The Impact of Human Factors on the Safety of Operating Rooms and everyday Surgical Practice
Keywords:
Human Factor Engineering, Usability Engineering, Risk Management, Surgical Flow Disruption, Human Machine InterfaceAbstract
Human Factors Engineering (HFE) principles were initially implemented in safety-related procedures in aviation and other high-risk industries to minimize human error-related risks. The introduction of HFE in healthcare aims not to eliminate the ‘human factor,’ but rather to enable ‘engineering’ to redesign clinical settings to become resilient to unanticipated events related to operational and/or safety shortcomings. Given the complexity of the Operating Room (OR) and the sociotechnico-cognitive activities that occur during a surgical operation, HFE needs to consider a wide spectrum of Surgical Flow Disruptions (SFD), such as miscommunications, fatigue, workload, physical layout of the site etc. The increase of fully automated/computer-assisted surgical systems into everyday surgical practice highlights the need for specialized technical skills and a subsequent change in mind-set and intraoperative decision-making. The complexity of the modern OR calls out for incorporation of a culture safety also illustrated by the close interaction of Usability Engineering (UE) and Risk Management (RM) throughout the lifecycle of a medical system and by Regulations currently in force. This article discusses the practical parameters of HFE incorporation into surgical practice and aims to highlight how this holistic redefinition of OR settings promotes patient and medical staff safety through mitigation of error-prone processes.
How to cite this article:
Valla V, Koukoura A, Lewis A, Dahlerup B, Tsianos GI, Vassiliadis E. The Impact of Human Factors on the Safety of Operating Rooms and everyday Surgical Practice. J Adv Res Med Sci Tech 2020; 7(1&2): 8-16.
DOI: https://doi.org/10.24321/2394.6539.202002
References
Reason J. Human error: models and management. BMJ 2000; 320(7237): 768-770.
Kurmann A, Tschan F, Semmer NK, Seelandt J, Candinas D, Beldi G. Human factors in the operating room - The surgeon’s view. Trends in Anaesthesia and Critical Care. 2012; 2(5): 224-227.
Hollnagel E. Human factors/ ergonomics as a systems discipline? “The human use of human beings” revisited. Appl Ergon 2014; 45(1): 40-44.
D’Addessi A, Bongiovanni L Fau - Volpe A, Volpe A Fau - Pinto F, Pinto F Fau - Bassi P, Bassi P. Human factors in surgery: from Three Mile Island to the operating room. Urol Int 2009; 83(3): 249-257.
Kohn LT. To err is human: building a safer health system. MS D, editor. Washington DC: National Academies Press; 2000. 6. Alsubaie H, Goldenberg M, Grantcharov T. Quantifying recall bias in surgical safety: a need for a modern approach to morbidity and mortality reviews. Can J Surg 2019; 62(1): 39-43.
Bosma E, Veen EJ, Roukema JA. Incidence, nature and impact of error in surgery. BJS (British Journal of Surgery) 2011; 98(11): 1654-1659.
Kim FJ, da Silva RD, Gustafson D, Nogueira L, Harlin T, Paul DL. Current issues in patient safety in surgery: a review. Patient Safety in Surgery 2015; 9(1): 26.
Panagioti M, Khan K, Keers RN, Abuzour A, Phipps D, Kontopantelis E et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ 2019; 366: l4185.
White AD, Skelton M, Mushtaq F, Pike TW, MonWilliams M, Lodge JP et al. Inconsistent reporting of minimally invasive surgery errors. Ann R Coll Surg Engl 2015; 97(8): 608-612.
Carayon P, Xie A Fau - Kianfar S, Kianfar S. Human factors and ergonomics as a patient safety practice. BMJ 2014; 23(3): 196-205.
Shouhed D Fau - Gewertz B, Gewertz B Fau - Wiegmann D, Wiegmann D Fau - Catchpole K, Catchpole K. Integrating human factors research and surgery: a review. Arch Surg 2012; 147(12): 1141-1146.
Rasmussen J PA, Goodstein LP. Cognitive Systems Engineering. New York: Wiley; 1994.
Cohen T. A Human Factors Approach for Identifying Latent Failures in Healthcare Settings. Daytona Beach, Florida: Embry-Riddle Aeronautical University; 2017.
Catanzarite T Fau - Tan-Kim J, Tan-Kim J Fau - Whitcomb EL, Whitcomb El Fau - Menefee S, Menefee S. Ergonomics in Surgery: A Review. Female Pelvic Med Reconstr Surg 2018; 24(1): 1-12.
Catchpole K, Bisantz A, Hallbeck MS, Weigl M, Randell R, Kossack M et al. Human factors in robotic assisted surgery: Lessons from studies ‘in the Wild’. Appl Ergon 2019; 78: 270-276.
Tabibzadeh M, Jahangiri G, editors. A Proactive Risk Assessment Framework to Enhance Patient Safety in Operating Rooms 2018: Springer International Publishing.
Wiegmann DA, ElBardissi Aw Fau - Dearani JA, Dearani Ja Fau - Daly RC, Daly Rc Fau - Sundt TM, 3rd, Sundt TM, 3rd. Disruptions in surgical flow and their relationship to surgical errors: an exploratory investigation. Surgery 2007; 142(5): 658-665.
Lingard LES, Whyte S, Regehr G, Baker GR, Reznick R, Bohnen J, Orser B, Doran D, Grober E. Communication failures in the operating room: an observational classification of recurrent types and effects. Qual Saf Health Care 2004; 13(5): 330-334.
ElBardissi AW, Wiegmann Da Fau - Henrickson S, Henrickson S Fau - Wadhera R, Wadhera R Fau - Sundt TM, 3rd, Sundt TM, 3rd. Identifying methods to improve heart surgery: an operative approach and strategy for implementation on an organizational level. Eur J Cardiothorac Surg 2008; 34(5): 1027-1033.
Frasier LL, Pavuluri Quamme SR, Ma Y, Wiegmann D, Leverson G, DuGoff EH et al. Familiarity and Communication in the Operating Room. Journal of Surgical Research 2019; 235(395-403).
Wakeman D, Langham MR, Jr. Creating a safer operating room: Groups, team dynamics and crew resource management principles. Semin Pediatr Surg 2018; 27(2): 107-113.
Antoniadis S, Passauer-Baierl S, Baschnegger H, Weigl M. Identification and interference of intraoperative distractions and interruptions in operating rooms. J Surg Res 2014; 188(1): 21-29.
Jung JJ, Elfassy J, Grantcharov T. Factors associated with surgeon’s perception of distraction in the operating room. doi: 10.1007/s00464-019-07088-z. Surgical Endocscopy 2019.
Vaisbuc Y, Moore JM, Jackler RK, Vaughan J, editors. Operating Room Ergonomics: A Practical Approach for Reducing Operating Room Ergonomic Hazards: Springer International Publishing. 2018.
Raghavendra Rao RS. Ergonomical aspects of anaesthetic practice. Indian J Anaesth 2016; 60(5): 306-311.
de Korne DF, Loh HP, Yin S. Human Factors and Operating Room Design Challenges. In: Sanchez JA, Barach P, Johnson JK, Jacobs JP, editors. Surgical Patient Care: Improving Safety, Quality and Value. Cham: Springer International Publishing 2017; 373-395.
Bas E. An integrated OSH risk management approach to surgical flow disruptions in operating rooms. Safety Science 2018; 109: 281-293.
Palmer GAJ, Swinton G, Allison D, Greenstein J, Shappell S, Juang K, Reeves ST. Realizing improved patient care through human-centered operating room design: a human factors methodology for observing flow disruptions in the cardiothoracic operating room. Anesthesiology 2013; 119(5): 1066-1077.
Sevdalis N FD, Undre S, Darzi A, Vincent C. Annoyances, disruptions, and interruptions in surgery: the Disruptions in Surgery Index (DiSI). World J Surg 2008; 32(8): 1643-1650.
Oppikofer C, Schwappach D. The Role of Checklists and Human Factors for Improved Patient Safety in Plastic Surgery. Plast Reconstr Surg 2 2017; 140(6): 812e-7e.
Hu YY AA, Roth EM, Peyre SE, Corso KA, Swanson RS, Osteen RT, Schmitt P, Bader AM, Zinner MJ, Greenberg CC. Protecting patients from an unsafe system: the etiology and recovery of intraoperative deviations in care. Ann Surg 2012; 256(2): 203-210.
Marshall SD, Touzell A. Human factors and the safety of surgical and anaesthetic care. Anaesthesia 2020; 75(S1): e34-e8.
Mueller BU, Neuspiel DR, Fisher ERS. Principles of Pediatric Patient Safety: Reducing Harm Due to Medical Care. Pediatrics 2019; 143(2): e20183649.
Fisher JA, Monahan T. Evaluation of real-time location systems in their hospital contexts. Int J Med Inform 2012; 81(10): 795-712.
Gholamhosseini L, Sadoughi F, Safaei A. Hospital Real-Time Location System (A Practical Approach in Healthcare): A Narrative Review Article. Iran J Public Health 2019; 48(4): 593-602.
Yoo S, Kim S, Kim E, Jung E, Lee K-H, Hwang H. Real-time location system-based asset tracking in the healthcare field: lessons learned from a feasibility study. BMC Med Inform Decis Mak 2018; 18(1): 80.
Doebbeling BN BM, Wiebke EA, Miller S, Baxter L, Miller D, Alvarez J, Pekny J. Optimizing perioperative decision making: improved information for clinical workflow planning. AMIA Annu Symp Proc 2012; 2012(154-163).
Nissan J, Campos V, Delgado H, Matadial C, Spector S. The Automated Operating Room: A Team Approach to Patient Safety and Communication. JAMA Surgery 2014; 149(11): 1209-1210.
Vankipuram M, Kahol K, Cohen T, Patel VL. Toward automated workflow analysis and visualization in clinical environments. Journal of Biomedical Informatics 2011; 44(3): 432-440.
Chen M-F, Tsai C-L, Chen Y-H, Huang Y-W, Wu C-N, Chou C, et al. Web-Based Experience Sharing Platform on Medical Device Incidents for Clinical Engineers in Hospitals. Journal of Medical and Biological Engineering 2018; 38(5): 835-844.
Flowers MG, Aggarwal R. Second Life™: a novel simulation platform for the training of surgical residents. Expert Review of Medical Devices 2014; 11(2): 101-103.
Vali Siar MM, Gholami S, Ramezanian R. Multi-period and multi-resource operating room scheduling and rescheduling using a rolling horizon approach: a case study. Journal of Industrial and Systems Engineering 2017; 10(special issue on healthcare): 97-115.
van Essen JT, Hurink JL, Hartholt W, van den Akker BJ. Decision support system for the operating room rescheduling problem. Health Care Management Science 2012; 15(4): 355-372.
Carpenter BT, Sundaram CP. Training the next generation of surgeons in robotic surgery. Robot Surg 2017; 4: 39-44. 46. Dirhold BM, Citak M, Al-Khateeb H, Haasper C, Kendoff D, Krettek C et al. Current state of computer-assisted trauma surgery. Curr Rev Musculoskelet Med 2012; 5(3): 184-191.
Peters BS, Armijo PR, Krause C, Choudhury SA, Oleynikov D. Review of emerging surgical robotic technology. Surgical Endoscopy 2018; 32(4): 1636-1655.
Ploussard G. Robotic surgery in urology: facts and reality. What are the real advantages of robotic approaches for prostate cancer patients? Curr Opin Urol 2018; 28(2): 153-158.
Rodriguez-Sanjuan JC, Gomez-Ruiz M, Trugeda-Carrera S, Manuel-Palazuelos C, Lopez-Useros A, Gomez-Fleitas M. Laparoscopic and robot-assisted laparoscopic digestive surgery: Present and future directions. World J Gastroenterol 2016; 22(6): 1975-2004.
Tsui C, Klein R, Garabrant M. Minimally invasive surgery: national trends in adoption and future directions for hospital strategy. Surg Endosc 2013; 27(7): 2253-2257.
Nik-Ahd F, Souders CP, Houman J, Zhao H, Chughtai B, Anger JT. Robotic Urologic Surgery: Trends in Food and Drug Administration-Reported Adverse Events Over the Last Decade. J Endourol 2019; 33(8): 649-654.
Oleynikov D. Robotic surgery. Surg Clin North Am. 2008; 88(5): 1121-1130.
Simorov A, Otte RS, Kopietz CM, Oleynikov D. Review of surgical robotics user interface: what is the best way to control robotic surgery? Surg Endosc 2012; 26(8): 2117-2125.
Alemzadeh H, Raman J, Leveson N, Kalbarczyk Z, Iyer RK. Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data. PLoS One 2016; 11(4): e0151470.
Schuler PJ. Robotic Surgery - Who is The Boss? Laryngorhinootologie 2018; 97(S 01): S231-S78.
Souders CP, Catchpole K, Hannemann A, Lyon R, Eilber KS, Bresee C et al. Flow disruptions in robotic-assisted abdominal sacrocolpopexy: does robotic surgery introduce unforeseen challenges for gynecologic surgeons? Int Urogynecol J 2019; 30(12): 2177-2182.
Dru CJ, Anger JT, Souders CP, Bresee C, Weigl M, Hallett E et al. Surgical flow disruptions during robotic-assisted radical prostatectomy. Can J Urol 2017; 24(3): 88148821.
Ahmad N, Hussein AA, Cavuoto L, Sharif M, Allers JC, Hinata N et al. Ambulatory movements, team dynamics and interactions during robot-assisted surgery. BJU Int 2016; 118(1): 132-139.
Garbey M, Joerger G, Huang A, Salmon R, Kim J, Sherman V et al. An intelligent hospital operating room to improve patient health care. Journal of Computational Surgery 2015; 2(1): 3.
Bharathan R, Aggarwa lR, Darzi A. Operating room of the future. Best Pract Res Clin Obstet Gynaecol 2013; 27(3): 311-322.
Bernardo A. The Changing Face of Technologically Integrated Neurosurgery: Today’s High-Tech Operating Room. World Neurosurgery 2017; 106: 1001-1014.
Nakamura T, Ogiwara T, Goto T, Fujii Y, Miyaoka Y, Hanaoka Y et al. Clinical Experience of Endoscopic Endonasal Approach in the Innovative, Newly Developed Operating Room “Smart Cyber Operating Theater (SCOT)”. World Neurosurg 2019; 9: 293-296.
Klein M AL, Alamili M, Gögenur I, Rosenberg J. Psychological and physical stress in surgeons operating in a standard or modern operating room. Surg Laparosc Endosc Percutan Tech 2 2010; 20(4): 237-242.
Catchpole KR, Hallett E, Curtis S, Mirchi T, Souders CP, Anger JT. Diagnosing barriers to safety and efficiency in robotic surgery. Ergonomics 2018; 61(1): 26-39.
Kopelman Y Fau - Lanzafame RJ, Lanzafame Rj Fau - Kopelman D, Kopelman D. Trends in evolving technologies in the operating room of the future. JSLS 2013; 17(2): 171-173.
ISO. International Organization for Standardization. Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015). 2015.
ISO. International Organization for Standardization. 14971:2019. Medical devices - Application of risk management to medical devices. 2019.
ISO. International Organization for Standardization. Medical. IEC 80001-1:2010. Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities. 2010.
EU-MDR(2017/745). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/ EEC and 93/42/EEC. April 5, 2017.
ANNEX-I. EU-MDR(2017/745). ANNEX I: General Safety and Performance Requirements: SPR1: […] Performance and safety : the medical device shall be ‘designed and manufactured in such a way’ that safety of patients and users shall not be compromised under the normal conditions of use. The design and construction should conform to safety principles, taking into account the ‘generally acknowledged state of the art […]; SPR5: […] In eliminating or reducing risks related to use error, the Manufacturer shall:(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety) […]; SPR 6: […] The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.[…]; SPR 14: […] Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: […] (a) the risk of injury, in connection with their physical features, including the volume/ pressure ratio, dimensional and where appropriate ergonomic features; […] Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used […]; SPR 22: […] Devices for use by lay persons shall be designed and manufactured in such a way as to: 1.ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information, 2.reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and 3.reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results. […].
ISO. International Organization for Standardization. Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485: 2016). 2016.
ISO(13485:2016). Clause 7.3.3 a: […] Usability and safety requirements according to the intended use shall be determined and recorded as an input for design and development […]; Clause 7.3.9: […] Significant of the change to usability for medical devices and its intended use shall be determined as part of control of design and development changes […]. 2016.
21CFR820.30. Part 820 -Quality System Regulation. Subpart C- Design Controls. Sec. 820.30 Design controls. 2019.
van der Peijl J, Klein J, Grass C, Freudenthal A. Design for risk control: the role of usability engineering in the management of use-related risks. J Biomed Inform 2012; 45(4): 795-812.
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Copyright (c) 2020 Vasiliki Valla, Angeliki Koukoura, Amy Lewisa, Benedicte Dahlerup, Georgios-Ioannis Tsianos, Efstathios Vassiliadis
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