Background and purpose Clinical introduction of in-house developed medical devices in Europe requires conformity to the Medical Device Regulation (MDR) 2017/745 Article 5(5). Published experience on regulatory aspects of these devices is limited. This work describes our in-house development and verifications of the 3D printed patient-tailored ARCHITECT brachytherapy applicator and accompanying software, prepared to support clinical investigation and in-house use. Materials and methods Article 5(5) mandates an ‘appropriate’ quality management system (QMS) and exempts in-house medical devices from all MDR requirements except general safety and performance requirements (GSPRs). An institutional QMS was available, comprising documented procedures and fill-in templates for all project phases to compile technical documentation. In the first phase, the QMS requires a market analysis to justify the in-house exemption. In the design phase a prototype is developed, to be iteratively improved during manufacturing and verification phases, based on risk evaluations, verification tests, and processing constraints. Documentation is lastly compiled to support clinical investigations and routine use of the device. Results After confirming that no suitable marketed device was available, risk-based design and manufacturing approaches were used to safeguard in-house development. Verifications of material, manufacturing, mechanical safety, cleaning and sterilisation, use and workflow, and compatibility with procedures showed compliance with GSPRs. Simulated dosimetric benefits were observed compared to marketed devices. Conclusion The ARCHITECT applicator was developed in a systematic process, resulting in documented workflows and verification steps. Our approach provides a practical framework for MDR-compliant introduction of in-house equipment and can inform future best practice guidelines.

Objective: To explore barriers and facilitators in implementing the Safety Climate Thermometer (SCT), a new tool designed to support team-level safety culture improvement in surgical settings. The SCT acts through visual insights into safety culture themes, acting as a conversation starter, and interdisciplinary team meetings about this topic. It aims to facilitate daily practice changes. The SCT has previously been developed using user-centered design methods, which consisted of a scoping literature review and international survey. Design: A qualitative implementation study using semi-structured interviews and observational data, guided by the implementation outcomes framework. Setting: Three surgical teams from Dutch hospitals of varying size participated between 2021 and 2023 and used the SCT's visual input and interdisciplinary team meeting structure for 7 months. Participants: Seventeen healthcare professionals, including nurses, surgeons, and managers, took part in the SCT process and subsequent interviews. Results: The SCT facilitated an anonymous, online assessment followed by structured interprofessional discussions and goal-setting for safety improvement. Participants reported high usability and acceptability due to the tool's intuitive design and anonymity. The SCT was adaptable to different surgical contexts, though smaller teams with motivated champions and in-person facilitation appeared most suitable. Key barriers included high turnover and work pressure, competing priorities, lack of trust, and survey fatigue. Facilitators include in-person external facilitation and “protected time.” Reported positive effects included strengthened team cohesion and a greater sense of being heard. Conclusions: The SCT is a practice-oriented, user-friendly tool for improving safety culture through team-based reflection and dialogue. Future use should prioritize exploration of contextual factors.

BACKGROUND AND PURPOSE: Although dose planning aims in cervical cancer brachytherapy are well-defined, variability in clinical practices makes it difficult to draw generalizable conclusions on achievable dosimetry. This review and meta-regression aim to assess clinical practices in terms of their therapeutic dose window, that is, the balance between target and organs-at-risk (OAR) doses. MATERIALS AND METHODS: A search of the literature was performed in Scopus, PubMed, and Web of Science databases. Peer-reviewed articles were included that described planning constraints and reported high-risk clinical target volume (CTV_HR) D_90% and OAR D_2cm³ for intracavitary (IC) tandem and ring (T&R) / tandem and ovoid (T&O) / mold (M) applicators, possibly supplemented with interstitial (IS) needles (+N). To determine factors associated with target volume coverage (D_90%) and OAR sparing (D_2cm³), multivariate meta-regressions were performed. RESULTS: Out of 1590 articles, 34 met the full inclusion criteria. In most studies, the CTV_HR D_90% aimed at ≥84–86 Gy EQD2_{α/β = 10Gy}, and constraints for the OARs were 80–90 Gy, 65–75 Gy and 70–75 Gy EQD2_{α/β = 3Gy} for the bladder, rectum and sigmoid D_2cm³, respectively. Studies using IC/IS applicators were associated with a ∼4 Gy increase in CTV_HR D_90% compared to IC only, with no effect on OAR dose. T&R studies achieved improvements of 3.2 Gy and 2.8–3.4 Gy at typical planning aims in comparison with T&O applicators in target and OAR doses. In 100% (15/15) of patient groups treated with T&R + N both CTV_HR and OAR objectives were met for the population average. For T&R, T&O, and T&O + N groups, this was the case in 89% (8/9), 43% (6/14), and 50% (4/8), respectively. CONCLUSION: Studies using interstitial needles with T&R applicators in MR-guided brachytherapy for cervical cancer seem to be associated with a favorable therapeutic target dose/OAR sparing ratio.

Background The Dutch healthcare system relies heavily on residents. This group is thought to be especially susceptible because of the system of hierarchy and dependence in which they work. Multiple studies have related overtime, safety climate, and supervisory support to medical errors. The aim of this study was to examine these themes and their correlations. Methods This cross-sectional questionnaire included multiple validated scales, and demographic and employment data. Correlations between themes were calculated using linear regression analysis. Between-group analyses concerning residents’ current position, department, clinical setting, and experience level compared the mean composite scores. The survey was distributed through Dutch physician associations and social media platforms between February and April 2020. 492 medical residents were included. Results Weekly average overtime was 7.8 hours, which was mostly uncompensated. Residents who were not in a training program, surgical residents, and those working in hospitals reported significantly more overtime. Over one in three felt they had fallen short in the quality of care they delivered. One-third of the respondents did not have a designated supervisor, and supervisor support scored mediocre overall. Medical errors were associated with a poorer safety climate, but other associations were not observed. Conclusions Overtime is abundant in residents, especially in surgical specialties. Safety is a priority but has a tendency to crumble under pressure. Strikingly, a substantial part of the residents felt that they had performed medical procedures that they were not properly trained for and that they had fallen short in the quality of care they delivered. Supervisor support was mostly present in the development of competencies and work-related problems, but residents reported poor rewarding behaviors, and a third did not have a designated mentor. Medical training programs should acknowledge the importance of these themes and make tangible efforts to monitor the needs and experiences of residents.

Purpose. Patient-tailored intracavitary/interstitial (IC/IS) brachytherapy (BT) applicators may increase dose conformity in cervical cancer patients. Current configuration planning methods in these custom applicators rely on manual specification or a small set of (straight) needles. This work introduces and validates a two-stage approach for establishing channel configurations in the 3D printed patient-tailored ARCHITECT applicator. Methods. For each patient, the patient-tailored applicator shape was based on the first BT application with a commercial applicator and integrated connectors to a commercial (Geneva) intrauterine tube and two lunar ring channels. First, a large candidate set was generated of channels that steer the needle to desired poses in the target region and are contained in the applicator. The channels’ centrelines were represented by Bézier curves. Channels running between straight target segments and entry points were optimised and refined to ensure (dynamic) feasibility. Second, channel configurations were selected using geometric coverage optimisation. This workflow was applied to establish patient-tailored geometries for twenty-two patients previously treated using the Venezia applicator. Treatment plans were automatically generated using the in-house developed algorithm BiCycle. Plans for the clinically used configuration, T P clin , and patient-tailored configuration, T P arch , were compared. Results. Channel configurations could be generated in clinically feasible time (median: 2651 s, range 1826-3812 s). All T P arch and T P clin plans were acceptable, but planning aims were more frequently attained with patient-tailored configurations (115/132 versus 100/132 instances). Median CTV_IR D 98 and bladder D 2 c m 3 doses significantly improved ( p < 0.001 and p < 0.01 respectively) in T P arch plans in comparison with T P clin plans, and in approximately half of the patients dosimetric indices improved. Conclusion. Automated patient-tailored BT channel configuration planning for 3D printed applicators is clinically feasible. A treatment planning study showed that all plans met planning limits for the patient-tailored configurations, and in selected cases improved the plan quality in comparison with commercial applicator configurations.

BACKGROUND AND PURPOSE: Although MRI-based image guided adaptive brachytherapy (IGABT) for locally advanced cervical cancer (LACC) has resulted in favorable outcomes, it can be logistically complex and time consuming compared to 2D image-based brachytherapy, and both physically and emotionally intensive for patients. This prospective study aims to perform time-action and patient experience analyses during IGABT to guide further improvements. MATERIALS AND METHODS: LACC patients treated with IGABT were included for the time-action (56 patients) and patient experience (29 patients) analyses. Times per treatment step were reported on a standardized form. For the patient experience analysis, a baseline health status was established with the EQ-5D-5L questionnaire and the perceived pain, anxiety and duration for each treatment step were assessed with the NRS-11. RESULTS: The median total procedure time from arrival until discharge was 530 (IQR: 480–565) minutes. Treatment planning (delineation, reconstruction, optimization) required the most time and took 175 (IQR: 145–195) minutes. Highest perceived pain was reported during applicator removal and treatment planning, anxiety during applicator removal, and duration during image acquisition and treatment planning. Perceived pain, anxiety and duration were correlated. Higher pre-treatment pain and anxiety scores were associated with higher perceived pain, anxiety and duration. CONCLUSION: This study highlights the complexity, duration and impact on patient experience of the current IGABT workflow. Patient reported pre-treatment pain and anxiety can help identify patients that may benefit from additional support. Research and implementation of measures aiming at shortening the overall procedure duration, which may include logistical, staffing and technological aspects, should be prioritized.

Background: The steep radiation dose gradients in cervical cancer brachytherapy (BT) necessitate a thorough understanding of the behavior of afterloader source cables or needles in the curved channels of (patient-tailored) applicators. Purpose: The purpose of this study is to develop and validate computer models to simulate: (1) BT source positions, and (2) insertion forces of needles in curved applicator channels. The methodology presented can be used to improve the knowledge of instrument behavior in current applicators and aid the development of novel (3D-printed) BT applicators. Methods: For the computer models, BT instruments were discretized in finite elements. Simulations were performed in SPACAR by formulating nodal contact force and motion input models and specifying the instruments’ kinematic and dynamic properties. To evaluate the source cable model, simulated source paths in ring applicators were compared with manufacturer-measured source paths. The impact of discrepancies on the dosimetry was estimated for standard plans. To validate needle models, simulated needle insertion forces in curved channels with varying curvature, torsion, and clearance, were compared with force measurements in dedicated 3D-printed templates. Results: Comparison of simulated with manufacturer-measured source positions showed 0.5–1.2 mm median and <2.0 mm maximum differences, in all but one applicator geometry. The resulting maximum relative dose differences at the lateral surface and at 5 mm depth were 5.5% and 4.7%, respectively. Simulated insertion forces for BT needles in curved channels accurately resembled the forces experimentally obtained by including experimental uncertainties in the simulation. Conclusion: The models developed can accurately predict source positions and insertion forces in BT applicators. Insights from these models can aid novel applicator design with improved motion and force transmission of BT instruments, and contribute to the estimation of overall treatment precision. The methodology presented can be extended to study other applicator geometries, flexible instruments, and afterloading systems.

Introduction Growth monitoring of preterm infants is essential for assessing the nutritional effects on their growth. The current growth monitoring techniques are too stressful, however, for the smallest preterm infants. We performed a systematic review to summarize studies on stress-free techniques for measuring the body size of preterm infants inside incubators other than the traditional calliper and tape measure-based instruments. Methods We searched four online literature databases: Embase, Medline, Web of Science Core Collection, and Cochrane, using search terms related to patients (neonates, infants, children) and body size measuring techniques. By means of expert judgement we assessed the techniques’ suitability for stress-free body size measurement of an infant lying in an incubator. As a criterion for suitability, we used an imaginary ideal technique. Results Twenty-six studies were included in this review. In 24 studies, the technique for body size measurement was related to 3D technology, and the majority of these studies acknowledged clinical superiority of 3D over 2D data. Two 3D techniques were assessed as suitable for stress-free measurement of preterm infants inside incubators. The first technique used a commercially available 3D handheld scanner which needed 3D postprocessing to derive measurement data. The second technique used a self-developed stereoscopic vision system. Conclusions 3D volumetric parameters have higher clinical value for growth monitoring than 2D. In addition, contactless 3D measurements enable stress-free growth monitoring of even the smallest preterm infants. However, the time-consuming 3D postprocessing challenges the usability of 3D techniques. Regrettably, none of the identified suitable 3D techniques met all our requirements of an ideal all-in-one body size measuring technique for extreme preterm infants. Handheld 3D scanning might have the best properties for developing this ideal technique.

Objective: Medical Crew Resource Management (CRM) training courses are designed to increase patient safety by reducing the effects of human errors. These training courses are most popular in surgery and a wide range of medical CRM training courses for surgical teams is now available. However, the effects of these CRM training courses on patient outcomes are inconclusive. Although surgical teams feel the need to be trained in team collaboration skills, they are often puzzled about what criteria to apply when choosing a medical CRM training course. This study aimed to compare CRM training courses on didactic components and simulation-exercises to explore if these courses are interchangeable. Methods: In this qualitative study, semi-structured interviews were conducted among 10 main CRM training providers of surgical teams in the Netherlands. Results: Although a large variety was found in the content of CRM training courses, the most substantial differences were found in the simulation-exercises. Nine out of 10 trainers stated that standard simulation-exercises would be a step forward to ensure quality in CRM trainings. According to the trainers, the implementation of medical CRM can reduce human errors and as a result, preventable patient complications. They suggested a quality standard for CRM trainers in the medical field to ensure the quality of medical team training as a way to reach this. Conclusions: Medical CRM training courses are diverse and noninterchangeable. Trainers expect that if CRM becomes part of surgical training and is embedded in operating theatre culture, it could be of great value for patients and professionals.

Background: Laparoscopy is a minimally-invasive surgical procedure that uses long slender instruments that require much smaller incisions than conventional surgery. This leads to faster recovery times, fewer post-surgical wound infections and shorter hospital stays. For these reasons, laparoscopy could be particularly advantageous to patients in low to middle income countries (LMICs). Unfortunately, sterile processing departments in LMIC hospitals are faced with limited access to equipment and trained staff which poses an obstacle to safe surgical care. The reprocessing of laparoscopic devices requires specialised equipment and training. Therefore, when LMIC hospitals invest in laparoscopy, an update of the standard operating procedure in sterile processing is required. Currently, it is unclear whether LMIC hospitals, that already perform laparoscopy, have managed to introduce updated reprocessing methods that minimally invasive equipment requires. The aim of this study was to identify the laparoscopic sterile reprocessing procedures in rural India and to test the effectiveness of the sterilisation equipment. Methods: We assessed laparoscopic instrument sterilisation capacity in four rural hospitals in different states in India using a mixed-methods approach. As the main form of data collection, we developed a standardised observational checklist based on reprocessing guidelines from several sources. Steam autoclave performance was measured by monitoring the autoclave cycles in two hospitals. Finally, the findings from the checklist data was supported by an interview survey with surgeons and nurses. Results: The checklist data revealed the reprocessing methods the hospitals used in the reprocessing of laparoscopic instruments. It showed that the standard operating procedures had not been updated since the introduction of laparoscopy and the same reprocessing methods for regular surgical instruments were still applied. The interviews confirmed that staff had not received additional training and that they were unaware of the hazardous effects of reprocessing detergents and disinfectants. Conclusion: As laparoscopy is becoming more prevalent in LMICs, updated policy is needed to incorporate minimally invasive instrument reprocessing in medical practitioner and staff training programmes. While reprocessing standards improve, it is essential to develop instruments and reprocessing equipment that is more suitable for resource-constrained rural surgical environments.

To comply with the large global need for surgery, surgical equipment that fits the challenging environment in low-and middle-income countries (LMICs) should be designed. The aim of this study is to present a context-specific design of an electrosurgical unit (ESU) and a monopolar handheld to improve global access to surgery. This paper presents both a detailed description of electrosurgery in clinical practice in LMICs and the design of an ESU generator and monopolar handheld for this specific setting. Extensive fieldwork (by means of surveys, interviews, observations, and collection of maintenance records) was done by authors RO, KO, and LH. Feedback from users working in Kenya on the first demonstrator designs was obtained, after which the designs were adapted into conceptual prototypes. These were further evaluated by surveying respondents who attended the annual meeting of the College of Surgeons of East, Central, and Southern Africa (COSECSA) in Kigali, Rwanda in December 2018. Conceptual prototypes were developed for (a) an affordable ESU that is compact and battery powered and (b) a robust reusable monopolar handheld that can be cleaned in the autoclave and by chemicals (e.g., glutaraldehyde solution). The conceptual prototypes were positively received by the 51 respondents of the survey. The findings from the field work and the feedback from users during the design phase have led to a clear understanding of the specific needs and potential solutions. The presented conceptual prototypes need to be further developed into functional prototypes, which could be implemented in Kenya and other settings for further evaluation.

MIS-SIM is a virtual reality (VR) environment designed and developed for the creation of virtual scenarios that can be used to train and acquire basic and advance laparoscopic skills. The environment is composed by a task editor where a content creator design and develop tasks for the simulator to play. Once they are completed, objective metrics are automatically stored and examined in MIS-SIM’s server so they can be displayed by an online platform. The project was validated in Semmelweis University in Budapest, Hungary where an experienced professor designed tasks for 16 young surgeons (PGY 3-4-5) from different surgical fields (gynaecology, general-, plastic-, vascular-, thoracic-, neurosurgery, etc.) with different experiences in laparoscopy. Each participant fulfilled each task as if they were completing them on physical simulator.