Technology and Health Care - Volume 31, issue 1

Authors: Zhang, Wenjuan | Guan, Ning | Zhang, Xiumei | Liu, Yizhen | Gao, Xiuqiu | Wang, Linyuan

Article Type: Research Article

Abstract: BACKGROUND: Macrophages commonly exist in two distinct subsets in different microenvironments: classically activated macrophages (M1) and alternatively activated macrophages (M2). The imbalance of M1-M2 macrophage polarization is often related to various diseases or inflammatory states. OBJECTIVE: The purpose of this study was to determine whether there is an imbalance in the expression of M1 and M2 macrophage-related cytokines in severe chronic periodontitis. METHODS: A total of 30 clinical specimens, including severe chronic periodontitis tissues (n = 15) and healthy control tissues (n = …15), were used in this study. Reverse transcription polymerase chain reaction (RT-PCR) and Western blot methods were used to detect the mRNA and protein expression levels of M1 macrophage-related cytokines (inducible nitric oxide synthase (iNOS) and signal transducer and activator of transcription 1 (STAT1)) and M2 macrophage-related cytokines (arginase-1 (Arg-1) and STAT6), respectively. RESULTS: The mRNA and protein expression levels of M1 macrophage-related cytokines (iNOS and STAT1) and M2 macrophage-related cytokines (Arg-1 and STAT6) were significantly increased in severe chronic periodontitis patients. In addition, the ratios of iNOS/Arg-1 and STAT1/STAT6 in the severe chronic periodontitis group were also significantly increased (P < 0.01). CONCLUSION: The imbalance of M1/M2 macrophages exists in the pathogenesis of severe chronic periodontitis, and has a tendency towards M1 polarization. Therefore, maintaining the immune balance of M1/M2 macrophages may be a novel therapeutic alternative for the management of severe chronic periodontitis. Show more

Keywords: Severe chronic periodontitis, macrophages, cytokine, M1, M2

DOI: 10.3233/THC-220092

Citation: Technology and Health Care, vol. 31, no. 1, pp. 117-124, 2023

Authors: Guo, Xinwei | Zhao, Hongyan | Zhang, Zhimin

Article Type: Research Article

Abstract: BACKGROUND: The similar elastic modulus of resin-matrix ceramics to dentin has resulted in their recent widespread application clinically. Nevertheless, the bacterial environment of oral cavity can degrade the resin composite. OBJECTIVE: The objective was to analyse the effect of S. mutans and its fluoride-resistant strains on the adhesion of three CAD/CAM ceramics. METHODS: S. mutans UA159 (UA) was identified, and its fluoride-resistant strain (FR) was induced. For crack observation, three kinds of CAD/CAM ceramics (IPS Empress, Lava Ultimate and Vita Enamic) were bonded with tooth complex (enamel, dentin and flowable resin) through adhesive. …For micro-tensile test, ceramics were bonded with flowable resin, and cut into strip test pieces. Then specimens were immersed into the UA, FR and the control solution (BHI) separately for 14 d. Ceramic-adhesive interface and adhesive-tooth complex interface were observed and analyzed through electron microscope and stereomicroscope. Micro-tensile test was conducted. RESULTS: Specimens in bacterial solutions had more cracks and comparatively weaker micro-tensile strength than those in BHI. In ceramic-adhesive interface, Lava Ultimate produced the most cracks. In adhesive-tooth complex interface, adhesive-dentin produced the most cracks. Meanwhile, IPS Empress had the strongest micro-tensile strength when bonded with resin. CONCLUSIONS: S. mutans and its fluoride resistant strain can cause cracks in the bonding of ceramics and dental tissue, especially resin-matrix ceramic and dentin, and weaken the bonding strength between ceramics and resin. Show more

Keywords: Computer-aided design, resin, ceramic, Streptococcus mutans, fluoride, tensile strength

DOI: 10.3233/THC-220117

Citation: Technology and Health Care, vol. 31, no. 1, pp. 125-139, 2023

Authors: Wu, Zhongping | Huang, Ruibo | Zhong, Liping | Zheng, Jinping | Gao, Yi

Article Type: Research Article

Abstract: BACKGROUND: Peak expiratory flow meters (PEFMs) have emerged as primary tools used for diagnosing and monitoring a range of respiratory diseases including asthma and chronic obstructive pulmonary disease, and the performance of these meters will thus impact disease evaluation. OBJECTIVE: The aim of this study was therefore to assess the technical performance of mechanical and electronic PEFMs commonly used in clinical practice. METHODS: The accuracy, repeatability, airflow resistance, frequency response, and linearity of five electronic and seven mechanical PEFMs were measured using a standard flow/volume simulator in accordance with nine A-waveforms and three …B-waveforms defined in ISO 23747:2015 issued by the International Standards Organization (ISO). RESULTS: The accuracy, repeatability, linearity, airflow resistance, and frequency response pass rates for these 12 different PEFM brands were 41.67%, 75.00%, 50.00%, 75.00%, and 25.00%, respectively. Just 16.67% (2/12) of the tested PEFMs met all evaluated criteria, whereas the remaining PEFMs partially met these criteria. There were no significant differences between the two tested PEFM types in the low flow rate waveform test (P > 0.05), although there were significant differences in the medium and high flow rate waveform test (P < 0.05). In addition, the overall PEFMs test had poor accuracy and good repeatability, although most of the repeatability errors occurred in the BTPS state. CONCLUSION: PEFMs commonly used in clinical settings exhibit variable technical performance, and relevant departments need to strengthen PEFM quality control and management in China. Show more

Keywords: Peak expiratory flow meter, standard flow/volume simulator, quality control, ISO 23747:2015

DOI: 10.3233/THC-220122

Citation: Technology and Health Care, vol. 31, no. 1, pp. 141-149, 2023

Authors: Mei, Hai-Long | Yao, Yao | Huang, Ying | Zhou, Ke | Wang, Zhi-Lie | Chen, Hou-Qiong

Article Type: Research Article

Abstract: BACKGROUND: Patellar fractures are common intra-articular fractures. Arthroscopically assisted reduction and fixation has been shown to advantageous in the treatment of patellar fractures. OBJECTIVE: This study aimed to investigate the effect of arthroscopically assisted percutaneous minimally invasive Kirschner wire tension band fixation on the treatment of patellar fractures. METHODS: Thirty-four patients with acute closed patellar fractures enrolled in the study and were managed by arthroscopically assisted percutaneous minimally invasive Kirschner wire tension band fixation under epidural anesthesia. Among these patients, 24 were males, and ten were females. The mean age of these patients …was 38 ± 0.8 years (range: 25–62 years). Of these patients, 20 had transverse fractures, five had longitudinal fractures, four had marginal oblique fractures, and five had multifragmentary upper and lower pole. Fracture causes: 25 were caused by falls, and nine were caused by traffic accidents. The time from injury to operation was 6–48 hours, with an average of 23 hours. The average post-operative follow-up was 12.8 months, and at the end of follow-up, the Boestman scoring system was used to evaluate knee joint function. RESULTS: All the wounds healed by first intention, and no infections, skin necrosis, joint stiffness, or other complications occurred. Three months after operation, the tension band wire had broken in one patient, but the fracture had united, and this did not affect the prognosis. In eight patients, the average circumference at 10 cm above the patella was 0.6 cm less on the injured side than on the contralateral side. The average Boestman score was 27.5. The final result was excellent in 25 patients, good in eight patients, and acceptable in one patient. CONCLUSION: Arthroscopic management of simple patellar fracture with percutaneous minimally invasive Kirschner wire tension band fixation is less invasive than open operation, while still leading to firm fixation, and is conducive to early functional training and functional recovery, and thus is an effective method of management for patellar fractures. Show more

Keywords: Patellar fracture, arthroscopy, percutaneous, tension band, internal fixation

DOI: 10.3233/THC-220133

Citation: Technology and Health Care, vol. 31, no. 1, pp. 151-156, 2023

Authors: Seemann, R.J. | Mielke, A.M. | Glauert, D.L. | Gehlen, T. | Poncette, A.S. | Mosch, L.K. | Back, D.A.

Article Type: Research Article

Abstract: BACKGROUND: Digital competencies are more and more required in everyday work, and training future healthcare professionals in digital health is highly important. OBJECTIVE: Aim of this study was to assess medical students’ gain of knowledge by participation in a teaching module “Digital Health”, and to evaluate their attitudes towards digital health and its role in medical education. METHODS: Students of the module were asked to complete a questionnaire and a multiple-choice-test before and after completing the classes. Students of the same educational level in different modules served as reference group. RESULTS: …34 students took part (n = 17 “Digital Health group”; n = 17 “reference group”). There was no significant difference in pre-existing knowledge between the groups. After having completed the module, participants reached significantly higher scores, compared to their preexisting knowledge (p < 0.05) and the reference group (p < 0.05). Most students found that digital medicine is not sufficiently represented in undergraduate medical education, but will influence everyday work of physicians in the next five years. CONCLUSIONS: Students showed a high awareness for the impact of digital health on physicians’ work. The results suggest that the format can sufficiently transfer knowledge about digital health. Teaching of digital knowledge and competencies should be firmly implemented into medical education to form digitally competent future doctors. Show more

Keywords: Digital health, Undergraduate Medical Education, digital competencies, medical students, data literacy

DOI: 10.3233/THC-220138

Citation: Technology and Health Care, vol. 31, no. 1, pp. 157-164, 2023

Authors: Deng, Chengliang | Adu, Jianhua | Xie, Shenghua | Li, Zhaohuan | Meng, Qingguo | Zhang, Qingfeng | Yin, Lixue | Peng, Bo

Article Type: Research Article

Abstract: BACKGROUND: Carotid atherosclerosis plaque rupture is an important cause of myocardial infarction and stroke. The effective segmentation of ultrasound images of carotid atherosclerotic plaques aids clinicians to accurately assess plaque stability. At present, this procedure relies mainly on the experience of the medical practitioner to manually segment the ultrasound image of the carotid atherosclerotic plaque. This method is also time-consuming. OBJECTIVE: This study intends to establish an automatic intelligent segmentation method of ultrasound images of carotid plaque. METHODS: The present study combined the U-Net and DenseNet networks, to automatically segment the ultrasound images …of carotid atherosclerotic plaques. The same test set was selected and segmented using the traditional U-Net network and the ResUNet network. The prediction results of the three network models were compared using Dice (Dice similarity coefficient), and VOE (volumetric overlap error) coefficients. RESULTS: Compared with the existing U-Net network and ResUNet network, the Dense-UNet network exhibited an optimal effect on the automated segmentation of the ultrasound images. CONCLUSION: The Dense-UNet network could realize the automatic segmentation of atherosclerotic plaque ultrasound images, and it could assist medical practitioners in plaque evaluation. Show more

Keywords: Carotid atherosclerotic plaque, ultrasound image, Dense-UNet network, fully automatic segmentation

DOI: 10.3233/THC-220152

Citation: Technology and Health Care, vol. 31, no. 1, pp. 165-179, 2023

Authors: Wang, Yongtao | Tian, Shengwei | Yu, Long | Wu, Weidong | Zhang, Dezhi | Wang, Junwen | Cheng, Junlong

Article Type: Research Article

Abstract: BACKGROUND: The results of medical image segmentation can provide reliable evidence for clinical diagnosis and treatment. The U-Net proposed previously has been widely used in the field of medical image segmentation. Its encoder extracts semantic features of different scales at different stages, but does not carry out special processing for semantic features of each scale. OBJECTIVE: To improve the feature expression ability and segmentation performance of U-Net, we proposed a feature supplement and optimization U-Net (FSOU-Net). METHODS: First, we put forward the view that semantic features of different scales should be treated differently. …Based on this view, we classify the semantic features automatically extracted by encoders into two categories: shallow semantic features and deep semantic features. Then, we propose the shallow feature supplement module (SFSM), which obtains fine-grained semantic features through up-sampling to supplement the shallow semantic information. Finally, we propose the deep feature optimization module (DFOM), which uses the expansive convolution of different receptive fields to obtain multi-scale features and then performs multi-scale feature fusion to optimize the deep semantic information. RESULTS: The proposed model is experimented on three medical image segmentation public datasets, and the experimental results prove the correctness of the proposed idea. The segmentation performance of the model is higher than the advanced models for medical image segmentation. Compared with baseline network U-NET, the main index of Dice index is 0.75% higher on the RITE dataset, 2.3% higher on the Kvasir-SEG dataset, and 0.24% higher on the GlaS dataset. CONCLUSIONS: The proposed method can greatly improve the feature representation ability and segmentation performance of the model. Show more

Keywords: Deep learning algorithm, medical image analysis, semantic segmentation, multi-scale, convolutional neural networks

DOI: 10.3233/THC-220174

Citation: Technology and Health Care, vol. 31, no. 1, pp. 181-195, 2023

Authors: Yang, Jiantao | Wang, Zekai | Sun, Tairen

Article Type: Research Article

Abstract: BACKGROUND: Human gait involves activities in nervous and musculoskeletal dynamics to modulate joint torques with time continuously for adapting to varieties of walking conditions. OBJECTIVE: The goal of this paper is to estimate the joint torques of lower limbs in human gait based on Gaussian process. METHOD: The potential uses of this study include optimization of exoskeleton assistance, control of the active prostheses, and modulating the joint torque for human-like robots. To achieve this, Gaussian process (GP) based data fusion algorithm is established with joint angles as the inputs. RESULTS: …The statistic nature of the proposed model can explore the correlations between joint angles and joint torques, and enable accurate joint-torque estimations. Experiments were conducted for 5 subjects at three walking speed (0.8 m/s, 1.2 m/s, 1.6 m/s). CONCLUSION: The results show that it is possible to estimate the joint torques at different scenarios. Show more

Keywords: GP, human gait, joint torque, prostheses, robots, mechanics

DOI: 10.3233/THC-220190

Citation: Technology and Health Care, vol. 31, no. 1, pp. 197-204, 2023

Authors: Kamal, Shahul Mujib | Babini, Mohammad Hossein | Tee, Rui | Krejcar, Ondrej | Namazi, Hamidreza

Article Type: Research Article

Abstract: BACKGROND: One of the important areas of heart research is to analyze heart rate variability during (HRV) walking. OBJECTIVE: In this research, we investigated the correction between heart activation and the variations of walking paths. METHOD: We employed Shannon entropy to analyze how the information content of walking paths affects the information content of HRV. Eight healthy students walked on three designed walking paths with different information contents while we recorded their ECG signals. We computed and analyzed the Shannon entropy of the R-R interval time series (as an indicator of HRV) versus …the Shannon entropy of different walking paths and accordingly evaluated their relation. RESULTS: According to the obtained results, walking on the path that contains more information leads to less information in the R-R time series. CONCLUSION: The analysis method employed in this research can be extended to analyze the relation between other physiological signals (such as brain or muscle reactions) and the walking path. Show more

Keywords: Heart Rate Variability (HRV), walking path, Shannon entropy, information content, R-R interval time series

DOI: 10.3233/THC-220191

Citation: Technology and Health Care, vol. 31, no. 1, pp. 205-215, 2023

Authors: Pan, Jingwen | Zhang, Chaoxue | Peng, Hu | Wang, Yadan | Wang, Yuanguo | Han, Zhihui

Article Type: Research Article

Abstract: BACKGROUND: A fundamental challenge in medical ultrasound imaging is to improve the resolution accurately. Adaptive beamforming is often used to improve lateral resolution, such as minimum variance (MV) and phase coherence factor (PCF). However, it is difficult to improve the axial resolution due to the limitation of the spatial pulse length (SPL) of the transmitted signal. OBJECTIVE: A deconvolution recovery method combines two adaptive weighting techniques to improve axial resolution. METHODS: A deconvolution recovery (DR) technique is used to improve axial resolution with a shorter SPL. Then, the DR is combined with MV …and PCF (DR-MVPCF) to suppress the sidelobe. The influence of different transmission modes, regularization parameters, and the estimation of point spread function are discussed on the proposed algorithm. RESULTS: In simulation, DR-MVPCF improved axial resolution from 0.41 mm (0.98 λ ) to 0.09 mm (0.21 λ ) compared with MV-PCF. In the water bath experiment, DR-MVPCF provided improvement of axial resolution from 0.39 mm (0.93 λ ) to 0.07 mm (0.17 λ ) compared with MV-PCF. In-vivo data experiment, the DR-MVPCF method increased the speckle signal-to-noise ratio and visibility of the structure while the contrast ratio and contrast-noise ratio decreased. CONCLUSIONS: The proposed method can improve the axial resolution significantly. Show more

Keywords: Ultrasound imaging, axial resolution, deconvolution recovery, adaptive beamforming

DOI: 10.3233/THC-220198

Citation: Technology and Health Care, vol. 31, no. 1, pp. 217-237, 2023

Authors: Kocet, Laura | Romarič, Katja | Žibert, Janez

Article Type: Research Article

Abstract: BACKGROUND: Quality control of magnetic resonance imaging includes image validation, which covers also artefact detection. The daily manual review of magnetic resonance images for possible artefacts can be time-consuming, so automated methods for computer-assisted quality assessment of magnetic resonance imaging need to be developed. OBJECTIVE: The aim of this study was to develop automatic detection of Gibbs artefacts in magnetic resonance imaging using a deep learning method called transfer learning, and to demonstrate the potential of this approach for the development of an automatic quality control tool for the detection of such artefacts in magnetic resonance …imaging. METHODS: The magnetic resonance image dataset of the scanned phantom for quality assurance was created using a turbo spin-echo pulse sequence in the transverse plane. Images were created to include Gibbs artefacts of varying intensities. The images were annotated by two independent reviewers. The annotated dataset was used to develop a method for Gibbs artefact detection using the transfer learning approach. The VGG-16, VGG-19, and ResNet-152 convolutional neural networks were used as pre-trained networks for transfer learning and compared using 5-fold cross-validation. RESULTS: All accuracies of the classification models were above 97%, while the AUC values were all above 0.99, confirming the high quality of the constructed models. CONCLUSION: We show that transfer learning can be successfully used to detect Gibbs artefacts on magnetic resonance images. The main advantages of transfer learning are that it can be applied on small training datasets, the procedures to build the models are not so complicated, and they do not require much computational power. This shows the potential of transfer learning for the more general task of detecting artefacts in magnetic resonance images of patients, which consequently can improve and speed up the process of quality assessment in medical imaging practice. Show more

Keywords: Gibbs artefact, transfer learning, automatic detection, image quality control

DOI: 10.3233/THC-220234

Citation: Technology and Health Care, vol. 31, no. 1, pp. 239-246, 2023

Authors: Alqahtani, Nasser M. | Chaturvedi, Saurabh | Tomar, Shobhit Singh | Kumari, Lalima | Gill, Shruti | Nayan, Kamal | Shariff, Mansoor | Bhagat, Tushar V. | Addas, Mohammed Khalid | Chaturvedi, Mudita

Article Type: Research Article

Abstract: BACKGROUND: Advances in digital dentistry lead to use of three-dimensional (3D) printed resin denture teeth. Fracture toughness of these teeth must be assessed. OBJECTIVE: This study aimed to compare the chipping and indirect tensile fracture resistance of denture teeth fabricated by 3D printing technique with traditionally fabricated resin denture teeth. METHOD: Four groups (Gr) were made (n = 50/group): Gr-1 3D printed denture teeth (denture teeth; Formlabs Inc., Somerville, MA, USA), Gr-2 SR-Orthosit-PE (Ivoclar Vivadent AG), Gr-3 Portrait IPN (Dentsply Sirona), Gr-4 Pala Premium 8 (Heraeus Kulzer GmbH). …Stereolithography 3D printing was used to create the methacrylate-based photopolymerized resin teeth models and remaining group teeth were collected commercially. A 1 mm/min chipping and indirect tensile fracture speed tests were carried out till fracture occurred. The data so obtained were statistically analysed using one-way analysis of variance with Tukey’s honestly significant difference multiple comparisons test (p < 0.05). At the end of the test, the fractured areas of the specimens were evaluated by the chief researcher to assess the fracture pattern of the teeth. RESULTS: The indirect tensile fracture values of the 3D printed teeth were more than that of Pala Premium-8 and SR-Orthosit-PE but it was lower than that of Portrait IPN teeth. In chipping test, buccal chipping of the loaded cusp was seen in 3D printed resin without distortion and in indirect tensile test in 3D printed resin teeth, line of fracture emerges near the loading point propagates from the inner incline of both cusps and extends cervically, unlike in other groups where first deformation occurs then fracture. CONCLUSION: Prosthetic teeth fabricated by the 3D printing technique using printable resin material provide adequate fracture resistance as denture teeth. Show more

Keywords: 3D printing, CAD/CAM, resin, denture teeth, fracture resistance

DOI: 10.3233/THC-220288

Citation: Technology and Health Care, vol. 31, no. 1, pp. 247-258, 2023

Authors: Alsubaiy, Ebrahim Fihaid

Article Type: Research Article

Abstract: BACKGROUND: The provisional crowns (PR) play an important role during the course of fixed prosthesis treatment. The fitting of PR varies and depends on various factors. OBJECTIVE: The aim of the study was to evaluate the marginal and internal fit of PR produced by three-dimensional (3D) printing technique and to compare those with PR made by the milling technique by using micro computed tomography (μ CT) on three commonly used finish line designs. METHOD: Ninety study models were made using metal die of #14 tooth (i.e. maxillary 1 st …premolar molar) prepared for full veneer crown with three different finish line chamfer (C), rounded shoulder (RS) and rounded shoulder with bevel (RSB). PR was fabricated on each study model, using milling (MiL group, n = 45), and 3D printing technique (3D-P group, n = 45). Marginal and internal fit of each study model was measured by micro computed tomography, at 7 Zones Pr-1- Pr-7 on each finish line. Recorded data were statistically analysed by one-way analysis of variance (ANOVA) and using Dunnett t -Test (p > 0.05). RESULTS: The mean gap at margins was minimum for provisional crowns in 3D-P group in any finish line with minimum in rounded shoulder with bevel at zone Pr-1 30.9 ± 5.3 and at zone Pr-7 32.7 ± 5.3. In the axial region, i.e. zone Pr-2, the smallest gap was recorded in the 3D-P group and in the occlusal region, for zone Pr-3, 4 and 5, the maximum gap was recorded in the MiL group. CONCLUSION: The provisional crowns fabricated by 3D printed technique have better marginal and internal fit than the provisional crowns made by milling technique. Show more

Keywords: Provisional restoration, additive manufacturing, 3D printing, CAD-CAM, micro-CT

DOI: 10.3233/THC-220304

Citation: Technology and Health Care, vol. 31, no. 1, pp. 259-268, 2023

Authors: Liu, Xinggu | Long, Zhiming | Li1, Zongyuan | Huang, Shudong | Wang, Zhuqing

Article Type: Research Article

Abstract: BACKGROUND: Wearable devices that monitor heart health of cardiac disease patients in real time are in great demand. OBJECTIVE: We propose an algorithm of improved segment periodical matrix construction for irregular electrocardiogram (ECG) signal denoising. METHOD: While splitting the heartbeat based on each RR interval for periodical segments matrix construction, the as-filtered ECG signal is reconstructed by the maximum singular value after a singular value decomposition. RESULTS: The results demonstrate a higher noise reduction effect with lower signal distortions of our methods compared to several singular value decomposition counterpart approaches. …CONCLUSION: Our method has great potential to enhance wearable devices diagnosis accuracy by denoising the complex noises such as electromyography artifacts in real-time ECG sensing. Show more

Keywords: Segment periodical matrix, irregular ECG, singular value decomposition

DOI: 10.3233/THC-220316

Citation: Technology and Health Care, vol. 31, no. 1, pp. 269-281, 2023

Authors: Xiao, Cong | Zhang, Shaoyun | Gao, Zhixiang | Tu, Chongqi

Article Type: Case Report

Abstract: BACKGROUND: Increases in the numbers of surgical procedures for primary total hip arthroplasty (THA) inevitably lead to increases in the requirements for revision THA. The achievement of long-term stability is difficult or impossible by conventional implants in patients with severe destruction of the acetabulum. OBJECTIVE: This case report presents a successful treatment using a specific three-dimensional (3D)-printed porous titanium acetabular composite component without a flange in the management of Paprosky type IIIB acetabular defects. METHOD: A 65-year-old female diagnosed with right hip prosthetic loosening with a huge acetabular defect presented to our hospital. …We designed the 3D model of the pelvis and created an individualized 3D-printed porous titanium acetabular composite component for revision THA. The procedure was performed through a posterolateral approach, and the component was implanted in the defect and fixed with cup screws using the drill guides. RESULTS: At the last follow-up at 2 years, the patient had a satisfactory hip joint function and no signs of loosening or other complications were found. CONCLUSIONS: The 3D-printed porous titanium acetabular composite component without a flange is showing promising clinical and radiological outcomes in the management of Paprosky type III acetabular defects. Show more

Keywords: Revision hip arthroplasty, acetabular defects, 3D printing, porous titanium, composite component, custom-made, case report

DOI: 10.3233/THC-212984

Citation: Technology and Health Care, vol. 31, no. 1, pp. 283-291, 2023

Authors: Badnjevic, Almir

Article Type: Editorial

DOI: 10.3233/THC-229005

Citation: Technology and Health Care, vol. 31, no. 1, pp. 293-305, 2023

Authors: Badnjevic, Almir | Magjarevic, Ratko | Mrdjanovic, Emina | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Monitoring cardiac parameters is the fundamental aspect of every diagnostic process and is facilitated by electrocardiography (ECG) devices. This way, continuous state-of-the-art performance of ECG devices can be ensured. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of ECG devices for post-market surveillance purposes. METHOD: …The method was developed on the basis of International Organisation of Legal Metrology (OIML) guidelines and applied in healthcare institutions from 2018 to 2021. RESULTS: The developed method was validated in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of the ECG device as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of ECG devices during PMS, besides increasing reliability of the devices, is the first step in the digital transformation of the management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, ECG, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229006

Citation: Technology and Health Care, vol. 31, no. 1, pp. 307-315, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Imamovic, Elma | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Defibrillators are medical devices (MDs) used in the most critical situations, hence their performance must be ensured at all times. This requires defibrillators to be subjected to regular performance assessments after they have been placed on the market. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel evidence-based method for conformity assessment testing of …defibrillators. METHOD: The proposed method is developed in accordance with the International Organisation of Legal Metrology (OIML) guidelines and is intended to be used for conformity assessment testing of defibrillators for post-market surveillance purposes. RESULTS: The developed method was validated from 2018 to 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of defibrillators as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of defibrillators during PMS, besides increasing reliability of the devices, is the first step in the digital transformation of the management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229007

Citation: Technology and Health Care, vol. 31, no. 1, pp. 317-325, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Softic, Adna | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Patient monitors are medical devices used to monitor vital parameters such as heart rate, respiratory rate, blood pressure, blood oxygen saturation, and body temperature during inpatient treatment. As such, patient monitors provide physicians with information necessary to adjust the treatment as well as evaluate the overall status and recovery of the patient. Measurements made by intrinsic sensors of patient monitors must be compliant and provide reliable readings in order to ensure safety and optimal quality of care to the patients. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of patient monitors in …healthcare institutions for post-market surveillance purposes. METHOD: The method was developed on the basis of metrology characteristics of sensors used to monitor vital parameters observed by patient monitors and evaluation of their vital safety and performance parameters. In addition to the evaluation of essential safety and visual integrity of patient monitors, their performance in terms of accuracy of the readings is evaluated. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of patient monitors as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of patient monitors during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, patient monitor, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229008

Citation: Technology and Health Care, vol. 31, no. 1, pp. 327-337, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Ademovic, Azra | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Therapeutic ultrasounds are medical devices used for treatment of conditions such muscle spasms, joint contractures or general muscle pain. Their function relies in the delivery of ultrasonic pulses that generate heat in tissue thus relieving the symptoms of aforementioned conditions. Accuracy of the delivered pulses directly affects the quality and effectiveness of the treatment and has to be ensured throughout the utilization of the therapeutic ultrasound in practice. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, …there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of therapeutic ultrasounds for post-market surveillance purposes. METHOD: The method was developed based on metrology characteristics of therapeutic ultrasounds and includes visual, electrical safety and performance inspections of therapeutic ultrasounds to ensure that both safety and treatment reliability are achieved. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of therapeutic ultrasounds as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of therapeutic ultrasounds during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, therapeutic ultrasound, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229009

Citation: Technology and Health Care, vol. 31, no. 1, pp. 339-346, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Smajlhodzic-Deljo, Merima | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Introduction of fluids, medicaments and nutrients into the human body during hospitalization is fundamental for treatment and healing of patients. Fluids are introduced by means of infusion pumps while nutrients and medicaments are introduced by perfusion pumps. It is of vital importance for these devices to deliver exact amounts of the aforementioned substances as significant deviations can result in severe patient harm. Therefore it is important to effectively monitor their performance and prevent failures. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes. …METHOD: The method was developed on the basis of metrology characteristics of the devices. In addition to the evaluation of essential safety and visual integrity of infusion and perfusion pumps, their performance in terms of delivered volumes was assessed and monitored. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of infusion and perfusion pumps as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of infusion and perfusion pumps during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, infusion pumps, perfusion pumps, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229010

Citation: Technology and Health Care, vol. 31, no. 1, pp. 347-355, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Biskovic, Dusanka | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Dialysis machines are used regularly in healthcare practice. They are classified as a type of medical device with moderate and high risk therefore significant requirements are placed on their safety and performance every time they are used on patients. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel evidence-based method for conformity assessment testing …of dialysis machines for post-market surveillance purposes. METHOD: The novel method is developed according to the International Organisation of Legal Metrology (OIML) guidelines and is to be used for the purpose of conformity assessment testing of Dialysis machines with respect to their metrological characteristics during PMS. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of dialysis machines as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of dialysis machines during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, dialysis machines performance, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229011

Citation: Technology and Health Care, vol. 31, no. 1, pp. 357-365, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Trakic, Ammar | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Mechanical ventilators are medical devices used in intensive care units when patients are in need of mechanical aid to facilitate the process of breathing. As the function of breathing is the exchange of gases, the mechanical ventilator takes over that function while the patient is incapable to spontaneous breathing. As these devices are used to maintain the life of patents, their performance must be ensured and there cannot be significant deviations in the volumes and pressure of gases they introduce to the patient. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by …independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of mechanical ventilators for post-market surveillance purposes. METHOD: The method was developed on the basis of metrology characteristics of mechanical ventilators and evaluation of their vital safety and performance parameters. In addition to the evaluation of essential safety and visual integrity of mechanical ventilators, their performance in terms of volume of oxygen delivered to the patient as well as the flow and pressure of the delivered gas is evaluated. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of mechanical ventilators as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of mechanical ventilators during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, mechanical ventilator, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229012

Citation: Technology and Health Care, vol. 31, no. 1, pp. 367-376, 2023

Authors: Badnjevic, Almir | Deumic, Amar | Dzemic, Zijad | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Anaesthesia machines, as moderate to high-risk medical devices intended for use on patients during surgical procedures must be safe and reliable with traceable performance every time they are used in healthcare practice. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel evidence-based method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes. …METHOD: The novel method is developed according to the International Organisation of Legal Metrology (OIML) guidelines and is to be used for the purpose of conformity assessment testing of anaesthesia machines with respect to their technical and metrological characteristics during PMS. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of anaesthesia machines as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of anaesthesia machines during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, anaesthesia machine, performance, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229013

Citation: Technology and Health Care, vol. 31, no. 1, pp. 377-387, 2023

Authors: Badnjevic, Almir | Spahic, Lemana | Jordamovic, Naida Babic | Pokvic, Lejla Gurbeta

Article Type: Other

Abstract: BACKGROUND: Premature born infants or infants born sick require immediate medical attention and decreasing the stress imposed onto their body by the environment. Infant incubators provide an enclosed environment that can be controlled to fit the needs of the infant. As such, their performance must be consistent and without significant deviations. The only manner to ensure this is by post-market surveillance (PMS) focused on evaluation of both safety and performance. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. …However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of infant incubators for post-market surveillance purposes. METHOD: The method was developed based on guidelines for devices providing measurements laid out by the International Organisation of Legal Metrology (OIML). The methodology was validated during a four year period in healthcare institutions of all levels. RESULTS: The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of infant incubators as a method used during PMS contributes to significant improvement in devices’ accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of infant incubators during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence. Show more

Keywords: Medical device, performance, infant incubators, testing, standardisation, post-market surveillance

DOI: 10.3233/THC-229014

Citation: Technology and Health Care, vol. 31, no. 1, pp. 389-399, 2023