General awareness has risen that patient safety needs to be improved, especially during procedures that are more dependent on technology and demand extra skills from the surgical team, such as laparoscopic surgery. Besides the skills of the surgeon, various nontechnical elements are of influence on surgical performance and patient safety [2, 4, 5]. Vincent et al. claimed that, amongst others, attention to ergonomics and equipment design and enhancing communication and team performance could even have a stronger influence on performance than surgical skills . The use of an integrated OR system has the potential to improve the ergonomics, safety, and efficiency of laparoscopic surgery [9–11]. The application of preoperative checklists also has been shown to improve patient safety considerably [13–16]. Our purpose was to investigate the combined effect of using an integrated OR system—the Karl Storz OR1—together with a procedure-specific digital checklist—the Pro/cheQ tool—on the number and type of equipment- and instrument-related RSE.
This study showed that, in comparison to the cart-based OR, the combined usage of the integrated OR and the Pro/cheQ tool had a stronger reducing effect on the number of RSE than the usage of the integrated OR alone (Table 1). The type of events that occurred also differed (Fig. 2). Most RSE during the 45 observed procedures were restored by adjustment of the equipment settings or position. However, each event disrupted and prolonged the surgical process. In many cases the origin of the event could be traced back to the circulating nurse, who had forgotten or knowingly omitted to prepare something timely without informing the other members of the surgical team. Routine usage of Pro/cheQ proved to be feasible, it supported the optimal workflow in a natural way and was considered to be constructive by surgeons, anesthesiologists, and both inexperienced and experienced OR nurses . The findings of this study are in concordance with previous investigations into the occurrence and type of equipment-related RSE during laparoscopic surgery, where equipment-related RSE were observed in 87 and 42% of the laparoscopic procedures [19, 20]. A study by Verdaasdonk et al. showed a similar effect on the reduction of RSE by the use of a reusable preoperative paper checklist for laparoscopic cholecystectomies; the number of procedures with one or more RSE was reduced from 87 to 47% .
The impact of using Pro/cheQ extended beyond a reduction of RSE. It increased the general safety awareness amongst the OR staff and improved the understanding of the importance of using all available means to work accordingly. To streamline the understanding of responsibilities and synchronize expectations amongst the members of the surgical team, Pro/cheQ structured several key elements of the communication within the team and required several issues to be uttered out loud in the presence of the whole team. The circulating nurse had the responsibility to secure the quality and course of the preparation process and to complete most of the checkmarks, but the whole team was responsible to execute Pro/cheQ properly. Catchpole et al. highlighted that improved team skills are associated with speedier completion of operations .
Unfortunately, adverse events can never be completely prevented. The engagement of the OR staff to look after quality and safety and the actual usage of supporting tools and setups, such as the integrated OR and checklist, is very important. In our hospital the technical department routinely checks all equipment following strict protocols and the scrub nurse checks the standard instruments before the start of each procedure, still several defects occurred during the observed procedures. Besides opportunities, new technology also brings along new risks and challenges . The introduction and instructions for the use of new instruments and equipment often focuses mainly on functionality, whereas new tools are not always intuitive or straightforward in use. When using new technology to perform a procedure being already standard, a surgeon might encounter problems that expose previously unidentified gaps in his knowledge (related to the surgical technique or utilization of the technology, for example), in such a case he cannot rely on existing heuristics or experience but has to find new ways to bridge these gaps on an ad hoc basis. Improper usage of a product can sometimes affect a product’s functionality and create unsafe situations. To keep a checklist workable and efficient, it cannot comprise all potential issues to ensure detection of equipment defects before surgery. The OR staff should have sufficient knowledge about the working of the equipment and instruments, how to use them aptly, and how to act and troubleshoot if something unexpected occurs.
It can be pivotal for the success of an innovation not to underestimate the value of the implementation process when introducing new products or tools [14, 22]. The implementation process should be broadly based within the hospital; all staff should be familiar and aware of the added value and importance of the innovation. Training should focus on the application of the innovation as a whole, and create awareness and understanding about its added value for the total care chain. Preferably, future users should have a sense of ownership of the solution [14, 22]. Pro/cheQ was developed following a user-centered and user-participatory design approach, which diminished the habitual reluctance to changes in the existing workflow. This effect also was recognized in a similar study by Lingard et al. .
The setup of this study had some limitations. Fifteen months after introduction of the integrated OR system, which did include brief training of the OR staff, many of its functionalities were not actively used. The use of functionalities, such as importing patient data from the digital hospital information system into the AIDA system, highly depended on the circulating nurse’s personal preferences. Using Pro/cheQ in the integrated OR setting enforced the use of the key functionalities of the integrated OR. Possibly, this has influenced the results. The decrease in RSE in the integrated OR setting where Pro/cheQ was used was probably not only achieved due to the use of Pro/cheQ but also by the better use of the OR1 system. Second, Pro/cheQ was designed to run of the touch screen of the OR1 system. However, for this study a laptop-based prototype of Pro/cheQ was used and some Pro/cheQ functionalities were simulated. This made the presence of the checklist tool less prominent and less enforcing. Using an integrated OR system or Pro/cheQ properly does require a change of mindset and routine, and although while the teams did receive training, only 15 procedures were analyzed per OR setting. Even though a considerable reduction of RSE was found, we expect that when used for a longer period of time, fully embedded, and no longer perceived as “the new routine,” the benefits for patient safety of these tools can be even greater.
This study focused on equipment- and instrument-related RSE only. However, Pro/cheQ is more than a preoperative checklist. It was developed not only to prevent equipment- and instrument-related RSE, but also to improve the quality control throughout laparoscopic surgical procedures. Additional research is needed to further investigate the contribution of the integrated OR and Pro/cheQ on overall surgical performance and safeguarding of quality control. To further improve the safety and quality of surgery, a multifaceted approach should be followed. In this the improvement of the usability of the instruments and equipment is important as well as crew resource management and implementation of protocols and checklist to standardize work routines [19, 20]. The focus should shift from the technical skills of the surgeon to the competence and performance of the whole surgical team.
In conclusion, this study shows that using both an integrated OR system and the Pro/cheQ tool reduces equipment- and instrument-related risk-sensitive events more than using only an integrated OR. Routine usage of the Pro/cheQ tool with the integrated OR proved to support the optimal workflow in a natural way, and its impact extended beyond the reduction of RSE. It increased general safety awareness and synchronized the mutual understanding of responsibilities and expectations amongst the members of the surgical team. The engagement of the OR staff to value having a safety culture and actively use tools, such as the integrated OR and checklist, is very important. The implementation process of such tools should therefore be broadly based within the hospital.