Background: During the implementation of new interventions (i.e., surgical devices and technologies) in the operating room, surgical safety might be compromised. Current safety measures are insufficient in detecting safety hazards during this process. The aim of the study was to observe whether surgical teams are capable of measuring surgical safety, especially with regard to the introduction of new interventions. Methods: A Surgical Safety Questionnaire was developed that had to be filled out directly postoperative by three surgical team members. A potential safety concern was defined as at least one answer between (strongly) disagree and indifferent. The validity of the questionnaire was assessed by comparison with the results from video analysis. Two different observers annotated the presence and effect of surgical flow disturbances during 40 laparoscopic hysterectomies performed between November 2010 and April 2012. Results: The surgeon reported a potential safety concern in 16% (85/520 questions). With respect to the scrub nurse and anesthesiologist, this was both 9% (46/520). With respect to the preparation, functioning, and ease of use of the devices in 37.5–47.5% (15–19/40 procedures) a potential safety concern was reported by one or more team members. During procedures after which a potential safety concern was reported, surgical flow disturbances lasted a higher percentage of the procedure duration [9.3 ± 6.2 vs. 2.9 ± 3.7% (mean ± SD), p < .001]. After procedures during which a new instrument or device was used, more potential safety concerns were reported (51.2 vs. 23.1%, p < .001). Conclusions: Potential safety concerns were especially reported during procedures in which a relatively high percentage of the duration consisted of surgical flow disturbances and during procedures in which a new instrument or device was used. The Surgical Safety Questionnaire can act as a validated tool to evaluate and maintain surgical safety during minimally invasive procedures, especially during the introduction of a new intervention.

Background: Since the introduction of minimally invasive surgery (MIS), concerns for patient safety are more often brought to the attention. Knowledge about and awareness of patient safety risk factors are crucial in order to improve and enhance the surgical team, the environment, and finally surgical performance. The aim of this study was to identify and quantify patient safety risk factors in laparoscopic hysterectomy and to determine their influence on surgical outcomes. Methods: A prospective multicenter study was conducted from April 2014 to January 2016, participating gynecologists registered their performed laparoscopic hysterectomies (LHs). If deemed necessary, gynecologists could fill out a checklist with validated patient safety risk factors. Association between procedures with and without an occurred risk factor(s) and the surgical outcomes (blood loss, operative time, and complications) were assessed, using multivariate logistic regression and generalized estimation equations. Results: Eighty-five gynecologists participated in the study, registering a total of 2237 LHs. For 627(28 %) procedures, the checklist was entered (in total 920 items). The most reported risk factors were related to the surgeon (19.6 %), the surgical team (14.4 %), technology (16.6 %), and the patient (26.8 %). The procedures where a risk factor was registered had significantly less favorable outcomes, higher complication rate (10.5 vs. 4.8 % (p = 0.002), longer operative time [114 vs. 95 min (p < 0.001)], and more blood loss [110 vs. 168 mL (p = 0.047)], which was mainly due to the technological and patient-related risk factors. Conclusion: Technological incidents are the most important and clinically relevant risk factors affecting surgical outcomes of LH. Future improvements of MIS need to focus on this. As awareness of safety risk factors in MIS is important, embedding of a safety risk factor checklist in registration systems will help surgeons to evaluate and improve their individual performance. This will inherently improve the surgical outcomes and thus patient safety.

Background: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)]. Methods: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device). Results: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p <.001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed. Conclusions: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise.