Failure Modes and Effects Analysis of Bilateral Same-day Cataract Surgery

Overview

Journal J Cataract Refract Surg

Specialty Ophthalmology

Date 2017 Apr 16

PMID 28410711

Citations 4

Authors

Neal H Shorstein

Carol Lucido

James Carolan

Liyan Liu

Geraldine Slean

Lisa J Herrinton

Affiliations

Soon will be listed here.

Abstract

Purpose: To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety.

Setting: Twenty-one Kaiser Permanente surgery centers, Northern California, USA.

Design: Retrospective cohort study.

Methods: Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014.

Results: The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding errors of intracameral antibiotics that could lead to endophthalmitis or TASS, and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence interval [CI], 0.1-12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures.

Conclusions: Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using an FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards.

Citing Articles

Healthcare Application of Failure Mode and Effect Analysis (FMEA): Is There Room in the Infectious Disease Setting? A Scoping Review.

Vecchia M, Sacchi P, Marvulli L, Ragazzoni L, Muzzi A, Polo L Healthcare (Basel). 2025; 13(1).

PMID: 39791689 PMC: 11719677. DOI: 10.3390/healthcare13010082.

Healthcare Failure Mode and Effect Analysis in Surgery Setting: A Bibliometrics Analysis and Literature Review.

Sumarwoto T, Ilyas M, Dewi A Acta Inform Med. 2024; 32(1):19-23.

PMID: 38585602 PMC: 10997166. DOI: 10.5455/aim.2024.32.19-23.

Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts.

Dickman M, Spekreijse L, Winkens B, Schouten J, Simons R, Dirksen C Cochrane Database Syst Rev. 2022; 4:CD013270.

PMID: 35467755 PMC: 9037598. DOI: 10.1002/14651858.CD013270.pub2.

Disruptive Innovation and Refractive IOLs: How the Game Will Change With Adjustable IOLs.

Chang D Asia Pac J Ophthalmol (Phila). 2019; 8(6):432-435.

PMID: 31789644 PMC: 6903318. DOI: 10.1097/APO.0000000000000266.

Immediate Sequential vs. Delayed Sequential Bilateral Cataract Surgery: Retrospective Comparison of Postoperative Visual Outcomes.

Herrinton L, Liu L, Alexeeff S, Carolan J, Shorstein N Ophthalmology. 2017; 124(8):1126-1135.

PMID: 28438415 PMC: 5531866. DOI: 10.1016/j.ophtha.2017.03.034.

References

Creuzot-Garcher C, Benzenine E, Mariet A, De Lazzer A, Chiquet C, Bron A . Incidence of Acute Postoperative Endophthalmitis after Cataract Surgery: A Nationwide Study in France from 2005 to 2014. Ophthalmology. 2016; 123(7):1414-20. DOI: 10.1016/j.ophtha.2016.02.019. View

Leivo T, Sarikkola A, Uusitalo R, Hellstedt T, Ess S, Kivela T . Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2. J Cataract Refract Surg. 2011; 37(6):1003-8. DOI: 10.1016/j.jcrs.2010.12.050. View

Arshinoff S, Chen S . Simultaneous bilateral cataract surgery: Financial differences among nations and jurisdictions. J Cataract Refract Surg. 2006; 32(8):1355-60. DOI: 10.1016/j.jcrs.2006.02.064. View

Neel S . A cost and policy analysis comparing immediate sequential cataract surgery and delayed sequential cataract surgery from the physician perspective in the United States. JAMA Ophthalmol. 2014; 132(11):1359-62. DOI: 10.1001/jamaophthalmol.2014.3335. View

Herrinton L, Shorstein N, Paschal J, Liu L, Contreras R, Winthrop K . Comparative Effectiveness of Antibiotic Prophylaxis in Cataract Surgery. Ophthalmology. 2015; 123(2):287-294. PMC: 5531863. DOI: 10.1016/j.ophtha.2015.08.039. View

Witkin A, Shah A, Engstrom R, Kron-Gray M, Baumal C, Johnson M . Postoperative Hemorrhagic Occlusive Retinal Vasculitis: Expanding the Clinical Spectrum and Possible Association with Vancomycin. Ophthalmology. 2015; 122(7):1438-51. DOI: 10.1016/j.ophtha.2015.03.016. View

Neily J, Chomsky A, Orcutt J, Paull D, Mills P, Gilbert C . Examining Wrong Eye Implant Adverse Events in the Veterans Health Administration With a Focus on Prevention: A Preliminary Report. J Patient Saf. 2015; 14(1):49-53. DOI: 10.1097/PTS.0000000000000170. View

. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007; 33(6):978-88. DOI: 10.1016/j.jcrs.2007.02.032. View

Li O, Kapetanakis V, Claoue C . Simultaneous bilateral endophthalmitis after immediate sequential bilateral cataract surgery: what's the risk of functional blindness?. Am J Ophthalmol. 2014; 157(4):749-751.e1. DOI: 10.1016/j.ajo.2014.01.002. View

10.

Schein O, Banta J, Chen T, Pritzker S, Schachat A . Lessons learned: wrong intraocular lens. Ophthalmology. 2012; 119(10):2059-64. DOI: 10.1016/j.ophtha.2012.04.011. View

11.

Bodnar Z, Clouser S, Mamalis N . Toxic anterior segment syndrome: Update on the most common causes. J Cataract Refract Surg. 2012; 38(11):1902-10. DOI: 10.1016/j.jcrs.2012.06.053. View

12.

Schachat A . Simultaneous bilateral endophthalmitis after immediate sequential bilateral cataract surgery: what's the risk of functional blindness?. Am J Ophthalmol. 2014; 158(2):410-1. DOI: 10.1016/j.ajo.2014.05.008. View

13.

Lee S . Mild toxic anterior segment syndrome mimicking delayed onset toxic anterior segment syndrome after cataract surgery. Indian J Ophthalmol. 2014; 62(8):890-2. PMC: 4185172. DOI: 10.4103/0301-4738.141067. View

14.

Friling E, Lundstrom M, Stenevi U, Montan P . Six-year incidence of endophthalmitis after cataract surgery: Swedish national study. J Cataract Refract Surg. 2012; 39(1):15-21. DOI: 10.1016/j.jcrs.2012.10.037. View

15.

Carnahan M, Chang W, Shorstein N, Herrinton L . New benchmark in preventing phacoemulsification-related endophthalmitis. J Cataract Refract Surg. 2014; 40(9):1568. DOI: 10.1016/j.jcrs.2014.07.011. View

16.

Wong D, Waxman M, Herrinton L, Shorstein N . Transient macular edema after intracameral injection of a moderately elevated dose of cefuroxime during phacoemulsification surgery. JAMA Ophthalmol. 2015; 133(10):1194-7. PMC: 5565143. DOI: 10.1001/jamaophthalmol.2015.2421. View

17.

Brown D, Bonacum D, Vonderheide-Liem D . The Kaiser Permanente FMEA model--simplified for healthcare personnel. J Healthc Qual. 2006; 27(1):48-55. DOI: 10.1111/j.1945-1474.2005.tb00546.x. View

18.

Arshinoff S . Same-day cataract surgery should be the standard of care for patients with bilateral visually significant cataract. Surv Ophthalmol. 2012; 57(6):574-9. DOI: 10.1016/j.survophthal.2012.05.002. View

19.

Neel S . A cost-minimization analysis comparing immediate sequential cataract surgery and delayed sequential cataract surgery from the payer, patient, and societal perspectives in the United States. JAMA Ophthalmol. 2014; 132(11):1282-8. DOI: 10.1001/jamaophthalmol.2014.2074. View

20.

Arshinoff S, Odorcic S . Same-day sequential cataract surgery. Curr Opin Ophthalmol. 2008; 20(1):3-12. DOI: 10.1097/ICU.0b013e32831b6daf. View