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Sterilization and High-Level Disinfection Update
SPECIAL REPORT: A Perspective on the Year in Surgical Site Infection Prevention
Sterilization and High-Level Disinfection Update HEATHER HOHENBERGER, BSN, RN, CIC, CNOR, CPHQ; MARGUERITE GRIBOGIANNIS, MPA, CIC; LINDA STEIN, RN, MPH, CIC; FRANK MYERS, MA, CIC
D
uring the past year, health care clinicians in the United States have reported a number of outbreaks of multidrug-resistant microorganisms, in particular, carbapenemase-producing Enterobacteriaceae (Table 1). Epidemiological investigations at each institution cited no breaches in reprocessing procedures.
endoscopes engineered with an elevator channel (eg, ERCP, endoscopic ultrasound with linear array) (Table 2). There is still much discussion on how best to guide users. Primary resources include the Centers for Disease Control and Prevention interim duodenoscope guidelines and current manufacturers’ instructions for use (Table 3).2
The source of the outbreaks has been attributed to the inability to adequately clean and high-level disinfect the elevator channel present in endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and endoscopic ultrasound with linear array endoscopes. Processing the endoscope elevator channel presents unique challenges to ensure the mechanism has been thoroughly precleaned at the point of use, cleaned, disinfected, and thoroughly dried before storage.1
PLANNED APPROACH TO MEET THE CHALLENGE: RISK ASSESSMENT
The mechanical structure of the elevator channel can potentially harbor bacteria, which may be capable of forming biofilms if there is a failure to clean the remote space behind the elevator channel. Each of the recent outbreaks had commonalities: Enterobacteriaceae microorganisms were identified as the infective agent, no breach was identified in reprocessing, a standard high-level disinfection process was used, the facilities conducted postexposure patient notification and testing, and a variety of interventions were implemented to halt the outbreak and help ensure safety with ERCP procedures. Various regulatory agencies, professional organizations, and manufacturers have gathered to address the challenges that perioperative managers and clinicians face in reprocessing
Ultimately, managers at health care facilities where reprocessing of endoscopes is performed need to conduct a risk assessment of these procedures. The risk assessment should include a process review of each stage involved in cleaning and disinfection and focus on variables such as volume of procedures performed, type of endoscope, inventory control, service support, adherence to manufacturers’ instructions for use, automated endoscopic reprocessor compatibility, cleaning supplies, chemical disinfectant, storage, and education and competency of health care workers performing high-level disinfection. The assessment of reprocessing adequacy is problematic. Should the focus be on how the endoscope is cleaned before disinfection? Should a quality control measure be added to the manual cleaning process to measure the adequacy of cleaning? What type of validation tool should be used? Should microbiological cultures or ATP sampling (ie, adenosine triphosphate indicator for protein material) be performed?
CURRENT OPTIONS FOR PROCESS AND VALIDATION CONTROL Currently, sterilization methodology is a common topic of conversation. Reprocessing pitfalls with processing duodenoscopes http://dx.doi.org/10.1016/j.aorn.2015.10.018 ª AORN, Inc, 2015
588 j AORN Journal
www.aornjournal.org
Timeline
Place
Microorganism Recovered From Patients
Recovered From Duodenoscope
Number of Number of Patients Patients Exposed Positive
Process Interventions to Resolve Outbreak
Rotterdam, Netherlands
P aeruginosa (drug-resistant strain VIM-2)
P aeruginosa (VIM-2) from recess under the forceps elevator
NA
24
Withdrawal of using newly designed duodenoscope
December 6, 2012, and January 10, 20132
Berlin, Germany
K pneumoniae (drug-resistant strain OXA-48)
Enterococci
NA
12
Maintenance revealed defects of the external layers and the distal cap of the duodenoscope; accurate manual brushing and locking of the forceps elevator at 45 before automated reprocessing
January 2013 to December 20133
Illinois, USA
E coli (drug-resistant strain New Delhi metallo-betalactamase )
E coli (NDM) and K pneumoniae from terminal part (around enclosed elevator mechanism)
226
39
HLD followed by ethylene oxide sterilization and routine scope culturing
June 2008 to January 20094
Florida, USA
K pneumoniae
E coli (CRE) from elevator area
51
7
Additional manual cleaning
October 2014 to January 20155
California, USA
CRE
NA
179
7
HLD followed by ethylene oxide sterilization
20156
North Carolina, USA
CRE
NA
18
7
HLD followed by ethylene oxide sterilization
August 2014 to January 20157
California, USA
CRE
135
67
4
Enhanced monitoring techniques involving microscopic laboratory analysis (including cultures) of the duodenoscopes both before and after procedures; cleaning and HLD as recommended by the manufacturer
AORN Journal j 589
(continued)
Special Report: Sterilization and High-Level Disinfection
January 2012 to April 20121
December 2015, Vol. 102, No. 6
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Table 1. Epidemiology-Linked Outbreaks to Endoscopy Suites
Timeline
Place
Microorganism Recovered From Patients
Recovered From Duodenoscope
Number of Number of Patients Patients Positive Exposed
Process Interventions to Resolve Outbreak
2011 to 20128
Pennsylvania, USA
CRE
K pneumoniae from ERCP; carbapenemsusceptible K pneumoniae from EUS
68
NA
Ethylene oxide and routine scope culturing
November 2012 to January 20149
Washington, USA
CRE
CRE
NA
35
Quarantine scopes for two days and culture test; increase scope inventory
Hohenberger et al
590 j AORN Journal
Table 1. (continued )
CRE ¼ carbapenem-resistant Enterobacteriaceae; E ¼ Escherichia; ERCP ¼ endoscopic retrograde cholangiopancreatography; EUS ¼ endoscopic ultrasound; HLD ¼ high-level disinfection; K ¼ Klebsiella; NA ¼ not available; NDM ¼ New Delhi Metallo-beta-lactamase enzyme that breaks down carbapenem antibiotics; OXA-48 ¼ enzyme that can breakdown penicillin and carbapenem antibiotics; P ¼ Pseudomonas; VIM-2 ¼ an enzyme VIM (Verona Integron-Mediated Metallo-b-lacatamse) that breaks down carbapenem antibiotics, making them ineffective, and has been reported in Pseudomonas. References 1. Verfaillie C, Bruno M, Poley JW, et al. Withdrawal of a duodenoscope stops outbreak by a Vim-2 Pseudomonas aeruginosa [Abstract K-1685]. 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 6-9, 2014; Washington, DC. http://www.icaaconline.com/php/icaac2014abstracts/data/index.htm. Accessed September 10, 2015. 2. Kola A, Piening B, Pape UF, et al. An outbreak of carbapenem-resistant OXA-48eproducing Klebsiella pneumonia associated to duodenoscopy. Antimicrob Resist Infect Control. 2015,4:8. 3. Epstein L, Hunter JC, Arwady MA, et al. New Delhi metallo-b-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA. 2014;312(14):1447-1455. 4. Alrabaa SF, Nquyen P, Sanderson R. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control. 2013;41(6):562-564. 5. CDC statement: Los Angeles County/UCLA investigation of CRE transmission and duodenoscopes. February 20, 2015. http://www.cdc.gov/hai/outbreaks/cdcstatement-LA-CRE.html. Accessed November 8, 2015. 6. Pyrek KM. Latest outbreak reminds us of reprocessing imperatives, prompts new and pending guidance. Infection Control Today. May 3, 2015. http://www.infectioncontroltoday.com/ articles/2015/05/latest-outbreak-reminds-us-of-reprocessing-imperatives-prompts-new-and-pending-guidance.aspx. Accessed November 8, 2015. 7. Cedars-Sinai reports superbug infections. Mod Healthc. March 5, 2015. http://www.modernhealthcare.com/article/20150305/NEWS/303059971. Accessed September 10, 2015. 8. McCool S, Clarke L, Querry A, et al. Carbapenem-resistant Enterobacteriaceae Klebsiella pneumonia (KP) cluster analysis associated with GI scopes with elevator channel [Abstract]. University of Pennsylvania. http://www.myendosite.com/articles/UPMC1.pdf. Accessed September 10, 2015. 9. CDC Healthcare News. A weekly compilation of clinical laboratory and related information from the division of laboratory systems. January 29, 2015. http://www.cdc.gov/ophss/csels/ dls/healthcare_news_archive/2015/healthcare_news_01292015.html. Accessed November 8, 2015.
December 2015, Vol. 102, No. 6
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Guideline (Year Released)
Cleaning Validation of Endoscope Reprocessing (Culturing, ATP, or Assay)
Sterilization of Elevator Scopes (ie, ECRP, EUS)
All scopes: “The use of methods that are able to quantitatively or chemically detect organic residues that are not detectable using visual inspection should be considered and included in facility policies and procedures on device cleaning.”1(p39)
All scopes: preferred method when allowed by instructions for use.1(p28)
AORN (2008)2
Periodic testing of cleaning methods. Tests not specified. Under review for publication in early 2016.
High-level disinfection or sterilization. Under review for 2016.
American Society for Gastrointestinal Endoscopy (ASGE) (interim dated March 17, 2015)3
Consider culture ATP and assay unresolved.3(p4)
Consider sterilization when allowed per manufacturer’s instructions for use.3(p3)
Centers for Disease Control and Prevention (CDC) (20154 and 20085)
Consider culturing in nonoutbreak settings.4 Recommend culturing in outbreak situations. ATP and assay unresolved issue.4 HICPAC did not recommend institution of routine surveillance culturing in the United States.4
Not addressed in 2015 guidelines; 2008 guidelines: “Process endoscopes (eg, arthroscope, cystoscope, laparoscope) that pass through normally sterile tissue using a sterilization procedure before each use; if this is not feasible, provide at least high-level disinfection.”5(p86)
ECRI (2015)6
Recommend culturing.6(p2) ATP and assay not addressed.
Not addressed.
US Food and Drug Administration7
The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee “discussed the CDC’s interim guidance for surveillance for bacterial contamination of duodenoscopes after reprocessing and concluded the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice.”
“Majority of the panel also believes it is necessary to reclassify duodenoscopes based on the Spaulding Classification from semi-critical to critical and support the move from high level disinfection towards sterilization. Although, some panelists maintained that high level disinfection is adequate, if done properly.”
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Special Report: Sterilization and High-Level Disinfection
American National Standards Institute/ Association for the Advancement of Medical Instrumentation ST91:2015 (2015)1
December 2015, Vol. 102, No. 6
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Table 2. Multiorganization Recommendations for Reprocessing of Endoscopes
Guideline (Year Released)
Cleaning Validation of Endoscope Reprocessing (Culturing, ATP, or Assay)
Sterilization of Elevator Scopes (ie, ECRP, EUS)
Multisociety guidelines (ASGE, Society for Healthcare Epidemiology of America, Association for Professionals in Infection Control and Epidemiology) (2011)8
All scopes: unresolved.8(p1075)
Not addressed.
Society of Gastroenterology Nurses and Associates (2013)9
Not addressed.
Not within the scope of the article.
Hohenberger et al
592 j AORN Journal
Table 2. (continued )
ATP ¼ adenosine triphosphate; ERCP ¼ endoscopic retrograde cholangiopancreatography; EUS ¼ endoscopic ultrasound; HICPAC ¼ Healthcare Infection Control Practices Advisory Committee. References 1. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3 2012dComprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2012. 2. Guideline for high-level disinfection. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:601-614. 3. Transmission of CRE bacteria through endoscopic retrograde cholangiopancreatography (ERCP). ASGE’s interim guidance. http://www.tsge.org/index.php?option¼com_lyftenbloggie &view¼entry&category¼legislative&id¼2%3Ainterim-guidance-transmission-of-cre-via-ercp&Itemid¼139. Accessed September 10, 2015. 4. Healthcare-associated infections (HAIs). Interim duodenoscope surveillance protocol interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing. http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html. Accessed September 10, 2015. 5. Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_ 2008.pdf. Accessed October 20, 2015. 6. CRE and Duodenoscope Resource Center. Guidance on reprocessing of ERCP endoscopes linked to the superbug outbreak. https://www.ecri.org/resource-center/Pages/Superbug .aspx. Accessed September 10, 2015. 7. FDA Executive Summary. Effective reprocessing of endoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. http://www.fda.gov/downloads/Advisory Committees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445592.pdf. Accessed September 10, 2015. 8. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. http://www.asge.org/uploadedFiles/Public_E-Blast_PDFs/ReprocessingEndoscopes.pdf. Accessed September 10, 2015. 9. Guideline for use of high level disinfectants & sterilants for reprocessing flexible gastrointestinal endoscopes. http://www.sgna.org/Portals/0/Education/PDF/Standards-Guidelines/ SGNA_HLDGuideline13.pdf. Accessed September 10, 2015.
December 2015, Vol. 102, No. 6
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December 2015, Vol. 102, No. 6
Special Report: Sterilization and High-Level Disinfection
Table 3. Timeline of Regulatory and Health Care Organization Response to CRE Outbreaks in 2015 Public News Services
January to February 2015 Three reported CRE outbreaks in US hospitals
US Food and Drug Administration (FDA)
Feb. 19, 2015 Issues safety alert for duodenoscopes (ERCP endoscopes)
Association for Professionals in Infection Control and Epidemiology (APIC) and Society for Healthcare Epidemiology of America (SHEA)
Feb. 24, 2015 Statement issued
Public News Services
March 2015 Another reported CRE outbreak in a US hospital
ERCI
March 3, 2015 High-priority hazard report
FDA
March 4, 2015 ERCP duodenoscopes: FDA safety communicationdDesign may impede effective cleaning
Centers for Disease Control and Prevention (CDC) Interim Duodenoscope Guidelines
March 12, 2015 Interim duodenoscope guidelines issued
American Society for Gastrointestinal Endoscopy (ASGE) Interim Guidance
March 17, 2015 Interim guidance issued
Olympus
March 26, 2015 Urgent safety notification; update on how to clean scopes
ASGE, FDA, CDC, American Gastroenterological Association (AGA)
March 30, 2015 Duodenoscope Infection Control Summit
Centers for Medicare & Medicaid Services (CMS)
April 3, 2015 CMS alert related to outbreaks of CRE during ERCP (surveyor memo)
American Society for Microbiology (ASM) Public and Scientific Affairs Board (PSAB) Laboratory Practices Committee
April 9, 2015 Prepares report on culturing of duodenoscopes
Public News Services
April 15, 2015 Reports to federal government on deadly bacterial outbreaks arrived late
FDA Advisory Panel
May 15, 2015 Call for mandatory sterilization of duodenoscopes
Association for the Advancement of Medical Instrumentation (AAMI)
May 26, 2015 ST91:2015: Flexible and semirigid endoscope processing in health care facilities released
CRE ¼ carbapenem-resistant Enterobacteriaceae; ERCP ¼ endoscopic retrograde cholangiopancreatography.
are in part caused by a lack of defined protocols and availability of ethylene oxide sterilizers. William A. Rutala, PhD, MS, MPH, director of the Statewide Program for Infection Control and Epidemiology and director of Hospital Epidemiology, Occupational Health and Safety Program, Chapel Hill, North Carolina, has recommended a list of options ranked according to priority for hospitals performing ERCP:
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high-level disinfection followed by ethylene oxide sterilization and then periodic microbiologic surveillance, high-level disinfection twice and then periodic microbiologic surveillance, high-level disinfection with scope quarantine until a negative culture is achieved, liquid chemical sterilant reprocessing with peracetic acid followed by rinsing with copious amounts of potable water and then periodic microbiologic surveillance, and
AORN Journal j 593
Hohenberger et al
high-level disinfection followed by periodic microbiologic surveillance.3 In regard to periodic or routine culturing of duodenoscopes, there is a lack of consensus about how best to use cultures to validate cleaning and disinfection practices. The US Food and Drug Administration has asked the American Society for Microbiology to convene experts and develop a protocol for the validation of an endoscope culturing method.4
OUTBREAK MANAGEMENT AND TRANSPARENCY In the event of an outbreak, it is important to remember that each health care organization has an interdepartmental team that includes a variety of networking services to assist during an outbreak event. Internal resources for the investigation team include physicians, nurses, infection preventionists, and personnel from infectious disease, laboratory, risk management, administration, public relations, environmental services, and sterile processing departments. External resources include local and state health departments, professional organizations (eg, AORN, Association for Professionals in Infection Control and Epidemiology, Society of Gastroenterology Nurses and Associates, Association for the Advancement of Medical Instrumentation, manufacturers, and federal and regulatory agencies [eg, Centers for Disease Control and Prevention, US Environmental Protection Agency, US Food and Drug Administration]). The 10-step approach for outbreak investigations is as follows: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
identify the facility’s investigation team and resources, establish the existence of the outbreak, verify the diagnosis, develop the case definition, conduct case finding and line listing, use descriptive epidemiology and develop a hypothesis, conduct additional studies and evaluate the hypothesis, implement control and prevention measures, communicate, and maintain surveillance5
Transparent communication with patients is a key factor in an outbreak investigation. Providing patients with information about the potential aftermath of acquiring an infection and discussing the procedures and resources available to them for help accomplishing the recommended follow-up screening associated with an outbreak (eg, transportation, testing, verbal and written notification of test results) are just
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some of the key elements. Conducting an epidemiologicallinked surveillance of potentially exposed patients often can provide the link in an investigation, especially when using laboratory molecular typing tools (eg, pulse-field gel electrophoresis, genomic sequencing) to find genetic commonalities.6
FUTURE DEVELOPMENTS There is a growing impetus to move away from high-level disinfection and toward actual endoscope sterilization. A recent study suggests that the problems identified with elevator scopes may not be limited and may not be uniquedthey may also affect other types of scopes.7 Additional research is needed to identify the best sterilization methods that will not affect the integrity of the materials that comprise the endoscopes. Additional research related to persistent biofilm on the device’s internal channel may lead to methods for eliminating the conditions leading to the development of biofilm. Innovations are needed in device design to include disposable, single-use parts and overall improved design to eliminate problematic recesses in the equipment making it difficult to clean and disinfect.3 Other possible alternatives could include the development of less invasive methods such as capsule endoscopy, blood tests, and stool DNA tests.3
References 1. Edmiston C, Spencer M. Endoscope reprocessing in 2014: why is the margin of safety so small? AORN J. 2014;100(6):609-615. 2. Interim Duodenoscope Surveillance Protocol. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cre/ cre-duodenoscope-surveillance-protocol.html. Accessed October 22, 2015. 3. Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol. 2015;36(6):643-648. 4. FDA invites ASM to expand duodenoscope culture standards. Microbe. 2015;10(7):297. 5. Moore Z. Outbreak investigations: the 10-step approach. North Carolina Division of Public Health. http://epi.publichealth.nc.gov/cd/ lhds/manuals/cd/training/Module_1_1.6_ppt_OutbreakInvestigation .pdf. Accessed September 10, 2015. 6. 2012 CRE toolkitdguidance for control of carbapenem-resistant Enterobacteriaceae (CRE). Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cre/cre-toolkit/index .html. Accessed September 10, 2015. 7. Ofstead CL, Wetzler HP, Doyle EM, et al. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. Am J Infect Control. 2015;43(8):794-801.
www.aornjournal.org
December 2015, Vol. 102, No. 6
Special Report: Sterilization and High-Level Disinfection
Heather Hohenberger, BSN, RN, CIC, CNOR,
Linda Stein, RN, MPH, CIC, is a manager of
CPHQ, is an infection preventionist and a perioperative quality improvement consultant at Indiana University Health, Indianapolis, IN. Ms Hohenberger has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Epidemiology and Infection Control at Advocate Good Shepard Hospital, Lake Barrington, IL. Ms Stein has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Frank Myers, MA, CIC, is an infection preventionist at Marguerite Gribogiannis, MPA, CIC, is an infection preventionist at Advocate Lutheran General Hospital, Park Ridge, IL. Ms Gribogiannis has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
www.aornjournal.org
UC San Diego Health System, San Diego, CA. Mr Myers has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
AORN Journal j 595
Sterilization and High-Level Disinfection Update HEATHER HOHENBERGER, BSN, RN, CIC, CNOR, CPHQ; MARGUERITE GRIBOGIANNIS, MPA, CIC; LINDA STEIN, RN, MPH, CIC; FRANK MYERS, MA, CIC
D
uring the past year, health care clinicians in the United States have reported a number of outbreaks of multidrug-resistant microorganisms, in particular, carbapenemase-producing Enterobacteriaceae (Table 1). Epidemiological investigations at each institution cited no breaches in reprocessing procedures.
endoscopes engineered with an elevator channel (eg, ERCP, endoscopic ultrasound with linear array) (Table 2). There is still much discussion on how best to guide users. Primary resources include the Centers for Disease Control and Prevention interim duodenoscope guidelines and current manufacturers’ instructions for use (Table 3).2
The source of the outbreaks has been attributed to the inability to adequately clean and high-level disinfect the elevator channel present in endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and endoscopic ultrasound with linear array endoscopes. Processing the endoscope elevator channel presents unique challenges to ensure the mechanism has been thoroughly precleaned at the point of use, cleaned, disinfected, and thoroughly dried before storage.1
PLANNED APPROACH TO MEET THE CHALLENGE: RISK ASSESSMENT
The mechanical structure of the elevator channel can potentially harbor bacteria, which may be capable of forming biofilms if there is a failure to clean the remote space behind the elevator channel. Each of the recent outbreaks had commonalities: Enterobacteriaceae microorganisms were identified as the infective agent, no breach was identified in reprocessing, a standard high-level disinfection process was used, the facilities conducted postexposure patient notification and testing, and a variety of interventions were implemented to halt the outbreak and help ensure safety with ERCP procedures. Various regulatory agencies, professional organizations, and manufacturers have gathered to address the challenges that perioperative managers and clinicians face in reprocessing
Ultimately, managers at health care facilities where reprocessing of endoscopes is performed need to conduct a risk assessment of these procedures. The risk assessment should include a process review of each stage involved in cleaning and disinfection and focus on variables such as volume of procedures performed, type of endoscope, inventory control, service support, adherence to manufacturers’ instructions for use, automated endoscopic reprocessor compatibility, cleaning supplies, chemical disinfectant, storage, and education and competency of health care workers performing high-level disinfection. The assessment of reprocessing adequacy is problematic. Should the focus be on how the endoscope is cleaned before disinfection? Should a quality control measure be added to the manual cleaning process to measure the adequacy of cleaning? What type of validation tool should be used? Should microbiological cultures or ATP sampling (ie, adenosine triphosphate indicator for protein material) be performed?
CURRENT OPTIONS FOR PROCESS AND VALIDATION CONTROL Currently, sterilization methodology is a common topic of conversation. Reprocessing pitfalls with processing duodenoscopes http://dx.doi.org/10.1016/j.aorn.2015.10.018 ª AORN, Inc, 2015
588 j AORN Journal
www.aornjournal.org
Timeline
Place
Microorganism Recovered From Patients
Recovered From Duodenoscope
Number of Number of Patients Patients Exposed Positive
Process Interventions to Resolve Outbreak
Rotterdam, Netherlands
P aeruginosa (drug-resistant strain VIM-2)
P aeruginosa (VIM-2) from recess under the forceps elevator
NA
24
Withdrawal of using newly designed duodenoscope
December 6, 2012, and January 10, 20132
Berlin, Germany
K pneumoniae (drug-resistant strain OXA-48)
Enterococci
NA
12
Maintenance revealed defects of the external layers and the distal cap of the duodenoscope; accurate manual brushing and locking of the forceps elevator at 45 before automated reprocessing
January 2013 to December 20133
Illinois, USA
E coli (drug-resistant strain New Delhi metallo-betalactamase )
E coli (NDM) and K pneumoniae from terminal part (around enclosed elevator mechanism)
226
39
HLD followed by ethylene oxide sterilization and routine scope culturing
June 2008 to January 20094
Florida, USA
K pneumoniae
E coli (CRE) from elevator area
51
7
Additional manual cleaning
October 2014 to January 20155
California, USA
CRE
NA
179
7
HLD followed by ethylene oxide sterilization
20156
North Carolina, USA
CRE
NA
18
7
HLD followed by ethylene oxide sterilization
August 2014 to January 20157
California, USA
CRE
135
67
4
Enhanced monitoring techniques involving microscopic laboratory analysis (including cultures) of the duodenoscopes both before and after procedures; cleaning and HLD as recommended by the manufacturer
AORN Journal j 589
(continued)
Special Report: Sterilization and High-Level Disinfection
January 2012 to April 20121
December 2015, Vol. 102, No. 6
www.aornjournal.org
Table 1. Epidemiology-Linked Outbreaks to Endoscopy Suites
Timeline
Place
Microorganism Recovered From Patients
Recovered From Duodenoscope
Number of Number of Patients Patients Positive Exposed
Process Interventions to Resolve Outbreak
2011 to 20128
Pennsylvania, USA
CRE
K pneumoniae from ERCP; carbapenemsusceptible K pneumoniae from EUS
68
NA
Ethylene oxide and routine scope culturing
November 2012 to January 20149
Washington, USA
CRE
CRE
NA
35
Quarantine scopes for two days and culture test; increase scope inventory
Hohenberger et al
590 j AORN Journal
Table 1. (continued )
CRE ¼ carbapenem-resistant Enterobacteriaceae; E ¼ Escherichia; ERCP ¼ endoscopic retrograde cholangiopancreatography; EUS ¼ endoscopic ultrasound; HLD ¼ high-level disinfection; K ¼ Klebsiella; NA ¼ not available; NDM ¼ New Delhi Metallo-beta-lactamase enzyme that breaks down carbapenem antibiotics; OXA-48 ¼ enzyme that can breakdown penicillin and carbapenem antibiotics; P ¼ Pseudomonas; VIM-2 ¼ an enzyme VIM (Verona Integron-Mediated Metallo-b-lacatamse) that breaks down carbapenem antibiotics, making them ineffective, and has been reported in Pseudomonas. References 1. Verfaillie C, Bruno M, Poley JW, et al. Withdrawal of a duodenoscope stops outbreak by a Vim-2 Pseudomonas aeruginosa [Abstract K-1685]. 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 6-9, 2014; Washington, DC. http://www.icaaconline.com/php/icaac2014abstracts/data/index.htm. Accessed September 10, 2015. 2. Kola A, Piening B, Pape UF, et al. An outbreak of carbapenem-resistant OXA-48eproducing Klebsiella pneumonia associated to duodenoscopy. Antimicrob Resist Infect Control. 2015,4:8. 3. Epstein L, Hunter JC, Arwady MA, et al. New Delhi metallo-b-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA. 2014;312(14):1447-1455. 4. Alrabaa SF, Nquyen P, Sanderson R. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control. 2013;41(6):562-564. 5. CDC statement: Los Angeles County/UCLA investigation of CRE transmission and duodenoscopes. February 20, 2015. http://www.cdc.gov/hai/outbreaks/cdcstatement-LA-CRE.html. Accessed November 8, 2015. 6. Pyrek KM. Latest outbreak reminds us of reprocessing imperatives, prompts new and pending guidance. Infection Control Today. May 3, 2015. http://www.infectioncontroltoday.com/ articles/2015/05/latest-outbreak-reminds-us-of-reprocessing-imperatives-prompts-new-and-pending-guidance.aspx. Accessed November 8, 2015. 7. Cedars-Sinai reports superbug infections. Mod Healthc. March 5, 2015. http://www.modernhealthcare.com/article/20150305/NEWS/303059971. Accessed September 10, 2015. 8. McCool S, Clarke L, Querry A, et al. Carbapenem-resistant Enterobacteriaceae Klebsiella pneumonia (KP) cluster analysis associated with GI scopes with elevator channel [Abstract]. University of Pennsylvania. http://www.myendosite.com/articles/UPMC1.pdf. Accessed September 10, 2015. 9. CDC Healthcare News. A weekly compilation of clinical laboratory and related information from the division of laboratory systems. January 29, 2015. http://www.cdc.gov/ophss/csels/ dls/healthcare_news_archive/2015/healthcare_news_01292015.html. Accessed November 8, 2015.
December 2015, Vol. 102, No. 6
www.aornjournal.org
Guideline (Year Released)
Cleaning Validation of Endoscope Reprocessing (Culturing, ATP, or Assay)
Sterilization of Elevator Scopes (ie, ECRP, EUS)
All scopes: “The use of methods that are able to quantitatively or chemically detect organic residues that are not detectable using visual inspection should be considered and included in facility policies and procedures on device cleaning.”1(p39)
All scopes: preferred method when allowed by instructions for use.1(p28)
AORN (2008)2
Periodic testing of cleaning methods. Tests not specified. Under review for publication in early 2016.
High-level disinfection or sterilization. Under review for 2016.
American Society for Gastrointestinal Endoscopy (ASGE) (interim dated March 17, 2015)3
Consider culture ATP and assay unresolved.3(p4)
Consider sterilization when allowed per manufacturer’s instructions for use.3(p3)
Centers for Disease Control and Prevention (CDC) (20154 and 20085)
Consider culturing in nonoutbreak settings.4 Recommend culturing in outbreak situations. ATP and assay unresolved issue.4 HICPAC did not recommend institution of routine surveillance culturing in the United States.4
Not addressed in 2015 guidelines; 2008 guidelines: “Process endoscopes (eg, arthroscope, cystoscope, laparoscope) that pass through normally sterile tissue using a sterilization procedure before each use; if this is not feasible, provide at least high-level disinfection.”5(p86)
ECRI (2015)6
Recommend culturing.6(p2) ATP and assay not addressed.
Not addressed.
US Food and Drug Administration7
The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee “discussed the CDC’s interim guidance for surveillance for bacterial contamination of duodenoscopes after reprocessing and concluded the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice.”
“Majority of the panel also believes it is necessary to reclassify duodenoscopes based on the Spaulding Classification from semi-critical to critical and support the move from high level disinfection towards sterilization. Although, some panelists maintained that high level disinfection is adequate, if done properly.”
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American National Standards Institute/ Association for the Advancement of Medical Instrumentation ST91:2015 (2015)1
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Table 2. Multiorganization Recommendations for Reprocessing of Endoscopes
Guideline (Year Released)
Cleaning Validation of Endoscope Reprocessing (Culturing, ATP, or Assay)
Sterilization of Elevator Scopes (ie, ECRP, EUS)
Multisociety guidelines (ASGE, Society for Healthcare Epidemiology of America, Association for Professionals in Infection Control and Epidemiology) (2011)8
All scopes: unresolved.8(p1075)
Not addressed.
Society of Gastroenterology Nurses and Associates (2013)9
Not addressed.
Not within the scope of the article.
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Table 2. (continued )
ATP ¼ adenosine triphosphate; ERCP ¼ endoscopic retrograde cholangiopancreatography; EUS ¼ endoscopic ultrasound; HICPAC ¼ Healthcare Infection Control Practices Advisory Committee. References 1. ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3 2012dComprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2012. 2. Guideline for high-level disinfection. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:601-614. 3. Transmission of CRE bacteria through endoscopic retrograde cholangiopancreatography (ERCP). ASGE’s interim guidance. http://www.tsge.org/index.php?option¼com_lyftenbloggie &view¼entry&category¼legislative&id¼2%3Ainterim-guidance-transmission-of-cre-via-ercp&Itemid¼139. Accessed September 10, 2015. 4. Healthcare-associated infections (HAIs). Interim duodenoscope surveillance protocol interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing. http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html. Accessed September 10, 2015. 5. Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_ 2008.pdf. Accessed October 20, 2015. 6. CRE and Duodenoscope Resource Center. Guidance on reprocessing of ERCP endoscopes linked to the superbug outbreak. https://www.ecri.org/resource-center/Pages/Superbug .aspx. Accessed September 10, 2015. 7. FDA Executive Summary. Effective reprocessing of endoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. http://www.fda.gov/downloads/Advisory Committees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445592.pdf. Accessed September 10, 2015. 8. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. http://www.asge.org/uploadedFiles/Public_E-Blast_PDFs/ReprocessingEndoscopes.pdf. Accessed September 10, 2015. 9. Guideline for use of high level disinfectants & sterilants for reprocessing flexible gastrointestinal endoscopes. http://www.sgna.org/Portals/0/Education/PDF/Standards-Guidelines/ SGNA_HLDGuideline13.pdf. Accessed September 10, 2015.
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Table 3. Timeline of Regulatory and Health Care Organization Response to CRE Outbreaks in 2015 Public News Services
January to February 2015 Three reported CRE outbreaks in US hospitals
US Food and Drug Administration (FDA)
Feb. 19, 2015 Issues safety alert for duodenoscopes (ERCP endoscopes)
Association for Professionals in Infection Control and Epidemiology (APIC) and Society for Healthcare Epidemiology of America (SHEA)
Feb. 24, 2015 Statement issued
Public News Services
March 2015 Another reported CRE outbreak in a US hospital
ERCI
March 3, 2015 High-priority hazard report
FDA
March 4, 2015 ERCP duodenoscopes: FDA safety communicationdDesign may impede effective cleaning
Centers for Disease Control and Prevention (CDC) Interim Duodenoscope Guidelines
March 12, 2015 Interim duodenoscope guidelines issued
American Society for Gastrointestinal Endoscopy (ASGE) Interim Guidance
March 17, 2015 Interim guidance issued
Olympus
March 26, 2015 Urgent safety notification; update on how to clean scopes
ASGE, FDA, CDC, American Gastroenterological Association (AGA)
March 30, 2015 Duodenoscope Infection Control Summit
Centers for Medicare & Medicaid Services (CMS)
April 3, 2015 CMS alert related to outbreaks of CRE during ERCP (surveyor memo)
American Society for Microbiology (ASM) Public and Scientific Affairs Board (PSAB) Laboratory Practices Committee
April 9, 2015 Prepares report on culturing of duodenoscopes
Public News Services
April 15, 2015 Reports to federal government on deadly bacterial outbreaks arrived late
FDA Advisory Panel
May 15, 2015 Call for mandatory sterilization of duodenoscopes
Association for the Advancement of Medical Instrumentation (AAMI)
May 26, 2015 ST91:2015: Flexible and semirigid endoscope processing in health care facilities released
CRE ¼ carbapenem-resistant Enterobacteriaceae; ERCP ¼ endoscopic retrograde cholangiopancreatography.
are in part caused by a lack of defined protocols and availability of ethylene oxide sterilizers. William A. Rutala, PhD, MS, MPH, director of the Statewide Program for Infection Control and Epidemiology and director of Hospital Epidemiology, Occupational Health and Safety Program, Chapel Hill, North Carolina, has recommended a list of options ranked according to priority for hospitals performing ERCP:
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high-level disinfection followed by ethylene oxide sterilization and then periodic microbiologic surveillance, high-level disinfection twice and then periodic microbiologic surveillance, high-level disinfection with scope quarantine until a negative culture is achieved, liquid chemical sterilant reprocessing with peracetic acid followed by rinsing with copious amounts of potable water and then periodic microbiologic surveillance, and
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high-level disinfection followed by periodic microbiologic surveillance.3 In regard to periodic or routine culturing of duodenoscopes, there is a lack of consensus about how best to use cultures to validate cleaning and disinfection practices. The US Food and Drug Administration has asked the American Society for Microbiology to convene experts and develop a protocol for the validation of an endoscope culturing method.4
OUTBREAK MANAGEMENT AND TRANSPARENCY In the event of an outbreak, it is important to remember that each health care organization has an interdepartmental team that includes a variety of networking services to assist during an outbreak event. Internal resources for the investigation team include physicians, nurses, infection preventionists, and personnel from infectious disease, laboratory, risk management, administration, public relations, environmental services, and sterile processing departments. External resources include local and state health departments, professional organizations (eg, AORN, Association for Professionals in Infection Control and Epidemiology, Society of Gastroenterology Nurses and Associates, Association for the Advancement of Medical Instrumentation, manufacturers, and federal and regulatory agencies [eg, Centers for Disease Control and Prevention, US Environmental Protection Agency, US Food and Drug Administration]). The 10-step approach for outbreak investigations is as follows: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
identify the facility’s investigation team and resources, establish the existence of the outbreak, verify the diagnosis, develop the case definition, conduct case finding and line listing, use descriptive epidemiology and develop a hypothesis, conduct additional studies and evaluate the hypothesis, implement control and prevention measures, communicate, and maintain surveillance5
Transparent communication with patients is a key factor in an outbreak investigation. Providing patients with information about the potential aftermath of acquiring an infection and discussing the procedures and resources available to them for help accomplishing the recommended follow-up screening associated with an outbreak (eg, transportation, testing, verbal and written notification of test results) are just
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some of the key elements. Conducting an epidemiologicallinked surveillance of potentially exposed patients often can provide the link in an investigation, especially when using laboratory molecular typing tools (eg, pulse-field gel electrophoresis, genomic sequencing) to find genetic commonalities.6
FUTURE DEVELOPMENTS There is a growing impetus to move away from high-level disinfection and toward actual endoscope sterilization. A recent study suggests that the problems identified with elevator scopes may not be limited and may not be uniquedthey may also affect other types of scopes.7 Additional research is needed to identify the best sterilization methods that will not affect the integrity of the materials that comprise the endoscopes. Additional research related to persistent biofilm on the device’s internal channel may lead to methods for eliminating the conditions leading to the development of biofilm. Innovations are needed in device design to include disposable, single-use parts and overall improved design to eliminate problematic recesses in the equipment making it difficult to clean and disinfect.3 Other possible alternatives could include the development of less invasive methods such as capsule endoscopy, blood tests, and stool DNA tests.3
References 1. Edmiston C, Spencer M. Endoscope reprocessing in 2014: why is the margin of safety so small? AORN J. 2014;100(6):609-615. 2. Interim Duodenoscope Surveillance Protocol. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cre/ cre-duodenoscope-surveillance-protocol.html. Accessed October 22, 2015. 3. Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol. 2015;36(6):643-648. 4. FDA invites ASM to expand duodenoscope culture standards. Microbe. 2015;10(7):297. 5. Moore Z. Outbreak investigations: the 10-step approach. North Carolina Division of Public Health. http://epi.publichealth.nc.gov/cd/ lhds/manuals/cd/training/Module_1_1.6_ppt_OutbreakInvestigation .pdf. Accessed September 10, 2015. 6. 2012 CRE toolkitdguidance for control of carbapenem-resistant Enterobacteriaceae (CRE). Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cre/cre-toolkit/index .html. Accessed September 10, 2015. 7. Ofstead CL, Wetzler HP, Doyle EM, et al. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. Am J Infect Control. 2015;43(8):794-801.
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Heather Hohenberger, BSN, RN, CIC, CNOR,
Linda Stein, RN, MPH, CIC, is a manager of
CPHQ, is an infection preventionist and a perioperative quality improvement consultant at Indiana University Health, Indianapolis, IN. Ms Hohenberger has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Epidemiology and Infection Control at Advocate Good Shepard Hospital, Lake Barrington, IL. Ms Stein has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Frank Myers, MA, CIC, is an infection preventionist at Marguerite Gribogiannis, MPA, CIC, is an infection preventionist at Advocate Lutheran General Hospital, Park Ridge, IL. Ms Gribogiannis has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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UC San Diego Health System, San Diego, CA. Mr Myers has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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