Technology and Health Care - Volume 31, issue 1

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