Incident reporting to BfArM - regulatory framework, results and challenges.

<p>Although great strides have been made to tackle hospital-acquired pressure ulcers (HAPUs), there is a need for greater recognition of device-related pressure ulcers (DRPUs), including their causes, management and prevention. This consensus statement, an updated second edition, aims to continue raising awareness of these largely preventable injuries and, crucially, to stimulate action. DRPUs are relatively common and account for a growing proportion of HAPUs. Updated information on the incidence of DRPUs is described in chapter 1. Although it is recognised that DRPUs increase the financial burden of healthcare, there is little formal analysis of their economic impact. This needs to be addressed; robust evidence on the burden of DRPUs and the value that can be released by adopting prevention strategies is needed to help drive action. Our understanding of the pathophysiology of DRPUs has improved significantly over the past few years; this is described in chapter 2. One crucial difference between PUs and DRPUs is that body-weight forces are less significant in DRPUs, with the force being exerted from a device that is typically strapped or taped onto the body. Devices and their securement may generate high stress concentrations in tissues, leading to cell and tissue-damage pathways associated with sustained deformation. As more evidence is published on DRPUs, recurring themes are emerging, as outlined in chapter 3: The most vulnerable patients are bearing the brunt of DRPUs; paediatric and neonatal patients, and all those needing critical care are particularly susceptible. During the COVID-19 pandemic, a new high-risk population (people with severe COVID-19 infection) emerged. They are at increased risk of DRPUs because of their need for prolonged ventilatory support, especially when 'proning' Devices associated with DRPUs are often used to perform essential, life-saving functions. They include continuous positive airway pressure (CPAP) masks or endotracheal tubes. Minimising their use is clearly not an option, so practice innovation is needed Although the most common locations for DRPUs are the face, ears, lower legs and heels, any location where a device comes into close contact with the skin can be at risk. In the same vein, any device, whether needed for a medical purpose or not, has the capacity to cause injury if its use is not properly managed. Vigilance is needed for all patients. What can be done? The importance of routine risk assessment is covered in chapter 4. Although use of a validated risk assessment tool is the vital first step, this will not be enough on its own. Several steps can be taken to ensure the safe use of devices. These are described in chapter 5 and include device repositioning, cushioning with prophylactic dressings and moisture control (only where possible and clinically appropriate). Of key importance is the development of an institutional protocol and champions to ensure all necessary steps are adopted. For any of these changes to be put into practice, awareness of DRPUs needs to increase. A number of proposals are outlined in chapter 6. A change of focus among health professionals and policy makers, along with more investment in education and training, are needed. All patients being managed with a medical device must be considered as at high risk. The pandemic introduced the world to the problem of DRPUs in health professionals caused by the extended wear of personal protective equipment. Health professionals also have a right to expect institutional protocols and provision of devices that protect them from DRPUs. Cutting-edge ideas and technologies that may be available in the future are described in chapter 7. When designing new products, manufacturers of medical devices have a duty of care to investigate the risks of DRPUs associated with their products and mitigate them, wherever possible. Our developing understanding of how the design, structure and materials used in medical devices contribute to DRPUs will help us develop new solutions for tomorrow. The first step is for everyone involved to ask themselves, 'what can I do to help?' There is work to be done-your journey to reduce DRPUs starts here!.</p>

Cybersecurity vulnerabilities of cardiac implantable electronic devices: Communication strategies for clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit

Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors.

Despite widespread and urgent therapeutic need, less than a quarter of new medical devices are developed and approved specifically for children, leaving this growing population with limited treatment options. The System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) framework is an initiative involving many key participants from both the private and public sectors which was developed to address this challenge. SHIP-MD is a multidisciplinary effort with a primary aim to improve the quantity and quality of medical devices that are specifically indicated for use in pediatric populations. The program centers on five priority areas: 1) finance (organizational and operating models; device development funding), 2) hospitals (criteria that hospitals must satisfy in order to participate), 3) navigation (on-boarding of innovators, coordination and management of evidence generation), 4) regulation (refining and optimizing current regulatory processes, recommending new regulatory options), and 5) reimbursement (harmonizing regulatory/reimbursement processes, expediting unique coding to optimize reimbursement, enhancing payments/coverage). SHIP-MD represents a path forward to addressing a long-standing public health matter. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. IMPACT: Pediatric device development faces significant challenges including economic disincentives, ethical concerns, and absence of robust advocacy. Potential solutions involve leveraging public-private partnerships to drive innovation. The System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) is an initiative involving the private and public sectors which was conceived to address these multiple challenges and represents an important path forward. The developed framework is feasible and actionable with steps presently being taken to operationalize this national approach. Less than a quarter of new medical devices are developed and authorized specifically for children. Pediatric device development faces significant challenges such as complex funding/reimbursement models and regulatory frameworks. Potential solutions involve leveraging unique public-private partnerships which have been proposed through the System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD) framework.

BackgroundMedical device adverse events (MDAEs) are critical incidents in healthcare systems that can lead to patient harm, necessitating thorough investigation and management. This study aims to comprehensively analyse MDAE reports collected over six months at a Medical Device Management Centre (MDMC). The investigation focuses on various aspects, including gender distribution, age demographics, types of medical devices implicated, department-wise distribution within hospitals, risk classification according to regulatory standards, and subsequent corrective and preventive actions undertaken.MethodsThe study collected and analysed 80 spontaneous MDAE reports from the MDMC database. Data were meticulously extracted, categorised, and quantified to facilitate detailed analysis. Mean and standard deviation were calculated for quantitative variables, and proportions were calculated for categorical variables to elucidate patterns and trends in MDAE occurrences.ResultsAnalysis revealed a gender disparity, with a higher proportion of MDAEs occurring in males (62%) compared to females (38%). Middle-aged individuals (41-50 years) constituted the largest age group affected by MDAEs, comprising 36.25% of reported cases. Patient monitors, IV catheters, and syringes emerged as the most frequently implicated medical devices, with patient monitors alone accounting for 18.75% of reported events. The Medicine ICU and Dialysis Unit reported the highest number of MDAEs, with 12.5% and 10% of total cases, respectively. Risk classification based on regulatory standards categorised the majority of events as Class B (51.25%), indicating low to moderate risk, while a notable proportion were classified as Class C (32.5%), signifying moderate to high risk. Additionally, in our study, most corrective actions after an MDAE involved repairing and returning the device for hospital use (94.59%). Two cases (5.41%) were sent to the manufacturer for replacement. Additionally, 43 out of 80 adverse events involved discarding single-use devices in hospital facilities. Preventive measures, such as staff training programs, were proposed to mitigate future risks.ConclusionThis study highlights important patterns in patient safety risks. Risk classification demonstrated that most events fell within Class B and Class C categories. Overall, this study emphasises the importance of systematic reporting, analysis, and management of MDAEs to reduce patient harm. Strengthening preventive measures, enhancing staff awareness, and ensuring robust regulatory compliance are essential steps toward improving medical device safety in hospital settings.

This RCA case study has been initiated before the Gas Turbo generator failure took place by timely intervention when the Gas Turbine incident alarm triggered. Root cause analysis (RCA) process was introduced in ADGAS back in 2004, the process was designed to ensure the elimination of defects and incidents with an integrity exposure or causing production losses from repeating by identifying the root cause and putting in place robust actions to ensure incidents don't reoccur. The RCA process enabled ADGAS to put in place a practical methodology for the initiation and execution of an investigation to resolve an incident that could cause a significant loss in production, Loss of functions and / or process contamination, an integrity risk or a repetitive problem that had to be eliminated. The RCA findings would have to undergo a review before the findings and actions are approved and issued. LG6 Gas Turbine is generating 1/3 of Das Island electrical power and very critical for ADMA / ADGAS production sustainability. In May2011 LG6 encountered a severe failure of its Gear Box, entire mechanical package misalignment, load coupling compression, severe foundation tilting and load gear box tilting. The inspection findings revealed a high risk of coupling destruction and production losses. Risk assessment highlighted that if the coupling damage while machine running, it could cause a flying objects to surrounding by 30.5 meters away and 4 meter width. This RCA case study has been initiated before the LG6 power generation Gas Turbine failure took place by timely intervention when the Gas Turbine incident alarm triggered. Risk has been assessed and decision made to shut down the machine immediately for site investigation and remedial actions. RCA team members faced a big challenge to get the machine back in service safely and efficiently as soon as possible to save the plant production and avoid bad reputation of partial electrical power off- black out. This also saved a company a rental fees of pack up power generation unit (estimated 24 MM US$ for two years) and assure providing of the required power to keep the operation of LNG, OAG trains and commission of IGD projects on time with no power shortage. This project resulted in significant potential enhancements for all of the ADGAS Turbo machinery units through the innovative application of a proven root cause analysis and remedial actions to identify the truly underlying "root causes" of incidents and developing sustainable repairs. Using a fault tree analysis process this project successfully identified 85 critical possible causes for the rare Frame 5 Gas turbine fault, eliminate by verification one by one pinpointed the cause of failure and developed a repair actions that prevent failure reoccur.

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medical devices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.

Caregiving is an inherently difficult role, replete with the emotional strains of watching a loved one deteriorate physically or mentally while trying to balance work and home responsibilities, and finding needed services with little or no guidance. These challenges are compounded by extreme stress, emotional overload, and a sense of isolation. Family caregiving is a lifespan issue, encompassing those with chronic conditions, disabilities, disease or the frailties of old age. Caregiving embraces a wide spectrum, ranging from the families of children with special needs to adult children caring for parents with Alzheimer's disease. Many family caregivers interact with medical devices in home settings.Advances in medical technology have allowed care recipients to remain ambulatory and independent. Because care recipients expect to be able to stay independent, mobile or active, the term “home use” extends beyond the home to encompass all environments in which a person plans to use his or her medical device to continue or enhance the quality of daily life.1For medical equipment designed for longterm use in the home, labeling will often not be with the device. In such cases, the home healthcare provider must develop his or her own basic instructions for use, maintenance, and cleaning. Through the MedWatch adverse event reporting system, the Food and Drug Administration (FDA) receives medical device reports of problems that stem from missing, absent or inadequate labeling, or misinterpretations of the information in labeling and instructions for use (IFU).The FDA also receives anecdotal information from consumers, healthcare practitioners (HCPs), healthcare organizations and device manufacturers suggesting interest in enhancing medical device equipment labeling content and format. Consumers and HCPs are particularly interested in having a searchable website containing medical device labeling and instructions for products intended for home use.This study was conducted to help the FDA better understand device labeling-related challenges that family caregivers face when care is provided in the home environment. Study respondents are members of the Caregiver Action Network (CAN), formerly the National Family Caregivers Association (NFCA), which educates, supports, empowers, and advocates for the more than 65 million Americans who care for loved ones with a chronic illness or disability or the frailties of old age,2 advocating for the needs of family caregivers, including their desires and need for instruction in the safe and effective use of medical devices in the home. These findings will assist in guiding the FDA's future efforts to characterize information pertinent to medical device labeling and provide online access in order to facilitate safe medical device use at home.A web-based survey contained multiple choice questions with pre-coded responses offering CAN respondents the opportunity to provide free-text responses and comments. The questionnaires were developed collaboratively by CAN, FDA/CDRH, and contractor to the FDA Social and Scientific Systems (SSS). Questions for both methods were based around the following topics:The survey questionnaire was administered via e-mail to a random sample of CAN members who met selection criteria (n=557; See Appendix 1 in online version of this article). The email provided background information about the FDA and the purpose of the study.The web-based survey was conducted October 5, 2011 through January 6, 2012. Reminders were sent four times over the course of the study, in October, November, and two in December. After the survey closed, results were collated and de-identified to maintain respondent confidentiality and then analyzed by the authors.One hundred twenty-seven respondents completed the web-based survey, a 22% response rate. Ninety-five percent of all respondents care for adult family members (over 21 years old). Forty-nine percent and 45% of these respondents care for a family member 65 years or over (n=63) or a family member between the ages 21–64 years (n=58), respectively.Of these 127 respondents, 77% care for their family member in their own home (n=99) and 59% of all respondents have cared for their family member more than five years (n=76). Forty-four percent of all respondents care for their spouse/partner (n=56).The majority of respondents indicated that they have been using their medical equipment for two or more years for chronic conditions, including heart disease, lung disease, and diabetes, or conditions related to stroke and cancer. Free text responses also included conditions, such as dementia and Alzheimer's disease.The survey determined that the home medical equipment respondents most commonly used in the care of family members included wheelchairs, specialty hospital beds, blood glucose monitors, patient lifts, nebulizers, and assistive equipment, such as canes, walkers, and bathroom handrails. Survey questions allowed respondents to share their experiences using the aforementioned medical products, specifically their experiences with the labeling and instructions that accompany the products they use.Respondents indicated that their medical equipment is most often delivered to their homes from the manufacturer or received from a pharmacy or drug store. From the free-text responses, respondents indicated that their equipment was handed down from friends or family after previous use. Respondents specified that it was ‘somewhat easy to very easy' to learn how to use their medical equipment, and most received training prior to use. Equipment use training was most often provided from the medical supply company representative.Other responses indicated that no training was received; or that training had been provided by the home health provider, rehabilitation staff, or hospital staff. Other methods besides training that helped respondents learn how to use their medical equipment included trial and error, following written (paper) instructions from the manufacturer, Internet instructions, verbal instruction, or observation and return demonstration.* Respondents noted that the best time to receive written instructions was upon delivery of equipment at home and the worst time was at the hospital.When manufacturer instructions came with their medical equipment, respondents indicated that it was ‘somewhat easy' to follow. Instructions were typically provided in a manual, booklet, or information sheet format. Respondents specify that the table of contents was most helpful in finding the information they need to use their equipment. When seeking information to troubleshoot their product, respondents believed they could ‘quickly and easily' find the information in the manufacturer's instructions.In free-text responses, respondents indicated that they would make use of the 1-800 helpline, or ask a nurse or company representative when they need information about using their product in general or for information about troubleshooting. Free-text comments indicated that a DVD would be helpful for these purposes.In addition to manufacturer's instructions, respondents indicated that they obtained information from medical supply companies, home health agencies, and hospitals, in the same format as the manufacturer's instructions. Interestingly, even when manufacturer's instructions are provided, information from additional sources is obtained in order to simplify and clarify the manufacturer's instructions.Respondents did not always use the instructions, because they felt the training they received was enough. The survey results indicated that most respondents commonly used their instructions when they were first learning to use their equipment; until they felt comfortable using it; and for information about cleaning.Respondents often referred back to their instructions when there was a problem, to find a phone number, or to refresh their memory and ensure they were using their equipment correctly. When respondents referred back to their instructions, they found what they needed to know. However, respondents specified that the information they needed was not always contained in the manufacturer's instructions. Instead, this information could come from other sources, such as from friends.Respondents who keep their instructions often file them with other medical information for as long as they own the equipment, which allows for easy access if needed. However, not all respondents have the instructions for their equipment. Whether this is because they never received it, or because they lost it requires further exploration.Most instructions include pictures and diagrams; however, whether respondents find them helpful is unclear. Interestingly, free-text responses indicated that pictures, diagrams, and other visuals are indeed useful and suggest that these be included in the instructions. Respondents report that the information they need to have to use their medical equipment, in the order of importance, includes the following:Respondents indicate that they most prefer to find information via paper instructions, such as a manual, brochure, or quick-start guide affixed to the equipment itself. In addition, respondents will also seek information online and find it helpful to obtain instructional information by phone with a company representative or home health nurse. To that end, respondents commonly turn to these sources, in addition to seeking advice from friends or others with the same condition or equipment.Respondents specify that a short version or quick-start guide would be helpful, especially if it includes the following:Sixty-five percent of all respondents are very comfortable with using computers (n=83), and 70% of respondents indicate they would welcome and make use of an FDA ‘searchable website that contained instructions for medical equipment used in the home' (n=90). Respondents noted that if the FDA created a searchable website, it should include videos to supplement the written instructions, diagrams, and pictures, all of which should be easy to print, and parallel the instruction preferences discussed above.Individuals likely to use medical products in the home setting may be elderly, chronically ill patients of any age, pregnant women, high-risk infants, and rehabilitation patients. These individuals vary significantly in their ability to operate and maintain devices. Complex instructions with multiple steps could confuse the user's ability to understand or adequately operate the device. To that end, instructions and information written in simple language should accompany any home use device product. Photographs, diagrams or other graphical representations may be used to provide clarity, as evidenced by respondent preferences.Survey results about medical equipment training portray an interesting situation: More complex devices used in the home environment are designed to be used by trained healthcare professionals in an acute care facility, rather than in a nonclinical setting. Furthermore, care recipients may not be able to choose the devices that they will ultimately use, as the device may be pre-selected by their insurance, for example.For these reasons, care recipients may not receive devices that are optimal for their comprehension level or that of a family caregiver. Therefore, it is imperative that home care recipients are properly trained on how to use their device as well as provided with instructional information that is readily accessible, easily understood and in a format that meets the users' needs.While this study generated important feedback on medical device labeling and use instructions, not all respondents (n=127) answered every question. Toward the end of the survey, there was attrition, evidenced by the dwindling number of responses to all remaining questions. This is likely due to the fact that respondents were requested to answer questions related to three pieces of medical equipment, which, in hindsight, is a large time commitment. While the free-text responses presented respondents with an opportunity to elaborate on their responses, many free-text reactions include ‘gripes' about the specific equipment(s) they use. Future studies like this one should consider responses of this nature during survey question development.Social desirability respondent bias was also present in this study. When comparing responses to questions with pre-coded selections with responses to questions that offered free text, there was a tendency for respondents to select favorable pre-coded responses to downplay the difficulties they experience, especially with regard to learning, following instructions, and using medical equipment.The pre-coded responses do not always match free-text feedback, which many times express frustration and confusion with regard to following medical device labeling and instructions. Furthermore, many free-text responses indicate that respondents do not recall receiving or did not receive instructions upon receipt of their medical equipment, which may also skew the results.Many study respondents are comfortable using computers, and often refer to information sources online and using a website that contains instructions for medical equipment used in the home. This finding, however, cannot be generalized to the entire population. Clearly there is selection bias at play: Respondents taking a web-based survey are likely to be more comfortable with computers, which could impact their ability to accurately respond to these questions.Another limitation to this study is that CAN respondent educational levels were not captured, nor were they included as part of the selection criteria eligibility. Authors suggest that in future studies of this nature, a question to obtain respondents' educational levels be included to determine whether there are relationships between education and labeling comprehension ease.

Artificial intelligence (AI) and machine-learning (ML) technologies are increasingly being incorporated into orthopaedic medical devices, offering the potential to enhance surgical planning, intraoperative precision, and personalized care. The incorporation of AI into medical devices introduces unique risks and challenges that traditional regulatory pathways in the United States and European Union (EU) were not designed to address. Although the EU Artificial Intelligence Act is currently being implemented to provide a specific framework for AI medical device assessment, no equivalent directive exists in the United States. In consideration of these evolving regulatory contexts, this study sought to address the following questions related to FDA-approved, AI/ML-enabled orthopaedic devices: (1) How often are FDA-approved, AI/ML-enabled orthopaedic devices also approved under the EU Medical Device Regulation (MDR)? (2) How often are AI/ML-enabled orthopaedic devices approved through the FDA 510(k) pathway using non-AI predicate devices? (3) How often do approved AI/ML-enabled orthopaedic devices have independent, peer-reviewed evidence supporting their use? (4) How often are the details of the training and validation datasets of these devices disclosed in publicly available regulatory documents? A total of 37 AI/ML-enabled orthopaedic device approvals were identified from the FDA's list of 1017 AI/ML-enabled medical devices as of May 2025. Regulatory documents were analyzed to identify training and validation data sets and predicate devices. A predicate device is an existing legally marketed device that the FDA has previously approved; a manufacturer may claim that a new device is "substantially equivalent" to this approved device to obtain clearance through the 510(k) pathway. The availability of devices in the EU was assessed through the publicly available European Database on Medical Devices (EUDAMED) database and manufacturer websites. A systematic review of PubMed and manufacturer websites identified peer-reviewed evidence for each device. Our results showed that 38% (14 of 37) of AI/ML-enabled orthopaedic devices were approved for use in the EU, and devices were more frequently available in the United States first. All AI/ML-enabled orthopaedic devices approved by the FDA received regulatory clearance through the 510(k) pathway; most devices (62% [23 of 37]) were approved based on substantial equivalence to non-AI enabled devices. Independent peer-reviewed evidence was identified for 30% (11 of 37) of devices, with 67% (34 of 51) of published studies reporting manufacturer involvement. Information on training and validation datasets was disclosed in 57% (21 of 37) of 510(k) summaries, with dataset sizes ranging from 21 to 150,000 for training and 20 to 29,991 for validation. AI/ML-enabled orthopaedic devices have entered the market under existing regulatory frameworks in the United States and, at a slower pace, in the EU. Reliance on non-AI comparators and limited postmarket evaluation raises concerns regarding their long-term clinical reliability. As the level of patient risk under the current regulatory pathways remains uncertain, future research should compare AI/ML-enabled device recall rates across jurisdictions to assess whether AI-specific regulatory frameworks improve patient safety and device reliability.

The China State Council released the new generation artificial intelligence (AI) development plan, outlining China's ambitious aspiration to assume global leadership in AI by the year 2030. This initiative underscores the extensive applicability of AI across diverse domains, including manufacturing, law, and medicine. With China establishing itself as a major producer and consumer of medical devices, there has been a notable increase in software registrations. This study aims to study the proliferation of health care-related software development within China. This work presents an overview of the Chinese regulatory framework for medical device software. The analysis covers both software as a medical device and software in a medical device. A comparative approach is employed to examine the regulations governing medical devices with AI and machine learning in China, the United States, and Europe. The study highlights the significant proliferation of health care-related software development within China, which has led to an increased demand for comprehensive regulatory guidance, particularly for international manufacturers. The comparative analysis reveals distinct regulatory frameworks and requirements across the three regions. This paper provides a useful outline of the current state of regulations for medical software in China and identifies the regulatory challenges posed by the rapid advancements in AI and machine learning technologies. Understanding these challenges is crucial for international manufacturers and stakeholders aiming to navigate the complex regulatory landscape.

Software as a Medical Device (SaMD) has become indispensable in diagnostics, treatment planning, and patient monitoring. While high-income countries have introduced clear regulatory frameworks, Bangladesh and many low- and middle-income countries (LMICs) still lack tailored pathways for medical software approval (IMDRF. Software as a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:(2013)); IMDRF. Software as a Medical Device (SaMD): Clinical Evaluation (IMDRF/SaMD WG/N41FINAL:(2017)); U.S. Food and Drug Administration (FDA). Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and FDA Staff (2017)). The current reliance on manual processes designed for physical devices leads to inefficiencies, inconsistent decisions, and potential risks to patient safety. This Comment proposes a semi-automated, risk-based intake roadmap for Bangladesh's Directorate General of Drug Administration (DGDA). Drawing on IMDRF, EU MDCG, and U.S. FDA frameworks, it presents a tangible workflow showing which submissions can be automatically triaged, which require human review, and where human override is maintained (European Commission (MDCG). Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 (MDCG 2019-11) and World Health Organization (WHO) Global Model Regulatory Framework for medical devices including IVDs (draft; WHO) (n.d.)). Key intake fields, escalation rules, and measurable performance indicators are defined. Anchored to Bangladesh's current DGDA and national digital health context, the proposal identifies specific legal and infrastructural gaps and outlines steps for phased modernization that may guide other LMICs.

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process —the historically dominant path to market for most medical devices— and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device “predicates” upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.

There are specific obstacles to designing medical devices for children, such as commercial distortions and regulatory hurdles. This study compares the regulatory frameworks and collaborative ecosystems of the United States (US) and Japan, enabling the development of pediatric medical devices. The study illustrates the differences as well as parallels between the two countries by outlining their primary obstacles, channels of assistance, and prospects. The regulatory regimes of the US and Japan pose substantial challenges due to their intricate approval procedures and the dearth of pediatric-specific guidelines. However, while Japan's ecosystem is more dispersed, the US offers more well-established support mechanisms, such as funding initiatives and research alliances. Despite these difficulties, there are still prospects for innovative thinking and collaborative work. The article demonstrates successful partnerships between business, academia, and government in both countries, which have helped propel the advancement of pediatric devices. For stakeholders endeavoring to maneuver through thecomplex terrain of pediatric medical device development, this study offers valuable insights. With a comprehensive understanding of the regulatory and collaborative frameworks in Japan and the US, developers can more effectively leverage resources, overcome obstacles, and bring vital technology to market. The study's findings have implications for researchers, industry leaders, and policy regulators, providing recommendations for strategies aimed at stimulating innovation and enhancing children's healthcare outcomes internationally.

Many accidents happen daily in different technological areas, and a great proportion of these accidents are due to human errors. Many of these incidents may be a consequence of flaws in the equipment software interface, which can be accountable for user’s’ errors. Touchscreen technology is more and more a part of everyday life in all types of devices, such as medical devices, for example. This methodology aims to determine the items presented in the form of a checklist to ensure that a medical device can actually incorporate touchscreen technology. The use of touchscreen technology in medical devices can be assessed on three different fronts: human factor engineering (HFE), manufacturers, and user experience. This essay is an initial study yet is extremely important to guide manufacturers about touchscreen technology usage not only on the devices already available in the market but also on new products to be launched in the future.

Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association