Transforming operating rooms: factors for successful implementations of new medical equipment

Operating Rooms (OR’s) are complex, high tech environments with extensive use of medical equipment and information technology. The implementation of new medical equipment with the aim to increase safety, improve patient outcomes or to improve efficiency may initially cause disruptions in the OR, which influence its success. Between and within hospitals the implementation of medical equipment varies and a generic implementation model omits. The aim of this study is to identify factors for successful implementations according to surgical supportive staff. Results are compared with findings from other published studies. In total 90 out of 235 surveys were returned (38%). Respondents, scrub nurses and circulating nurses, indicate that implementation and integration of new medical equipment in current activities and ICT systems remain a challenge. In this study we identified the following factors: a coherent and holistic implementation approach; integration of medical equipment in processes, systems and organization; knowledge and skill development and effective communication during the implementation process

User-friendliness of a dedicated orthopedic device for knee joint distraction: Experiences from clinical practice

Introduction: Knee joint distraction (KJD) is a surgical technique for treatment of severe knee osteoarthritis at a relatively young age. In the absence of devices intended for KJD, this procedure has only been performed with devices with another intended use. In collaboration with patients, clinicians and medical device experts, a dedicated distraction (DD) device intended for KJD was developed. Objectives: To compare user-friendliness between the new DD device and a previously used concept distraction (CD) device. Methods: Patients were treated with either of the devices (n = 22 versus n = 22). The intervention duration and treatment complications were registered. After treatment, patients filled out a questionnaire about user-friendliness of the device during treatment, containing questions on difficulties performing activities regarding clothing, sleeping, pin care, daily activities, mobility, and complications. Results were compared between the 2 groups. Results: Intervention duration was on average 56 versus 44 minutes (P .1). Conclusions: The DD device intended for KJD reduces surgery time and improves user-friendliness compared to the CD device. As such, the DD device contributes to implementation of KJD treatment in regular care

Attenuated XPC expression is not associated with impaired DNA repair in bladder cancer

Bladder cancer has a high incidence with significant morbidity and mortality. Attenuated expression of the DNA damage response protein Xeroderma Pigmentosum complementation group C (XPC) has been described in bladder cancer. XPC plays an essential role as the main initiator and damage-detector in global genome nucleotide excision repair (NER) of UV-induced lesions, bulky DNA adducts and intrastrand crosslinks, such as those made by the chemotherapeutic agent Cisplatin. Hence, XPC protein might be an informative biomarker to guide personalized therapy strategies in a subset of bladder cancer cases. Therefore, we measured the XPC protein expression level and functional NER activity of 36 bladder tumors in a standardized manner. We optimized conditions for dissociation and in vitro culture of primary bladder cancer cells and confirmed attenuated XPC expression in approximately 40% of the tumors. However, NER activity was similar to co-cultured wild type cells in all but one of 36 bladder tumors. We conclude, that (i) functional NER deficiency is a relatively rare phenomenon in bladder cancer and (ii) XPC protein levels are not useful as biomarker for NER activity in these tumors

Electrocardiogram Devices for Home Use: Technological and Clinical Scoping Review

Background: Electrocardiograms (ECGs) are used by physicians to record, monitor, and diagnose the electrical activity of the heart. Recent technological advances have allowed ECG devices to move out of the clinic and into the home environment. There is a great variety of mobile ECG devices with the capabilities to be used in home environments. Objective: This scoping review aimed to provide a comprehensive overview of the current landscape of mobile ECG devices, including the technology used, intended clinical use, and available clinical evidence. Methods: We conducted a scoping review to identify studies concerning mobile ECG devices in the electronic database PubMed. Secondarily, an internet search was performed to identify other ECG devices available in the market. We summarized the devices' technical information and usability characteristics based on manufacturer data such as datasheets and user manuals. For each device, we searched for clinical evidence on the capabilities to record heart disorders by performing individual searches in PubMed and ClinicalTrials.gov, as well as the Food and Drug Administration (FDA) 510(k) Premarket Notification and De Novo databases. Results: From the PubMed database and internet search, we identified 58 ECG devices with available manufacturer information. Technical characteristics such as shape, number of electrodes, and signal processing influence the capabilities of the devices to record cardiac disorders. Of the 58 devices, only 26 (45%) had clinical evidence available regarding their ability to detect heart disorders such as rhythm disorders, more specifically atrial fibrillation. Conclusions: ECG devices available in the market are mainly intended to be used for the detection of arrhythmias. No devices are intended to be used for the detection of other cardiac disorders. Technical and design characteristics influence the intended use of the devices and use environments. For mobile ECG devices to be intended to detect other cardiac disorders, challenges regarding signal processing and sensor characteristics should be solved to increase their detection capabilities. Devices recently released include the use of other sensors on ECG devices to increase their detection capabilities

Real-World Insights on the Management of Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) With Caplacizumab

peer reviewe

Detection of Ischemic ST-Segment Changes Using a Novel Handheld ECG Device in a Porcine Model

Background: Portable, smartphone-sized electrocardiography (ECG) has the potential to reduce time to treatment for patients suffering acute cardiac ischemia, thereby lowering the morbidity and mortality. In the UMC Utrecht, a portable, smartphone-sized, multi-lead precordial ECG recording device (miniECG 1.0, UMC Utrecht) was developed. Objectives: The purpose of this study was to investigate the ability of the miniECG to capture ischemic ECG changes in a porcine coronary occlusion model. Methods: In 8 animals, antero-septal myocardial infarction was induced by 75-minute occlusion of the left anterior descending artery, after the first or second diagonal. MiniECG and 12-lead ECG recordings were acquired simultaneously before, during and after coronary artery occlusion and ST-segment deviation was evaluated. Results: During the complete occlusion and reperfusion period, miniECG showed large ST-segment deviation in comparison to 12-lead ECG. MiniECG ST-segment deviation was observed within 1 minute for most animals. The miniECG was positive for ischemia (ie, ST-segment deviation ≥1 mm) for 99.7% (Q1-Q3: 99.6%-99.9%) of the occlusion time, while the 12-lead was only positive for 79.8% (Q1-Q3: 81.1%-98.7%) of the time (P = 0.018). ST-segment deviation reached maxima of 10.5 mm [95% CI: 6.5-14.5 mm] vs 5.0 mm [95% CI: 2.0-8.0 mm] for the miniECG vs 12-lead ECG, respectively. Conclusions: MiniECG ST-segment deviation was observed early and was of large magnitude during 75 minutes of porcine transmural antero-septal infarction. The miniECG was positive for ischemia for the complete occlusion period. These findings demonstrate the potential of the miniECG in the detection of cardiac ischemia. Although clinical research is required, data suggests that the miniECG is a promising tool for the detection of cardiac ischemia

The Minimally Invasive Manipulator : An ergonomic and economic non-robotic alternative for endoscopy?

Introduction: Since the da Vinci robotic system was introduced, it has been reported to have ergonomic advantages over conventional laparoscopy (COV). High investments associated with this system challenged us to design a more economical, mechanical alternative for improvement of laparoscopic ergonomics: the Minimally Invasive Manipulator (MIM). Material and methods: An earlier reported MIM prototype was investigated. Its shortcomings were input for the establishment of design criteria for a new prototype. Results: A new prototype was developed, aiming at improved intuitiveness and ergonomics. The handle and instrument tip were redesigned and the parallelogram mechanism was converted from linear moving parts to mainly rotating parts. Discussion: The new prototype was tested by a panel of experts and novices during an indicative ergonomic experiment. A major advantage of the MIM seems to be the possibility to perform laparoscopic surgery in a sitting position, in line with the working axis, instead of standing at the side of the patient. At an estimated cost level of 10% of the da Vinci system, the MIM can be an economical alternative for the enhancement of laparoscopy ergonomics. However, further development for clinical feasibility is necessary

A novel, intuitive instrument positioner for endoscopy, involving surgeons in design and feasibility

Background: Existing laparoscopic instrument holders do not seem to sufficiently fulfil the needs of surgeons performing minimally invasive surgery (MIS) in several respects. Therefore, we developed and tested a novel laparoscopic instrument positioner in close cooperation between surgeons and engineers. Material and methods: Design requirements were established by attending laparoscopic interventions, interviews and involving surgeons during the design cycle by evaluation of early mock-ups and prototypes. Results: Two concepts, based on a scissor- and a deflectable ball principle, were elaborated and evaluated yielding a simple, affordable system, fixating all degrees of freedom in the centre of motion. A sterile functional prototype was fabricated and successfully tested during three clinical interventions. Users reported a stable image, easy and intuitive handling and no interference with other surgical instrumentation. The posture was conceived to be more ergonomic and surgeons liked the ability to control the positioning of the endoscope directly themselves. Conclusions: Three successful interventions show that involving surgeons in the design and testing phase of product development leads to a novel instrument positioner that can be used safely in a clinical setting. It can be concluded that the system is simple and intuitive to use, as there was no learning curve