R E V I E W S & A N A LY S E S Colonoscopy-Associated Perforation: Systematic Review and Meta-Analysis of Incidence and Risk Factors Meredith Noble, MS Editor’s Note Senior Research Analyst, Pennsylvania Patient Safety Authority Perforations of the colon associated with colonoscopy were addressed in an article in the December 2006 issue of the Pennsylvania Patient Safety Advisory. At that time, the analysts noted 125 to152 John R. Clarke, MD perforations reported to the Pennsylvania Patient Safety Authority for a one-year period in Pennsyl- Editor, Pennsylvania Patient Safety Advisory vania. Since then, the number of reports mentioning perforation with colonoscopy has not changed Clinical Director, Pennsylvania Patient Safety Authority greatly. The number for the most recent year is estimated to be in the range of 140 to 170. The Professor of Surgery, Drexel University Authority publishes this meta-analysis to provide facilities with benchmarks to assess their perforation Robert E. Schoen, MD, MPH rates for screening and for diagnostic colonoscopies. Facilities that would like to improve their per- Professor of Medicine and Epidemiology, foration rates may wish to reference a June 2008 Advisory article, “Colon Perforations Complicating University of Pittsburgh Colonoscopies: What is the Best Known Evidence for Prevention?” James C. Reynolds, MD Professor and Chairman of Medicine, Drexel University INTRODUCTION Karen Schoelles, MD, SM Director, Evidence-Based Practice Center, ECRI Institute Colonoscopy is a standard method of screening for colorectal cancer, the second leading cause of cancer death in the United States.1 In the United States in 2009, an estimated 146,970 new cases of colon or rectal cancer were diagnosed, and 49,920 ABSTRACT individuals died.2 Worldwide in 2008, an estimated 695,000 people died from colon or Colonoscopy is an important tool for rectal cancer.3 Early detection of lesions by screening has been shown to reduce mortal- colorectal cancer screening and diag- ity from colorectal cancer.4,5 nosis, but reports of the incidence of Colonoscopy has advantages over other colorectal cancer screening methods: it allows perforation, a serious complication, vary for examination of the entire length of the colon, has high diagnostic sensitivity, and widely, and risk factors have not been enables the endoscopist to immediately biopsy or remove discovered polyps or other clearly identified. Using meta-analysis suspicious lesions. However, colonoscopy can result in bowel perforation, a rare but and a qualitative literature review, the serious and potentially fatal adverse event. Because a range of perforation rates has authors systematically assessed the been reported in the medical literature, the actual risk is unclear.6 Furthermore, risk incidence of and risk factors for colo- factors, especially modifiable ones, have not been well defined. The authors’ research noscopy-associated perforation. Data group has previously found very little published literature on the prevention of perfo- on 966,172 screening and diagnostic ration or the identification of modifiable risk factors.7 These deficiencies complicate colonoscopies from 38 original stud- estimating risk for an individual patient, assessing whether the perforation rate of a ies was combined in random-effects particular provider or center is aberrant, and determining cost-effectiveness. meta-analysis. The overall perforation incidence was 91 (95% CI: 77 to 104) Although previous reviews have addressed this topic,8,9 to the authors’ knowledge, per 100,000 colonoscopies. Screening this is the first published full-text review to systematically investigate perforation risk colonoscopy had a lower incidence rate factors and summarize perforation incidence using a meta-analytic method in patients (41 [95% CI: 8 to 75] per 100,000 colo- not selected for any particular characteristics. The authors also performed a systematic noscopies) than diagnostic colonoscopy qualitative literature review to report risk factors identified in primary literature. and studies with mixed indications for colonoscopy (102 [95% CI: 86 to 118] METHODS per 100,000 colonoscopies). No other The authors searched 12 databases for clinical studies and reference lists published risk factor was identified by this meta- from January 1, 1990, through June, 16, 2010, and hand-searched the results. Data- analysis. Published evidence suggests bases searched, controlled vocabulary terms, and search strategy are shown in Table 1. advanced age, polypectomy/biopsy, pre- vious abdominal surgery, gastrointestinal The authors included in their study English-language full-length studies published comorbidities, and hemodialysis may be between January 1, 1990, and June 16, 2010, that assessed patients undergoing conven- associated with increased risk. Despite tional colonoscopy and reported original data collected since January 1, 1990, from the widespread use of colonoscopy and objective records (i.e., patient record charts, databases, or prospective clinical studies, the seriousness of bowel perforation, not recall-based surveys or questionnaires). information on risk factors, especially The authors compiled the original studies’ results into a meta-analysis in order to modifiable risk factors, is limited. (Pa generate an overall summary estimate of perforation incidence, investigate reasons for Patient Saf Advis 2012 Mar;9[1]:5-10.) differences in findings among studies, and assess the robustness of the authors’ own findings. (For further details, see "Methods Summary" on the Authority website.) CORRESPONDING AUTHOR: E-mail address: mnoble@ecri.org Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 5 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S RESULTS Table 1. Search Strategy The searches identified 535 citations, Databases Searched of which most were excluded, most Cumulative Index to Nursing and Allied Health Literature, Cochrane Central frequently due to lack of relevance to Register of Controlled Trials, Embase, Excerpta Medica database, MEDLINE, colonoscopy-associated perforation or for PreMEDLINE, Cochrane Database of Systematic Reviews, Cochrane Database of reporting data collected prior to 1990. The Methodology, Health Technology Assessment Database, Healthcare Standards authors included 38 clinical studies that Directory, National Guideline Clearinghouse, and National Health Service Economic Evaluation Database addressed perforation incidence, of which 16 also reported risk factors (see Figure 1). Terms Searched The 38 studies were published between A combination of controlled vocabulary terms and text words, including but 1998 and June 16, 2010, and reported not limited to: adverse, colonoscop*, complication*, etiology, harm*, hazard*, iatrogenic, intestine perforation, perforat*, prevention and control, and risk on a total of 966,172 colonoscopies (for a list of all included studies and SEARCH STRATEGY (OVID FORMAT, PARALLEL STRATEGIES CREATED FOR a summary of their characteristics, OTHER DATABASES) see Table 2 on the Authority website). Set Fifteen studies were conducted in the Number Concept Search Statement United States; the rest were conducted 1 Colonoscopy Colonoscopy/ or colonoscope in Israel, Canada, Europe, or Asia. Only 2 Perforation Exp intestine perforation/ or intestine 11 studies collected perforation data perforation/ or perforate prospectively. Duration of follow-up was 3 Combine sets 1 and 2 periprocedural. 4 Eliminate overlap Remove duplicates from 3 Many studies did not report basic demographic characteristics or clini- 5 Limit by publication 4 not (letter/ or editorial/ or news/ or cal information. Where reported, most type comment/ or note/ or conference paper)/ or (letter or editorial or news or comment).pt.) studies examined perforation rates in asymptomatic patients undergoing 6 Risk 5 and (exp risk/ or risk$.ti. or proportional hazards models/ or proportional hazards screening colonoscopy or colonoscopy model/) for diagnostic or therapeutic reasons, but two studies limited enrollment to 7 Etiology 5 and (etiology or et.fs.) either screening or follow-up of another 8 Prevention 5 and pc.fs. screening method (e.g., fecal occult blood 9 Complication 5 and (ae.fs. or co.fs.) test),10,11 and one only examined patients 10 Iatrogenic disease 5 and (iatrogenic disease/ or iatrogenic.ti,ab.) with acute diverticulitis.12 The authors of this meta-analysis did not limit inclu- 11 Combine sets or/6-10 sion by patient age, but only two studies focused on pediatric patients.13,14 Colonoscopy procedures were also poorly bases, third-party payer reimbursement Few characteristics of the clinicians pro- described. Most studies did not report databases, and the Medicare Surveillance viding colonoscopy services, such as board methods of bowel preparation, type Epidemiology and End Results database. certification or experience, were reported. of colonoscope used, or polypectomy Two studies collected data on random- For the most part, gastroenterologists methods or frequency. Most healthcare ized samples of patients;16,17 the others provided colonoscopy services, though providers administered conscious seda- collected data from a consecutive series. sometimes colorectal surgeons, general tion for anesthesia to most or all patients; The number of patients enrolled or surgeons, coloproctologists, hepatologists, however, one study reported only 10% of records examined varied widely, from or medical or surgical trainees performed patients requested anesthesia,11 and one 2118 to 277,434.19 Some studies had so colonoscopies. Providers were affiliated study reported administration of anesthe- few patients that they were probably with a variety of healthcare settings, sia to less than 5% of patients.15 underpowered to detect a rare event (e.g., including university hospitals, general perforation). Since the authors planned to hospitals, and ambulatory centers. Databases used in some retrospective assessments included single-hospital data- conduct a meta-analysis, studies meeting inclusion criteria were analyzed regardless Page 6 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority Figure 1. Study Selection Process enrolling symptomatic and mixed-indica- tion groups of patients, but appears less stable (and therefore more likely to change 535 citations with the publication of additional studies) identified in studies with asymptomatic patients. Additional analyses did not indicate that perforation incidence was significantly 391 excluded: related to the following factors: country Not relevant based on title or abstract where the study occurred, number of patients, publication date or first or median year of data collection, or whether 106 excluded: data was collected prospectively or retro- 144 full-text 49 Do not report relevant data or risk factors spectively. No other potential factors could articles reviewed 41 Some or all data collected before 1990 be investigated due to sparse reporting. 9 Data from survey or questionnaire 2 Not full article Literature Review of Published 2 Perforations due to colonoscopy not reported separately Risk Factors from those due to other causes Reviewing findings from original stud- 1 Not English-language article ies is useful because it provides findings 1 Colonoscopy performed only for targeted lesion therapy, from patient-level investigations of the 38 articles not screening or diagnosis MS12029 data, whereas data was only available for included 1 Duplicate data in earlier publication of an included study study-level analysis in the above meta- analysis. All factors in the original studies identified as risk factors for perforation (or identified as not being risk factors) are of the number of patients enrolled. After very likely to change appreciably with the reported in the following text. running the analysis again to include publication of additional studies. only studies with at least 10,000 records, Patient characteristics. Older age was Statistical investigation (i.e., meta- investigated as a risk factor and found the authors did not find a significant regression) showed that perforation rates difference in summary rate. Most stud- to be associated with perforation in six were lower in asymptomatic patients studies, Tian et al.,24 Gatto et al.,16 Levin ies did not report how they diagnosed undergoing screening than in symptomatic or searched databases for perforation. et al.10, Korman et al.,25 Rabeneck et al.,21 patients or groups of mixed-indication and Arora et al.,19 but not in the two most Of those that did, several database patients. However, these factors did not reviews used International Classification recently published studies, Imai et al.26 and explain a significant proportion of the Rotholz et al.23 Findings regarding sex were of Diseases codes to identify perfora- differences in results among studies, tions,10,16,17,19,20,21 and two studies reviewed inconsistent in five studies: Gatto et al.16 including when other factors were taken and Arora et al.19 reported that sex was not only cases of perforation requiring opera- into consideration. The perforation inci- tive intervention.22,23 associated with perforation; Korman et dence among asymptomatic individuals al.25 and Paspatis et al.27 found that women Following the combination of all data, sta- seeking screening was 41 (95% CI: 8 to 75) were more likely to suffer perforation; tistics indicated large differences among per 100,000 colonoscopies. The remain- and Rabeneck et al.21 found women had the study findings (I2 = 99.7%). The all- ing studies, which enrolled symptomatic lower rates. Gatto et al.16 and Arora et al.19 studies summary estimate of perforation and mixed populations (i.e., both symp- found that race was not associated with incidence was 91 (95% CI: 77 to 104) per tomatic and asymptomatic patients) had perforation. 100,000 colonoscopies (Figure 2). The an incidence of 102 (95% CI: 86 to 118) incidence did not substantially change perforations per 100,000 colonoscopies. Number of comorbidities was identified when additional analyses (i.e., cumulative Even with the clinical groups considered as a risk factor by Gatto et al.,16 and higher and influence analyses) were conducted, separately, large differences in perforation comorbidity indexes were associated with suggesting that no single study has undue incidence rates remained. Additional perforation in Rabeneck et al.21 and Arora influence over the summary effect size, statistical tests (e.g., sensitivity analyses) et al.19 Diverticulitis or diverticular disease and that the overall perforation rate is not suggest the rate is stable among studies was associated with perforation in two Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 7 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Figure 2. Incidence of Perforation per 100,000 Colonoscopies studies, Tian et al.24 and Korman et al.25 that greater annual caseload was associated that study.19 Rabeneck et al.21 did not find Previous abdominal surgery was identified with lower rates of perforation. Cobb et al. any association between provider character- as a risk factor by both Tian et al.24 and reported that the rate of perforation was istics and perforation. Korman et al.25 Arora et al.19 found an higher for general surgeons than gastro- Procedural factors. Bowles et al.,31 increased risk in the presence of obstruc- enterologists, although only 1 of the Vokura, and Rabeneck et al.21 found 32 tion; however, Misra et al.20 did not find 14 perforations in the study occurred when that polypectomy/biopsy was associated an association between the reason for a surgeon performed the colonoscopy, with an increased perforation rate, but colonoscopy and perforation. Imai et and that surgeon was a resident.30 This Arora et al.19 did not. Cobb et al. found al. found that patients on hemodialysis difference was not found to be statistically that four out of six colonoscopies in adults regimens had a statistically significant significant (P = 0.353). Arora et al. found for whom colonoscopy was attempted increase in occurrence of perforation.26 that surgeons had higher perforation rates with a pediatric colonoscope resulted Provider characteristics.Wexner et al.28 than gastroenterologists but did not find in perforation, and that both cases of found that practitioner experience was not this was true once other factors were taken perforation that appeared to be due to associated with perforation, but Rabeneck into account.19 Primary care practitioners overinsufflation in the entire series were et al.21 and Lorenzo-Zuniga et al.29 found had lower rates than gastroenterologists in associated with pediatric colonoscope Page 8 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority use.30 However, the difficulties that led to Several potential sources of bias may improving the overall safety of colonos- the selection of the pediatric colonoscope affect this data. The authors included copy. Although the risk of perforation to may have been the underlying risk factor data from any country but limited inclu- any individual is not high, minimizing the for perforation rather than the colono- sion to English-language studies. Most of perforation rate is important as a greater scope itself. Rabeneck et al. did not find the data for the meta-analysis was from number of individuals can be expected to a difference in rate between hospital studies from the United States, Western seek colonoscopy for screening, diagnos- and clinics.21 Europe, and Canada. Only one study was tic, and therapeutic purposes. Improving Methodological factors. Gatto et al.16 and from Central or South America and none the safety of colonoscopy might improve Arora et al.19 did not find a significant were from Africa. As for any meta-analysis, patient compliance with colorectal cancer association between year of data collec- the possibility that publication bias has screening, reportedly only about 60% tion and perforation rate, though both affected these numbers cannot be ruled in 2006,33 and would improve the cost- observed a trend toward decreased rates out. Since about 90% of the data came effectiveness of colonoscopy by reducing over time. from retrospective studies, it is possible iatrogenic morbidity. The need for reliable that these could be underestimations due information on the identification of risk to the mode of data collection, although factors is particularly pressing as the num- DISCUSSION meta-regression does not suggest prospec- ber of individuals undergoing colorectal The perforation incidence among asymp- tively and retrospectively collected data cancer screening can be expected to tomatic patients undergoing colonoscopy significantly differs. None of the other increase. To identify means for reducing for screening was 41 (95% CI: 8 to 75) methodological factors investigated as colonoscopy-associated perforation, pro- per 100,000 colonoscopies, which is sig- potential quality indicators were associ- spective study of risk factors is warranted. nificantly lower than the rate in the rest ated with perforation rate either. Such studies could be integrated with of the studies combined, which was 102 clinical care. Although reporting was too limited to (95% CI: 86 to 118) per 100,000 colonos- enable thorough investigation, no modi- ACKNOWLEDGMENTS copies. Summary estimates subgrouped fiable risk factors for perforation were Nancy Bacci, RN; R. Bradley Hayward, MD; Ann by indication should be more useful for identified, limiting the authors’ ability to Ouyang, MD; Robert J. Sinnott, MD; and Joel L. modeling decisions or cost analyses; Weissfeld, MD, MPH, contributed to the develop- inform clinical practice. Findings from the ment of this project. Jonathan R. Treadwell, PhD, however, since sensitivity analyses sug- individual studies using patient-level data contributed to the review process and statistical gest the incidence of perforation among analysis. Eileen Erinoff, MLIS, contributed to were also few and sometimes conflicting. screening studies may be subject to change literature searches. Helen Dunn and Tracey Mon- with the publication of additional data, Identifying factors associated with an asterno-Stem organized the retrieval of articles, and Helen Dunn generated the reference list. literature for the application should increased risk of perforation, especially be monitored. modifiable risk factors, is desirable for NOTES 1. Jemal A, Murray T, Ward E, et al. Cancer on the incidence of colorectal cancer. N Available from Internet: http://patient- statistics, 2005. CA Cancer J Clin 2005 Engl J Med 2000 Nov 30;343(22):1603-7. safetyauthority.org/ADVISORIES/ Jan-Feb;55(1):10-30. 5. Winawer SJ, Zauber AG, Ho MN, et al. AdvisoryLibrary/2008/Jun5(2)/Pages/ 2. American Cancer Society (ACS). Prevention of colorectal cancer by colono- 57.aspx. Cancer facts and figures 2009. scopic polypectomy. The National Polyp 8. Lohsiriwat V. Colonoscopic perforation: Atlanta (GA): ACS; 2009. Also avail- Study Workgroup. N Engl J Med 1993 Dec incidence, risk factors, management and able: http://www.cancer.org/acs/ 30;329(27):1977-81. outcome. World J Gastroenterol 2010 Jan groups/content/@nho/documents/ 6. Perforations of the colon during colo- 28;16(4):425-30. document/500809webpdf.pdf. noscopy. Pa PSRS Patient Saf Advis 9. Panteris V, Haringsma J, Kuipers EJ. 3. Projections of mortality and burden of [online] 2006 Dec [cited 2009 Apr 16]. Colonoscopy perforation rate, mecha- disease, 2002-2030: Mortality—baseline Available from Internet: http://patient- nisms and outcome: from diagnostic to scenario 2008 [website]. [cited 2009 Sep safetyauthority.org/ADVISORIES/ therapeutic colonoscopy. Endoscopy 2009 1]. Geneva: World Health Organization AdvisoryLibrary/2006/Dec3(4)/Pages/ Nov;41(11):941-51. (WHO). Available from Internet: http:// 10.aspx. 10. Levin TR, Zhao W, Conell C, et al. Com- www.who.int/healthinfo/global_burden_ 7. Colon perforations complicating plications of colonoscopy in an integrated disease/projections2002/en/index.html. colonoscopies: what is the best known health care delivery system. Ann Intern 4. Mandel JS, Church TR, Bond JH, et al. evidence for prevention? Pa Patient Saf Med 2006 Dec 19;145(12):880-6. The effect of fecal occult-blood screening Advis [online] 2008 Jun [2009 Apr 16]. Vol. 9, No. 1—March 2012 Pennsylvania Patient Safety Advisory Page 9 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S 11. Gondal G, Grotmol T, Hofstad B, et al. 19. Arora G, Mannalithara A, Singh G, et al. large public county hospital in Greece. A The Norwegian Colorectal Cancer Pre- Risk of perforation from a colonoscopy 10-year study. Dig Liver Dis 2008 Dec; vention (NORCCAP) screening study: in adults: a large population-based 40(12):951-7. baseline findings and implementations study. Gastrointest Endosc 2009 Mar;69 28. Wexner SD, Garbus JE, Singh JJ, for clinical work-up in age groups (3 Suppl):654-64. SAGES Colonoscopy Study Outcomes 50-64 years. Scand J Gastroenterol 2003 20. Misra T, Lalor E, Fedorak RN. Endo- Group. A prospective analysis of 13,580 Jun;38(6):635-42. scopic perforation rates at a Canadian colonoscopies. Reevaluation of cre- 12. Lahat A, Yanai H, Menachem Y, et al. university teaching hospital. Can J Gastro- dentialing guidelines. Surg Endosc 2001 The feasibility and risk of early enterol 2004 Apr;18(4):221-6. Mar;15(3):251-61. colonoscopy in acute diverticulitis: a pro- 21. Rabeneck L, Paszat LF, Hilsden RJ, et al. 29. Lorenzo-Zuniga V, Moreno de Vega V, spective controlled study. Endoscopy 2007 Bleeding and perforation after outpatient Domenech E, et al. Endoscopist Jun;39(6):521-4. colonoscopy and their risk factors in usual experience as a risk factor for colono- 13. Thakkar K, El-Serag HB, Mattek N, et al. clinical practice. Gastroenterology 2008 scopic complications. Colorectal Dis 2010 Complications of pediatric colonoscopy: a Dec;135(6):1899-1906, 1906.e1. Oct;12:273-7. five-year multicenter experience. Clin Gas- 22. Tran DQ, Rosen L, Kim R, et al. Actual 30. Cobb WS, Heniford BT, Sigmon LB, troenterol Hepatol 2008 May;6(5):515-20. colonoscopy: what are the risks of per- Hasan R, Simms C, Kercher KW, 14. Stringer MD, Pinfield A, Revell L, et al. foration? Am Surg 2001 Sep;67(9):845-7; Matthews BDet al. Colonoscopic per- A prospective audit of paediatric colo- discussion 847-8. forations: incidence, management, and noscopy under general anaesthesia. Acta 23. Rotholtz NA, Laporte M, Lencinas S, outcomes. Am Surg 2004 Sep;70(9):750-7; Paediatr 1999 Feb;88(2):199-202. et al. Laparoscopic approach to colonic discussion 757-8. 15. Eckardt VF, Kanzler G, Schmitt T, et al. perforation due to colonoscopy. World J 31. Bowles CJ, Leicester R, Romaya C, et al. Complications and adverse effects of Surg 2010 Aug;34(8):1949-53. A prospective study of colonoscopy colonoscopy with selective sedation. Gas- 24. Tian YF, Liang JT, Chang KJ, et al. The practice in the UK today: are we ade- trointest Endosc 1999 May;49(5):560-5. clinical values and pitfalls of colonoscopy; quately prepared for national colorectal 16. Gatto NM, Frucht H, Sundararajan V, et al. our five year experience. J Surg Assoc Repub cancer screening tomorrow? Gut 2004 Risk of perforation after colonoscopy and China 1998;31(3):173-9. Feb;53(2):277-83. sigmoidoscopy: a population-based study. 25. Korman LY, Overholt BF, Box T, et al. 32. Vokurka J. Iatrogenic perforation dur- J Natl Cancer Inst 2003 Feb 5;95(3):230-6. Perforation during colonoscopy in ing an endoscopic examination of the 17. Warren JL, Klabunde CN, Mariotto AB, endoscopic ambulatory surgical centers. gastrointestinal tract. Bratisl Lek Listy et al. Adverse events after outpatient colo- Gastrointest Endosc 2003 Oct;58(4):554-7. 2004;105(10-11):387-9. noscopy in the Medicare population. Ann 26. Imai N, Takeda K, Kuzuya T, et al. High 33. Centers for Disease Control and Preven- Intern Med 2009 Jun 16;150(12):849-57. incidence of colonic perforation during tion (CDC). Use of colorectal cancer 18. Friedland S, Soetikno R. Colonoscopy colonoscopy in hemodialysis patients with tests—United States, 2002, 2004, and with polypectomy in anticoagulated end-stage renal disease. Clin Gastroenterol 2006. MMWR Morb Mortal Wkly Rep 2008 patients. Gastrointest Endosc 2006 Jul; Hepatol 2010 Jan;8(1):55-9. Mar 14;57(10):253-8. 64(1):98-100. 27. Paspatis GA, Vardas E, Theodoropoulou A, et al. Complications of colonoscopy in a Page 10 Pennsylvania Patient Safety Advisory Vol. 9, No. 1—March 2012 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, No. 1—March 2012. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2012 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s An Independent Agency of the Commonwealth of Pennsylvania website at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and indepen- dence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions. Scan this code with your mobile device’s QR reader to subscribe to receive the Advisory for free.