Retained Surgical Items Evidence Table
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Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 1 Wilson C. Foreign bodies left in the Case series of foreign bodies left in the abdomen. Cases VC Literature n/a n/a n/a n/a Retained abdomen after laparotomy. Trans Am found through publication, interviews, and the author's own Review, Clinician sponges Gynecol Soc. 1884;9:94-117. experience. Experience, and Case Report 2 The Joint Commission. Preventing The Joint Commission recommends that facilities develop IVB Consensus n/a n/a n/a n/a n/a unintended retained foreign objects. effective processes and procedures for preventing Sentinel Event Alert. October 17, unintended retained foreign objects. Their recommendations 2013;51. include a standardized and highly reliable counting system; http://www.jointcommission.org/sea_i development of policies and procedures; practices for ssue_51/. Accessed November 10, counting, wound opening, and closing procedures; 2015. performance of intraoperative radiographs; use of effective communication to include briefings and debriefings; documentation of counts; and assistive technologies (ie, RF tags, RFID, radiopaque, bar coding). Also, the hospital should define a process for conducting RCA for sentinel events, such as URFO. Page 1 of 60 Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 3 Moffatt-Bruce SD, Cook CH, Steinberg 7 elevated risk factors for RSI in pooled data in case-control IIIA Systematic USA hospitals, n/a n/a 3 studies: Estimated SM, Stawicki SP. Risk factors for studies: Estimated intraoperative blood loss >500mL, Review with patients with Lincourt, intraoperativ retained surgical items: a meta-anal- incorrect surgical count, more than one subprocedure, more Meta-analysis RSI Gawande, and e blood loss ysis and proposed risk stratification than one surgical team*, operative time, surgical count not Stawicki >500mL, system. J Surg Res. 2014;190(2):429- performed*, and unexpected intraoperative factors*. incorrect 436. (*p=0.001) There was not a statistically significant RSI risk surgical with the following factors: BMI, emergency procedure, count, more changes in nursing staff, operating after hours, and presence than one of surgical trainee. Recommend use of risk stratification for subprocedure prevention methods. , more than one surgical team, operative time, surgical count not performed, unexpected intraoperativ e factors, BMI, emergency procedure, changes in nursing staff, operating after hours, and presence of surgical Page 2 of 60 Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 4 Gawande AA, Studdert DM, Orav EJ, The risk of a retained sponge or instrument significantly IIIA Non- USA, Patients n/a Cases matched 54 patients Emergency Brennan TA, Zinner MJ. Risk factors for increases in emergencies, with unplanned changes in experimental with to 4 random with 61 RSI, procedure, retained instruments and sponges procedure, and with higher BMI. Cases reviewed were malpractice controls who 235 controls unexpected after surgery. N Engl J Med. reported from 1985-2001. claims or underwent the change in 2003;348(3):229-235. incident report same type of procedure, >1 for retained operation team, change surgical sponge during the in nursing or instrument same 6-month staff during in period procedure, Massachusetts BMI, est. blood loss, counts of sponges and instruments performed, females Page 3 of 60 Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 5 Lincourt AE, Harrell A, Cristiano J, RSI was associated with multiple major surgical procedures IIIB Non- USA, patients n/a Cases matched 30 cases, 131 Incorrect Sechrist C, Kercher K, Heniford BT. being performed at the same time and an incorrect experimental with ICD-9 code to at least 4 control count Retained foreign bodies after surgery. J instrument or sponge count. Cases reviewed were from 1996- 998.4 random recorded, Surg Res. 2007;138(2):170-174. 2005. (unintentional controls who total number foreign object underwent the of major remaining in same type of procedures, the body during operation multiple surgery) and during the surgical incident reports same time teams, period unexpected change in procedure, OR time, OR procedure performed after 5pm, and emergency procedure. 6 Stawicki SP, Moffatt-Bruce SD, Ahmed RSI risk increased with longer duration of surgery, safety IIIB Non- USA, 7 n/a Cases matched 59 cases, 118 BMI, HM, et al. Retained surgical items: a variances, and incorrect counts. Recommend zero tolerance experimental Teaching to 2 controls controls procedure problem yet to be solved. J Am Coll approach for safety variances and enhancing reporting Hospitals who factors, Surg. 2013;216(1):15-22. systems. Cases reviewed were from 2003-2009. underwent the unexpected same intraoperativ procedure e events, type within a 6- safety month period omissions/var iances, and trainee presence. Page 4 of 60 Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 7 Chen Q, Rosen AK, Cevasco M, Shin RSI cases found by AHRQ PSI 5 measure and corresponding IIIB Non- 28 Veterans n/a n/a 93 cases Cases flagged M, Itani KM, Borzecki AM. Detecting ICD-9-CM codes. PSI 5 had a positive predictive value of 45% experimental Health flagged as PSI as AHRQ's patient safety indicators: how valid is for identifying RSI, and included both medical and surgical Administration 5 Patient Safety “foreign body left during procedure” procedures. Sponges were the most commonly retained hospitals Indicator (PSI) in the Veterans Health Administration? item. 5, foreign J Am Coll Surg. 2011;212(6):977-983. body left during procedure 8 Cima RR, Kollengode A, Garnatz J, Cases reviewed were from 2003-2006. May have more RSI IIIB Non- Tertiary care n/a n/a 34 near miss, Retained Storsveen A, Weisbrod C, Deschamps C. cases than expected at a facility that performs routine Experimental institution 34 retained foreign Incidence and characteristics of postoperative imaging for all operative procedures. 21/34 foreign objects objects potential and actual retained foreign (62%) of RSIs had a correct count but were found on routine identified on object events in surgical patients. J Am imaging. Adjunct technology is warranted to achieve reliable postoperative Coll Surg. 2008;207(1):80-87. counts. imaging and near misses 9 Wan W, Le T, Riskin L, Macario A. Systematic review of case reports. Gossypibomas most VA Literature Review n/a n/a n/a 254 Retained Improving safety in the operating room: common in the abdomen, pelvis, and thorax. Complications Gossypiboma surgical a systematic literature review of included adhesion, abscess, and fistula. Average discovery sponges retained surgical sponges. Curr Opin time 6.9 years. Most cases occurred with a correct count. Anaesthesiol. 2009;22(2):207-214. 10 Zantvoord Y, van der Weiden RM, van Although retained surgical sponges may migrate transmurally VB Case Review n/a n/a n/a 64 cases of Transmural Hooff MH. Transmural migration of and be expelled through the rectum spontaneously, 93% of transmural migration of retained surgical sponges: a systematic cases required an intervention for removal. migration retained review. Obstet Gynecol Surv. surgical 2008;63(7):465-471. sponges Page 5 of 60 Guideline for Prevention of Retained Surgical Items Evidence Table CITATION CONCLUSION(S) SAMPLE SIZE REFERENCE # POPULATION COMPARISON EVIDENCE TYPE INTERVENTIONS CONSENSUS SCORE OUTCOME MEASURE 11 Cohen SB, Bartz PJ, Earing MG, Sheil A, 20-year old man experienced cardiac arrest due to VB Case Report USA n/a n/a 1 case n/a Nicolosi A, Woods RK. Myocardial myocardial infarction from retained epicardial pacing wire infarction due to a retained epicardial after surgery as an infant to repair ASD defect. Pacing wires pacing wire. Ann Thorac Surg. should be managed and accounted for intraoperatively. 2012;94(5):1724-1726. 12 Suh DH, Yoon JR, Kang KB, Han SB, Kim 60-year old man experienced a femur fracture from a VC Case Report Korea n/a n/a n/a n/a HJ, Lee SJ. A gossypiboma-induced retained surgical sponge on the bone after previous surgery pathological fracture of the proximal for ORIF of the femur. femur. Clin Radiol. 2009;64(11):1132- 1135. 13 Tateishi M, Tomizawa Y. Intravascular Review of intravascular unretrieved device fragments. Many VB Literature Review Japan n/a n/a n/a n/a foreign bodies: danger of unretrieved preventable device-fracture complications are related to fragmented medical devices. J Artif inappropriate use of intravascular devices, including use of Organs. 2009;12(2):80-89. devices for off-label purposes and reuse of single-use devices. 14 Al-Moghairi AM, Al-Amri HS. Intervention guide-wire fracture and entrapment may lead to VA Literature Review n/a n/a n/a n/a n/a Management of retained intervention RSI during vascular procedures. guide-wire: a literature review. Curr Cardiol Rev. 2013;9(3):260-266. 15 Johnson C, Alomari AI, Chaudry G. 16-year old male