When Are "Paraphernalia" Critical Medical Supplies?

Evidence of harm reduction interventions' morbidity and mortality benefits is abundant and of high quality, so there are good reasons for regional and national groups to advocate for more widespread distribution of legally regulated "drug paraphernalia," including needles, syringes, and fentanyl test strips. But lack of consistency among states' laws means that patients' interstate travel can subject them to being charged with possession of illegal items. This commentary on a case offers guidance to clinicians looking to help patients understand legal risks of interstate travel with supplies that are prescribed or recommended to reduce harms of their drug use and explores the ethical responsibilities of physicians in jurisdictions that legally prohibit these harm reduction interventions.

COVID-19 and the Medical Devices in India: Trade for a Resilient Health System.

BACKGROUND: The medical devices industry plays a critical role in public health and requires attention in research and policy. The COVID-19 pandemic exposed a lack of resilience in areas of drugs and vaccines but also in medical products. OBJECTIVES: The study analyzes India's strengths and weaknesses in the trade of medical devices and identifies specific devices where India can attain self-sufficiency and areas where trade is still beneficial. MATERIALS AND METHODS: A set of critical products traded during the COVID-19 pandemic were identified from the World Integrated Trade Solution website at the 6-digit Harmonized System code level. A detailed analysis of exports and imports of medical products at disaggregated 8-digit codes was carried out. RESULTS: During the pandemic, India had a trade surplus in some low-technology-based products such as suture needles, catheters, and cannulae along with X-ray apparatus and electrocardiographs among the medium-tech products. The imports of high-tech devices like in vitro diagnostics almost doubled to meet the surge in demand. The requirement of pulse oximeters, ventilators, and other monitoring devices jumped, and their imports reported an 800% increase from $134 million in 2019-2020 to $1162 million in 2021-2022. Most of India's imports of medical devices come from the top five exporting countries, with the share of the USA and China at 39%-40%. CONCLUSION: There is a need to expand the manufacturing capacity of surgical instruments, consumables and disposables, apart from some high-tech products. The public health care facilities should procure domestically manufactured medical devices and trade with neighbouring countries to reduce import concentration must be prioritised.

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Towards inclusive biodesign and innovation: lowering barriers to entry in medical device development through large language model tools.

In the following narrative review, we discuss the potential role of large language models (LLMs) in medical device innovation, specifically examples using generative pretrained transformer-4. Throughout the biodesign process, LLMs can offer prompt-driven insights, aiding problem identification, knowledge assimilation and decision-making. Intellectual property analysis, regulatory assessment and market analysis emerge as key LLM applications. Through case examples, we underscore LLMs' transformative ability to democratise information access and expertise, facilitating inclusive innovation in medical devices as well as its effectiveness with providing real-time, individualised feedback for innovators of all experience levels. By mitigating entry barriers, LLMs accelerate transformative advancements, fostering collaboration among established and emerging stakeholders.

A cross-sectional survey of first-aid kit equipment in a family in Sichuan, China.

PURPOSE: To examine residents' first-aid kit preparation and its influencing factors. DESIGN: Cross-sectional survey. METHODS: A questionnaire survey was conducted among 449 permanent residents in Sichuan Province using convenience sampling. We examined participants' demographic characteristics, self-efficacy, health literacy, and personality. FINDINGS: Of the participants, 111 (24.7%) stocked a home first-aid kit. The most frequent supplies were disinfection supplies (91.9%), common medicines (86.5%), and dressing supplies (76.6%). Family per capita monthly income, medical expenses payment method, chronic diseases, general self-efficacy, and health literacy were influencing factors of family first-aid kit preparedness. CONCLUSION: A multilevel and interactive emergency literacy education system should be established to improve residents' abilities to prevent emergencies.

[The problems and prospects of import substitution in medical industry].

The achievement of economic sustainability and assurance of national security through activation of production sectors, medical industry in particular, is the integral component of successful strategy of state development. The importance of achieving autonomy in production of medical technique is targeted to reducing dependence of external factors, ensuring continuity of supply of critically important equipment and increasing level of technical characteristics of production. Besides it, expansion of medical production positively impact on innovative development, organization of new work places and level of scientific research in this industry. The development of national medical industry contributes to improvement of quality of medical care that directly affect population health. The necessity to maintain stability of health care through import substitution of medical products is indisputable fact in modern conditions, determined by strategically important direction from national security point of view. The article considers measures within the framework of import substitution plan in medical industry of the Russian Federation for period up to 2024. The analysis of volume of national production of medical equipment in dynamics over 5 years was carried out. The main problems of production of medical devices at the present stage were considered. The measures of state support targeted to development of national production of medical equipment and innovative medical technologies were discussed.

Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol.

INTRODUCTION: The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature. METHODS AND ANALYSIS: The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis. ETHICS AND DISSEMINATION: This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC. STUDY REGISTRATION: Open Science Framework (https://osf.io/k72bn).

Resource sustainability and challenges in the supply chain: implications for infection prevention.

PURPOSE OF REVIEW: Infection prevention and control practices remain the bedrock of healthcare associated infection prevention and outbreak and epidemic control efforts. However, issues in supply chain management can hinder these efforts, as exemplified by various public health emergencies. This review explores the key role of supply chains in infection prevention and explores specific challenges. RECENT FINDINGS: In all of the critical components of infection prevention and control - hand hygiene, personal protective equipment, sterile supplies, environmental disinfection, and waste management - disruptions in supply chains have led to limited availability and dissemination. SUMMARY: Strategies to mitigate these resource constraints in the inter-epidemic period will also be highlighted. The infection prevention workforce is well poised to inform supply chain dynamics. Without robust and adequate supply chains, infection prevention and control efforts suffer which perpetuates healthcare-associated infections, clusters, and epidemics.

A systematic review and bayesian meta-analysis of medical devices used in chronic pain management.

Whilst. pharmacological therapies remain the cornerstone of pain management in chronic pain, factors including the current opioid epidemic have led to non-pharmacological techniques becoming a more attractive proposition. We explored the prevalence of medical device use and their treatment efficacy in non-cancer pain management. A systematic methodology was developed, peer reviewed and published in PROSPERO (CRD42021235384). Key words of medical device, pain management devices, chronic pain, lower back pain, back pain, leg pain and chronic pelvic pain using Science direct, PubMed, Web of Science, PROSPERO, MEDLINE, EMBASE, PorQuest and ClinicalTrials.gov. All clinical trials, epidemiology and mixed methods studies that reported the use of medical devices for non-cancer chronic pain management published between the 1st of January 1990 and the 30th of April 2022 were included. 13 studies were included in systematic review, of these 6 were used in the meta-analysis. Our meta-analysis for pain reduction showed that transcutaneous electrical nerve stimulation combined with instrument-assisted soft tissue mobilization treatment and pulsed electromagnetic therapy produced significant treatment on chronic lower back pain patients. Pooled evidence revealed the use of medical device related interventions resulted in 0.7 degree of pain reduction under a 0-10 scale. Significant improvement in disability scores, with a 7.44 degree reduction in disability level compared to a placebo using a 50 score range was also seen. Our analysis has shown that the optimal use of medical devices in a sustainable manner requires further research, needing larger cohort studies, greater gender parity, in a more diverse range of geographical locations.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

[Several Aspects Worthy of Attention in the Pre-research of Medical Device Standards].

The pre-research of medical device standards is of great significance for the enactment and amendment of standards. This study discusses four aspects and explores how to promote more scientific and reasonable pre-research. Based on the pre-research practice of medical device standards project, this study puts forward relevant work ideas and suggestions.

[Printing Process Quality Control of Bioprinting Medical Devices].

Objective: This study analyzes the risk points in the quality control of bioink and the main processes of bioprinting, clarifies and explores the quality control and supervision model for bioprinting medical devices, and provides theoretical and practical guidance to ensure the safety and effectiveness of bioprinting medical devices. Methods: The quality control risk points throughout the bioprinting process were comprehensively analyzed, with a particular focus on bioprinting materials and key processes. The regulatory model and methods for bioprinting medical devices were examined. This research concentrated on critical technologies such as extrusion, laser-assisted, and in situ bioprinting, assessing their potential for clinical applications and regulatory challenges. Results: Bioink from different sources should meet regulatory requirements. It is essential to ensure aseptic handling of raw materials and to validate sterilization under "worst-case" conditions. Conclusion: As bioprinting technology advances rapidly, corresponding research into materials, processes, and quality risk control should be conducted to ensure the concurrent development of the regulatory system. This will continuously contribute to the orderly progression of the entire industry and human health.

[Application of NGO-BP Neural Network in Battery Life Prediction of Portable Medical Devices].

The development of portable medical devices cannot be separated from safe and efficient batteries. Accurately predicting the remaining life of batteries can greatly improve the reliability of batteries, which is of great significance for portable medical devices. This article focuses on the high dependence of the BP neural network algorithm on initial weights and thresholds, as well as its tendency to fall into local minima. The Northern Goshawk Optimization (NGO) algorithm is used to optimize the BP neural network and to test the 18650 lithium battery data under different ambient temperatures (4, 24, 43°C) typical of medical equipment. The experimental results show that the NGO algorithm can significantly improve the prediction accuracy of the BP neural network under various temperature conditions, achieving accurate and effective prediction of the remaining battery life.

[Medical Equipment Management System Based on the Concept of Whole Life Cycle].

Objective: Strengthen the legal, compliant, and rational use of medical equipment and further guide the rationalization of medical behaviors. Methods: By utilizing the Internet of Things (IoT) and image analysis technology, collect real-time operation data of the equipment, establish a real-time running database for medical equipment, and cooperate with the 12 key links of the "whole life" of the equipment and the 8+6 management system framework to implement lean management of the efficiency, benefit, and effectiveness of medical equipment usage. Results: It realizes the improvement of the quality and efficiency of medical equipment, cost reduction and cost control, and provides data support for scientific decision-making. Conclusion: This study innovates the management model for the entire life cycle of medical equipment, providing a scientific approach to the management of hospital equipment.

[Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device].

With the encouragement of policies and the rapid development of the biopharmaceutical industry, the number of software as medical device (SaMD) registration applications in Shanghai has continued to increase in recent years, and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023, and the results show that nearly 70% of the problems were found in the software development process. Through in-depth analysis, this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements, software design, software testing, software defect management and software configuration management, combined with the characteristics of software development. These suggested measures have certain reference significance for medical device software development and quality control personnel, and technical reviewer and inspectors.

Pattern of Medical Device Adverse Events in a Tertiary Care Hospital in Northern India: An Ambispective Study.

BACKGROUND: Knowledge about the pattern of adverse events caused by medical devices (MDs) is limited in India. We aimed to assess the pattern of MD adverse events (MDAEs) in a tertiary hospital in Northern India. MATERIALS AND METHODS: This descriptive study was conducted ambispectively at various clinical departments of PGIMER, Chandigarh. We followed the guidelines edged by the Materiovigilance Program of India (MvPI) to conduct this study. The prospective study (PS) was done from January to December 2020, with a concurrent retrospective study (RS) proceeding to 3 years to learn more about the reporting culture, demographics, notification status, risk class of defective devices, and the type of adverse events. RESULTS: We received 224 MDAE in the PS and identified 413 MDAE in the RS. Reporting of adverse events to the national MvPI was negligible in the RS. In the PS, nurses reported the majority of MDAEs (65%), followed by doctors (30%). The occurrence of MDAE was higher in males (PS; 52%, RS; 57%) and age groups between 21 and 30 years (PS; 19.1%, RS; 23.2%) in both studies. MDAEs were frequent in low- to moderate-risk devices (class B: 66%) in the PS, while it was documented only for high-risk devices (class C: 51% and class D: 49%) in the RS. Most of the serious adverse events (SAEs) were reported among moderate to high-risk devices, and an increased frequency of SAE (60.4%) was observed among nonnotified MDs. The overall incidence of near-miss events was 14%. CONCLUSION: Knowledge of MDAEs and reporting of defective devices to regulatory authorities is essential to prevent further incidence. Adverse events caused by MDs are ubiquitous irrespective of their risk classification, notification status, and patient demographic factors. Accelerated reporting of MDAE by all cadre of healthcare professionals is urgently required to safeguard the health of Indians.