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.
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.
Artificial Intelligence , Defibrillators , Humans , Reproducibility of Results
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.
Artificial Intelligence , Vital Signs , Humans , Reproducibility of Results , Blood Pressure/physiology , Heart Rate
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.
Artificial Intelligence , Ultrasonic Therapy , Humans , Reproducibility of Results
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.
Artificial Intelligence , Infusion Pumps , Humans , Reproducibility of Results
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.
Artificial Intelligence , Renal Dialysis , Humans , Reproducibility of Results
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.
Artificial Intelligence , Ventilators, Mechanical , Humans , Reproducibility of Results , Respiration , Oxygen , Equipment Design
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.
Anesthesia , Artificial Intelligence , Humans , Reproducibility of Results
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.
Artificial Intelligence , Incubators, Infant , Humans , Reproducibility of Results
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.
Artificial Intelligence , Electrocardiography , Humans , Reproducibility of Results
BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. OBJECTIVE: This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. METHODS: Medline (1980-2021), EBSCO (1991-2021), and PubMed (1980-2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as the European Commission and the Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices and relevant national and international legislation, standards and guidelines concerning the topic were included in the review. RESULTS: The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. CONCLUSION: Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.
Commerce , Humans , Reproducibility of Results , Reference Standards
BACKGROUND: The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. METHODOLOGY: The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. DISCUSSION: It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.
Betacoronavirus , Commerce/legislation & jurisprudence , Coronavirus Infections , Licensure/legislation & jurisprudence , Manufacturing Industry/legislation & jurisprudence , Pandemics , Personal Protective Equipment/supply & distribution , Pneumonia, Viral , Reagent Kits, Diagnostic/supply & distribution , Ventilators, Mechanical/supply & distribution , COVID-19 , COVID-19 Testing , Clinical Laboratory Techniques/standards , Coronavirus Infections/diagnosis , Equipment Failure , European Union , Global Health , Humans , Personal Protective Equipment/standards , Reagent Kits, Diagnostic/standards , Risk Assessment , SARS-CoV-2 , United States , United States Food and Drug Administration , Ventilators, Mechanical/standards
