Implementation of the classification of medical devices of Ukraine in international approaches.

OBJECTIVE: Aim: To study the level of compliance of the National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ with international approaches to the classification and use of medical devices. PATIENTS AND METHODS: Materials and Methods: National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ and the international nomenclature of medical devices Global Medical Device Nomenclature. Methods: bibliosemantic, of content analysis and of structural-and-logical analysis. CONCLUSION: Conclusions: In the course of the study, full compliance of the national classifier of medical devices of Ukraine NC 024: 2023 with the GMDN system was established.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

INTRODUCTION: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS). AREAS COVERED: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years. We highlight significant changes in regulation, and explain the direction of efforts to translate the results of NGS and complementary diagnostics into clinical practice. EXPERT OPINION: NGS holds a number of advantages over conventional companion and complementary diagnostics that enable simultaneous analyzes of multiple cancer genes to detect actionable mutations. Parallel technological developments and regulatory changes have led to the rapid adoption of NGS into clinical practice. NGS-based genomic data have been leveraged to better understand the characteristics of a disease that affects its patient's response to a given therapy. As NGS-based tests become more widespread, however, Japanese authorities will face significant challenges particularly with respect to the complexity of genomic data, which will have to be managed if NGS is to benefit patients.

Accuracy assessment of bolus and basal rate delivery of different insulin pump systems used in insulin pump therapy of children and adolescents.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is commonly used in patients with diabetes. Accurate and reliable delivery by insulin pumps is essential for a safe and effective therapy, particularly when using small doses. In this study, accuracy of bolus and basal rate delivery of various available insulin pumps was evaluated. METHODS: In total, 13 insulin pump systems were tested: eight durable pumps with different infusion sets and one patch pump. Based on IEC 60601-2-24, insulin delivery was measured by recording weight gain of a beaker into which insulin was infused by the pumps. Bolus accuracy was determined by individually weighing 25 consecutive 0.1 or 1.0 U boluses and basal rate accuracy was determined during basal rate delivery of 0.1 or 1.0 U/h for 72 hours. For analyses, basal rate delivery was divided into 1-hour windows and deviation from target was calculated. RESULTS: Regarding different systems, average 0.1 U bolus delivery was -2% to +9% of the intended volume with 53% to 96% of boluses within ±15% of target. During 0.1 U/h basal rate delivery, most pumps showed an initial over-delivery for the first few hours. Three systems reached a total basal rate error <5%; others showed up to +24%. In general, delivery was more accurate when using larger doses. CONCLUSIONS: Considerable differences in insulin delivery accuracy were observed between the tested pumps. In general, when using very low doses, accuracy of insulin delivery is limited in most insulin pumps. This should be considered for CSII therapy in children.

Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)?

Real-time continuous glucose monitors using subcutaneous needle-type sensors continue to develop. The limitations of currently available systems, however, include time lag behind changes in blood glucose, the invasive nature of such systems, and in some cases, their accuracy. Non-invasive techniques have been developed, but, to date, no commercial device has been successful. A key research priority for people with Type 1 diabetes identified by the James Lind Alliance was to identify ways of monitoring blood glucose constantly and accurately using a discrete device, invasive or non-invasive. Integration of such a sensor is important in the development of a closed-loop system and the technology must be rapid, selective and acceptable for continuous use by individuals. The present review provides an update on existing continuous glucose-sensing technologies, and an overview of emergent techniques, including their accuracy and limitations.

Medical Devices: Classification and Analysis of Faults Leading to Harms.

INTRODUCTION: Harms from medical devices are important, but have been much less well studied than adverse drug reactions. Information provided to device users is of variable quality. OBJECTIVE: Our aim was to define "medical device fault" and "adverse effect of a medical device"; to establish whether medical device faults arise in design, manufacture, or use; and to consider ways of mitigating the adverse effects of medical devices. METHODS: We analysed 100 consecutive faults reported by the US Food and Drug Administration (FDA) and 50 faults reported by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and classified faults according to the point at which they occurred. RESULTS: Nearly 70% of reported faults related to devices that entered the body. Over 70% arose at the design stage, a quarter of the faults were associated with manufacture, and less than 5% were primarily caused by faulty use. CONCLUSION: We defined a medical device fault as an unintended failure in the design, manufacture, or use of a medical device that leads to, or has the potential to lead to, harm to the patient, and an adverse effect of a medical device as an unintended and appreciably harmful effect, caused by a medical device, which demonstrates a hazard of the device and may warrant preventive measures, or a change in the mode of use, or withdrawal of the device. Most faults that generate warnings arise from problems at the design stage, some arise at the manufacturing stage, and a few in usage. Careful assessment of the design of safety-critical devices in the light of previous problems may help to prevent repetition of errors. It would be helpful if, in addition to user manuals, manufacturers were required to produce Summaries of Device Characteristics (SDCs, "labels") that contained a systematically presented set of information about a product.

Medical Devices: Definition, Classification, and Regulatory Implications.

We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.

Broncalt®, class II medical device, in patients with acute upper airways disease: a survey in clinical practice.

Inflammation is a common pathogenic mechanism involved in many otorhinolaryngological (ORL) disorders. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It has been reported that it exerted a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with acute upper airways disease. The 3,533 (1,797 males, mean age 43.5 years) patients were evaluated at baseline (T0) and after a 2-week treatment (T1) with or without Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly and safely diminished the clinical features in all sub-groups (p<0.001 for all). Interestingly, Broncalt® significantly induced a faster symptom relief already within 3 days after the start of the treatment. In conclusion, Broncalt® is a class II Medical Device able to exert a safe and effective activity in patients with acute ORL disorders.

Broncalt®, class II medical device, in patients with chronic upper airways disease: a survey in clinical practice.

Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.

Broncalt®, class II medical device, in patients with chronic relapsed upper airways disease: a survey in clinical practice.

Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.

Reprocessing Flexible Endoscopes in the Otolaryngology Clinic.

Reprocessing a flexible endoscope is a complex multistep process. Attention to detail is essential for patient safety. Physicians need to empower their staff to function as guardians and advocates for best practices in endoscope reprocessing. Current best practice standards and guidelines for flexible endoscope reprocessing in the United States have been led by the Society of Gastroenterology Nurses and Associates, the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses, American Society for Gastrointestinal Endoscopy, and Multisociety Guideline. This article focuses on important aspects and current best practices for flexible endoscope cleaning and high-level disinfection.

Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial.

Identifying the needs of dementia caregivers is critical for supporting dementia home care. This study identified a typology of expert interventions delivered to dementia caregivers during an innovative telehealth trial that used in-home video recordings to directly observe care challenges. Qualitative content analysis was used to analyze narrative notes describing interventions that were developed based on video data submitted by 33 caregiver-care recipient dyads. Two major themes emerged: education and skills for dementia care and caregiver support. Ten subthemes included education and skills related to: behavioral and psychological symptoms of dementia, disease expectations, safety, activities of daily living, medical care optimization, and medication utilization and caregiver support related to: respite, positive reinforcement, social and financial support, and self-care. Families providing in-home dementia care experience a wide range of care challenges. By using video data, dementia care experts were able to witness and evaluate challenging care situations and provide individualized feedback.

Reprocessing Standards for Medical Devices and Equipment in Otolaryngology: Safe Practices for Scopes, Speculums, and Single-Use Devices.

Stringent regulatory standards for reprocessing medical devices and equipment have proliferated in response to patient safety incidents in which improperly disinfected or contaminated endoscopes lead to large-scale disease transmission or outbreaks. This article details best practices in reprocessing reusable and single-use devices in otolaryngology, with particular attention to flexible fiberoptic endoscopes/nasophyarngoscopes, nasal speculums, and other clinic and operating room instruments. High-risk devices require sterilization, whereas lower risk devices may be reprocessed using various disinfection procedures. Reprocessing practices have implications for adequacy, efficiency, and cost. Nuanced understanding of procedures and their rationale ensures delivery of safe, ethical, and quality patient care.

Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe.

OBJECTIVE: Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA). The aim of the work presented here was to test its plausibility and applicability by considering real-world HTA practices. METHODS: HTA reports on MDs from European institutions were collected in a systematic manner and the evaluated devices and/or related procedures were matched to a position on the taxonomy. Following this, representatives from 16 European HTA institutions were asked about the usefulness of the taxonomy in semi-structured interviews. RESULTS: 1237 HTA reports (2004-2015) from 33 European institutions were included in the sample. The majority of reports was on technologies from the taxonomic positions initially estimated as having high relevance. Most of the experts interviewed stated that they found the taxonomy useful, particularly regarding its potential to aid in selecting technologies for assessment and to highlight potential methodological particularities per taxonomic position. CONCLUSIONS: Overall, the distribution of identified reports on the matrix confirmed that the initial estimation of the relevance and necessity of HTA provided in the taxonomic model is plausible. In addition, interviews with representatives of European HTA institutions showed that the taxonomy could be useful.

Medical device classification: focus on vascular access.

Developments in the medical device industry are driven by a rapidly changing healthcare arena in combination with advances in technological fields such as materials science, bio-engineering and electronics. Subsequently, it is now estimated that over 500 000 different types of medical devices are produced globally. This article aims to give a simple explanation of device classification as it relates to vascular access devices. It aims to provide the reader with information to increase their knowledge and understanding of this topic.

Medical Devices; Exemptions From Premarket Notification: Class II Devices. Final order.

The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

[Analysis of Changes in Medical Device Classification Concept of the New EU Regulations].

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.

[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management].

OBJECTIVES: To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use. METHODS: Based on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results. RESULTS: Building a classification monitoring model of medical device adverse events based on risk management. CONCLUSIONS: The classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.