Effectiveness of steam sterilization of reusable medical devices in primary and secondary care public hospitals in Nepal and factors associated with ineffective sterilization: A nation-wide cross-sectional study


Autoři: Gopal Panta aff001;  Ann K. Richardson aff001;  Ian C. Shaw aff002;  Stephen Chambers aff003;  Patricia A. Coope aff004
Působiště autorů: School of Health Sciences, University of Canterbury, Christchurch, New Zealand aff001;  School of Physical and Chemical Sciences, University of Canterbury, Christchurch, New Zealand aff002;  Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand aff003;  College of Education, Health and Human Development, University of Canterbury, Christchurch, New Zealand aff004
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0225595

Souhrn

Background

Inadequate sterilization of reusable medical devices can lead to healthcare associated infections (HAIs) through person-to-person or environmental transmission of pathogens. Autoclaving (steam sterilization) is most commonly used for sterilizing medical devices in healthcare facilities. We conducted a nation-wide cross-sectional study to evaluate the effectiveness of steam sterilization practices in primary and secondary care public hospitals in Nepal and to identify factors associated with ineffective sterilization.

Methods

Using a stratified clustered random sampling, 13 primary- and secondary-care public hospitals in Nepal were selected. 189 steam sterilization cycles from these hospitals were evaluated for their effectiveness using self-contained biological indicators, class-5 chemical indicators, autoclave indicator tape and physical parameters. Information about the hospitals and the types of autoclaves being used was also collected. Data were analysed to estimate the proportion of ineffective steam sterilization cycles. Logistic regression was used to identify factors associated with ineffective sterilization.

Findings

In primary and secondary care public hospitals in Nepal, 71.0% (95% CI 46.8% - 87.2%) of the autoclave cycles were ineffective (i.e. showed positive results) when tested with biological indicators and 69.8% (95% CI 44.4% - 87.0%) showed ‘reject’ results with class 5 chemical indicators. There was no statistically significant difference in proportions showing positive or reject results by hospital types for either biological (p = 0.51) or class 5 chemical (p = 0.87) indicators. Autoclave type and pressure achieved during sterilization were statistically significantly associated with steam sterilization failures, adjusted for holding period, evenness of pressure and barrier system used.

Conclusion

Primary and secondary care hospitals in Nepal have a high proportion of steam sterilization failure, indicating a risk of person-to-person transmission of pathogens through reusable medical devices. There is an urgent need to improve steam sterilization processes in these hospitals.

Klíčová slova:

Autoclaving – Cross-sectional studies – Equipment sterilization – Medical devices and equipment – Nepal – Nosocomial infections – Pathogens – Decontamination


Zdroje

1. Spaulding EH. Chemical disinfect of medical and surgical materials. Disinfection, sterilization and preservation. 1968: 517–531.

2. World Health Organization (WHO). Decontamination and reprocessing of medical devices for health-care facilities. 2016 [cited 17 December 2017]–Available from: http://apps.who.int/iris/bitstream/10665/250232/1/9789241549851-eng.pdf.

3. Alfa MJ. Medical-device reprocessing. Infect Control Hosp Epidemiol. 2000; 21(8):496–498. doi: 10.1086/501792 10968713

4. Rutala WA, Weber DJ. Infection control: The role of disinfection and sterilization. J Hosp Infect. 1999; 43:S43–S55. doi: 10.1016/s0195-6701(99)90065-8 10658758

5. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008. [cited 2 August 2017]–Available from: https://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf.

6. Esel D, Doganay M, Bozdemir N, Yildiz O, Tezcaner T, Sumerkan B, Aygen B, Selcuklu A. Polymicrobial ventriculitis and evaluation of an outbreak in a surgical intensive care unit due to inadequate sterilization. J Hosp Infect. 2002; 50(3):170–174. doi: 10.1053/jhin.2002.1187 11886191

7. Dancer SJ, Stewart M, Coulombe C, Gregori A, Virdi M. Surgical site infections linked to contaminated surgical instruments. J Hosp Infect. 2012; 81(4):231–238. doi: 10.1016/j.jhin.2012.04.023 22704634

8. Tosh PK, Disbot M, Duffy JM, Boom ML, Heseltine G, Srinivasan A, Gould CV, Berríos-Torres SI. Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures: Texas, 2009. Infect Control Hosp Epidemiol. 2011; 32(12):1179–1186. doi: 10.1086/662712 22080656

9. Hildy M, Brown-Elliott BA, Douglas M, Curry J, Cecile T, Yansheng Z, Wallace Jr RJ. An outbreak of Mycobacterium chelonae infection following liposuction. Clin Infect Dis. 2002; 34(11):1500–1507. doi: 10.1086/340399 12015697

10. Lu WP, Lin GX, Shi S, Dong JH. Simultaneously high prevalence of hepatitis B and C virus infection in a population in Putian County, China. J Clin Microbiol. 2012; 50(6):2142–2144. doi: 10.1128/JCM.00273-12 22403430

11. WHO. Report on the burden of endemic health care-associated infection worldwide. 2011 [cited 7 July 2016]–Available from: http://apps.who.int/iris/bitstream/10665/80135/1/9789241501507_eng.pdf.

12. Giri BR, Pant HP, Shankar PR, Sreeramareddy CT, Sen PK. Surgical site infection and antibiotics use pattern in a tertiary care hospital in Nepal. J Pak Med Assoc. 2008; 58(3):148–151. 18517124

13. Giri S, Kandel BP, Pant S, Lakhey PJ, Singh YP, Vaidya P. Risk factors for surgical site infections in abdominal surgery: a study in nepal. Surg infect. 2013; 14(3):313–318.

14. Shrestha S, Wenju P, Shrestha R, Karmacharya RM. Incidence and risk factors of surgical site infections in Kathmandu university hospital, Kavre, Nepal. Kathmandu University Medical Journal. 2016; 14(54):107–111.

15. Chapagain K, Pokharel R, Acharya R, Shah S, Paranjape BD. Incidence of Post-operative Wound Infection Following the Use of Antibiotics in Clean Contaminated Head and Neck Surgery in a Tertiary Care Centre in Eastern Nepal. Birat Journal of Health Sciences. 2017; 1(1):51–55.

16. Skaug N. Proper monitoring of sterilization procedures used in oral surgery. Int J Oral Maxillofac Surg. 1983; 12(3):153–158.

17. Palenik CJ, King TN, Newton CW, Miller CH, Koerber LG. A survey of sterilization practices in selected endodontic offices. J Endod. 1986; 12(5):206–209. doi: 10.1016/S0099-2399(86)80156-X 3459805

18. Scheutz F, Reinholdt J. Outcome of sterilization by steam autoclaves in Danish dental offices. Eur J Oral Sci. 1988; 96(2):167–170.

19. Messieha N, Rosen S, Beck FM. Evaluation of sterilization monitoring for dental offices in Ohio. Ohio Dent J. 1990; 64(2):8. 2129135

20. McErlane B, Rosebush WJ, Waterfield JD. Assessment of the effectiveness of dental sterilizers using biological monitors. J Can Dent Assoc. 1992; 58(6):481–483. 1633580

21. Burke FJ, Coulter WA, Cheung SW, Palenik CJ. Autoclave performance and practitioner knowledge of autoclave use: a survey of selected UK practices. Quintessence Int. 1998; 29(4):231–238. 9643261

22. Skaug N, Lingaas E, Nielsen Ø, Palenik CJ. Biological monitoring of sterilizers and sterilization failures in Norwegian dental offices in 1985 and 1996. Acta Odontologica Scandinavica. 1999; 57(4):175–180. doi: 10.1080/000163599428733 10540925

23. Coulter WA, Chew-Graham CA, Cheung SW, Burke FJ. Autoclave performance and operator knowledge of autoclave use in primary care: a survey of UK practices. J Hosp Infect. 2001; 48(3):180–185. doi: 10.1053/jhin.2001.0959 11439004

24. Acosta-Gío AE, Mata-Portuguez VH, Herrero-Farías A, Pérez LS. Biologic monitoring of dental office sterilizers in Mexico. Am J Infect Control. 2002; 30(3):153–157. doi: 10.1067/mic.2002.121098 11988709

25. Kelkar U, Bal AM, Kulkarni S. Monitoring of steam sterilization process by biologic indicators—a necessary surveillance tool. Am J Infect Control. 2004; 32(8):512–513. doi: 10.1016/j.ajic.2004.07.005 15609450

26. Healy CM, Kearns HP, Coulter WA, Stevenson M, Burke FJ. Autoclave use in dental practice in the Republic of Ireland. Int Dent J. 2004; 54(4):182–186. doi: 10.1111/j.1875-595x.2004.tb00278.x 15335087

27. Chan AW, Law NC. Autoclave performance in private dental Practices in Hong Kong. Hong Kong Dent J. 2007; 4:102–112.

28. Miranzadeh MB, Sabahibidgoli M, Afshar M, Zarjam R. Study on the biological monitoring of steam sterilizer in kashan governmental hospitals during 2011. JASES. 2013; 8(1):61–66.

29. Okemwa KA, Kibosia CJ, Nyamagoba H. Instrument Sterilization Practices and Monitoring in Private and Public Dental Clinics in Eldoret, Nakuru and Kisumu Municipalities in Western Kenya. J Kenya Den Assoc. 2014; 5:219–226.

30. Patiño-Marín N, Martínez-Castañón GA, Zavala-Alonso NV, Medina-Solís CE, Torres-Méndez F, Cepeda-Argüelles O. Biologic monitoring and causes of failure in cycles of sterilization in dental care offices in Mexico. Am J Infect Control. 2015; 43(10):1092–1095. doi: 10.1016/j.ajic.2015.05.034 26190385

31. Department of Health Services—Ministry of Health and Population—Government of Nepal. Annual report 2013/2014. [cited 17 August 2015]–Available from: http://dohs.gov.np/wp-content/uploads/2014/04/Annual_Report_2070_71.pdf.

32. Bennett S, Woods T, Liyanage WM, Smith DL. A simplified general method for cluster-sample surveys of health in developing countries. World Health Stat Q. 1991; 44(3):98–106. 1949887

33. Mesa Labs Inc. ProSpore2 biological indicator. 2015 [cited 6 June 2015]–Available from: http://biologicalindicators.mesalabs.com/prospore2/.

34. Mesa Labs Inc. Multi variable indicators and integrators. 2015 [cited 6 June 2015]–Available from: http://biologicalindicators.mesalabs.com/multi-variable-indicators-and-integrators/.

35. Mesa Labs Inc. Process indicators. 2015 [cited 6 June 2015]–Available from: http://biologicalindicators.mesalabs.com/process-indicators/.

36. International Organization for Standardization. ISO 17665–1:2006 E. Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Geneva, Switzerland: ISO; 2006.

37. International Organization for Standardization. ISO/TS 17665–2:2009 E. Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665–1. Geneva, Switzerland: ISO; 2009

38. Kirckof S, Kshirsagar T, Bennaars-Eiden A. Class 6 Emulating Indicators and Class 5 Integrating Indicators: A comparison of their ability to detect temperature failures within a steam sterilization cycle. 2009 [cited 23 September 2016]. In: 3M Science [Internet]. Available from: http://multimedia.3m.com/mws/media/575962O/comparison-of-class-6-and-class-5-indicators-hi-res-complete.pdf.

39. Van Doornmalen JP, Verschueren M, Kopinga K. Penetration of water vapour into narrow channels during steam sterilization processes. J Phys D: Appl Phys. 2013; 46(6):065201.

40. Perkins JJ. Principles and methods of sterilization in health sciences. Springfield, IL: Thomas; 1956.

41. McDonnell G, Sheard D. A practical guide to decontamination in healthcare. John Wiley & Sons; 2012.

42. Huys J. Sterilization of medical supplies by steam: General theory. 3rd ed. Vol I. Wageningen, Netherlands: MHP Verlag GmbH and Heart Consultancy; 2010.

43. Winter S, Smith A, Lappin D, McDonagh G, Kirk B. Investigating steam penetration using thermometric methods in dental handpieces with narrow internal lumens during sterilizing processes with non-vacuum or vacuum processes. J Hosp Infect. 2017; 97(4):338–342. doi: 10.1016/j.jhin.2017.07.033 28778810

44. Donskey CJ, Yowler M, Falck-Ytter Y, Kundrapu S, Salata RA, Rutala WA. A case study of a real-time evaluation of the risk of disease transmission associated with a failure to follow recommended sterilization procedures. Antimicrob Resist Infect Control. 2014; 3(1):4. doi: 10.1186/2047-2994-3-4 24447336

45. Rutala WA, Weber DJ. How to assess risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines. Infect Control Hosp Epidemiol. 2007; 28(2):146–155. doi: 10.1086/511700 17265395


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2019 Číslo 11