American Journal of Infection Control 41 (2013) 1188-94
`
`Contents lists available at ScienceDirect
`
`American Journal of Infection Control
`
`j o u r n a l h o m e p a g e : w w w . a j i c j o u r n a l . o r g
`
`American Journal of
`Infection Control
`
`Major article
`Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg
`Alexandra M. Dirlam Langlay PhD a, Cori L. Ofstead MSPH a,*, Natalie J. Mueller MPH a,
`Pritish K. Tosh MD b, Todd H. Baron MD c, Harry P. Wetzler MD, MSPH a
`a Ofstead & Associates, Inc, Saint Paul, MN
`b Division of Infectious Diseases, Mayo Clinic, Rochester, MN
`c Division of Gastroenterology & Hepatology, Mayo Clinic, Rochester, MN
`
`Key Words:
`Instrument cleaning
`Guideline adherence
`High-level disinfection
`Epidemiology
`Colonoscopy
`Multidrug-resistant organisms
`Infection
`
`Background: Most cases of microbial transmission to patients via contaminated endoscopes have
`resulted from nonadherence to reprocessing guidelines. We evaluated the occurrence, features, and
`implications of reprocessing lapses to gauge the nature and breadth of the problem in the context of
`widely available and accepted practice guidelines.
`Methods: We examined peer-reviewed and non-peer-reviewed literature to identify lapses reported in
`North America during 2005 to 2012 resulting in patient exposure to potentially contaminated gastro-
`intestinal endoscopes.
`Results: Lapses occurred in various types of facilities and involved errors in all major steps of reproc-
`essing. Each lapse continued for several months or years until the problem was discovered except for one
`that was described as a single incident. There were significant implications for patients, including
`notification and testing, microbial transmission, and increased morbidity and mortality. Only 1 reproc-
`essing lapse was found in a peer-reviewed journal article, and other incidents were reported in
`governmental reports, legal documents, conference abstracts, and media reports.
`Conclusion: Reprocessing lapses are an ongoing and widespread problem despite the existence of
`guidelines. Lack of publication in peer-reviewed literature contributes to the perception that lapses are
`rare and inconsequential. Reporting requirements and epidemiologic investigations are needed to
`develop better evidence-based policies and practices.
`Copyright Ó 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc.
`Published by Elsevier Inc. All rights reserved.
`
`Gastrointestinal (GI) endoscopes are used in bodily cavities that
`are heavily colonized with microorganisms.1 Proper endoscope
`reprocessing, including thorough cleaning and high-level disin-
`fection (HLD), is necessary between patients to minimize the risk
`of cross contamination.1 Reprocessing guidelines for fiberoptic
`endoscopes were first published in 1978.2 Since then, governmental
`and professional organizations have updated them and developed
`new guidelines for reprocessing specific types of endoscopes.1,3,4
`
`* Address correspondence to Cori L. Ofstead, MSPH, Ofstead & Associates, Inc, 400
`Selby Avenue, Suite V, Blair Arcade West, Saint Paul, MN 55102.
`E-mail address: cori@ofsteadinsights.com (C.L. Ofstead).
`Ofstead & Associates, Inc. has received funding from Johnson & Johnson and 3M
`Company for infection prevention studies. Research reported here was supported
`with internal resources from Ofstead and Mayo Clinic. Outside corporations did not
`have access to data and were not involved in manuscript preparation.
`Conflicts of interest: C.L.O. has received honoraria from Johnson & Johnson
`and 3M Company for speaking engagements related to instrument reprocessing.
`A.M.D.L., C.L.O., N.J.M., and H.P.W. are employed by Ofstead & Associates, Inc. The
`remaining authors disclose no conflicts.
`
`Guideline nonadherence led to the use of improperly reproc-
`essed endoscopes at Veterans Affairs (VA) medical facilities in
`Tennessee, Florida, and Georgia between 2003 and 2009, requiring
`notification of over 10,000 patients.5,6 Other reprocessing lapses
`(“lapses”) have come to light following investigations into facilities’
`practices.5-8 In 2008, the United States Centers for Medicare and
`Medicaid Services (CMS) conducted unannounced inspections of
`infection control practices at 68 ambulatory surgical centers, over
`half of which performed endoscopies.7 Among these facilities, 39
`had deficiencies in infection control serious enough to warrant
`citation, and 19 failed to properly reprocess instruments. In 2010,
`an observational, multisite study revealed that only 48% of 183 GI
`endoscopes were properly reprocessed, even though managers at
`all sites asserted institutional adherence to guidelines and reproc-
`essing personnel were aware of being observed.8 Nonadherence
`was particularly high (99%) when manual methods were used to
`clean endoscopes.8
`A study conducted at Beth Israel Deaconess Medical Center and
`Harvard Medical School
`found that GI endoscopy-associated
`
`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.2013.04.022
`
`GeneriCo, Flat Line Capital
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`A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94
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`1189
`
`complications resulting in an emergency department visit or hos-
`pitalization occurred after approximately 1% of 18,015 outpatient
`including screening colonoscopies.9 Complications
`procedures,
`included fever and other potential signs of infection. Other res-
`earchers have reported numerous cases of postendoscopy infection
`associated with endoscope contamination, including transmission
`of multidrug-resistant organisms (MDROs).2,10-12 Although the risk
`of infection following endoscopy is stated to be extremely remote
`by nearly all major guidelines including the 2008 Centers for
`Disease Control and Prevention/Healthcare Infection Control Prac-
`tices Advisory Committee (CDC/HICPAC) Guideline for Disinfection
`and Sterilization in Healthcare Facilities and the 2011 Multisociety
`Guideline on Reprocessing Flexible GI Endoscopes,1,4 existing risk
`estimates were recently found to be outdated, inaccurate, based on
`flawed methods, and too low.13
`Since the introduction of reprocessing guidelines, there have
`been increases in the volume of endoscopic procedures, the
`complexity of endoscope design, and the economic pressures on
`institutions. Given the current challenges, we evaluated the
`occurrence, features, and implications of recently reported lapses.
`
`METHODS
`
`Searches for scientific, peer-reviewed journal articles describing
`lapses were conducted via PubMed. Internet searches were per-
`formed to identify lapses published in media reports, including
`newspapers, magazines, press releases, or other articles. Govern-
`ment Web sites and reports were also reviewed, including sources
`from state departments of health, the Department of Veterans
`Affairs Office of Inspector General (VAOIG), CDC’s Epidemic Intel-
`ligence Service, and the Food and Drug Administration (FDA).
`Whenever possible, multiple sources were obtained to compile
`information about a lapse because individual documents often
`contained incomplete information.
`We sought to identify lapses reported between January 2005
`and June 2012 in North America. Reports that met these search
`parameters and described a lapse resulting in patient exposure
`to a potentially contaminated GI endoscope were included. Lap-
`ses were defined as any incident involving 1 or more reprocessing
`errors resulting in the exposure of 1 or more patients. Errors
`included nonadherence to cleaning and disinfection guidelines,
`improper use of reprocessing equipment, or inadequate standard
`operating procedures or staff competence records for reproces-
`sing. Endoscopes under consideration included colonoscopes,
`gastroscopes, duodenoscopes (eg, endoscopic retrograde chol-
`angiopancreatography endoscopes), and endoscopes not other-
`wise specified.
`
`RESULTS
`
`Geographic and facility spread
`
`Reported lapses occurred with various GI endoscopes and
`procedures at health care facilities throughout the United States
`and Canada (Tables 1 and 2). Public and private facilities, including
`hospitals, medical centers from large health systems, outpatient
`endoscopy centers, and outpatient surgical centers were involved
`(Tables 1 and 2). In some cases, multiple facilities within the same
`health system were implicated.5,14,15
`
`Sources of reports
`
`Among the lapses identified, only 1 was published in a peer-
`reviewed journal,16 whereas all others were described in media
`reports and related sources (Table 1) or government reports
`
`(Table 2). Individual government documents and certain media
`reports described lapses at multiple health care facilities, including
`4 reports published by state agencies (Table 2).17-20
`Following the well-publicized lapses at 3 VA medical facilities,
`unannounced inspections of 36 VA medical facilities with 38
`reprocessing units for colonoscopes were conducted by the VAOIG
`in 2009.5 Among these units, 52.6% were found to have inadequate
`standard operating procedures or documentation of demonstrated
`staff competence for reprocessing (Table 2). Since then, the VAOIG
`has continued to monitor facilities and publish reviews that indicate
`whether processes are in place to ensure effective reprocessing.
`These recent reviews described additional lapses in the reprocessing
`of reusable medical equipment, including GI endoscopes.
`Lapses were also readily identifiable in the FDA’s Manufacturer
`and User Facility Device Experience (MAUDE) database, which
`consists of adverse event reports involving medical devices. These
`are voluntary reports or other reports submitted by device manu-
`facturers, distributors, and health care facilities, typically following
`device malfunction or incidents resulting in serious patient injury
`or death. Recent MAUDE reports described postendoscopy com-
`plications, including infections or chemical colitis, attributed to
`reprocessing errors or defective equipment that was undetected
`prior to patient use. When the FDA reviewed MAUDE reports on
`endoscopes filed between January 1, 2007, and May 11, 2010, the
`agency found 80 reports of lapses and 28 reports of infection
`possibly because of inadequate reprocessing (Table 2).21 Supple-
`mental data and references documenting lapses described in
`MAUDE and VAOIG reports are available from the authors on
`request.
`
`Duration and nature of errors
`
`Reports described errors in each of the major reprocessing steps,
`whereas general noncompliance with guidelines and manufacturer
`protocols was also cited. Steps were skipped or done improperly for
`entire endoscopes as well as for certain channels (Tables 1 and 2).
`Only 1 lapse was described as a single incident,22 whereas multiple
`lapses continued for several years, exposing numerous patients to
`potentially contaminated endoscopes.23-27 In some cases, the lapse
`duration was unknown, either because it was not disclosed or
`because investigators were unable to determine when the prob-
`lems started.28,29
`Many lapses were identified as a result of surveillance or
`inspections. The single lapse reported in a peer-reviewed journal
`was discovered during surveillance for deviations from reprocess-
`ing protocols.16 Government reports also described improper
`reprocessing practices identified through inspections or mandatory
`adverse event reports.17,18 Generally, states having multiple lapses,
`such as Pennsylvania, New Jersey, and California, had mandatory
`patient safety reporting requirements, whereas other states may
`not gather data or publicly report lapses.
`Improper cleaning occurred on multiple occasions, and
`employees detected visually apparent residual matter on endo-
`scopes during several of these lapses.18,30-34 At 3 hospitals, residue
`on duodenoscopes was associated with bacterial infections.31,34 At
`one of the hospitals, guidelines were violated over a period of 20
`months when contaminated duodenoscopes were allowed to dry
`before cleaning.30,35 MAUDE reports described multiple lapses
`involving detection of debris or residue in various endoscope
`channels or components. Other lapses described in MAUDE reports
`involved broken cleaning brushes that were left in endoscopes and
`found during subsequent procedures, occasionally after being
`expelled into patients.
`Errors in disinfection often involved lack of HLD for entire endo-
`scopes or certain channels.16,18,19,23,36-39 For example, endoscopes at
`
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`1190
`
`Estimated
`duration
`of lapse
`5 months
`
`Estimated patients
`
`Exposed
`10
`
`Notified
`Yes
`
`Tested
`Yes (viral)
`
`Tested
`positive
`ND
`
`ND
`
`Microorganisms found
`
`Table 1
`Lapses published in media reports and related sources: North America, January 2005-June 2012
`
`Type of health care facility
`Private hospital32,33
`
`Location
`North Carolina
`
`Pub. Year
`2012
`
`Ontario
`
`9 years
`
`6,800
`
`Yes
`
`Yes (viral)
`
`Errors
`Type of endoscope
`GI endoscope NOS No cleaning or sterilization
`for 1 channel
`Outpatient endoscopy
`2011; 2012 GI endoscope NOS Multiple reprocessing
`clinic26,71-73
`and chemical issues
`Academic medical center36,74
`GI endoscope NOS No HLD
`2011
`Louisiana
`Private medical center38,75,76 Oregon
`Colonoscope
`No HLD
`2011
`Academic medical center77-79
`GI endoscope NOS Inadequate HLD temperature
`2011
`Louisiana
`Public hospital30,31,35,80
`British Columbia 2010; 2011 Duodenoscope
`Improper reprocessing; Endoscopes
`allowed to dry before cleaning
`GI endoscope NOS Improper HLD of 1 channel
`
`Minnesota
`
`2010
`
`California
`
`2010
`
`Colonoscope
`
`Improper HLD; Expired disinfectant 16 months
`
`Pennsylvania
`British Columbia
`
`2010
`2010
`
`8 months
`ND
`8 weeks
`20 months
`
`3 years
`
`222
`18
`360
`536
`
`2,600
`
`3,400
`
`75
`9,000
`
`Public hospital and academic
`medical center23,81
`Private medical center,
`hospital, and outpatient
`surgery center14,82,83
`Private hospital24
`Public hospital27,39,84
`
`Yes
`Yes
`Yes
`Yes
`
`Yes (viral)
`Yes (viral)
`Yes (viral)
`Yes (viral)
`
`Yes
`
`No
`
`ND
`ND
`ND
`11
`
`408 Hepatitis B;
`hepatitis C
`ND
`ND
`ND
`Pseudomonas;
`hepatitis C*; HIV*
`ND
`
`ND
`
`Yes
`
`Yes (viral)
`
`ND
`
`ND
`
`Yes
`Yes
`
`Yes
`No
`
`Yes
`
`ND
`ND
`
`ND
`ND
`
`13
`
`A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94
`
`Two county hospitals and
`a regional cancer treatment
`center34,54,56
`
`Florida
`
`GI endoscope NOS Improper HLD of 1 channel
`Colonoscope;
`No HLD for 1 channel
`Gastroscope
`2009; 2010 Duodenoscope
`
`Improper cleaning of elevator
`channel
`
`5 years
`28 months
`8 months
`
`191
`
`Yes
`
`Klebsiella pneumoniae
`(carbapenemase-producing);
`Escherichia coli
`(carbapenemase-producing);
`Pseudomonas aeruginosa;
`Proteus mirabilis; Serratia
`ND
`
`Yes
`
`Yes
`
`ND
`
`ND
`
`ND
`
`ND
`
`ND
`
`Yes
`ND
`
`Yes
`ND
`
`4 years
`
`>1 year
`19 months
`4 months
`10 days
`ND
`
`2,872 (300 due to
`endo-scopes)
`305
`“100s”
`200
`144
`2,116
`
`Yes
`
`Yes (viral)
`
`Yes
`Yes
`Yes
`Yes
`Yes
`
`Yes
`ND
`Yes (viral)
`Yes (viral)
`Yes (viral)
`
`ND
`ND
`
`ND
`
`ND
`ND
`ND
`ND
`ND
`
`ND
`ND
`
`Staphylococcus aureus
`(methicillin-resistant)
`ND
`ND
`ND
`ND
`ND
`
`Georgia
`
`2009; 2010 Colonoscope
`
`Inadequate HLD time
`
`Outpatient surgery
`center41,85,86
`Public hospital44,46
`
`Newfoundland
`and Labrador
`Outpatient surgery center42,87 Nevada
`GI facility NOS22
`U.S. NOS
`
`Public hospital25,50,52,88,89
`
`Alberta
`
`Two private hospitals15,90,91
`Private hospital92
`Private hospital37,93
`Private hospital94
`Private hospital28,95
`
`California
`West Virginia
`Pennsylvania
`Virginia
`California
`
`2009
`
`2007; 2008 Endoscope NOS
`
`GI endoscope NOS Inadequate disinfectant amount;
`AER malfunction
`2008; 2009 GI endoscope NOS Inadequate HLD time
`2008
`Colonoscope
`Improper storage of contaminated,
`damaged endoscope
`Improper cleaning and HLD;
`No disassembly
`Improper reprocessing
`Gastroscope
`Improper HLD
`Endoscope NOS
`No HLD of auxiliary channels
`Colonoscope
`GI endoscope NOS Inadequate HLD time
`GI endoscope NOS Multiple equipment and
`operator issues
`
`2006
`2006
`2005
`2005
`2005
`
`17 months
`
`17 months
`
`2 years
`Single incident
`
`1,300
`
`2,900
`
`ND
`1
`
`AER, automated endoscope reprocessor; GI, gastrointestinal; HLD, high-level disinfection; ND, not disclosed; NOS, not otherwise specified.
`*Indicates previously identified cases that tested positive.
`
`GeneriCo, Flat Line Capital
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`A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94
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`1191
`
`a large medical center received no HLD during an 8-month
`period.36,40 At another large center, HLD was not performed
`on an endoscope channel
`for nearly 3 years because of
`misinformation from the manufacturer.23 MAUDE reports dis-
`cussed incorrect connectors used to attach endoscopes to
`automated endoscope reprocessors (AERs) or flushing aids,
`resulting in no HLD of certain channels. Other failures involved
`inadequate HLD time or temperature41-43 and errors in disin-
`fectant
`concentration or water quality during reprocess-
`ing.14,44,45 At 1 hospital, only 25% of the required amount of
`disinfectant was used over a period of 17 months.46 Expired
`disinfectant was used for over 1 year at each of 4 other
`facilities.14,47 In addition, 1 MAUDE report described a lapse
`where water was used in place of disinfectant, and problems
`with endoscope flushing or rinsing were found when residual
`chemicals caused chemical colitis.
`Improper endoscope storage was also reported.22 One lapse
`involved patient exposure to a damaged, contaminated colono-
`scope that was hung unlabeled in a cabinet with clean endo-
`scopes.22 Other errors involved equipment problems, including
`AER malfunction or incorrect programming.46,48 In some cases,
`inadequate staff training was recognized as an underlying prob-
`lem.5,49 VAOIG investigations revealed insufficient documentation
`of staff competency at several VA medical centers.5 One state
`agency reported receiving 3 notifications when staff knowingly
`used incompletely reprocessed endoscopes on patients.18
`Certain individual
`lapses
`involved multiple reprocessing
`errors.26,30,31,50 At 1 private endoscopy clinic, reprocessing errors
`involved expired chemicals, inadequate cleaning and HLD, and
`cross contamination of clean and dirty endoscopes.26,51 At a large
`general hospital, failure to preclean duodenoscopes contributed to
`problems cleaning them.31,35 Multiple cleaning and HLD errors also
`occurred at another general hospital.25,50,52
`
`Effects on patient safety
`
`The impact of lapses on patient safety was a focus of media
`reports, but not the peer-reviewed journal article or government
`reports, with the exception of MAUDE reports. Lapses discussed in
`the media typically involved exposure and notification of hundreds
`of patients, and several lapses involved more than 1,000 patients
`(Table 1). Patient notification often recommended testing for
`infection transmission; however, testing was typically done only
`for viruses such as HIV, hepatitis B, and hepatitis C rather than for
`enteric pathogens. In 1 lapse at a single provider’s clinic, 6,800
`patients were exposed to potentially contaminated GI endoscopes
`and offered only viral testing.26 In 2 other lapses, thousands of
`patients treated at large medical facilities were notified about the
`lapse but not tested.23,53 In each instance, national health author-
`ities had asserted the risk of disease transmission was too low to
`warrant testing.23,53
`Microorganisms were reported to have been transmitted by
`contaminated endoscopes.31,34 Various types of microorganisms
`and occasionally multiple species were detected, including viruses
`and bacteria (Table 1). Pseudomonas spp was most common, and
`other bacterial pathogens included Serratia spp, Proteus mirabilis,
`and Clostridium difficile (Table 1). One MAUDE report described 9
`patients who acquired C difficile after undergoing procedures with
`an endoscope that was found to have retained debris. Multidrug-
`resistant bacteria,
`including methicillin-resistant Staphylococcus
`aureus (MRSA) and Klebsiella pneumoniae carbapanemase (KPC)-
`producing Klebsiella pneumoniae and Escherichia coli, were detected
`following 2 lapses.25,34 One of these lapses involving a contami-
`nated duodenoscope resulted in 13 cases of multidrug-resistant K
`pneumoniae among 191 endoscopy patients, indicating a 7% attack
`
`Impropersterilizationandreassembly
`
`competenceforreprocessing
`proceduresordocumentationofstaff
`
`Inadequatestandardoperating
`
`incompletelyreprocessedendoscope
`documentation;Knowinglyused
`
`Impropercleaning,HLD,and
`
`waterandcleaningsolution
`
`Improperreprocessing;Unchanged
`Inadequatereprocessing
`
`Inadequatestafftraining
`UsedimproperAERconnector;
`Reprocessingasingle-usedevice;
`
`ImpropercleaningandHLD;
`
`Errors
`
`*Indicatesreports.
`NOTE.SupplementaldataandreferencesdocumentinglapsesdescribedinMAUDEandVAOIGreportsareavailablefromtheauthorsonrequest.
`AER,automatedendoscopereprocessor;GI,gastrointestinal;NA,notapplicable;ND,notdisclosed;NOS,nototherwisespecified;VAOIG,VeteransAffairsOfficeofInspectorGeneral.
`
`GIendoscopeNOS
`
`2007
`
`CADepartmentofHealthServices
`
`California
`
`3
`
`NA
`
`Hospitals19
`
`Colonoscope
`
`2009
`
`MultipleUSstatesVAOIG
`
`20units
`
`38units
`36facilities;
`
`VeteransAffairsmedical
`
`facilities5
`
`Non-GIendoscopes
`
`Gastroscope;EndoscopeNOS;
`
`Colonoscope;EndoscopeNOS
`EndoscopeNOS
`
`2010
`
`2011
`2011
`
`Non-GIendoscopes
`Gastroscope;UpperGIendoscope;
`
`Colonoscope;Duodenoscope;
`Typeofendoscope
`
`2012
`Pub.Year
`
`MNDepartmentofHealth
`Reportingagency
`
`PAPatientSafetyAuthority
`
`Pennsylvania
`
`NJHealthCareQualityInstitute
`FDA
`
`NewJersey
`USNOS
`
`62*
`
`3
`80*
`
`107*
`
`91
`NA
`
`andsurgicalpractices17
`Outpatientsurgerycenters
`ND21
`
`ND18
`
`7lapses;5facilitiesMinnesota
`
`NA
`
`Locations
`
`No.withlapses
`
`inspected
`TotalNo.
`
`Healthcarefacilities
`
`5hospitals20,96
`1outpatientclinic;
`
`1outpatientsurgerycenter;
`Typeofhealthcarefacility
`
`Lapsespublishedingovernmentreports:NorthAmerica,January2005-June2012
`Table2
`
`GeneriCo, Flat Line Capital
`Exhibit 1062 Page 4
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`1192
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`A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94
`
`rate.34,54 Two other lapses were associated with patients who
`tested positive for viruses. In 1 instance, 408 of 4,353 exposed
`patients who underwent laboratory testing for bloodborne patho-
`gens tested positive for hepatitis B or C, including previously
`undiagnosed cases and 20 cases of active infection.26,55 Viral
`transmission was attributed to patient lifestyles, yet reports did not
`provide substantiating data to rule out transmission from con-
`taminated endoscopes.26 In the other instance, 10 patients tested
`positive for hepatitis C and HIV after exposure to a contaminated
`duodenoscope; however, these cases had been previously diag-
`nosed.55 Nonetheless,
`these reports revealed that numerous
`patients were exposed to improperly reprocessed endoscopes that
`had been previously used on patients with viral infections.
`Several
`lapses were associated with serious patient injury.
`On multiple occasions, reprocessing chemicals remaining in endo-
`scopes caused colitis in exposed patients. MAUDE reports described
`a variety of patient complications after exposure to contaminated
`endoscopes, including abdominal pain, inflammation, and bacter-
`emia. In other instances, patients who tested positive for microor-
`ganisms after a lapse required treatment and hospitalization.31,56 At
`1 hospital, an ill patient who had undergone endoscopy with
`a contaminated duodenoscope was hospitalized with a Pseudo-
`monas infection.31 The patient died soon after acquiring the infec-
`tion as a result of the preexisting illness.31 Following another lapse,
`patients who underwent endoscopies and acquired multidrug-
`resistant K pneumoniae were found to have longer hospital stays
`and 5 times higher mortality than other patients.34,54,56
`
`DISCUSSION
`
`By looking beyond peer-reviewed literature for evidence, we
`identified numerous recent reprocessing lapses in North America,
`including several that were associated with patient infection, injury,
`or death.21,31,34,56 Recent lapses have also been reported in other
`countries,10,11,57-61 indicating that improper reprocessing is wide-
`spread and continues to occur despite the existence of reprocessing
`guidelines. Other researchers have acknowledged that most lapses
`never get publicly reported.2,6 Reluctance by institutions to report
`lapses may contribute to the lack of peer-reviewed articles
`describing them. In addition, some journals do not publish case
`reports.62,63 Lack of reporting in peer-reviewed journals contributes
`to the perception that lapses are rare and inconsequential.
`Current endoscopy-associated infection (EAI) risk estimates are
`erroneously based on the number of infections reported in peer-
`reviewed articles.13 As a result, numerous experts and organiza-
`tions have asserted the risk of EAI is virtually nonexistent.1,3,4,12 Based
`on existing estimates, fewer than a dozen EAIs would be expected to
`occur each year in the United States. However, multiple cases of EAI
`resulting from individual lapses have exceeded these estimates,
`indicating current estimates are inaccurate and far too low.13
`Researchers have identified retained debris in lumened instru-
`ments, including endoscopes, as a result of inadequate reprocessing
`and complex device design.64,65 A recent study found that protein
`residue and water remained on endoscope channels even after
`thorough cleaning.66 Studies by Alfa et al found that 14% of patient-
`ready GI endoscopes had bacterial or fungal growth67 and that up
`to 19% of manually cleaned channels tested positive for protein,
`hemoglobin, or carbohydrates.68 Detailed outbreak investigations
`have implicated endoscopes as likely sources of microbial trans-
`mission.10,11,31,34,64 Matching strains of MDROs were collected from
`patients and endoscopes following several of these lapses, indi-
`cating that MDROs may be transmitted by contaminated endo-
`scopes.10,11,34,56 With the exception of methicillin-resistant
`Staphylococcus aureus, the vast majority of MDROs are harbored
`in the GI tract and can be clinically silent for months to years before
`
`causing extraintestinal infection. Endoscopies with contaminated
`devices may place patients at high risk for acquiring MDROs
`because bowel preparation alters colonic microflora,69,70 thereby
`reducing patient resistance to colonization with MDROs.
`At present, there is no central repository for reports on lapses
`and no requirement that local or federal officials maintain records
`or make them available to clinicians, researchers, or policy makers.
`Exposed patients are not routinely recalled for testing because the
`health risks are assumed to be very low.23,27 This leads to a vicious
`cycle whereby institutions do not notify or test patients when
`a lapse is discovered because decision makers rely on erroneous
`risk estimates that have been propagated in the guidelines.
`Mandatory reporting of lapses to a national registry would support
`epidemiologic review and investigation and the consideration of
`new policies based on sound data.
`Adherence to reprocessing guidelines needs to be improved.8 In
`a multisite study that revealed poor adherence, staff reported that
`they did not like to do various reprocessing tasks, felt pressure to
`work quickly, and attributed health problems to working with
`endoscopes.8 The link between reprocessing errors and factors that
`may influence health care worker behavior suggests that training
`and competency testing need to be supplemented with account-
`ability measures and active surveillance of reprocessing effective-
`ness so that contaminated endoscopes can be identified before they
`are used on patients.
`
`Limitations
`
`Because of the lack of a central repository or peer-reviewed
`journal articles describing lapses, ad hoc searches of media,
`government reports, and other online sources were used to identify
`them. Even when multiple reports on individual
`lapses were
`available, the information was frequently incomplete and difficult
`to interpret. Thus, the results of this review may not be generaliz-
`able. Furthermore,
`the information provided in media and
`government reports was neither scrutinized by peer reviewers nor
`edited for technical accuracy or clarity of communication. Data
`were sometimes reported using potentially inaccurate terms (eg,
`sterilization rather than HLD).
`
`Conclusion
`
`Improper endoscope reprocessing is an ongoing and pervasive
`problem that has the potential to cause significant patient harm.
`Reprocessing guidelines should be revised to reflect the true risk of
`transmitting infections, including enteric pathogens and MDROs,
`when lapses occur. These revisions will require additional research
`because the magnitude of risk associated with particular types of
`lapses is unknown. As such, there is a need for a central repository
`of data pertaining to lapses and associated outcomes. Infection
`preventionists should recognize risks associated with improper
`reprocessing and continuously evaluate reprocessing effectiveness
`to ensure that endoscopes are clean and disinfected prior to use on
`every patient.
`
`Acknowledgment
`
`The authors thank Jeremy Ward and Lisa Mattson for the
`research, editorial, and logistical assistance provided.
`
`References
`
`1. Rutala WA, Weber DJ. Healthcare Infection Control Practices Advisory
`Committee (HICPAC). Guideline for disinfection and sterilization in healthcare
`facilities, 2008. Washington [DC]: Department of Health and Human Services;
`2008.
`
`GeneriCo, Flat Line Capital
`Exhibit 1062 Page 5
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`

`
`A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94
`
`1193
`
`2. Spach DH, Silverstein FE, Stamm WE. Transmission of infection by gastroin-
`testinal endoscopy and bronchoscopy. Ann Intern Med 1993;118:117-28.
`3. Society of Gastroenterology Nurses and Associates, Inc. Standards of infection
`control in reprocessing of flexible gastrointestinal endoscopes. Chicago [IL]:
`Society of Gastroenterology Nurses and Associates, Inc; 2012.
`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. Veterans Affairs Office of Inspector General. Use and reprocessing of flexible
`fiberoptic endoscopes at VA medical facilities. Report No.: 09-01784-146.
`Washington [DC]: Department of Veterans Affairs; 2009.
`6. Holodniy M, Oda G, Schirmer PL, Lucero CA, Khudyakov YE, Xia G, et al. Results
`from a large-scale epidemiologic look-back investigation of improperly reproc-
`essed endoscopy equipment. Infect Control Hosp Epidemiol 2012;33:649-56.
`7. 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.
`8. 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.
`9. 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.
`10. Aumeran C, Poincloux L, Souweine B, Robin F, Laurichesse H, Baud O, et al.
`Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retro-
`grade cholangiopancreatography. Endoscopy 2010;42:895-9.
`11. 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 pneu-
`moniae type 2 in France, September to October 2009. Euro Surveill 2010;15:
`1-6.
`12. Nelson DB, Muscarella LF. Current issues in endoscope reprocessing and
`infection control during gastrointestinal endoscopy. World J Gastroenterol
`2006;12:3953-64.
`13. Ofstead CL, Dirlam Langlay AM, Mueller NJ, Tosh PK, Wetzler HP. Re-evaluating
`endoscopy-associated infection risk estimates and their implications. Am J
`Infect Control 2013;41:734-6.
`14. Garrick D. Escondido: PPH testing 3,400 patients when only 45 at risk of
`exposure. The San Diego Union-Tribune; June 15, 2010. Available from: http://
`www.utsandiego.com/news/2010/Jun/15/escondido-pph-testing-3400-patients-
`when-only-45/. Accessed January 21, 2011.
`15. Clark C. Hospital’s surgical tool was improperly sterilized. The San Diego
`Union-Tribune; June 13, 2006. Available from: http://www.utsandiego.com/
`uniontrib/20060613/news_1m13scripps.html. Accessed May 16, 2012.
`16. Kelly LL. When your best is not good enough. Gastroenterol Nurs 2010;33:
`62-4.
`17. New Jersey ambulatory surgery center and surgical practice transparency
`report. Pennington [NJ]: New Jersey Health Care Quality Institute; 2011.
`18. Pennsylvania Patient Safety Authority. The dirt on flexible endoscope reproc-
`essing. Harrisburg [PA]: Pennsylvania Patient Safety Advisory; 2010;7:135-40.
`19. Billingsley K. Inadequate reprocessing of semicritical instruments. Sacramento
`[CA]: California Department