi.org/10. 1016/j.apergo.2007.10.002
28. Rich S, El-Shammaa M. Medical device reporting -- a model for patient safety. Am Nurse Today. 2017;12(2): 10-2. https://ejournal.mahidol.ac.th/login?url=https:// search.ebscohost.com/login.aspx?direct=true&db=ccm &AN=121353619&site=ehost-live
29. Knudson L. Management Connections: Ensuring safe use of medical devices. AORN J. 2013;98(1):C1-C10. DOI: https://doi.org/10.1016/S0001-2092(13)00606-6
30. Kao CC, Cha TL, Sun GH, Yu DS, Chen HI, Chang SY, et al. Cost-effective homemade specimen retrieval bag for use in laparoscopic surgery: Experience at a single center. Asian J Surg. 2012;35(4):140-3. DOI: https://dx.doi.org/ 10.1016/j.asjsur.2012.04.025
31. Richardson DB, Chesney TR, Englesakis M, Govindarajan A, Cleary SP, Swallow CJ. Trends in port-site metastasis after laparoscopic resection of incidental gallbladder cancer: A systematic review. Surgery. 2017;161:618-27. DOI: https://dx.doi.org/10.1016/j.surg.2016.08.007
32. Jin K, Lan H, Zhu T, He K, Teng L. Gallbladder carcinoma incidentally encountered during laparoscopic cholecystectomy: How to deal with it. Clin Transl Oncol. 2011;13(1):25-33. DOI: https://dx.doi.org/10.1007/ s12094-011-0613-1
33. Siddiqui NA, Azami R, Murtaza G, Nasim S. Postoperative port-site pain after gall bladder retrieval from epigastric vs. umbilical port in laparoscopic cholecystectomy: A randomized controlled trial. Int J Surg. 2012;10(4):213- 6. DOI: https://dx.doi.org/10.1016/j.ijsu.2012.03.008
34. Tracey MW. Design and development research: A model validation case. Education Tech Research Dev. 2009; 57:553–71. DOI: https://dx.doi.org/10.1007/s1142 3-007-9075-0
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2018-06-07
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Bhumisirikul P, Chiannilkulchai N. Development of a RAMA Gallbladder Retrieval Bag for Improved Patient Safety: A Nursing Innovation. PRIJNR [Internet]. 2018 Jun. 7 [cited 2024 Nov. 14];22(3):264-77. Available from: https://he02.tci-thaijo.org/index.php/PRIJNR/article/view/103190
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