* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Re-evaluating endoscopy-associated infection risk
Survey
Document related concepts
Gastroenteritis wikipedia , lookup
Traveler's diarrhea wikipedia , lookup
Common cold wikipedia , lookup
Hygiene hypothesis wikipedia , lookup
Childhood immunizations in the United States wikipedia , lookup
Sarcocystis wikipedia , lookup
Transmission (medicine) wikipedia , lookup
Urinary tract infection wikipedia , lookup
Human cytomegalovirus wikipedia , lookup
Schistosomiasis wikipedia , lookup
Marburg virus disease wikipedia , lookup
Sociality and disease transmission wikipedia , lookup
Carbapenem-resistant enterobacteriaceae wikipedia , lookup
Hepatitis B wikipedia , lookup
Neonatal infection wikipedia , lookup
Hepatitis C wikipedia , lookup
Transcript
American Journal of Infection Control 41 (2013) 734-6 Contents lists available at ScienceDirect American Journal of Infection Control American Journal of Infection Control journal homepage: www.ajicjournal.org Commentary Re-evaluating endoscopy-associated infection risk estimates and their implications Cori L. Ofstead MSPH a, *, Alexandra M. Dirlam Langlay PhD a, Natalie J. Mueller MPH a, Pritish K. Tosh MD b, Harry P. Wetzler MD, MSPH a a b Ofstead & Associates, Inc, Saint Paul, MN Division of Infectious Diseases, Mayo Clinic, Rochester, MN According to the Centers for Disease Control and Prevention (CDC), approximately 11 million gastrointestinal endoscopies are performed annually in the United States.1,2 The 2008 CDC/Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities states that contaminated endoscopes have been linked to more health care-associated infections than any other medical device.3 Paradoxically, several guideline-issuing organizations assert that the risk of endoscopy-associated infection (EAI) is only 1 in 1.8 million procedures.3-6 Recent audits have documented widespread lapses in infection control involving medical equipment.7-11 Inspections of multiple facilities determined that certain endoscopy equipment was not properly reprocessed for up to several years.8,11-15 Direct observation in a multisite study revealed that endoscopes were virtually never reprocessed in accordance with guidelines.7 The implications of these lapses are unknown because no epidemiologic studies have determined the risk of EAI associated with reprocessing quality. Research was conducted to evaluate the origins and accuracy of the risk estimates after a single outbreak involved more cases of EAI than would be expected in 1 year nationwide.15,16 This article describes the methodology used to estimate risk and discusses the patient safety implications of relying on the statistics appearing in guidelines. EVALUATING THE ORIGINS OF CURRENT EAI RISK ESTIMATES How risk was calculated The EAI risk estimate of “1 in 1.8 million procedures” first appeared in a 1993 Technology Assessment Position Paper by the American Society for Gastrointestinal Endoscopy (ASGE).17 ASGE authors calculated risk by dividing a subset of EAIs (28) in the * Address correspondence to Cori L. Ofstead, MSPH, Ofstead & Associates, Inc, 400 Selby Avenue, Suite V, Blair Arcade West, Saint Paul, MN 55102-4520. E-mail address: [email protected] (C.L. Ofstead). Conflicts of interest: None to report. United States from 1988 to 1992 reported in 1 review article18 by an estimated number of gastrointestinal endoscopies performed during that time (40 million).17 This estimate is erroneous in part because of mathematical errors (28 cases in 40 million procedures represents a risk of 1 in 1.4 million procedures). There were also substantially more transmission events documented in the review than selected by the ASGE authors (145 rather than 28).18 When all 145 cases are used, the risk estimate is 1 in 276,000da 6-fold increase over the stated risk. In terms of the denominator for this calculation, there are large discrepancies in the reported number of procedures performed in the United States. For example, ASGE asserts that 34 million gastrointestinal endoscopies are done annually,19 compared with 20 million stated in the 2011 Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes,4 11 million estimated using CDC data,1,2 and 5 million reported in the CDC/HICPAC Guideline.3 Recent government data suggest that 11 million to 22 million procedures are performed annually.1,2,20 Dividing minimal numbers of published case reports by high procedural volumes results in very low EAI risk estimates that are neither reliable nor representative of actual infection risk. Problems inherent in relying on published case reports Recently, ASGE cited a 2006 article that used the same methodology to estimate an EAI risk of 1 in 10 million procedures (35 EAIs in 340 million procedures).19,21 Although the newer risk estimate suggests a considerable decrease in EAIs since the first estimate was published in 1993, this method of estimating risk is highly prone to reporting bias.22 This estimate likely exemplifies decreasing numbers of published case reports rather than actual reduction in risk. As an analogy, if case reports published in peerreviewed journals were used to determine risk of penicillinresistant Staphylococcus aureus infection during the last decade, the risk would be almost zero. S aureus was universally penicillin susceptible until the 1950s, when case reports of penicillin-resistant S aureus were first published. By the 1970s, penicillin-resistant S aureus was so prevalent that it was considered commonplace, and case reports were rarely published. 0196-6553/$36.00 - Copyright Ó 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajic.2012.10.008 C.L. Ofstead et al. / American Journal of Infection Control 41 (2013) 734-6 At present, there is no incentive for practitioners to report EAIs or other adverse events. A recent study found that complications associated with outpatient endoscopy were rarely reported by physicians.23 The authors of the original review cited by ASGE stated that the cases included in their paper probably represented only a small fraction of actual EAIs because reported incidents frequently involved large outbreaks or unusual clusters of cases, and most were due to bacterial infections that were easy to recognize and had brief incubation periods.18 Because of the substantial reporting bias, using published case reports to calculate EAI risk is not methodologically sound. REPROCESSING LAPSES AND ASSOCIATED OUTCOMES Discordance between stated EAI risks and observed complications Nearly all EAIs have resulted from failure to adequately clean and disinfect endoscopes.4,6 Recent reports indicate reprocessing lapses are ongoing and widespread.7,8,10,11 Although outcomes of reprocessing lapses have been described on a case-by-case basis,15,16,18,24 to our knowledge no epidemiologic data exist. However, 3 recent studies have examined postendoscopy complications, with incidence rates ranging from 0.5% to 3.4%.23,25,26 Complications included fever, diarrhea, abdominal pain, and other signs and symptoms that may indicate infection.23 These findings suggest that the risk of EAI may be substantially higher than current estimates. Furthermore, it is reasonable to assume that the infection risk is greater when lapses occur than when there is rigorous adherence to reprocessing protocols. For example, contaminated duodenoscopes have been associated with outbreaks of multiple microorganisms, including Klebsiella pneumoniae carbapenemase-producing organisms, with multidrugresistant organism (MDRO) attack rates ranging from 8% to 41% of exposed patients.15,16,27,28 Improper focus on bloodborne virus transmission When reprocessing lapses are documented, patients are often told there is little to no risk and no need for testing or followup.14,29,30 In rare instances when exposed patients are tested for infections, institutions typically choose to test only for viral infections, such as HIV and hepatitis B and C, which are unlikely to be transmitted by an endoscope.12,31-33 The focus on viral transmission is improper because these viruses are less prevalent in the population,34-37 have shorter survival times outside the body,34,38,39 and are easier to kill with standard disinfectants3,38 than bacterial pathogens, such as Clostridium difficile. Endoscopes are exposed to very high numbers of enteric microbes during each procedure,3 and Alfa et al found viable bacteria or fungi on 14% of patient-ready endoscopes.40 Transmission and subsequent colonization with MDROs and other enteric pathogens through a fecally contaminated endoscope have not been assessed. Most MDROs become colonizers in the gastrointestinal tract before causing infection elsewhere in the body.41 As such, transmission and subsequent colonization are clinically unapparent but of high consequence. Because the gastrointestinal tract is a reservoir for pathogens, transmission of MDROs between patients through a contaminated endoscope is not only feasible but potentially quite common depending on the colonization status of prior endoscopy patients, the quality of reprocessing, and the degree of disruption of normal flora caused by pre-endoscopy bowel preparation. The frequency of MDRO colonization following endoscopy needs to be studied to accurately evaluate risk and reframe the clinical consequences of improperly reprocessed endoscopes. 735 CONCLUSION Evidence indicates that current EAI risk estimates are inaccurate, outdated, based on flawed methodology, and can have profound effects on patients. These extremely low risk estimates are used to justify the lack of reporting, routine monitoring, patient notification, and laboratory testing following a lapse. In 1993, researchers recommended prospective studies involving both patient monitoring and laboratory cultures be conducted to evaluate the risk of transmitting infections via contaminated endoscopes.18 Today, there remains a need for epidemiologic studies to accurately estimate the risk of EAI and other complications. Prospective studies should involve observation of reprocessing practices, microbial testing, and outcomes assessment. The results could be used to develop criteria for patient notification and reporting of reprocessing lapses and assist decision makers in determining what actions to take when a lapse occurs. Acknowledgments The authors thank Jeremy Ward for his thoughtful comments and assistance editing this manuscript. References 1. Centers for Disease Control and Prevention. National Hospital Discharge Survey: 2009 table, procedures by selected patient characteristics. Available from: http://www.cdc.gov/nchs/fastats/insurg.htm. Accessed June 15, 2012. 2. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Rep 2009;11:1-25. 3. Rutala WA, Weber DJ. In: Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities, Vol 2012. Washington [DC]: Department of Health and Human Services; 2008. 4. Petersen BT, Chennat J, Cohen J, Cotton PB, Greenwald DA, Kowalski TE, et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2011. Infect Control Hosp Epidemiol 2011;32:527-37. 5. ASGE Standards of Practice Committee, Banerjee S, Shen B, Nelson DB, Lichtenstein DR, Baron TH, et al. Infection control during GI endoscopy. Gastrointest Endosc 2008;67:781-90. 6. Society of Gastroenterology Nurses and Associates Inc. SGNA Standards: Standards of infection control in reprocessing of flexible gastrointestinal endoscopes. Gastroenterol Nurs 2010;33:70-80. 7. Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope reprocessing methods: a prospective study on the impact of human factors and automation. Gastroenterol Nurs 2010;33:304-11. 8. Schaefer MK, Jhung M, Dahl M, Schillie S, Simpson C, Llata E, et al. Infection control assessment of ambulatory surgical centers. JAMA 2010;303:2273-9. 9. Tosh PK, Disbot M, Duffy JM, Boom ML, Heseltine G, Srinivasan A, et al. Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures: Texas, 2009. Infect Control Hosp Epidemiol 2011;32:1179-86. 10. VA Office of Inspector General. Follow-up colonoscope reprocessing at VA medical facilities. Washington [DC]: Department of Veterans Affairs; 2009. 11. VA Office of Inspector General. Use and reprocessing of flexible fiberoptic endoscopes at VA medical facilities. Washington [DC]: Department of Veterans Affairs; 2009. 12. Holodniy M, Oda G, Schirmer PL, et al. Results from a large-scale epidemiologic look-back investigation of improperly reprocessed endoscopy equipment. Infect Control Hosp Epidemiol 2012;33:649-56. 13. New Jersey Ambulatory Surgery Center and Surgical Practice Transparency Report. Pennington [NJ]: New Jersey Health Care Quality Institute; 2011. p. 35. 14. Ochsner Medical Center. Jefferson Highway Endoscopy Lab audit shows small number of endoscopes did not complete high level disinfection process. New Orleans [LA]: Ochsner Health System; April 19, 2011. 15. Sanderson R, Braithwaite L, Ball L, Ragan P, Eisenstein L. An outbreak of carbapenem-resistant Klebsiella pneumoniae infections associated with endoscopic retrograde cholangiopancreatography (ERCP) procedures at a hospital. Am J Infect Control 2010;38:e141. 16. DePasquale JM, Endimimani A, Forero S, Roberts D, Fiorella P, Pickens N, et al. Outbreak of carbapenem-resistant Klebsiella pneumoniae infections in a longterm acute care hospital-Florida, 2008. 58th Annual EIS Conference. Atlanta [GA]: CDC; 2009. 17. Kimmery MB, Burnett DA, Carr-Locke DL, DiMarino AJ, Jensen DM, Katon R, et al. ASGE Technology assessment position paper: transmission of infection by gastrointestinal endoscopy. Gastrointest Endosc 1993;39:885-8. 18. Spach DH, Silverstein FE, Stamm WE. Transmission of infection by gastrointestinal endoscopy and bronchoscopy. Ann Intern Med 1993;118:117-28. 736 C.L. Ofstead et al. / American Journal of Infection Control 41 (2013) 734-6 19. American Society for Gastrointestinal Endoscopy. Endoscope reprocessing and infection control. 2010. Available from: http://www.asge.org/press/press.aspx? id¼6858. Accessed May 23, 2012. 20. Sonnenberg A, Amorosi SL, Lacey MJ, Lieberman DA. Patterns of endoscopy in the United States: analysis of data from the Centers for Medicare and Medicaid Services and the National Endoscopic Database. Gastrointest Endosc 2008;67: 489-96. 21. Nelson DB, Muscarella LF. Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy. World J Gastroenterol 2006;12:3953-64. 22. McGauran N, Wieseler B, Kreis J, Schuler YB, Kolsch H, Kaiser T. Reporting bias in medical research: a narrative review. Trials 2010;11:37. 23. Leffler DA, Kheraj R, Garud S, Neeman N, Nathanson LA, Kelly CP, et al. The incidence and cost of unexpected hospital use after scheduled outpatient endoscopy. Arch Intern Med 2010;170:1752-7. 24. Nelson DB. Infectious disease complications of GI endoscopy: part II, exogenous infections. Gastrointest Endosc 2003;57:695-711. 25. Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, et al. Colonoscopy versus fecal immunochemical testing in colorectal cancer screening. N Engl J Med 2012;366:697-706. 26. Azrak MF, Huang Y-lA, Howard DH, Tangka F, Warren J, Klabunde C, et al. The utilization and complication rates of outpatient colonoscopy performed at ambulatory surgical centers versus hospitals 1992-2007. Chicago [IL]: Digestive Disease Week; 2011. 27. Aumeran C, Poincloux L, Souweine B, Robin F, Laurichesse H, Baud O, et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:895-9. 28. Carbonne A, Thiolet JM, Fournier S, Fortineau N, Kassis-Chikhani N, Boytchev I, et al. Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumoniae type 2 in France, September to October 2009. Euro Surveill 2010;15:1-6. 29. Lerner M. HCMC tells 2,600 patients device wasn’t properly disinfected. Star Tribune; June 22, 2010. 30. The Canadian Press. 9,000 B.C. patients warned of surgical tools. CBC News; December 8, 2010. 31. Ciancio A, Manzini P, Castagno F, D’Antico S, Reynaudo P, Coucourde L, et al. Digestive endoscopy is not a major risk factor for transmitting hepatitis C virus. Ann Intern Med 2005;142:903-9. 32. Barrow B. Ochsner Health System notifies 222 patients of potential errors sanitizing endoscopes. The Times-Picayune; April 19, 2011. 33. Barrow B. Tulane Medical Center alerts patients after medical gear improperly sterilized. The Times-Picayune; March 10, 2011. 34. Weber DJ, Rutala WA, Miller MB, Huslage K, Sickbert-Bennett E. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species. Am J Infect Control 2010;38(5 Suppl 1):S25-33. 35. Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol 2010;31:431-55. 36. Centers for Disease Control and Prevention. HIV/AIDS statistics and surveillance: basic statistics. Available from: http://www.cdc.gov/hiv/topics/surveillance/ basic.htm. Accessed September 27, 2012. 37. Centers for Disease Control and Prevention. Viral hepatitis statistics & surveillance. Available from: http://www.cdc.gov/hepatitis/statistics/index.htm. Accessed September 27, 2012. 38. Hota B. Contamination, disinfection, and cross-colonization: are hospital surfaces reservoirs for nosocomial infection? Clin Infect Dis 2004;39:1182-9. 39. Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis 2006;6:130. 40. Alfa MJ, Sepehri S, Olson N, Wald A. Establishing a clinically relevant bioburden benchmark: a quality indicator for adequate reprocessing and storage of flexible gastrointestinal endoscopes. Am J Infect Control 2012;40:233-6. 41. Tosh PK, McDonald LC. Infection control in the multidrug-resistant era: tending the human microbiome. Clin Infect Dis 2012;54:707-13.