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Sterility and Microbiological Assessment of Reused Single-Use Cardiac Electrophysiology Catheters

Published online by Cambridge University Press:  21 June 2016

Francesco Tessarolo ,
Iole Caola ,
Patrizio Caciagli ,
Giovanni M. Guarrera  and
Giandomenico Nollo
Francesco Tessarolo*
Affiliation:
Departments of Materials Engineering and Industrial Technologies, University of Trento, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Iole Caola
Affiliation:
Departments of Microbiology and Virology, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Patrizio Caciagli
Affiliation:
Departments of Microbiology and Virology, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Giovanni M. Guarrera
Affiliation:
Heathcare and Rehabilitation, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Giandomenico Nollo
Affiliation:
Physics, University of Trento, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
*
Department of Materials Engineering and Industrial Technologies, University of Trento, Via Mesiano 77, 1-38050 Trento, Italy (tessaro@science.unitn.it)
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Abstract

Objective.

To assess the performance and limitations of a reprocessing protocol for nonlumen electrophysiology catheters by testing the sterility of reprocessed devices and defining the maximum number of reprocessing cycles sustainable by the device in hygienically safe conditions.

Design.

Simulated use, reprocessing, and testing of the catheters.

Setting.

Microbiology and virology department of a public health diagnostic laboratory.

Interventions.

Seventy-three catheters were collected after clinical use on patients. The first group of devices was tested for sterility after 1 cycle of reprocessing. By the repetition of simulated use (blood inoculated with bacteria) and reprocessing (decontamination, cleaning, and hydrogen peroxide gas plasma sterilization), we obtained 39 sample devices reprocessed 2 times, 26 reprocessed 3 times, 28 reprocessed 4 times, 36 reprocessed 5 times, and 22 reprocessed 6 times. Devices were cultured for 28 days in trypticase soy broth.

Results.

We tested 208 catheters with 6 cycles of reprocessing and 4 inoculated bacteria species. No devices tested positive for the inoculated strains until the fourth cycle of reprocessing. One of 35 catheters showed the growth of the inoculated strain Bacillus subtilis after 5 cycles of reprocessing, and 1 of 22 catheters showed growth of this organism 6 cycles. After the second reprocessing, 7 of 36 devices showed growth of gram-negative bacteria other than the strain inoculated.

Conclusions.

Reprocessing according to the reprocessing protocol was insufficient to guarantee device sterility after 5 reuses. Cleaning with enzymatic solution revealed good cleaning properties with efficient bioburden reduction. Storage intervals of longer than 24 hours during reprocessing should be avoided to limit contamination or bacterial overgrowth. Technical considerations suggest the introduction of reprocessing procedures only in hospitals with considerable workloads.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 27 , Issue 12 , December 2006 , pp. 1385 - 1392
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2006

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References

1. Mickelsen, S, Mickelsen, C, MacIndoe, C, et al. Trends and patterns in electrophysiologic and ablation catheter reuse in the United States. Am J Cardiol 2001; 87:351–353.CrossRefGoogle ScholarPubMed
2. Food and Drug Administration. Reuse of Medical Disposable Devices: Compliance Policy Guide No. 7124-16. Washington, DC: Food and Drug Administration; 1987.Google Scholar
3. European Commission Directive 93/42/EEC- Medical Devices (MDD). Brussels: Council of the European Communities, June 14, 2003.Google Scholar
4. Aton, EA, Murray, P, Fraser, V, Coaway, L, Cain, ME. Safety of reusing cardiac electrophysiology catheters. Am J Cardiol 1994; 74:1173–1175.Google Scholar
5. Ferrell, M, Wolf, CE, Ellenbogen, KA, Wood, MA, Clemo, HF, Gilligan, DM. Ethylene oxide on electrophysiology catheters following resterilization: implications for catheter reuse. Am J Cardiol 1997; 80:1558–1561.Google Scholar
6. O'Donoghue, S, Platia, EV. Reuse of pacing catheters: a survey of safety and efficacy. PACE 1988; 11:1279–1280.Google Scholar
7. Dunnigan, A, Roberts, C, McNamara, M, Benson, DW, Benditt, DG. Success of re-use of cardiac electrode catheters. Am J Cardiol 1987; 60:807–810.CrossRefGoogle ScholarPubMed
8. Avitall, B, Khan, M, Krum, D, Jazayeri, M, Hare, J. Repeated use of ablation catheters: a prospective study. J Am Coll Cardiol 1993;22:1367–1372.CrossRefGoogle ScholarPubMed
9. Bathina, MN, Mickelsen, S, Brooks, C, Jaramillo, J, Hepton, T, Kusumoto, FM. Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters. J Am Coll Cardiol 1998; 32:1384–1388.Google Scholar
10. Penna, TCV, Ferraz, AAM. Cleaning of blood-contaminated reprocessed angiographic catheters and spinal needles. Infect Control Hosp Epidemiol 2000;21:499–504.Google Scholar
11. Penna, TCV, Ferraz, AAM, Cassola, MA. The presterilization load on used medical devices and the effectiveness of hydrogen peroxide gas plasma against Bacillus subtilis spores. Infect Control Hosp Epidemiol 1999; 20:465–472.Google Scholar
12. National Health and Medical Research Council. Report of the NHMRC Expert Panel on Re-use of Medical Devices Labeled as Single Use. Canberra, Australia: Commonwealth of Australia; 1997.Google Scholar
13. Grabsch, EA, Grayson, ML, Johnson, PDR, Yates, LA, Harper, RW, Smolich, JJ. Bactericidal efficacy of sterilizing protocol for reused cardiac electrophysiology catheters. Am J Cardiol 2002; 89:770–772.CrossRefGoogle ScholarPubMed
14. Druce, JD, Russell, JS, Birch, CJ, Yates, LA, Harper, RW, Smolich, JJ. A decontamination and sterilization protocol employed during reuse of cardiac electrophysiology catheters inactivates human immunodeficiency virus. Infect Control Hosp Epidemiol 2003; 24:184–190.CrossRefGoogle ScholarPubMed
15. Conseil d'évaluation des technologies du Québec. The reuse of single-use cardiac catheters: safety economical ethical and legal issues. Can J Cardiol 1994; 10:413–421.Google Scholar
16. Bryce, EA, Mack, JH, Cantafio, C, Neumann, S. Evaluation of the Cathetron system for recycling angioplasty catheters. Cathet Cardiovasc Diagn 1997; 41:132–135.Google Scholar
17. Robert Kock Institute recommendations: hygienic requirements for processing of medical devices. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2001; 44:1115–1126.Google Scholar
18. Krebs, MC, Becasse, P, Verjat, D, Darbord, JD. Gas-plasma sterilization: relative efficacy of the hydrogen peroxide phase compared with that of the plasma phase. Int J Pharm 1998; 160:75–81.Google Scholar
19. Decreto legislativo 28/09/1990: norme di protezione dal contagio professionale da HIV nelle strutture sanitarie ed assistenziali pubbliche e private. Gazzetta Uffciale Repubblica Italiana 1990; 235:78–80.Google Scholar
20. Queensland Government. Infection Control Guidelines, Queensland Health. November 2001. Available at: http://www.health.qld.gov.au/. Accessed February 1, 2005.Google Scholar
21. Moisan, M, Barbeau, J, Moreau, S, Pelletier, J, Tabrizian, M, Yahia, LH. Low-temperature sterilization using gas plasmas: a review of the experiments and an analysis of the inactivation mechanisms. Int J Pharm 2001; 226:1–21.CrossRefGoogle Scholar
22. Lerouge, S, Guignot, C, Tabrizian, M, Ferrier, D, Yagoubi, N, Yahia, L. Plasma-based sterilization: effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters. J Biomed Mater Res 2000; 52:774–782.3.0.CO;2-O>CrossRefGoogle ScholarPubMed
23. Oga, M, Sugioka, Y, Hobgood, CD, Gristina, AG, Myrvik, QN. Surgical biomaterials and differential colonization by Staphylococcus epidermidis . Biomaterials 1988; 9:285–289.CrossRefGoogle ScholarPubMed
24. Francois, P, Vaudaux, P, Foster, TJ, Lew, DP. Host-bacteria interactions in foreign body infections. Infect Control Hosp Epidemiol 1996; 17:514–520.Google Scholar
25. Tessarolo, F, Ferrari, P, Bortoluzzi, S, et al. Evaluation and quantification of reprocessing modification in single use devices in interventional cardiology. Appl Surface Sci 2004; 238:341–346.CrossRefGoogle Scholar
26. Roberts, C, Antonoplos, P. Inactivation of human immunodeficiency virus type 1, hepatitis A virus, respiratory syncytial virus, vaccinia virus, herpes simplex virus type 1, and poliovirus type 2 by hydrogen peroxide gas plasma sterilization. Am J Infect Control 1998; 26:94–101.Google Scholar
27. Vickery, K, Deva, AK, Zou, J, Kumaradeva, P, Bissett, L, Cossart, YE. Inactivation of duck hepatitis B virus by a hydrogen peroxide gas plasma sterilization system: laboratory and “in use” testing. J Hosp Infect 1999; 41:317–322.Google Scholar
28. Rutala, WA. APIC guideline for selection and use of disinfectants: 1994, 1995, and 1996 APIC Guidelines Committee. Association for Professionals in Infection Control and Epidemiology, Inc. Am J Infect Control 1996; 24:313–342.CrossRefGoogle ScholarPubMed
29. Wysowsky, DK, Flynt, JW, Goldfield, M, Altman, R, Davis, AT. Epidemic neonatal hyperbilirubinemia and use of a phenolic disinfectant detergent. Pediatrics 1978; 61:165–170.CrossRefGoogle Scholar
30. Julich, WD, Woedtke, T. Reprocessing of thermosensitive materials-efficacy against bacterial spores and viruses. J Hosp Infect 2001; 48(Suppl A):S69–S79.Google Scholar