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Implementing Medical Technological Equipment in the OR: Factors for Successful Implementations

Implementing Medical Technological Equipment in the OR: Factors for Successful Implementations isational factors, and job factors [7, 8]. However, much review results were discussed, resulting in a selection of ab- remains unexplored, especially when considering all these stracts for full-article review. Duplicate abstracts were re- perspectives holistically. )e overall aim of our research is moved. In the third phase, the selection of full articles was to develop a holistic model for implementation of new reviewed for inclusion or exclusion, according to the purpose equipment in ORs, which helps hospitals and medical of the research (NSM). In case of doubt, the second reviewer equipment companies to implement medical technology in (BVZ) was asked to assess the article. Results of the full-article review were discussed, and articles were in- or excluded by a safe, efficient, and cost-effective way. For reasons of de- marcating and focus, we concentrate on the implementation of consensus. new medical technological equipment, which includes medical equipment and medical information technology (i.e., hardware 2.2. Coding. Coding of included articles should be resulting and/or embedded software). )is study is the first step towards in all types of influencing factors for the implementation of our overall aim, and we analyze existing recent literature medical equipment in ORs as well as resulting factors of an available on implementations of technology in the OR, in order implementation of medical equipment for instance per- to identify success factors for efficient implementations. Re- formance. During a coding process, relevant sections in sults from this study will be included in the development of articles are marked and a descriptive name or code is added a holistic implementation model for new technological to the section. During coding of included articles, all relevant equipment in ORs. In the following section, we explain the sections were coded inductively using NVivo (version 11 for literature search and analysis procedure, followed by a section Windows) [10]. )rough “open coding,” we identified fac- that describes the literature review results. In the discussion, we tors or categories of importance in our literature sources, reflect on the results. In the last section conclusions, limitations following principles as presented by Strauss and Corbin and and plans for further research are provided. leveraging Nvivo tooling [11]. 2. Method 3. Results )e aim of our systematic literature review is to identify all types of relevant factors on the implementation of medical 3.1. Search Results. Our searches resulted in 1592 potentially technology in ORs and to categorize these factors. To ensure eligible articles (Figure 2). After screening titles, 1451 articles quality and rigor, this systematic literature review com- were excluded. After reviewing the abstracts of 141 studies, menced by setting up a literature search protocol following 49 articles remained. Reviewing these articles and applying the guidelines of Kitchenham and Charters (Figure 1) [9]. the inclusion and exclusion criteria resulted in 35 remaining )e following databases were accessed in the search process: articles for detailed coding and analysis. Two articles were Academic Search, ACM, DOJ, Embase, NARCIS, Pubmed, added to this selection based on references and feedback Science Direct, Springerlink, Web of Science, and Wiley. from coresearchers, that is, Raman et al. and Stefanidis et al. We entered the following terms and operators: “Implement” [12, 13]. During the search and coding process, the article of OR “Implementation” AND “Technology” AND “Operating Raman et al. was an accepted, not yet published, manuscript. Room.” )ese terms were searched for in “all fields” of )is article provided insights into the implementation of selected databases. checklists in OR and was therefore included in this research. )e second article from Stefanidis et al. was published as 2.1. Inclusion and Exclusion Criteria. We used no date re- a set of guidelines for the introduction of new technology strictions during the database search. Articles regarding the and techniques from a surgeons’ perspective. )is article did implementation of medical equipment as well as in- not include an abstract nor keywords that were related to formation technology were included in the reviewing pro- this research. )e research team advised to include these cess. Titles of articles included in reference lists related to the articles due to their relevance and the scope of this research. search criteria were considered. Articles published in other Following the review process and criteria for inclusion than the English language were excluded. We excluded and exclusion, 37 articles were included in this study. secondary literature, for example, books. Conference ab- Table 1 provides an overview of included articles related stracts, poster presentations, and letters were excluded as to the year of publication, with intervals of 5 years. )ree well, due to limited availability of detailed information in included articles were published in interval I, period proceedings and other sources. 1997–2002. Six articles were published in the periods re- We reviewed the results in three steps. Firstly, two ferring to intervals II and IV. Most included articles (n � 22) members of the research team (NSM and BVZ) reviewed were published in interval III, corresponding to the period titles independently according to predefined inclusion and 2009–2014. Journal of Healthcare Engineering 3 Title review (two members) Abstract review (two members) Included Coding in Constructed Search per Identify databases Factors Analyse factors papers Nvivo model database Paper review yes OK? Doubt? Second review Figure 1: Overview of search activities and coding. Exclusion of conference Abstracts considered relevant Titles identified for review abstracts and poster Full articles for review for review (n = 1592) presentations (n = 49) (n = 141) and removal of duplicates After applying inclusion and exclusion criteria (n = 35) Results on search per Results after review of titles Academic search (n = 14) database Academic search (n = 61) ACM (n = 7) Added papers from references ACM (n = 303) DOJ (n = 1) and supervisors DOJ (n = 1) Embase (n = 34) (n = 2) Embase (n = 176) NARCIS (n = 1) PubMed (n = 15) NARCIS (n = 1) PubMed (n = 123) ScienceDirect (n = 19) ScienceDirect (n = 424) SpringerLink (n = 9) SpringerLink (n = 247) Web of Science (n = 22) Included papers for coding Web of Science (n = 150) Wiley (n = 19) (n = 37) Total: 141 Wiley (n = 106) Figure 2: Search results. Table 1: Results: distribution of articles according to the year of Table 2: Results: frequencies of coded categories. publication. Number Aggregated frequency Legend Categories/factors Interval Period (year) Number of articles (n  37) of articles of coding I 1997–2002 3 1 Communication 24 86 II 2003–2008 6 2 Performance 22 86 III 2009–2014 22 3 Process and activities 29 240 IV 2015–2016 6 4 Project management 24 510 5 Sta� 30 190 6 Technology 27 355 7 Training 25 176 3.2. Coding Results. e coding process resulted in a long list of descriptive names or items. Related items were grouped in categories or factors. is process is traceably and trans- parently performed in NVivo. aggregated frequency of items, the categories project Table 2 shows seven categories that are derived from the management, technology, and process and activities, are coded items: communication, performance, process and coded most often, respectively, 510, 355, and 240 times. activities, project management, sta�, technology, and ese results imply that underlying items of these categories training. Each category consists of one or more underlying are coded more than once in corresponding articles. items, resulting from coding articles in NVivo. Furthermore, e identiŠed categories are explained in the following Table 1 shows the number of coded articles per category sections: (“number of articles”). e categories process and activities, sta�, and technology are referenced in the majority of the coded articles, respectively, 29, 30, and 27 articles. Table 2 3.3. Communication. Communication is a category that was also shows the aggregated frequency of coded items per coded in 24 articles. When new technology (i.e., medical category (“aggregated frequency of coding”). Based on the equipment) is introduced, disruptions in activities and 4 Journal of Healthcare Engineering 3.8. Technology. In this review, technology is used as cate- workflow occur, which require communication and team- work. Communication with relevant stakeholders is one of gory for coding referring to medical equipment and (em- bedded) Information Technology (IT). Studies show that the the factors to prevent errors when introducing new tech- nological equipment. )e use of updated checklists is de- implementation of new medical equipment involves in- scribed as one of the communication tools, which regulate tegrating new technology in the daily processes and activ- activities and the workflow for stakeholders such as sur- ities. Relevant training for staff is required which includes geons, anaesthesiologists, and surgical supporting staff. )e setup, use, disassembly of equipment, the interpretation of use of these updated checklists contributes to improved data and screens (if applicable), and troubleshooting in case safety in the OR [12–34]. problems occur [5, 12, 13, 15–20, 22, 24–26, 28, 29, 31, 32, 34, 36–38, 40, 42–45, 47]. 3.4. Performance. In 22 articles, various indicators regarding 3.9. Training. Studies showed that staff needs training to performance are identified such as OR efficiency and per- formance, patient care, patient outcomes, finance, safety, setup, configure, use, and disassembly new medical equip- ment. Training starts during the project with involved ergonomics, and user-friendliness of technological equip- ment [5, 12, 16, 19, 21–24, 26–32, 35–41]. project members and based on the project plan and product requirements. Training elements are described in training programs, which entail technical and nontechnical skills. 3.5. Processes and Activities. )e majority of the articles Nontechnical skills are described as skills regarding com- included in this study showed that the introduction of new munication, teamwork, and leadership. Depending on the technological equipment affects processes and activities of contents of training, staff gain experience and skills to use employees in the OR. Tasks and activities of OR employees are medical equipment and to interpret data (on screens if recorded in protocols and checklists to ensure safety and applicable). Skills to troubleshoot when problems occur are quality in pre-, per- and postoperative activities of surgeries. needed as well. Based on the type of equipment and cor- Task deconstructions of involved employees are used to responding risks, manufacturers and educators should analyze the impact of a new device on performed activities, define ways of (ongoing) training assessment [5, 12, 15, processes, and workflows. Alterations in processes and 17–19, 21, 22, 25–30, 32–34, 37–42, 44, 46]. workflows result in updated protocols and checklists, affecting tasks and activities for involved employees [5, 12–18, 4. Discussion 21–32, 34, 36–40, 42–46]. )ere is overwhelming evidence that the use of medical technology and information technology in ORs will increase. 3.6. Project Management. In the OR, many stakeholders are )is will affect costs, quality of care, complexity of surgical involved, executing various protocolled tasks and activities. procedures and, as a consequence, also patient safety. Implementation of new technological equipment as a proj- Current guidelines, available for implementation of new ect requires management to achieve predetermined goals. devices in the OR, in essence include safety based on the Identified elements for project management regard the local policies according to the covenant medical technology identification of stakeholders, defining the purpose of the in the Netherlands (CMT) [4]. )e OR is a dynamic, project, as well as benefits and gains. A project plan and multidisciplinary, multistakeholder, and innovative envi- planning are considered to be part of this category. During the ronment, and the development and implementation of process of implementation, team members are identified to medical equipment should not only consider safety but also execute a project plan. Multiple articles mention the alloca- cost and effects. Although the CMT policy represents tion of a multidisciplinary team as one of the necessary factors a guideline for local hospitals and audits are performed by for the implementation of new technology, as different per- the Dutch Health and Youth Care Inspectorate (HYI), we spectives to the implementation are addressed. Examples of learned from literature and experience that implementation these perspectives are change management, simulations, and of new medical equipment runs along all different sorts of stakeholder management [12, 14–18, 20–23, 25–27, 29–31, pathways before being accepted in clinical surgical practice. 33–35, 37–43, 47]. We also learned that implementations vary in duration and success. In this review, coded seven main categories are 3.7. Staff. When referred to as staff in the OR, we refer to indeed relevant, and all have their impact in the process of employees or surgical supportive staff who are involved in implementation: “processes and activities,” “staff,” “com- setting up, preparing, using, and disassembling medical munication,” “project management,” “technology,” “train- equipment. )e ease of use of new medical equipment ing,” and “performance.” Table 1 shows that the number of contributes to the adoption of this equipment by staff. referenced articles varies between 22 articles and 30 articles During the project, staff need to be involved in activities out of a total of 37 articles. )e aggregated frequency of regarding the new equipment, such as training, setting up, coding shows that the categories project management, using, and disassembling medical equipment and updating technology, and processes and activities are referenced 510, corresponding protocols and checklists [5, 12, 13, 15, 16, 255, and 240 times. Prior to the coding process, we expected 18–27, 29, 30, 32–37, 39–41, 48]. that implementations of new technologies effected processes Journal of Healthcare Engineering 5 and activities, technology, and staff; this is indeed confirmed implement new technological equipment in a generic way in by literature. Results show that the category project man- ORs, contributing to further enhanced safety as well as efficiency and to shorten the duration of the implementation agement scores high, due to the accumulation of frequencies of underlying coded items. )ese items are expected to be process. part of an integral implementation project of new medical equipment, consisting of various project activities. Conflicts of Interest We postulate that aforementioned categories provide a baseline for a holistic perspective on implementations of )e authors declare that there are no conflicts of interest new medical equipment in ORs. )e category performance regarding the publication of this paper. can be identified as a resulting category related to the outcome of an implementation, while the other categories can be Acknowledgments identified as influencing categories. We further postulate that tailoring or aligning these influencing categories and un- )e authors thank Mr. Maurits Konings, Ph.D., physicist, at derlying items to the context such as organisation, type of the University Medical Center Utrecht for his helpful sug- medical equipment, or involved stakeholders affect the out- gestions while reviewing drafts of this paper. come of an implementation. 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Implementing Medical Technological Equipment in the OR: Factors for Successful Implementations

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Copyright © 2018 Navin Sewberath Misser et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Abstract

isational factors, and job factors [7, 8]. However, much review results were discussed, resulting in a selection of ab- remains unexplored, especially when considering all these stracts for full-article review. Duplicate abstracts were re- perspectives holistically. )e overall aim of our research is moved. In the third phase, the selection of full articles was to develop a holistic model for implementation of new reviewed for inclusion or exclusion, according to the purpose equipment in ORs, which helps hospitals and medical of the research (NSM). In case of doubt, the second reviewer equipment companies to implement medical technology in (BVZ) was asked to assess the article. Results of the full-article review were discussed, and articles were in- or excluded by a safe, efficient, and cost-effective way. For reasons of de- marcating and focus, we concentrate on the implementation of consensus. new medical technological equipment, which includes medical equipment and medical information technology (i.e., hardware 2.2. Coding. Coding of included articles should be resulting and/or embedded software). )is study is the first step towards in all types of influencing factors for the implementation of our overall aim, and we analyze existing recent literature medical equipment in ORs as well as resulting factors of an available on implementations of technology in the OR, in order implementation of medical equipment for instance per- to identify success factors for efficient implementations. Re- formance. During a coding process, relevant sections in sults from this study will be included in the development of articles are marked and a descriptive name or code is added a holistic implementation model for new technological to the section. During coding of included articles, all relevant equipment in ORs. In the following section, we explain the sections were coded inductively using NVivo (version 11 for literature search and analysis procedure, followed by a section Windows) [10]. )rough “open coding,” we identified fac- that describes the literature review results. In the discussion, we tors or categories of importance in our literature sources, reflect on the results. In the last section conclusions, limitations following principles as presented by Strauss and Corbin and and plans for further research are provided. leveraging Nvivo tooling [11]. 2. Method 3. Results )e aim of our systematic literature review is to identify all types of relevant factors on the implementation of medical 3.1. Search Results. Our searches resulted in 1592 potentially technology in ORs and to categorize these factors. To ensure eligible articles (Figure 2). After screening titles, 1451 articles quality and rigor, this systematic literature review com- were excluded. After reviewing the abstracts of 141 studies, menced by setting up a literature search protocol following 49 articles remained. Reviewing these articles and applying the guidelines of Kitchenham and Charters (Figure 1) [9]. the inclusion and exclusion criteria resulted in 35 remaining )e following databases were accessed in the search process: articles for detailed coding and analysis. Two articles were Academic Search, ACM, DOJ, Embase, NARCIS, Pubmed, added to this selection based on references and feedback Science Direct, Springerlink, Web of Science, and Wiley. from coresearchers, that is, Raman et al. and Stefanidis et al. We entered the following terms and operators: “Implement” [12, 13]. During the search and coding process, the article of OR “Implementation” AND “Technology” AND “Operating Raman et al. was an accepted, not yet published, manuscript. Room.” )ese terms were searched for in “all fields” of )is article provided insights into the implementation of selected databases. checklists in OR and was therefore included in this research. )e second article from Stefanidis et al. was published as 2.1. Inclusion and Exclusion Criteria. We used no date re- a set of guidelines for the introduction of new technology strictions during the database search. Articles regarding the and techniques from a surgeons’ perspective. )is article did implementation of medical equipment as well as in- not include an abstract nor keywords that were related to formation technology were included in the reviewing pro- this research. )e research team advised to include these cess. Titles of articles included in reference lists related to the articles due to their relevance and the scope of this research. search criteria were considered. Articles published in other Following the review process and criteria for inclusion than the English language were excluded. We excluded and exclusion, 37 articles were included in this study. secondary literature, for example, books. Conference ab- Table 1 provides an overview of included articles related stracts, poster presentations, and letters were excluded as to the year of publication, with intervals of 5 years. )ree well, due to limited availability of detailed information in included articles were published in interval I, period proceedings and other sources. 1997–2002. Six articles were published in the periods re- We reviewed the results in three steps. Firstly, two ferring to intervals II and IV. Most included articles (n � 22) members of the research team (NSM and BVZ) reviewed were published in interval III, corresponding to the period titles independently according to predefined inclusion and 2009–2014. Journal of Healthcare Engineering 3 Title review (two members) Abstract review (two members) Included Coding in Constructed Search per Identify databases Factors Analyse factors papers Nvivo model database Paper review yes OK? Doubt? Second review Figure 1: Overview of search activities and coding. Exclusion of conference Abstracts considered relevant Titles identified for review abstracts and poster Full articles for review for review (n = 1592) presentations (n = 49) (n = 141) and removal of duplicates After applying inclusion and exclusion criteria (n = 35) Results on search per Results after review of titles Academic search (n = 14) database Academic search (n = 61) ACM (n = 7) Added papers from references ACM (n = 303) DOJ (n = 1) and supervisors DOJ (n = 1) Embase (n = 34) (n = 2) Embase (n = 176) NARCIS (n = 1) PubMed (n = 15) NARCIS (n = 1) PubMed (n = 123) ScienceDirect (n = 19) ScienceDirect (n = 424) SpringerLink (n = 9) SpringerLink (n = 247) Web of Science (n = 22) Included papers for coding Web of Science (n = 150) Wiley (n = 19) (n = 37) Total: 141 Wiley (n = 106) Figure 2: Search results. Table 1: Results: distribution of articles according to the year of Table 2: Results: frequencies of coded categories. publication. Number Aggregated frequency Legend Categories/factors Interval Period (year) Number of articles (n  37) of articles of coding I 1997–2002 3 1 Communication 24 86 II 2003–2008 6 2 Performance 22 86 III 2009–2014 22 3 Process and activities 29 240 IV 2015–2016 6 4 Project management 24 510 5 Sta� 30 190 6 Technology 27 355 7 Training 25 176 3.2. Coding Results. e coding process resulted in a long list of descriptive names or items. Related items were grouped in categories or factors. is process is traceably and trans- parently performed in NVivo. aggregated frequency of items, the categories project Table 2 shows seven categories that are derived from the management, technology, and process and activities, are coded items: communication, performance, process and coded most often, respectively, 510, 355, and 240 times. activities, project management, sta�, technology, and ese results imply that underlying items of these categories training. Each category consists of one or more underlying are coded more than once in corresponding articles. items, resulting from coding articles in NVivo. Furthermore, e identiŠed categories are explained in the following Table 1 shows the number of coded articles per category sections: (“number of articles”). e categories process and activities, sta�, and technology are referenced in the majority of the coded articles, respectively, 29, 30, and 27 articles. Table 2 3.3. Communication. Communication is a category that was also shows the aggregated frequency of coded items per coded in 24 articles. When new technology (i.e., medical category (“aggregated frequency of coding”). Based on the equipment) is introduced, disruptions in activities and 4 Journal of Healthcare Engineering 3.8. Technology. In this review, technology is used as cate- workflow occur, which require communication and team- work. Communication with relevant stakeholders is one of gory for coding referring to medical equipment and (em- bedded) Information Technology (IT). Studies show that the the factors to prevent errors when introducing new tech- nological equipment. )e use of updated checklists is de- implementation of new medical equipment involves in- scribed as one of the communication tools, which regulate tegrating new technology in the daily processes and activ- activities and the workflow for stakeholders such as sur- ities. Relevant training for staff is required which includes geons, anaesthesiologists, and surgical supporting staff. )e setup, use, disassembly of equipment, the interpretation of use of these updated checklists contributes to improved data and screens (if applicable), and troubleshooting in case safety in the OR [12–34]. problems occur [5, 12, 13, 15–20, 22, 24–26, 28, 29, 31, 32, 34, 36–38, 40, 42–45, 47]. 3.4. Performance. In 22 articles, various indicators regarding 3.9. Training. Studies showed that staff needs training to performance are identified such as OR efficiency and per- formance, patient care, patient outcomes, finance, safety, setup, configure, use, and disassembly new medical equip- ment. Training starts during the project with involved ergonomics, and user-friendliness of technological equip- ment [5, 12, 16, 19, 21–24, 26–32, 35–41]. project members and based on the project plan and product requirements. Training elements are described in training programs, which entail technical and nontechnical skills. 3.5. Processes and Activities. )e majority of the articles Nontechnical skills are described as skills regarding com- included in this study showed that the introduction of new munication, teamwork, and leadership. Depending on the technological equipment affects processes and activities of contents of training, staff gain experience and skills to use employees in the OR. Tasks and activities of OR employees are medical equipment and to interpret data (on screens if recorded in protocols and checklists to ensure safety and applicable). Skills to troubleshoot when problems occur are quality in pre-, per- and postoperative activities of surgeries. needed as well. Based on the type of equipment and cor- Task deconstructions of involved employees are used to responding risks, manufacturers and educators should analyze the impact of a new device on performed activities, define ways of (ongoing) training assessment [5, 12, 15, processes, and workflows. Alterations in processes and 17–19, 21, 22, 25–30, 32–34, 37–42, 44, 46]. workflows result in updated protocols and checklists, affecting tasks and activities for involved employees [5, 12–18, 4. Discussion 21–32, 34, 36–40, 42–46]. )ere is overwhelming evidence that the use of medical technology and information technology in ORs will increase. 3.6. Project Management. In the OR, many stakeholders are )is will affect costs, quality of care, complexity of surgical involved, executing various protocolled tasks and activities. procedures and, as a consequence, also patient safety. Implementation of new technological equipment as a proj- Current guidelines, available for implementation of new ect requires management to achieve predetermined goals. devices in the OR, in essence include safety based on the Identified elements for project management regard the local policies according to the covenant medical technology identification of stakeholders, defining the purpose of the in the Netherlands (CMT) [4]. )e OR is a dynamic, project, as well as benefits and gains. A project plan and multidisciplinary, multistakeholder, and innovative envi- planning are considered to be part of this category. During the ronment, and the development and implementation of process of implementation, team members are identified to medical equipment should not only consider safety but also execute a project plan. Multiple articles mention the alloca- cost and effects. Although the CMT policy represents tion of a multidisciplinary team as one of the necessary factors a guideline for local hospitals and audits are performed by for the implementation of new technology, as different per- the Dutch Health and Youth Care Inspectorate (HYI), we spectives to the implementation are addressed. Examples of learned from literature and experience that implementation these perspectives are change management, simulations, and of new medical equipment runs along all different sorts of stakeholder management [12, 14–18, 20–23, 25–27, 29–31, pathways before being accepted in clinical surgical practice. 33–35, 37–43, 47]. We also learned that implementations vary in duration and success. In this review, coded seven main categories are 3.7. Staff. When referred to as staff in the OR, we refer to indeed relevant, and all have their impact in the process of employees or surgical supportive staff who are involved in implementation: “processes and activities,” “staff,” “com- setting up, preparing, using, and disassembling medical munication,” “project management,” “technology,” “train- equipment. )e ease of use of new medical equipment ing,” and “performance.” Table 1 shows that the number of contributes to the adoption of this equipment by staff. referenced articles varies between 22 articles and 30 articles During the project, staff need to be involved in activities out of a total of 37 articles. )e aggregated frequency of regarding the new equipment, such as training, setting up, coding shows that the categories project management, using, and disassembling medical equipment and updating technology, and processes and activities are referenced 510, corresponding protocols and checklists [5, 12, 13, 15, 16, 255, and 240 times. Prior to the coding process, we expected 18–27, 29, 30, 32–37, 39–41, 48]. that implementations of new technologies effected processes Journal of Healthcare Engineering 5 and activities, technology, and staff; this is indeed confirmed implement new technological equipment in a generic way in by literature. Results show that the category project man- ORs, contributing to further enhanced safety as well as efficiency and to shorten the duration of the implementation agement scores high, due to the accumulation of frequencies of underlying coded items. )ese items are expected to be process. part of an integral implementation project of new medical equipment, consisting of various project activities. Conflicts of Interest We postulate that aforementioned categories provide a baseline for a holistic perspective on implementations of )e authors declare that there are no conflicts of interest new medical equipment in ORs. )e category performance regarding the publication of this paper. can be identified as a resulting category related to the outcome of an implementation, while the other categories can be Acknowledgments identified as influencing categories. We further postulate that tailoring or aligning these influencing categories and un- )e authors thank Mr. Maurits Konings, Ph.D., physicist, at derlying items to the context such as organisation, type of the University Medical Center Utrecht for his helpful sug- medical equipment, or involved stakeholders affect the out- gestions while reviewing drafts of this paper. come of an implementation. 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