Hostname: page-component-7dd5485656-hw7sx Total loading time: 0 Render date: 2025-10-31T03:45:56.172Z Has data issue: false hasContentIssue false
  • English
  • Français

How to Assess Risk of Disease Transmission to Patients When There Is a Failure to Follow Recommended Disinfection and Sterilization Guidelines

Published online by Cambridge University Press:  02 January 2015

William A. Rutala  and
David J. Weber
William A. Rutala
Affiliation:
Department of Hospital Epidemiology, University of North Carolina Health Care System, and the Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill
David J. Weber
Affiliation:
Department of Hospital Epidemiology, University of North Carolina Health Care System, and the Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill
Get access Rights & Permissions [Opens in a new window]

Abstract

Background.

Disinfection and sterilization are critical components of infection control. Unfortunately, breaches of disinfection and sterilization guidelines are not uncommon.

Objective.

To describe a method for evaluating a potential breach of guidelines for high-level disinfection and sterilization of medical devices.

Methods.

The appropriate scientific literature was reviewed to determine the frequency of failures of compliance. A risk assessment model was constructed.

Results.

A 14-step protocol was constructed to aid infection control professionals in the evaluation of potential disinfection and sterilization failures. In addition, a model is presented for aiding in determining how patients should be notified of the potential adverse event. Sample statements and letters are provided for communicating with the public and individual patients.

Conclusion.

Use of a protocol can guide an institution in managing potential disinfection and sterilization failures.

Information

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 28 , Issue 2 , February 2007 , pp. 146 - 155
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2007

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.)

Article purchase

Temporarily unavailable

References

1.Centers for Disease Control and Prevention. Ambulatory and inpatient procedures in the United States, 1996. Atlanta: Centers for Disease Control and Prevention;1998:1–39.Google Scholar
2.Weber, DJ, Rutala, WA. Lessons from outbreaks associated with bronchoscopy. Infect Control Hosp Epidemiol 2001;22:403–408.Google Scholar
3.Weber, DJ, Rutala, WA, DiMarino, AJ Jr. The prevention of infection following gastrointestinal endoscopy: the importance of prophylaxis and reprocessing. In: DiMarino, AJ Jr, Benjamin, SB, eds. Gastrointestinal Diseases: An Endoscopic Approach. Thorofare, NJ: Slack, 2002:87–106.Google Scholar
4.Nelson, DB. Infectious disease complications of GI endoscopy: part II, exogenous infections. Gastrointest Endosc 2003;57:695–711.Google Scholar
5.Centers for Disease Control and Prevention. Bronchoscopy-related infections and pseudoinfections—New York, 1996 and 1998. MMWR Morb Mortal Wkly Rep 1999;48:557–560.Google Scholar
6.Vanhems, P, Gayet-Ageron, A, Ponchon, T, et al. Follow-up and management of patients exposed to a flawed automated endoscope washer-disinfector in a digestive diseases unit. Infect Control Hosp Epidemiol 2006;27:89–92.Google Scholar
7.Roy, KM, Ahmed, S, Cameron, SO, Shaw, L, Yirrell, D, Goldberg, D. Patient notification exercise following a dentist's admission of the periodic use of unsterilized equipment. J Hosp Infect 2005;60:163–168.Google Scholar
8.Carsauw, H, Debacker, N. Recall of patients after the use of an inactive lot of Cidex disinfection solution in Belgian hospitals. In: Program and abstracts of the 5th International Conference of the Hospital Infection Society, Edinburgh, Scotland, September 15-18, 2002. Abstract P7.16.Google Scholar
9.Srinivasan, A, Wolfenden, LL, Song, X, et al. An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes. N Engl J Med 2003;348:221–227.Google Scholar
10.Kirschke, DL, Jones, TF, Craig, AS, et al. Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes. N Engl J Med 2003;348:214–220.Google Scholar
11.Amoore, J, Ingram, P. Learning from adverse incidents involving medical devices. Br Med J 2002;325:272–275.Google Scholar
12.Spaulding, EH. Chemical disinfection of medical and surgical materials. In: Lawrence, C, Block, SS, eds. Disinfection, Sterilization, and Preservation. Philadelphia: Lea & Febiger, 1968:517–531.Google Scholar
13.Favero, MS, Bond, WW. Chemical disinfection of medical and surgical materials. In: Block, SS, ed. Disinfection, Sterilization, and Preservation. Philadelphia: Lippincott Williams & Wilkins, 2001:881–917.Google Scholar
14.Simmons, BP. CDC guidelines for the prevention and control of nosocomial infections. Guideline for hospital environmental control. Am J Infect Control 1983;11:97–120.Google Scholar
15.Garner, JS, Favero, MS. CDC Guideline for handwashing and hospital environmental control, 1985. Infect Control 1986;7:231–43.Google Scholar
16.Rutala, WA. APIC guideline for selection and use of disinfectants. Am f Infect Control 1990;18:99–117.Google Scholar
17.Rutala, WA, 1994, 1995, and 1996 APIC Guidelines Committee. APIC guideline for selection and use of disinfectants. Association for Professionals in Infection Control and Epidemiology. Am J Infect Control 1996;24:313–342.Google Scholar
18.Rutala, WA, Weber, DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities: recommendations of CDC. MMWR In press.Google Scholar
19.Sehulster, L, Chinn, RYW, Healthcare Infection Control Practices Advisory Committee. Guidelines for environmental infection control in healthcare facilities. MMWR Morb Mortal Wkly Rep 2003;52:1–44.Google Scholar
20.Weber, DJ, Rutala, WA. Environmental issues and nosocomial infections. In: Wenzel, RP, ed. Prevention and Control of Nosocomial Infections. Baltimore: Williams and Wilkins, 1997:491–514.Google ScholarPubMed
21.Schembre, DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am 2000;10:215–232.Google Scholar
22.Spach, DH, Silverstein, FE, Stamm, WE. Transmission of infection by gastrointestinal endoscopy and bronchoscopy. Ann Intern Med 1993;118:117–128.Google Scholar
23.Nelson, DB, Jarvis, WR, Rutala, WA, et al. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. Infect Control Hosp Epidemiol 2003;24:532–537.CrossRefGoogle ScholarPubMed
24.Jackson, FW, Ball, MD. Correction of deficiencies in flexible fiberoptic sigmoidoscope cleaning and disinfection technique in family practice and internal medicine offices. Arch Earn Med 1997;6:578–582.Google Scholar
25.Orsi, GB, Filocamo, A, Di Stefano, L, Tittobello, A. Italian national survey of digestive endoscopy disinfection procedures. Endoscopy 1997;29:732–738.Google Scholar
26.Honeybourne, D, Neumann, CS. An audit of bronchoscopy practice in the United Kingdom: a survey of adherence to national guidelines. Thorax 1997;52:709–713.Google Scholar
27.Cetse, JC, Vanhems, P. Outbreak of infection associated with bronchoscopes. N Engl J Med 2003;348:2039–2040.Google Scholar
28.Gerding, DN, Peterson, LR, Vennes, JA. Cleaning and disinfection of fiberoptic endoscopes: evaluation of glutaraldehyde exposure time and forced-air drying. Gastroenterology 1982;83:613–8.Google Scholar
29. Food and Drug Administration, Centers for Disease Control and Prevention. FDA and CDC public health advisory: infections from endoscopes inadequately reprocessed by an automated endoscope reprocessing system. Rockville, MD: Food and Drug Administration; 1999.Google Scholar
30.Favero, MS. Sterility assurance: concepts for patient safety. In: Rutala, WA, ed. Disinfection, Sterilization and Antisepsis: Principles and Practices in Healthcare Facilities. Washington, DC: Association for Professionals in Infection Control and Epidemiology, 2001:110–119.Google Scholar
31.Duffy, RE, Brown, SE, Caldwell, KL, et al. An epidemic of corneal destruction caused by plasma gas sterilization. Arch Ophthalmol 2000;118:1167–1176.Google Scholar
32.Leape, LL. Reporting of adverse events. N EnglJ Med 2002;347:1633–1638.Google Scholar
33. North Carolina General Statute §90-21.2.Google Scholar
34.Nystrom, B. Disinfection of surgical instruments. J Hosp Infect 1981;2:363–368.Google Scholar
35.Rutala, WA, Gergen, MF, Jones, JF, Weber, DJ. Levels of microbial contamination on surgical instruments. Am J Infect Control 1998;26:143–145.Google Scholar
36.McQuillan, GM, Kruszon-Moran, D, Kottiri, BJ, et al. Prevalence of HIV in the US household population: the national health and nutrition examination surveys, 1988 to 2002. J Acquir Immune Defic Syndr 2006;41:651–656.Google Scholar
37.Ippolito, G, Puro, V, De Carli, G, Italian Study Group on Occupational Risk of HIV Infection. The risk of occupational human immunodeficiency virus in health care workers. Arch Int Med 1993;153:1451–1458.Google Scholar
38.Centers for Disease Control and Prevention. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep 2001;50(RR-11):1–42.Google Scholar
39.Resnick, L, Veren, K, Salahuddin, SZ, Tondreau, S, Markham, PD. Stability and inactivation of HTLV-III/LAV under clinical and laboratory environments. JAMA 1986;255:1887–1891.Google Scholar
40.Zou, S, Notari, EP IV, Stramer, SL, Wahab, F, Musavi, F, Dodd, RY. Patterns of age- and sex-specific prevalence of major blood-borne infections in United States blood donors, 1995 to 2002: American Red Cross blood donor study. Transfusion 2004;44:1640–1647.Google Scholar
41.Heymann, DL. Control of Communicable Diseases Manual. Washington DC: American Public Health Association, 2004.Google Scholar
42.McLaughlin, RA, Genter, MB, Cook, MG, Zublena, JP. Pollutants in ground water: risk assessment. Raleigh, NC: North Carolina Cooperative Extension Service;1994. Available at: http://www.soil.ncsu.edu/publications/Soilfacts/AG-439-08/AG-439-8.pdf. Accessed July 2006.Google Scholar
43.Van Aerts, LAGJM, Kasper, P, Queckenberg, O, Mueller, L, Cartwright, A. International workshop on qualification and control of impurities. Drug Inf J 2006;40:155–163.CrossRefGoogle Scholar
44.Kroes, R, Kleiner, J, Renwick, A. The threshold of toxicological concern concept in risk assessment. Toxicol Sci 2005;86:226–230.Google Scholar
45.European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the limits of genotoxic impurities, 2004. Available at: http://www.emea.eu.int/pdfs/human/swp/519902en.pdf. Accessed July 2006.Google Scholar
46.Department of Transportation. Most Americans live in elevated cancer risk areas, EPA study shows. Available at: http://knowledge.fhwa.dot.gov/cops/italladdsup.nsf. Accessed June 2006.Google Scholar