Hostname: page-component-cd9895bd7-hc48f Total loading time: 0 Render date: 2024-12-23T00:05:10.540Z Has data issue: false hasContentIssue false

A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles

Published online by Cambridge University Press:  12 February 2016

C. Haupt
Affiliation:
Occupational Medical Service, University Medical Center Freiburg, Freiburg, Germany
J. Spaeth
Affiliation:
Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Freiburg, Freiburg, Germany
T. Ahne
Affiliation:
Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Freiburg, Freiburg, Germany
U. Goebel
Affiliation:
Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Freiburg, Freiburg, Germany
D. Steinmann*
Affiliation:
Occupational Medical Service, University Medical Center Freiburg, Freiburg, Germany
*
Address correspondence to Daniel Steinmann, MD, Occupational Medical Service, University Medical Center Freiburg, Berliner Allee 6, D-79110 Freiburg, Germany ([email protected]).

Abstract

OBJECTIVE

To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles.

DESIGN

Randomized model-based simulation study.

SETTING

University medical center.

PARTICIPANTS

A total of 33 third-year medical students.

METHODS

Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism.

RESULTS

The overall successful activation rate during the second trial was equal for all 4 devices (94%–100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism.

CONCLUSION

Significant differences exist between safety mechanisms of winged blood collection needles.

Infect Control Hosp Epidemiol 2016;37:505–511

Type
Original Articles
Copyright
© 2016 by The Society for Healthcare Epidemiology of America. All rights reserved 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Rice, BD, Tomkins, SE, Ncube, FM. Sharp truth: health care workers remain at risk of bloodborne infection. Occup Med 2015;65:210214.CrossRefGoogle ScholarPubMed
2. Mendelson, MH, Lin-Chen, BY, Solomon, R, Bailey, E, Kogan, G, Goldbold, J. Evaluation of a safety resheathable winged steel needle for prevention of percutaneous injuries associated with intravascular-access procedures among healthcare workers. Infect Control Hosp Epidemiol 2003;24:105112.CrossRefGoogle ScholarPubMed
3. Tuma, S, Sepkowitz, KA. Efficacy of safety-engineered device implementation in the prevention of percutaneous injuries: a review of published studies. Clin Infect Dis 2006;42:11591170.CrossRefGoogle ScholarPubMed
4. Hoffmann, C, Buchholz, L, Schnitzler, P. Reduction of needlestick injuries in healthcare personnel at a university hospital using safety devices. J Occup Med Toxicol 2013;8:20.Google Scholar
5. Yang, L, Mullan, B. Reducing needle stick injuries in healthcare occupations: an integrative review of the literature. ISRN Nurs 2011;2011:315432.Google ScholarPubMed
6. Tosini, W, Ciotti, C, Goyer, F, et al. Needlestick injury rates according to different types of safety-engineered devices: results of a French multicenter study. Infect Control Hosp Epidemiol 2010;31:402407.Google Scholar
7. Laramie, AK, Pun, VC, Fang, SC, Kriebel, D, Davis, L. Sharps injuries among employees of acute care hospitals in Massachusetts, 2002-2007. Infect Control Hosp Epidemiol 2011;32:538544.Google Scholar
8. Black, L, Parker, G, Jagger, J. Chinks in the armor: activation patterns of hollow-bore safety-engineered sharp devices. Infect Control Hosp Epidemiol 2012;33:842844.Google Scholar
9. Black, L. Chinks in the armor: percutaneous injuries from hollow bore safety-engineered sharps devices. Am J Infect Control 2013;41:427432.Google Scholar
10. Tarigan, LH, Cifuentes, M, Quinn, M, Kriebel, D. Prevention of needle-stick injuries in healthcare facilities: a meta-analysis. Infect Control Hosp Epidemiol 2015;36:823829.Google Scholar
11. Lu, Y, Senthilselvan, A, Joffe, AM, Beach, J. Effectiveness of safety-engineered devices in reducing sharp object injuries. Occup Med 2015;65:3944.Google Scholar
12. Needlestick Safety and Prevention Act of 2000. Public Law No. 106-430, 114 Stat. 1901, November 6, 2000. National Institutes of Health website. https://history.nih.gov/research/downloads/PL106-430.pdf. Accessed January 19, 2016.Google Scholar
13. Jagger, J, Perry, J, Gomaa, A, Phillips, EK. The impact of U.S. policies to protect healthcare workers from bloodborne pathogens: the critical role of safety-engineered devices. J Infect Public Health 2008;1:6271.Google Scholar
14. Council directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU. https://osha.europa.eu/en/legislation/directives/council-directive-2010-32-eu-prevention-from-sharp-injuries-in-the-hospital-and-healthcare-sector. Accessed January 19, 2016.Google Scholar
15. Asai, T, Hidaka, I, Kawashima, A, Miki, T, Inada, K, Kawachi, S. Efficacy of catheter needles with safeguard mechanisms. Anaesthesia 2002;57:572577.Google Scholar
16. Adams, D, Elliott, TS. A comparative user evaluation of three needle-protective devices. Br J Nurs 2003;12:470474.Google Scholar
17. Menezes, JA, Bandeira, CS, Quintana, M, de Lima, E, Silva, JC, Calvet, GA, Brasil, P. Impact of a single safety-engineered device on the occurrence of percutaneous injuries in a general hospital in Brazil. Am J Infect Control 2014;42:174177.Google Scholar
18. Lamontagne, F, Abiteboul, D, Lolom, I, et al. Role of safety-engineered devices in preventing needlestick injuries in 32 French hospitals. Infect Control Hosp Epidemiol 2007;28:1823.Google Scholar
19. Hotaling, M. A retractable winged steel (butterfly) needle performance improvement project. Jt Comm J Qual Patient Saf 2009;35:100105.Google Scholar
20. Lavoie, MC, Verbeek, JH, Pahwa, M. Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel. Cochrane Database Syst Rev 2014;3:CD009740.Google Scholar
21. Centers for Disease Control and Prevention (CDC). Workbook for designing, implementing, and evaluating a sharps injury preventing program. CDC website. http://www.cdc.gov/sharpssafety/pdf/sharpsworkbook_2008.pdf. Published 2008. Accessed February 12, 2015.Google Scholar
22. Guidance for industry and FDA staff: medical devices with sharps injury prevention features. US Food and Drug Administration website. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071755.pdf. Published 2005. Accessed February 12, 2015.Google Scholar
23. Ford, JL, Phillips, P. How to evaluate sharp safety-engineered devices. Nurs Times 2008;104:4245.Google Scholar
24. Pugliese, G, Germanson, TP, Bartley, J, et al. Evaluating sharps safety devices: meeting OSHA’s intent. Occupational Safety and Health Administration. Infect Control Hosp Epidemiol 2001;22:456458.Google Scholar
25. Wittmann, A, Köver, J, Kralj, N, Gasthaus, K, Tosch, M, Hofmann, F. Mucocutaneous blood contact: blood release behavior of safety peripheral intravenous catheters. Am J Infect Control 2013;41:12141217.Google Scholar
26. Tso, D, Langer, M, Blair, GK, Butterworth, S. Sharps-handling practices among junior surgical residents: a video analysis. Can J Surg 2012;55:S178S183.Google Scholar
27. Jagger, J, Perry, J. Safety-engineered devices in 2012: the critical role of healthcare workers in device selection. Infect Control Hosp Epidemiol 2013;34:615618.Google Scholar
28. Adams, D, Elliott, TS. Safety-engineered needle devices: evaluation prior to introduction is essential. J Hosp Infect 2011;79:174175.CrossRefGoogle ScholarPubMed
29. Onia, R, Wu, Y, Parvu, V, Eshun-Wilson, I, Kassler-Taub, K. Simulated evaluation of a non-Luer safety connector system for use in neuraxial procedures. Br J Anaesth 2012;108:134139.Google Scholar