Editorial
483
Author
Ulrike Beilenhoff
Institution
European Society of Gastroenterology and Endoscopy Nurses and Associates, Ulm, Germany
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1392153 Published online: 0.0. Endoscopy 2015; 47: 483–485 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X
Since the late 1970s, there have been sporadic reports of endoscopic transmission of exogenous infections in gastrointestinal endoscopy. The majority of documented cases were the result of noncompliance with national and international guidelines, including [1]: ▶ failures and mistakes in the reprocessing procedure, in combination with inadequate systems of work and insufficient training of staff; ▶ inadequate reprocessing equipment (e. g. inappropriate brushes); ▶ damaged and improperly maintained endoscopes and washer disinfectors; ▶ contaminated environment (e. g. contaminated surfaces, water); ▶ insufficient hand hygiene; ▶ inappropriate administration of intravenous medication. Several endoscopic retrograde cholangiopancreatography (ERCP)-related outbreaks have been reported, caused by insufficiently reprocessed or stored endoscopes, contaminated washer disinfectors, or contaminated surfaces [1]. Infections by multidrug-resistant organisms have become more and more problematic for healthcare services worldwide. In recent years, outbreaks of multidrug-resistant pathogens associated with ERCP procedures have also been reported [2 – 7]. In February 2015, an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) in conjunction with ERCP procedures caused big media attention in the USA [8]. The FDA published several statements to raise awareness among healthcare professionals of the complex design of duodenoscopes that may impede effective reprocessing [8]. The American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA) informed their members accordingly. The outbreak reported by Verfaillie et al. [7] in this issue of Endoscopy gives helpful information
Corresponding author Ulrike Beilenhoff, RN Scientific Secretariat European Society of Gastroenterology and Endoscopy Nurses and Associates Ferdinand-Sauerbruch-Weg 16 89075 Ulm Germany Fax: +49-731-9503958 [email protected]
Please see related article from Verfaillie et al. p. 493.
on how to manage infection outbreaks with the support of a multidisciplinary team. The structured approach can be used by others in similar situations. It also highlights a number of important issues around reprocessing. Despite manufacturers’ responsibilities, what can endoscopy departments do to prevent or manage infectious outbreaks?
Duodenoscopes – special requirements for reprocessing !
Duodenoscopes have a complex design. The sideviewing distal tip and the elevator mechanism have been a challenge for reprocessing since the establishment of ERCP in the 1970s. Currently available designs differ, depending on the manufacturer and the endoscope generation. Duodenoscopes are available with: ▶ a fixed distal end and a rinsable elevator channel; ▶ a fixed distal end and a sealed elevator channel; ▶ a removable distal cap and a rinsable elevator channel; ▶ a removable distal end, which can be dismantled and autoclaved, with a brushable elevator channel. The published outbreaks revealed that correct cleaning of the elevator mechanism is essential [2 – 7]. If the elevator channel is accessible, flushing and brushing during the manual pre-cleaning steps, correct connection of the elevator channel in the washer disinfector, and final thorough drying are essential. Removable distal caps and distal ends make precleaning easier as they enable free access for brushes to the elevator mechanism, but the removable parts need careful reattachment before use.
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
ERCP and reprocessing in focus: what can we do to prevent or manage infection outbreaks?
Editorial
Fixed distal ends demand more accuracy during pre-cleaning, because the narrow lumen behind the elevator is difficult to access with routine cleaning brushes [2 – 7]. Special brushes are needed but these should not cause any damage. Therefore, it is of utmost importance to follow the manufacturer’s recommendations [8]. Only purpose-designed cleaning brushes should be used [2, 8, 9]. In order to avoid “off-label” practice, manufacturers (of endoscopes or cleaning accessories) should provide relevant data about the compatibility of their cleaning devices [2]. Even when automated reprocessing is performed, a thorough manual pre-cleaning is essential, as it is the prerequisite for a satisfactory disinfection [9 – 12]. Staff should be aware of the importance of this step. Any deviation from guidelines and protocols may result in failures of the reprocessing procedure [9 – 12].
Training, awareness, and professional duty !
As reprocessing of medical devices requires specialized knowledge and skills, national and international guidelines recommend that only specially trained and competent staff should carry out the reprocessing of endoscopes [9 – 12]. Many countries have established formal training courses for endoscope reprocessing and systems to assess competency. In addition to general qualifications, reprocessing staff need to be familiar with the specific design of every single endoscope used in a unit, including endoscopes on loan. General reprocessing protocols are not enough. Written reprocessing protocols, based on the manufacturer’s instructions, should be available for each type of endoscope. The majority of published outbreaks have been caused by various deficiencies in reprocessing procedures, which might also be supported by insufficient training or awareness [1, 2]. Physicians, endoscopy nurses and reprocessing staff should be aware of their responsibilities concerning patient safety. If national guidelines and local protocols are not followed strictly, the potential risk of infections increases [2]. Periodic audits of the reprocessing procedure, regular training sessions, and competency assessment are helpful tools to identify deficiencies, to implement improvements, and to ensure up-to-date practice [2, 11]. New designs of endoscopes aim to improve technical features, user convenience, and patient safety. In recent publications, new designs of duodenoscopes were discussed as a potential source of transmission of infectious agents [3 – 7]. If healthcare professionals (physicians, nurses, reprocessing experts) have the impression that new or a changed design hampers safe reprocessing, it is their professional responsibility to contact the manufacturer immediately in order to inform the manufacturer of these difficulties. Manufacturers should provide relevant data about changed designs [2]. Verfaillie et al. demonstrated close cooperation with the manufacturer and relevant bodies in repeated maintenance and technical research [7]. Close cooperation with official bodies, national societies, and manufacturers is essential to manage outbreaks and to learn from them, as well as to implement improvements. Following recent outbreaks, relevant national bodies were involved and
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
raised awareness concerning the newly designed endoscopes; the manufacturer reviewed and modified the reprocessing protocol for the model of duodenoscope [4, 7, 8]. As shown by FDA safety communications, investigations continue [8].
Process validation and microbiological surveillance !
According to the EN ISO 15883 standard, reprocessing processes using washer disinfectors need to be validated. The operational qualification has to be performed with different loads in the specific washer disinfector. The validation of washer disinfectors is a helpful tool to evaluate the reprocessing cycle as a whole [13, 14]. In addition, routine technical tests and microbiological surveillance evaluate the outcome quality and are helpful tools to identify any problems, deficiencies, and weaknesses early [13, 14]. The US bodies responded to the outbreaks [2, 4, 8] and published interim recommendations on microbiological surveillance of duodenoscopes, which do not cover all parts and channels of the endoscope [15]. The European guidelines recommend regular microbiological surveillance every 3 months, and emphasize the need to sample all parts and available channels of an endoscope. Frequency and test procedures are the focus of controversial discussions in various publications and need further research [2, 10 – 12, 16, 17]. In cases of contamination, it is the responsibility of the clinical service provider to take the suspect piece of equipment out of service until corrective actions have been taken and satisfactory results have been achieved [10, 13]. In the outbreak reported by Verfaillie et al., official infection control bodies were involved in this decision [7].
Summary and conclusion !
Reprocessing of duodenoscopes needs special attention. Training of staff, strict adherence to guidelines and reprocessing protocols based on manufactures’ recommendations, as well as regular quality assessment are most important in preventing infection transmission. Clinicians should be encouraged to publish outbreaks of infections, as it provides an opportunity to review and improve daily practice. This should be done in a nonblaming environment in which all parties work together to identify and resolve the problem. Close cooperation between customers, regulatory bodies, and manufacturers is essential in the development of new equipment and in the management of outbreaks. Healthcare professionals and manufacturers should be aware of their responsibility to ensure patient safety. Competing interests: None
References 1 Kovaleva J, Peters FT, van der Mei HC et al. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev 2013; 26: 231 – 254 2 Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy. World J Gastrointest Endosc 2014; 6: 457 – 474
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
484
3 Aumeran C, Poincloux L, Souweine B et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010; 42: 895 – 899 4 Epstein L, Hunter J, Allison A et al. New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014; 312: 1447 – 1455 5 Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated infections: we may only be seeing the tip of the iceberg. Infection 2014; 42: 15 – 21 6 Kola A, Piening B, Pape UF et al. An outbreak of carbapenem-resistant OXA-48-producing Klebsiella pneumonia associated to duodenoscopy. Antimicrob Resist Infect Control 2015; 4: 8 7 Verfaillie CF, Bruno MJ, Voor in ’t holt AF et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy 2015; 47: 493 – 502 8 Food and Drug Administration. Safety communication. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. Issued February and March 2015. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 9 Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline: cleaning and disinfection in gastrointestinal endoscopy. Endoscopy 2008; 40: 939 – 957 10 ASGE and SHEA. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes. Gastrointest Endosc 2011; 73: 1075 – 1084
11 Working Party of the British Society of Gastroenterology Endoscopy Committee. BSG guidance on decontamination of equipment for gastrointestinal endoscopy. June 2014. Available from: http://www.bsg. org.uk/images/stories/docs/clinical/guidelines/endoscopy/decontamination_2014.pdf 12 Professional standard handbook cleaning and disinfection. Flexible endoscopes. Version 3.1, 2014. Available from: http://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook3_1.pdf 13 Beilenhoff U, Neumann CS, Biering H et al. ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy 2007; 39: 85 – 94 14 Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy 2007; 39: 175 – 181 15 Centers for Disease Control and Prevention (CDC). Interim duodenoscope surveillance protocol. Updated April 3, 2015. Available from: http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html 16 Buss AJ, Been MH, Borgers RP et al. Endoscope disinfection and its pitfalls – requirement for retrograde surveillance cultures. Endoscopy 2008; 40: 327 – 332 17 Kovaleva J, Meessen NE, Peters FT et al. Is bacteriologic surveillance in endoscope reprocessing stringent enough? Endoscopy 2009; 41: 913 – 916
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
485
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Editorial
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
483
Author
Ulrike Beilenhoff
Institution
European Society of Gastroenterology and Endoscopy Nurses and Associates, Ulm, Germany
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1392153 Published online: 0.0. Endoscopy 2015; 47: 483–485 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X
Since the late 1970s, there have been sporadic reports of endoscopic transmission of exogenous infections in gastrointestinal endoscopy. The majority of documented cases were the result of noncompliance with national and international guidelines, including [1]: ▶ failures and mistakes in the reprocessing procedure, in combination with inadequate systems of work and insufficient training of staff; ▶ inadequate reprocessing equipment (e. g. inappropriate brushes); ▶ damaged and improperly maintained endoscopes and washer disinfectors; ▶ contaminated environment (e. g. contaminated surfaces, water); ▶ insufficient hand hygiene; ▶ inappropriate administration of intravenous medication. Several endoscopic retrograde cholangiopancreatography (ERCP)-related outbreaks have been reported, caused by insufficiently reprocessed or stored endoscopes, contaminated washer disinfectors, or contaminated surfaces [1]. Infections by multidrug-resistant organisms have become more and more problematic for healthcare services worldwide. In recent years, outbreaks of multidrug-resistant pathogens associated with ERCP procedures have also been reported [2 – 7]. In February 2015, an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) in conjunction with ERCP procedures caused big media attention in the USA [8]. The FDA published several statements to raise awareness among healthcare professionals of the complex design of duodenoscopes that may impede effective reprocessing [8]. The American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA) informed their members accordingly. The outbreak reported by Verfaillie et al. [7] in this issue of Endoscopy gives helpful information
Corresponding author Ulrike Beilenhoff, RN Scientific Secretariat European Society of Gastroenterology and Endoscopy Nurses and Associates Ferdinand-Sauerbruch-Weg 16 89075 Ulm Germany Fax: +49-731-9503958 [email protected]
Please see related article from Verfaillie et al. p. 493.
on how to manage infection outbreaks with the support of a multidisciplinary team. The structured approach can be used by others in similar situations. It also highlights a number of important issues around reprocessing. Despite manufacturers’ responsibilities, what can endoscopy departments do to prevent or manage infectious outbreaks?
Duodenoscopes – special requirements for reprocessing !
Duodenoscopes have a complex design. The sideviewing distal tip and the elevator mechanism have been a challenge for reprocessing since the establishment of ERCP in the 1970s. Currently available designs differ, depending on the manufacturer and the endoscope generation. Duodenoscopes are available with: ▶ a fixed distal end and a rinsable elevator channel; ▶ a fixed distal end and a sealed elevator channel; ▶ a removable distal cap and a rinsable elevator channel; ▶ a removable distal end, which can be dismantled and autoclaved, with a brushable elevator channel. The published outbreaks revealed that correct cleaning of the elevator mechanism is essential [2 – 7]. If the elevator channel is accessible, flushing and brushing during the manual pre-cleaning steps, correct connection of the elevator channel in the washer disinfector, and final thorough drying are essential. Removable distal caps and distal ends make precleaning easier as they enable free access for brushes to the elevator mechanism, but the removable parts need careful reattachment before use.
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
ERCP and reprocessing in focus: what can we do to prevent or manage infection outbreaks?
Editorial
Fixed distal ends demand more accuracy during pre-cleaning, because the narrow lumen behind the elevator is difficult to access with routine cleaning brushes [2 – 7]. Special brushes are needed but these should not cause any damage. Therefore, it is of utmost importance to follow the manufacturer’s recommendations [8]. Only purpose-designed cleaning brushes should be used [2, 8, 9]. In order to avoid “off-label” practice, manufacturers (of endoscopes or cleaning accessories) should provide relevant data about the compatibility of their cleaning devices [2]. Even when automated reprocessing is performed, a thorough manual pre-cleaning is essential, as it is the prerequisite for a satisfactory disinfection [9 – 12]. Staff should be aware of the importance of this step. Any deviation from guidelines and protocols may result in failures of the reprocessing procedure [9 – 12].
Training, awareness, and professional duty !
As reprocessing of medical devices requires specialized knowledge and skills, national and international guidelines recommend that only specially trained and competent staff should carry out the reprocessing of endoscopes [9 – 12]. Many countries have established formal training courses for endoscope reprocessing and systems to assess competency. In addition to general qualifications, reprocessing staff need to be familiar with the specific design of every single endoscope used in a unit, including endoscopes on loan. General reprocessing protocols are not enough. Written reprocessing protocols, based on the manufacturer’s instructions, should be available for each type of endoscope. The majority of published outbreaks have been caused by various deficiencies in reprocessing procedures, which might also be supported by insufficient training or awareness [1, 2]. Physicians, endoscopy nurses and reprocessing staff should be aware of their responsibilities concerning patient safety. If national guidelines and local protocols are not followed strictly, the potential risk of infections increases [2]. Periodic audits of the reprocessing procedure, regular training sessions, and competency assessment are helpful tools to identify deficiencies, to implement improvements, and to ensure up-to-date practice [2, 11]. New designs of endoscopes aim to improve technical features, user convenience, and patient safety. In recent publications, new designs of duodenoscopes were discussed as a potential source of transmission of infectious agents [3 – 7]. If healthcare professionals (physicians, nurses, reprocessing experts) have the impression that new or a changed design hampers safe reprocessing, it is their professional responsibility to contact the manufacturer immediately in order to inform the manufacturer of these difficulties. Manufacturers should provide relevant data about changed designs [2]. Verfaillie et al. demonstrated close cooperation with the manufacturer and relevant bodies in repeated maintenance and technical research [7]. Close cooperation with official bodies, national societies, and manufacturers is essential to manage outbreaks and to learn from them, as well as to implement improvements. Following recent outbreaks, relevant national bodies were involved and
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
raised awareness concerning the newly designed endoscopes; the manufacturer reviewed and modified the reprocessing protocol for the model of duodenoscope [4, 7, 8]. As shown by FDA safety communications, investigations continue [8].
Process validation and microbiological surveillance !
According to the EN ISO 15883 standard, reprocessing processes using washer disinfectors need to be validated. The operational qualification has to be performed with different loads in the specific washer disinfector. The validation of washer disinfectors is a helpful tool to evaluate the reprocessing cycle as a whole [13, 14]. In addition, routine technical tests and microbiological surveillance evaluate the outcome quality and are helpful tools to identify any problems, deficiencies, and weaknesses early [13, 14]. The US bodies responded to the outbreaks [2, 4, 8] and published interim recommendations on microbiological surveillance of duodenoscopes, which do not cover all parts and channels of the endoscope [15]. The European guidelines recommend regular microbiological surveillance every 3 months, and emphasize the need to sample all parts and available channels of an endoscope. Frequency and test procedures are the focus of controversial discussions in various publications and need further research [2, 10 – 12, 16, 17]. In cases of contamination, it is the responsibility of the clinical service provider to take the suspect piece of equipment out of service until corrective actions have been taken and satisfactory results have been achieved [10, 13]. In the outbreak reported by Verfaillie et al., official infection control bodies were involved in this decision [7].
Summary and conclusion !
Reprocessing of duodenoscopes needs special attention. Training of staff, strict adherence to guidelines and reprocessing protocols based on manufactures’ recommendations, as well as regular quality assessment are most important in preventing infection transmission. Clinicians should be encouraged to publish outbreaks of infections, as it provides an opportunity to review and improve daily practice. This should be done in a nonblaming environment in which all parties work together to identify and resolve the problem. Close cooperation between customers, regulatory bodies, and manufacturers is essential in the development of new equipment and in the management of outbreaks. Healthcare professionals and manufacturers should be aware of their responsibility to ensure patient safety. Competing interests: None
References 1 Kovaleva J, Peters FT, van der Mei HC et al. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev 2013; 26: 231 – 254 2 Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy. World J Gastrointest Endosc 2014; 6: 457 – 474
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
484
3 Aumeran C, Poincloux L, Souweine B et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010; 42: 895 – 899 4 Epstein L, Hunter J, Allison A et al. New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014; 312: 1447 – 1455 5 Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated infections: we may only be seeing the tip of the iceberg. Infection 2014; 42: 15 – 21 6 Kola A, Piening B, Pape UF et al. An outbreak of carbapenem-resistant OXA-48-producing Klebsiella pneumonia associated to duodenoscopy. Antimicrob Resist Infect Control 2015; 4: 8 7 Verfaillie CF, Bruno MJ, Voor in ’t holt AF et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy 2015; 47: 493 – 502 8 Food and Drug Administration. Safety communication. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. Issued February and March 2015. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 9 Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline: cleaning and disinfection in gastrointestinal endoscopy. Endoscopy 2008; 40: 939 – 957 10 ASGE and SHEA. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes. Gastrointest Endosc 2011; 73: 1075 – 1084
11 Working Party of the British Society of Gastroenterology Endoscopy Committee. BSG guidance on decontamination of equipment for gastrointestinal endoscopy. June 2014. Available from: http://www.bsg. org.uk/images/stories/docs/clinical/guidelines/endoscopy/decontamination_2014.pdf 12 Professional standard handbook cleaning and disinfection. Flexible endoscopes. Version 3.1, 2014. Available from: http://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook3_1.pdf 13 Beilenhoff U, Neumann CS, Biering H et al. ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy 2007; 39: 85 – 94 14 Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy 2007; 39: 175 – 181 15 Centers for Disease Control and Prevention (CDC). Interim duodenoscope surveillance protocol. Updated April 3, 2015. Available from: http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html 16 Buss AJ, Been MH, Borgers RP et al. Endoscope disinfection and its pitfalls – requirement for retrograde surveillance cultures. Endoscopy 2008; 40: 327 – 332 17 Kovaleva J, Meessen NE, Peters FT et al. Is bacteriologic surveillance in endoscope reprocessing stringent enough? Endoscopy 2009; 41: 913 – 916
Beilenhoff Ulrike. ERCP and reprocessing … Endoscopy 2015; 47: 483–485
485
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Editorial
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
