Prediction of interactomic hub genes in PBMC cells in type 2 diabetes mellitus, dyslipidemia, and periodontitis.

BACKGROUND AND OBJECTIVE: In recent years, the complex interplay between systemic health and oral well-being has emerged as a focal point for researchers and healthcare practitioners. Among the several important connections, the convergence of Type 2 Diabetes Mellitus (T2DM), dyslipidemia, chronic periodontitis, and peripheral blood mononuclear cells (PBMCs) is a remarkable example. These components collectively contribute to a network of interactions that extends beyond their domains, underscoring the intricate nature of human health. In the current study, bioinformatics analysis was utilized to predict the interactomic hub genes involved in type 2 diabetes mellitus (T2DM), dyslipidemia, and periodontitis and their relationships to peripheral blood mononuclear cells (PBMC) by machine learning algorithms. MATERIALS AND METHODS: Gene Expression Omnibus datasets were utilized to identify the genes linked to type 2 diabetes mellitus(T2DM), dyslipidemia, and Periodontitis (GSE156993).Gene Ontology (G.O.) Enrichr, Genemania, and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways were used for analysis for identification and functionalities of hub genes. The expression of hub D.E.G.s was confirmed, and an orange machine learning tool was used to predict the hub genes. RESULT: The decision tree, AdaBoost, and Random Forest had an A.U.C. of 0.982, 1.000, and 0.991 in the R.O.C. curve. The AdaBoost model showed an accuracy of (1.000). The findings imply that the AdaBoost model showed a good predictive value and may support the clinical evaluation and assist in accurately detecting periodontitis associated with T2DM and dyslipidemia. Moreover, the genes with p-value < 0.05 and A.U.C.>0.90, which showed excellent predictive value, were thus considered hub genes. CONCLUSION: The hub genes and the D.E.G.s identified in the present study contribute immensely to the fundamentals of the molecular mechanisms occurring in the PBMC associated with the progression of periodontitis in the presence of T2DM and dyslipidemia. They may be considered potential biomarkers and offer novel therapeutic strategies for chronic inflammatory diseases.

Light gradient boosting-based prediction of quality of life among oral cancer-treated patients.

BACKGROUND AND INTRODUCTION: Statisticians rank oral and lip cancer sixth in global mortality at 10.2%. Mouth opening and swallowing are challenging. Hence, most oral cancer patients only report later stages. They worry about surviving cancer and receiving therapy. Oral cancer severely affects QOL. QOL is affected by risk factors, disease site, and treatment. Using oral cancer patient questionnaires, we use light gradient Boost Tree classifiers to predict life quality. METHODS: DIAS records were used for 111 oral cancer patients. The European Organisation for Research and Treatment of Cancer's QLQ-C30 and QLQ-HN43 were used to document the findings. Anyone could enroll, regardless of gender or age. The IHEC/SDC/PhD/OPATH-1954/19/TH-001 Institutional Ethical Clearance Committee approved this work. After informed consent, patients received the EORTC QLQ-C30 and QLQ-HN43 questionnaires. Surveys were in Tamil and English. Overall, QOL ratings covered several domains. We obtained patient demographics, case history, and therapy information from our DIAS (Dental Information Archival Software). Enrolled patients were monitored for at least a year. After one year, the EORTC questionnaire was retaken, and scores were recorded. This prospective analytical exploratory study at Saveetha Dental College, Chennai, India, examined QOL at diagnosis and at least 12 months after primary therapy in patients with histopathologically diagnosed oral malignancies. We measured oral cancer patients' quality of life using data preprocessing, feature selection, and model construction. A confusion matrix was created using light gradient boosting to measure accuracy. RESULTS: Light gradient boosting predicted cancer patients' quality of life with 96% accuracy and 0.20 log loss. CONCLUSION: Oral surgeons and oncologists can improve planning and therapy with this prediction model.

Artificial intelligence as a new answer to old challenges in maternal-fetal medicine and obstetrics.

BACKGROUND: Following the latest trends in the development of artificial intelligence (AI), the possibility of processing an immense amount of data has created a breakthrough in the medical field. Practitioners can now utilize AI tools to advance diagnostic protocols and improve patient care. OBJECTIVE: The aim of this article is to present the importance and modalities of AI in maternal-fetal medicine and obstetrics and its usefulness in daily clinical work and decision-making process. METHODS: A comprehensive literature review was performed by searching PubMed for articles published from inception up until August 2023, including the search terms "artificial intelligence in obstetrics", "maternal-fetal medicine", and "machine learning" combined through Boolean operators. In addition, references lists of identified articles were further reviewed for inclusion. RESULTS: According to recent research, AI has demonstrated remarkable potential in improving the accuracy and timeliness of diagnoses in maternal-fetal medicine and obstetrics, e.g., advancing perinatal ultrasound technique, monitoring fetal heart rate during labor, or predicting mode of delivery. The combination of AI and obstetric ultrasound can help optimize fetal ultrasound assessment by reducing examination time and improving diagnostic accuracy while reducing physician workload. CONCLUSION: The integration of AI in maternal-fetal medicine and obstetrics has the potential to significantly improve patient outcomes, enhance healthcare efficiency, and individualized care plans. As technology evolves, AI algorithms are likely to become even more sophisticated. However, the successful implementation of AI in maternal-fetal medicine and obstetrics needs to address challenges related to interpretability and reliability.

Application of artificial intelligence for the classification of the clinical outcome and therapy in patients with viral infections: The case of COVID-19.

BACKGROUND: With the end of the coronavirus disease 2019 (COVID-19) pandemic, it becomes intriguing to observe the impact of innovative digital technologies on the diagnosis and management of diseases, in order to improve clinical outcomes for patients. OBJECTIVE: The research aims to enhance diagnostics, prediction, and personalized treatment for patients across three classes of clinical severity (mild, moderate, and severe). What sets this study apart is its innovative approach, wherein classification extends beyond mere disease presence, encompassing the classification of disease severity. This novel perspective lays the foundation for a crucial decision support system during patient triage. METHODS: An artificial neural network, as a deep learning technique, enabled the development of a complex model based on the analysis of data collected during the process of diagnosing and treating 1000 patients at the Tesanj General Hospital, Bosnia and Herzegovina. RESULTS: The final model achieved a classification accuracy of 82.4% on the validation data set, which testifies to the successful application of the artificial neural network in the classification of clinical outcomes and therapy in patients infected with viral infections. CONCLUSION: The results obtained show that expert systems are valuable tools for decision support in healthcare in communities with limited resources and increased demands. The research has the potential to improve patient care for future epidemics and pandemics.

Left atrial strain analysis in the realm of pediatric cardiology: Advantages and implications.

BACKGROUND: Left atrial (LA) strain analysis has emerged as a noninvasive technique for assessing LA function and early detection of myocardial deformation. Recently, its application has also shown promise in the pediatric population, spanning diverse cardiac conditions that demand accurate and sensitive diagnostic measures. OBJECTIVE: This research endeavors to explore the role of LA strain parameters and contribute to the growing body of knowledge in pediatric cardiology, paving the way for more effective and tailored approaches to patient care. METHODS: A comprehensive literature review was conducted to gather evidence from studies using echocardiographic strain imaging techniques across pediatric populations. RESULTS: LA strain parameters exhibited greater sensitivity than conventional atrial function indicators, with early detection of diastolic dysfunction and LA remodeling in pediatric cardiomyopathy, children with multisystem inflammatory syndrome, rheumatic heart disease, as well as childhood renal insufficiency and obesity offering prognostic relevance as potential markers in these pediatric subpopulations. However, there remains a paucity of evidence concerning pediatric mitral valve pathology, justifying further exploration. CONCLUSION: LA strain analysis carries crucial clinical and prognostic implications in pediatric cardiac conditions, with reliable accuracy and sensitivity to early functional changes.

Biomarkers and their combination in a prediction of decompensation after an index hospitalization for acute heart failure.

Introduction: Heart failure (HF) still remains as one of the most common causes of hospital admission with a high mortality rate. Aim: To investigate the possible prognostic role of brain natriuretic peptide (BNP), high-sensitivity (hs) cardiac troponin (cTn) I, cystatin C, and cancer antigen 125 (CA125) in the prediction of decompensation after an index hospitalization and to investigate their possible additive prognostic value. Patients and Methods: Two hundred twenty-two patients hospitalized with acute HF were monitored and followed for 18 months. Results: BNP at discharge has the highest sensitivity and specificity in the prediction of decompensation. For a cutoff value of 423.3 pg/ml, sensitivity was 64.3% and specificity was 64.5%, with a positive predictive value of 71.6% and an area under the curve (AUC) of 0.69 (P < 0.001). The hazard risk (HR) for decompensation when the discharge BNP was above the cutoff value was 2.18. Cystatin C, at a cutoff value of 1.46 mg/L, had a sensitivity of 57% and specificity of 57.8%, with a positive predictive value of 65.8% and an AUC of 0.59 (P = 0.028). CA125, in the prediction of decompensation in patients with acute heart failure (AHF) and at a cutoff value of 80.5 IU/L, had a sensitivity of 60.5% and specificity of 53.3%, with a positive predictive value of 64.5% and an AUC of 0.59 (P = 0.022). The time till onset of decompensation was significantly shorter in patients with four versus three elevated biomarkers (P = 0.047), with five versus three elevated biomarkers (P = 0.026), and in patients with four versus two elevated biomarkers (P = 0.026). The HR for decompensation in patients with five positive biomarkers was 3.7 (P = 0.001) and in patients with four positive biomarkers was 2.5 (P = 0.014), compared to patients who had fewer positive biomarkers. Conclusion: BNP, cystatin C, and CA125 are predictors of decompensation, and their combined usage leads to better prediction of new decompensation.

The Cytotoxic Effect of Thermoplastic Denture Base Resins: A Systematic Review.

Partial or complete dentures are constructed from thermoplastic resins that are thermally processed and molded. This review examines the presently available evidence for the cytotoxicity of thermoplasticized denture base resins on human gingival epithelial cells, adipose cells, and fibroblasts; human amnion fibroblasts; and mouse fibroblasts. Electronic searches were performed on PubMed, Scopus, Web of Science, and Google Scholar databases to identify relevant articles to be included in the review until September 2022. Clinical, in vivo, and in vitro studies in English language were searched for. The quality of the studies was assessed using the Toxicological data Reliability Assessment tool (ToxRTool) developed by the European Commission's Joint Research Centre. GRADE assessment was used to evaluate the certainty of evidence. Seven in vitro studies were included in the review. The overall risk of bias was determined to be high, with the majority of studies assessed found to be reliable with restrictions or not reliable. Only two studies were considered reliable without restrictions based on ToxRTool assessment. The effect of thermoplastic denture base resins on viability and cell adherence of human gingival or amnion fibroblasts and mouse fibroblasts (L929s) is not significant. Conditioned media from unpolished specimens of resins were significantly more toxic to cultured cells than those from polished specimens. This may be of concern in cases of poor post-processing of dentures. Based on the limited evidence available, there is low-certainty evidence that thermoplastic denture base resins appear to be biocompatible and show insignificant cytotoxicity. Further well-designed trials adhering to standard reporting guidelines and using objective measures are necessary before outlining universal guidelines for best practice. Long-term in vivo and clinical assessment is necessary to corroborate laboratory findings with clinical outcomes. Denture base resins are in constant contact with oral tissues, and cytotoxic components released by the resins may irritate or inflame the tissues or provoke an allergic response.

Probiotics in the Treatment of Radiotherapy-Induced Oral Mucositis: Systematic Review with Meta-Analysis.

The inflammatory injury of the mucous membranes lining the digestive tract, from the mouth to the anus, is called mucositis. One of the intriguing and compelling new therapeutic modalities that has emerged in recent decades due to advances in our understanding of this condition's pathophysiology is probiotics. The purpose of this meta-analysis is to evaluate the efficiency of probiotics in the treatment of chemotherapy-induced mucositis for head and neck malignancies; a literature search was performed on PubMed, Lilacs, and Web of Science, and articles published from 2000 to 31 January 2023 were considered, according to the keywords entered. The term "Probiotics" was combined with "oral mucositis" using the Boolean connector AND; at the end of the research, 189 studies were identified from the search on the three engines. Only three were used to draw up the present systematic study and metanalysis; this meta-analysis showed that the treatment of mucositis with probiotics is an effective method, and the analysis of the results of these studies showed that the use of probiotics promoted a decrease in the severity of mucositis symptoms.

Triglyceride level as a potential marker of residual cardiovascular risk and its relation to HeartScore.

BACKGROUND: Atherosclerotic cardiovascular diseases (ASCVD) are still the leading cause of morbidity and mortality in Bosnia and Herzegovina. Elevated LDL-cholesterol is established as a strong marker of cardiovascular risk. Some researchers believe that measuring triglyceride levels gives a good assessment of the residual risk for ASCVD besides the measurement of LDL-cholesterol. OBJECTIVE: The aim of this study was to evaluate the overall prevalence of major risk factors for ASCVD, lipid profile and 10-year fatal cardiovascular risk using the HeartSCORE scoring system. Further, we want to evaluate the prevalence and relationship between elevated triglyceride levels and high 10-year fatal cardiovascular risk calculated as a HeartSCORE. METHODS: This is a cross-sectional study conducted on 832 volunteers aged between 40 and 65 years without a diagnosis of diabetes and without known preexisting cardiovascular disease, as a part of the preventive program conducted at the Family Medicine office. Data were collected for ASCVD risk factors and lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides). 10-year fatal cardiovascular risk was calculated using the HeartSCORE scoring system for countries with high CV risk. RESULTS: Among 832 participants included, 565 (67.9%) were female, and 267 (32.1%) were male. We found high prevalence of hypertension (27.7%), obesity (32.2%), and smoking (36.2%). All lipid parameters, except HDL-C, were not optimal. Only 17.4% of participants had normal estimated HeartSCORE risk, while more than one-third (33.9%) had high or very high estimated HeartSCORE risk. Although we found a higher percentage of participants with elevated triglycerides in groups with higher HeartSCORE, there was a very weak positive correlation between values of triglycerides and the 10-year risk of a fatal cardiovascular event (r= 0.249, p= 0.000). CONCLUSION: The high prevalence of major known risk factors and high estimated HeartSCORE risk indicate a high overall risk for ASCVD in the sample. The proportion of participants with elevated triglycerides was increased in patients with high HeartSCORE risk what implicates importance of triglyceride measurement.

Correlation between Temporomandibular Disorders (TMD) and Posture Evaluated trough the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD): A Systematic Review with Meta-Analysis.

BACKGROUND: Temporomandibular disorders (TMDs) are a series of disorders that affect the muscles and joint. Symptoms include joint pain, muscle pain, and limitation of mouth opening. One of several multifactorial diseases, temporomandibular dysfunction has mostly been linked to five etiological factors: occlusion, trauma, severe pain stimuli, parafunctional activities, and psychological elements, including stress, anxiety, and depression. The position of the human body as it is displayed in space is referred to as posture. Several nerve pathways regulate posture, and through ligaments, TMD and posture affect each other. The purpose of this study is to evaluate the possible correlation between posture and TMD through a meta-analysis of the literature; Methods: A literature search was performed on PubMed, Lilacs, and Web of science, and articles published from 2000 to 31 December 2022 were considered, according to the keywords entered. The term "temporomandibular disorders" has been combined with "posture", using the Boolean connector AND; Results: At the end of the research, 896 studies were identified from the search conducted on the 3 engines. Only three were chosen to draw up the present systematic study summarizing the article's main findings. The meta-analysis showed through forest plot analysis a correlation between posture and TMD Conclusions: This literature meta-analysis showed a correlation between posture and TMD. Nerve pathways probably regulate both body posture and mandibular posture. Further clinical studies will be needed to confirm this hypothesis and to indicate the main conclusions or interpretations.

Gaucher: A Systematic Review on Oral and Radiological Aspects.

Background and Objectives: Gaucher disease (GD) is a lysosomal storage disorder with the genetic autosomal recessive transmission. Bone involvement is a prevalent finding in Gaucher disease. It causes deformity and limits daily activities and the quality of life. In 75% of patients, there is bone involvement. This review aims to evaluate the principal findings in the jaw by a Cone-beam computed tomography (CBTC) and X-ray orthopantomography; Materials and Methods: PubMed, Web of Science, Lilacs and Scopus were systematically searched until 31 December 2022. In addition, a manual search was performed using the bibliography of selected articles and a Google Scholar search. Clinical studies were selected that considered principal radiographic findings in radiography in a group of patients affected by GD. Results: Out of 5079 papers, four studies were included. The main findings are generalized rarefaction and enlarged narrow space, anodontia. Conclusions: The exact mechanism of bone manifestation is probably due to the infiltration of Gaucher cells in the bone marrow and, consequently, the destruction of bone architecture. All long bones are a potential means of skeletal manifestation. The jaw is more affected than the maxilla, and the principal features are cortical thinning, osteosclerosis, pseudocystic lesions, mental demineralization, flattening in the head of the condyle, effacement of anatomical structures, thickening of maxillary sinus mucosa. The dentist plays a crucial role in diagnosing and treating these patients. Sometimes the diagnosis can be made by a simple panoramic radiograph. All long bones are affected, and the mandible is particularly involved.

The Association between COVID-19 Related Anxiety, Stress, Depression, Temporomandibular Disorders, and Headaches from Childhood to Adulthood: A Systematic Review.

Objective: The coronavirus belongs to the family of Coronaviridae, which are not branched single-stranded RNA viruses. COVID-19 creates respiratory problems and infections ranging from mild to severe. The virus features mechanisms that serve to delay the cellular immune response. The host's response is responsible for the pathological process that leads to tissue destruction. Temporomandibular disorders are manifested by painful jaw musculature and jaw joint areas, clicks, or creaks when opening or closing the mouth. All these symptoms can be disabling and occur during chewing and when the patient yawns or even speaks. The pandemic situation has exacerbated anxieties and amplified the vulnerability of individuals. Therefore, from this mechanism, how the COVID-19 pandemic may have increased the incidence of temporomandibular disorders is perceived. The purpose of this review is to evaluate whether COVID-19-related anxiety has caused an increase in temporomandibular dysfunction symptoms in adults to children. Methods: PubMed, Web of Science, Lilacs, and Scopus were systematically searched, until 30 July 2022, to identify studies presenting: the connection between COVID-19 with temporomandibular disorders. Results: From 198 papers, 4 studies were included. Literature studies have shown that the state of uncertainty and anxiety has led to an increase in the incidence of this type of disorder, although not all studies agree. Seventy-three studies were identified after viewing all four search engines; at the end of the screening phase, only four were considered that met the PECO, the planned inclusion, and the exclusion criteria. All studies showed a statistically significant correlation between temporomandibular disorders and COVID-19 with a p < 0.05. Conclusions: All studies agreed that there is an association between COVID-19 and increased incidence of temporomandibular disorders.

Heat-not-burn tobacco products and cardiovascular risk reduction: A systematic review of randomized controlled trials.

BACKGROUND: Heat-not-burn (HNB) technology by the U.S. Food and Drug Administration has been classified as a modified risk tobacco product, which can be a better option for those populations who cannot give up the habit of smoking. The outlook on the effects of these products is quite controversial in the scientific world. OBJECTIVE: To present the effect of HNB tobacco products on the cardiovascular system, with reference to the existence of possible benefits of the technology. METHODS: The literature search was conducted in PubMed/Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases, with reliance on a well-defined guiding research statement. Quality appraisal was performed using the CASP checklist for randomized controlled trials. RESULTS: The search of three databases identified 167 records, and after selection process, 25 randomized controlled trials were eligible for our study's criteria. Twenty studies investigated the effects of HNB products on biomarkers of clinical relevance. Five studies evaluated other functional heart parameters rather than biomarkers. CONCLUSION: With HNB tobacco products, significant reductions were found in biomarkers of exposure and biological effect related to pathways involved in cardiovascular disease, including inflammation, oxidative stress, lipid metabolism, platelet function, and endothelial dysfunction.

A novel method for conformity assessment testing of defibrillators for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of patient monitors for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of therapeutic ultrasounds for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of infusion and perfusion pumps for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of dialysis machines for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of mechanical ventilators for post-market surveillance purposes.

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.

A novel method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes.

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.