Current Healthcare Policy and Environmental Status of Digital Health Medical Devices in South Korea

Objectives: COVID 19 and increasing unmet needs of health technology had accelerated an adoption of digital health globally and the major categories are mobile-health, health information technology, telemedicine. Digital health interventions have various benefit on clinical efficacy, quality of care and reducing healthcare costs. The objective of the study is to identify new reimbursement policy trend of digital health medical devices in South Korea. Method(s): Official announcements published in national bodies and supplementary secondary research were used to capture policies, frameworks and currently approved products since 2019. Result(s): With policy development, several digital health devices and AI software have been introduced as non-reimbursement by utilizing new Health Technology Assessment (nHTA) pathway including grace period of nHTA and innovative medical devices integrated assessment pathway. AI based cardiac arrest risk management software (DeepCARS) and electroceutical device for major depressive disorders (MINDD STIM) have been approved as non-reimbursement use for about 3 years. Two digital therapeutics for insomnia and AI software for diagnosis of cerebral infarction were approved as the first innovative medical devices under new integrated assessment system, and they could be treated in the market. In addition, there is remote patient monitoring (RPM) reimbursement service fee. Continuous glucose monitoring devices have been reimbursed for type 1 diabetes patients by the National Health Insurance Service (NHIS) since January 2019. Homecare RPM service for peritoneal dialysis patients with cloud platform (Sharesource) has been reimbursed since December 2019, and long-term continuous ECG monitoring service fee for wearable ECG monitoring devices (ATpatch, MEMO) became reimbursement since January 2022. Conclusion(s): Although Korean government has been developed guidelines for digital health actively, only few products had been reimbursed. To introduce new technologies for improved patient centric treatment, novel value-based assessment and new pricing guideline of digital health medical devices are quite required.Copyright © 2023

Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

Manufacturing Innovation

(ProQuest: ... denotes non-USASCII text omitted.) The annual Global Innovation Index released in September 2021 ranked China twelfth, surpassing developed economies such as Japan, Israel, and Canada and raising fears in the United States amidst sluggish growth in North America and strong growth in the Asia Pacific region.1 Interestingly, the United States government responded by boycotting the Beijing Olympic Games, citing human rights abuses as the main reason.2 A tech war between China and the United States brewed beneath the diplomatic rancor over the attendance at the Olympic Games. Part I documents how the United States has assisted China's tech and intellectual property domination through President Nixon's historic visit to China, giving China Most Favorite Nation (MFN) status and ascending China to the World Trade Organization (WTO). [...]under Deng Xiaoping's leadership during the reform period, China rapidly developed its special economic zones (SEZs), laying the foundation for subsequent tech innovation and production. [...]broadcasting, telecommunications, office machines, computers, integrated circuits, and cell phones are among China's notable exports to the world.9 China dominates in commodities and raw materials, exporting refined petroleum, cotton, plywood, and tea.10 For agricultural products, China occupies the perch as the world's largest producer. Shenzhen rose as the largest among the four.18 Shenzhen, a small fishing locale in the southern part of China's southern province, Guangdong, served as the pioneer of Deng Xiaoping's embrace of economic reforms.19 A market-oriented economy took root in Shenzhen, allowing foreign companies and entities from Hong Kong and Macau to operate and allowing Chinese talents the freedom to leave their hometowns and move into the SEZs.20 Cheap labor proved to be another significant factor facilitating China's rise as a global manufacturer.21 In the 1980s, multinational corporations from Taiwan, Japan, and South Korea, as well as domestic Chinese companies, opened their factories in the SEZs and other cities in China to take advantage of the cheap and plentiful labor force.22 Indeed, when Deng Xiaoping began his pilot SEZs, China's young workers who wished to lift themselves out of poverty descended into the economic zones in search of better opportunities.23 Shenzhen grew from a population of 59,000 in 1980 to a population of 12,357,000 in 2020.24 The new migrants became the workers, participants, and stakeholders in the global manufacturing frontier.25 Because of the abundance of cheap labor, manufacturers in China have no difficulty keeping production prices low and pleasing consumers and businesses worldwide.26 China's currency manipulation is another factor propelling China to its domination in global manufacturing.27 The United States Congress attempted numerous times to introduce legislation to combat China's currency manipulation.28 China artificially devalued its currency through government control of the exchange rate and refused to let the Chinese Renminbi (RMB) float.29 Despite strong criticisms from the United States, China refuses to allow its currency to freely float.30 China's currency manipulations, according to critics, caused the widening of trade deficits between the United States and China.31 China's currency manipulation allows products to be manufactured at lower prices, hampering competitors and thereafter replacing them.32 In order to cope with China's currency practices, United States manufacturers facing their own existential crises must decide to either outsource jobs overseas or face large risks, including financial ruin.33 The United States lost millions of manufacturing jobs due to massive job outsourcing as the trade deficits between the United States and China continued to persist.34 Geopolitically, in shaping post-Cold-War powers, the United States decided to assist China in its transformation from a poverty-stricken country to a global manufacturer.

ID: 213412 Comparison of Remote Programming and On-Site Programming in Patients With SCS and DRG Stimulation

Introduction: Spinal cord and dorsal root ganglion stimulation (SCS and DRG) are standard of care in chronic neuropathic pain. During the COVID-19 pandemic, it was critical to arrange postoperative care. Furthermore, the disparity between travel times and transportation options could influence the decision on seeking healthcare. Lacking financial resources could enhance this issue. Telehealth is usually restricted to video conferences, without interfering with implanted medical devices. Now, there exists a platform for remote programming of those devices. It is accessible via smartphones and allows direct contact between a patient and their doctor. Method(s): We initiated a pilot study for evaluating the performance of remote care in patients with SCS or DRG stimulation. We plan the enrollment of 20 patients, 10 each in the retrospective and the prospective group. Retrospective data has been collected from on-site programmed patients in our outpatient clinic in a large registry study. Prospective data is being collected under the new standard of care in the remotely programmed patients. We assess ten scores and categories to evaluate the status preoperatively, at implantation, and the postoperative course. The postoperative data are assessed in the context of video conferences for remote programming. 12 months after implantation, a final video conference is scheduled. In both groups, the same stimulation systems are used. Result(s): The study is ongoing. In the retrospective group (n=8), the mean duration of the programming appointment including waiting time was 43 minutes and the mean travel time 71 minutes (mean travel distance 106km with corresponding costs). So far, 5 patients have been enrolled for remote programming. Measured with the Telehealth Usability Questionnaire, their overall satisfaction with the system is high. In the Patient Global Impression of Change Scale 6 months after implantation, the retrospective group has a mean of 5 and the prospective group of 6 points. Considering the Visual Analog Scale, there was an improvement in both groups between the baseline and follow-up (in the retrospective group from mean 8 to 5 and in the prospective group from mean 8 to 2). Conclusion(s): The general convenience with the remote programming is high. Compared to the retrospective group, the patients do not experience a lack of efficacy of their stimulation. The use of remote programming offers various advantages, e.g., no travel times nor costs that allow simplified and more frequent programming. Especially in a pandemic or in case of travel limitations it is a very helpful tool. Disclosure: Mareike Mueller, MD: None, Andrea Dreyer: None, Phyllis McPhillips, RN: None, Guilherme Santos Piedade, MD: None, Sebastian Gillner, MD: ABBOTT: Consulting Fee:, Boston Scientific: Consulting Fee:, Philipp Slotty, MD: None, Jan Vesper, MD,PhD: Abbott: Consulting Fee:, Abbott: Fees for Non-CME/CE Services (e.g. advisor):, Medtronic: Fees for Non-CME/CE Services (e.g. advisor):, Boston Scientific: Consulting Fee:, Medtronic: Consulting Fee:, UniQure: Fees for Non-CME/CE Services (e.g. advisor):, ABBOTT: Consulting Fee:, Abbott: Speakers Bureau:, ABBOTT: Consulting Fee: Self, ABBOTT: Speakers Bureau: Self, ABBOTT: Contracted Research: Self, Boston Scientific: Consulting Fee: Self, Boston Scientific: Contracted Research: SelfCopyright © 2023

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

Strategizing for Strength in EU PharmaN

"Though Europe's response has demonstrated strengths," the strategy document reports, "existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines, or the availability of manufacturing capacities to adapt and support the production of medicines" (2). [...]a lot of the strategy's proposals stem from the European Green Deal, published in late 2019 (4), from which has emanated last year's EU industrial strategy (5). [...]setting up critical medicines production capacity in the EU would have to be compliant with the Union's competition rules and those of the World Trade Organization, the commission warned (2).

Evidence Trends in Remote Patient Monitoring and Remote Therapeutic Monitoring

Objectives: To provide an overview of trends in the current evidence landscape of products and services in development that support remote patient monitoring (RPM) and remote therapeutic monitoring (RTM), given the release of new billing codes for RPM and RTM by Centers for Medicare and Medicaid Services (CMS) in 2019. Method(s): A focused literature review was conducted in PubMed. Articles published between January 1, 2013 and January 1, 2023 were eligible for inclusion if reported technologies were classified as RPM (defined as the collection and interpretation of physiologic data digitally stored and/or transmitted by patients and/or caregivers to qualified health care professionals) or RTM (defined as the use of medical devices to monitor a patient's health or response to treatment using non-physiological data), following CMS definitions. RPM and RTM technologies included hardware, software, telehealth, and blockchain applications. Articles were then categorized using a semi-automated software platform (AutoLit, Nested Knowledge, St. Paul, MN) based on disease area, study design, intervention, and outcomes studied. Result(s): Of the 673 records screened, 245 articles were included. Observational studies (19.6%) were the most common study design, followed by systematic or focused literature reviews (11.0%) and narrative reviews (10.6%). The most common disease areas included cardiology (25.7%), coronavirus disease of 2019 (COVID-19;13.9%), and diabetes (9.4%). The most frequent clinical, non-clinical, and patient-reported outcomes were symptom monitoring (20.8%), all cause readmission and hospitalization rates (both 7.3%), and patient experience (7.8%), respectively. Conclusion(s): CMS policy and coding practices for RPM and RTM are evolving, and this trend is likely to continue into the future. This review provides details on the current evidence trends associated with RPM/RTM technologies. Evidence development of RPM and RTM should be assessed as evidence needs for coverage and reimbursement may receive increased payer management.Copyright © 2023

Isometric thumb extension exercise as part of a multimodal intervention for de Quervain's syndrome: A randomised feasibility trial

Introduction: de Quervain's syndrome is a painful condition commonly presented to hand therapists. Exercise is utilised as an intervention, but isometric exercise has not been investigated. We aimed to assess the feasibility and safety of isometric thumb extension exercise for de Quervain's syndrome and to explore differences between high-load and low-load isometric exercise. Method(s): This parallel-group randomised clinical feasibility trial included individuals with de Quervain's syndrome. All participants underwent a 2 week washout period where they received an orthosis, education, and range of motion exercises. Eligible participants were then randomised to receive high or low-load isometric thumb extension exercises, performed daily for 4 weeks. Feasibility and safety were assessed by recruitment and drop-out rates, adherence, adverse events, and participant feedback via semi-structured interviews. Secondary outcomes included patient-reported outcomes for pain and function, and blinded assessment of range of motion and strength. Result(s): Twenty-eight participants were randomised. There were no drop-outs after randomisation, and no serious adverse events. Adherence to exercise was 86.7%, with 84% of participants stating they would choose to participate again. There were clinically and statistically significant improvements in pain and function over time (p < 0.001) but not in range of motion or strength. There were no statistically significant between-group differences. Conclusion(s): Isometric thumb extension exercise within a multimodal approach appears a safe and feasible intervention for people with de Quervain's syndrome. A large multi-centre trial would be required to compare high- and low-load isometric exercises. Further research investigating exercise and multimodal interventions in this population is warranted.Copyright © The Author(s) 2023.

Patrolling portals: the regulation of online genetic data sharing

Background/Objectives: Online portals are being increasingly used to disseminate genetics data. While portal-facilitated sharing might have significant scientific value, it is also likely to raise difficult legal and ethical questions. Many of these questions were highlighted during the Covid-19 pandemic, as the urgency of efficient data sharing became apparent. Responding to these emerging concerns, regulators around the world have implemented regimes for 'software used as a medical device.' It is unclear how these regimes affect online portals for genetic data sharing. This study addresses how online data sharing may be shaped by new forms of regulatory oversight. Method(s): We performed an international comparative analysis of advisory documents applicable to software as medical devices prepared by medical regulators in Canada, the United States, France, and the United Kingdom. We selected 20 documents for review. Result(s): We found that regulatory agencies are likely to regulate online tools as medical devices only when they are intended to perform a medical purpose. Online portals for genetic data sharing will not usually meet this threshold. Nevertheless, regulatory guidance provides significant insight into the kinds of issues to which regulators are likely to be attentive in addressing online data sharing. We identify eight normative and logistical issues: efficiency, equity, transparency, confidentiality, communication, empowerment, training, and safety. Conclusion(s): This review clarifies how the regulation of medical software might apply to portals for genetic data sharing. We offer recommendations to portal developers and researchers.

Clinical Uses of Cuffless Blood Pressure Monitoring Devices Using Photoplethysmography as a Promising Ambulatory Telemonitoring Tool: A Systematic Review and Meta-Analysis

Introduction: As check-ups in healthcare facilities are much arduous during the pandemic including blood pressure (BP) control, an alternative is urgently needed to replace the use of disturbing cuff-based office and ambulatory BP monitoring (BPM) devices. With the advancement of telemedicine, real-time checking and reporting of blood pressure may be potentially achieved using photoplethysmography (PPG) technology in cuffless devices. Therefore, this study evaluated the accuracy of these devices compared to the cuff-based BPM devices. Method(s): This systematic review and meta-analysis was conducted based on the PRISMA 2020 guideline through multiple databases using Rayyan according to the prearranged inclusion and exclusion criteria, yielding six clinical studies to be included in the final review and analysis. Result(s): Overall fixed-effect meta-analysis of all studies (total of 319 subjects) presented small differences between cuffless and cuff-based devices, showing promising accuracy according to the current medical instrumentation guideline both in measuring systolic BP (SMD: 0.23 mmHg [95% CI: 0.07-0.39], p = 0.004;I2= 0%, p = 0.55) and diastolic BP (SMD: 0.27 mmHg [95% CI: 0.11-0.43], p = 0.0007;I2= 39%, p = 0.14). Discussion(s): PPG itself is a noninvasive technology, consisting of an infrared-emitting light source and a photodetector to measure the blood-reflected light intensity. Despite its ease in equipment, it measures BP accurately without being influenced by various positions and activities. Moreover, the data can be accessed real-time by both users and healthcare providers. Conclusion(s): In summary, cuffless PPG BPM devices have the potential in becoming a telemonitoring device for ambulatory patients for its accuracy. Its presence may be the answer to current restriction towards healthcare access during the COVID-19 pandemic. Therefore, in order to further confirm our findings, more clinical studies with various settings are encouraged to be held.

Global Health Technologies are Transforming Intellectual Property and World Trade

The nano-enabled technology of 3-D printing for medical devices presents a dynamic new avenue for meeting patient needs. 3-D printers can generate food, soaps, cosmetics, body parts, metal devices, or medicines. This technology enables continuity of health care delivery despite disruptive breaks in any supply chain due to war, shortage, or broken distribution lines due to pandemic force majeure.1 Featuring custom-tailored attributes for each device, economic efficiency by eliminating transport costs during emergencies, avoiding issues of distribution supply chains, and offering biocompatibility, 3-D printed medical devices during the COVID-19 pandemic2 provided a very attractive alternative to enduring medical supply shortages worldwide. Beyond the covid-19 pandemic exigencies, 3-D printed medical devices promise custom-tailored meals to meet medical needs that are unique for each patient's metabolism and a wide variety of tools for patient care that will change the shape of global commerce.3 3-D printing offers the alluring promise of biocompatible medical devices, matching any patient's unique anatomy, using a specific patient's imaging data, or using a standard design to make multiple identical copies of the same device, but without delays for transport or shipping and insurance costs. The global health impact of these efforts, from the standpoint of patient safety4 and overall deterrence of unnecessary or unsafe medical practices, remains unclear due to the absence of regulation and monitoring. The reality is that commerce can reduce or eliminate transport and storage costs associated with shipping and can change international trade. Yet, 3-D printing simultaneously offers great promise to meet challenges arising from the arcane role of intellectual property rights (IPR)5 in shaping the creation and transfer of nanomedicines and nanotechnologies to attain health equity and meet universal needs of health for all. These millennial technological changes may permanently alter how civil society does business for global health. © 2022, Andover House, Inc.. All rights reserved.

Regulating Digital Therapeutics

Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.

Business on Hold? EMA's Full Recovery in Question

The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).

Strategic management and organizational culture of medical device companies in relation to corporate performance.

AIMS: Strategies focus on securing the competitiveness of medical device corporations by strengthening their organizational capabilities, which, in turn, ensure their continuous development. This study aims to investigate both management strategies and organizational culture, which may affect the performance of these companies, and analyzes the influence of education and training investment. MATERIALS AND METHODS: We used data from the 3rd to 6th Human Capital Corporate Panel surveys by the Korea Research Institute for Vocational Education and Training as well as data from the Korea Information Service and 6,112 workers and 260 companies were analyzed. For the analysis, management strategy and organizational culture were set as independent variables, and corporation performance was set as the dependent variable. Additionally, investment in education and training was set as a control variable between the independent and dependent variables. Corporate performance was analyzed by dividing into organizational satisfaction and organizational commitment. RESULTS: Differentiation strategy and innovative culture had a positive (+) effect on organizational satisfaction, while cost leadership strategy and hierarchical culture had a negative (-) effect. On the other hand, in the case of interaction with education and training investment, cost leadership strategy and hierarchical culture had a positive (+) effect, while differentiation strategy and innovation culture had a negative (-) effect. In organizational commitment, innovation culture had a positive (+) effect, and hierarchical culture had a negative (-) effect. In the case of interaction with investment in education and training, only the hierarchical culture had a positive (+) effect. CONCLUSIONS: The innovation culture positively influenced the performance of medical device companies. Furthermore, cost leadership strategy, hierarchical culture, education and training investment improved the corporate performance of these companies. To enhance corporate performance, these companies should create an innovation culture and invest in education and training in accordance with the organizational culture.

COVID-19 has proven the excellence of Korea's medical devices, and the medical device industry is expected to continue to grow due to the increase in chronic disease and non-face-to-face treatment. However, the current medical device industry is monopolized by global companies with capital and technological prowess. To overcome this, Korean medical device companies are developing innovative medical devices centered on start-ups, but now is the time to strategically respond to them in order to compete with global companies. In general, companies establish management strategies for survival and growth by analyzing threats and opportunities based on the market environment to maintain the optimal organization according to market competition, government policies, and changes in consumer needs. Strategies are often established based on the culture of the organizations that make up the company. When it comes to strategy establishment, the medical device industry has special characteristics compared to other industries. The medical device industry is based on advanced technology and puts patient safety first, requiring continuous product upgrades. Therefore, it is an essential industry for employees to invest in education and training. The analysis shows the effectiveness of investment in education and training according to the management strategy and organizational culture of medical device companies. It was confirmed that when medical device companies create an Innovation culture, their performance improves. It also shows that when medical device companies adopt a cost leadership strategy, they need to increase their investment in education and training to improve corporate performance.

The Artificial Intelligence in Teledermatology: A Narrative Review on Opportunities, Perspectives, and Bottlenecks.

Artificial intelligence (AI) is recently seeing significant advances in teledermatology (TD), also thanks to the developments that have taken place during the COVID-19 pandemic. In the last two years, there was an important development of studies that focused on opportunities, perspectives, and problems in this field. The topic is very important because the telemedicine and AI applied to dermatology have the opportunity to improve both the quality of healthcare for citizens and the workflow of healthcare professionals. This study conducted an overview on the opportunities, the perspectives, and the problems related to the integration of TD with AI. The methodology of this review, following a standardized checklist, was based on: (I) a search of PubMed and Scopus and (II) an eligibility assessment, using parameters with five levels of score. The outcome highlighted that applications of this integration have been identified in various skin pathologies and in quality control, both in eHealth and mHealth. Many of these applications are based on Apps used by citizens in mHealth for self-care with new opportunities but also open questions. A generalized enthusiasm has been registered regarding the opportunities and general perspectives on improving the quality of care, optimizing the healthcare processes, minimizing costs, reducing the stress in the healthcare facilities, and in making citizens, now at the center, more satisfied. However, critical issues have emerged related to: (a) the need to improve the process of diffusion of the Apps in the hands of citizens, with better design, validation, standardization, and cybersecurity; (b) the need for better attention paid to medico-legal and ethical issues; and (c) the need for the stabilization of international and national regulations. Targeted agreement initiatives, such as position statements, guidelines, and/or consensus initiatives, are needed to ensure a better result for all, along with the design of both specific plans and shared workflows.

A Case Series of Kodamaea Ohmeri Infection: The Hidden Threat Unleashed

Intro: Kodamaea ohmeri, previously known as Pichia ohmeri, is an ascomycetous yeast that has emerged as an important cause of fungemia in immunocompromised patients. During the anamorphic stage this organism is also known as Candida guillermondii var. membranaefaciens. Method(s): We report five cases of Kodamaea ohmeri encountered from multicenter in Malaysia. Antifungal agent of choice will be discussed based on literature review. Finding(s): The cases were: (1) a contaminated peritoneal fluid in an adult patient on peritoneal dialysis;(2) a 60-year-old man with infected diabetic foot isolated K. ohmeri from a bone sample. Both cases discharged well without active antifungal fungal therapy. We observed fatality cases involving (3) an old man with underlying gastric adenocarcinoma who complicated with catheter- related bloodstream infection caused by K. ohmeri;(4) a patient with ventilator- associated pneumonia and septicaemic shock secondary to perforated terminal ileum;(5) and a severely ill COVID-19 stage 5b patient who passed away due to systemic fungaemia caused by K. ohmeri. Discussion(s): All three fatal cases received either amphotericin B or caspofungin as active antifungal agent. Literature evidence has shown that 40% of patient met demise despite on active antifungal agent, suggesting that currently no definitive antifungal agent proven to be a superior treatment option for K. ohmeri infection. Removal of indwelling medical device combined with antifungal therapy has favorable clinical outcome. Conclusion(s): Therefore, K. ohmeri infection in severely ill patients should be considered as a critical condition. Potential of alternative antifungal combinations need to be explored for an effective treatment option.Copyright © 2023

A Medical Device Information Data Sheet (MDIDS) to Support the Interoperability of Externally Controllable Infusion Pumps for Tele-Critical Care1

Problem and Motivation. Medical device remote control technologies can enable remote experts to contribute to patient care during tele-critical care during public health emergencies like COVID-19 to address the shortage of local clinical expertise. The benefit of such technologies may be further amplified if one remote-control application can operate multiple interoperable medical devices (e.g. multiple types of ventilators or IV pumps) to support the typical diversity of deployed medical devices in one institution. However, due to the variation in capabilities of different makes/models of the same device type, this unified remote control capability requires the standardization of the data interfaces of similar devices to provide sufficient information about these devices to enable safe remote control. Method(s): Medical Device Interface Data Sheets (MDIDS) [1] can provide a useful tool for documenting current and future device interface requirements and capabilities. We examined several clinical use scenarios where externally controllable infusion pumps are used to support tele-critical care, based on which we generalized an MDIDS for remotely controllable infusion pumps. To validate this generic MDIDS, we cross-checked it with the capabilities of several externally controllable infusion pumps: the NeuroWave Accupump, Eitan Medical Sapphire, and the BD Alaris GH. Result(s): During the development of the generic remotely controllerable infusion pump MDIDS, we were able to identify the common and specific data elements that different infusion pumps need to provide at their data interfaces, considering the great diversity in these devices related to infusion mechanism, infusion programming methods, device alarms and alerts, and system settings. The resulting MDIDS includes over 100 data elements, many of which are essential for safety, including those common across different pump types (e.g., maximum settable infusion rate, occlusion alarm) and those specific to certain pump types (e.g., syringe size for syringe pumps). We developed the generic MDIDS as the theoretical basis and developed an application in our OpenICE open-source interoperability research platform [2] to remotely control the above three infusion pumps either via serial communication (representing controlling the infusion pump at a distance limited by a physical wired connection inside or outside the patient room) or across the Internet using the web extension service of OpenICE (representing situations where remote experts have no physical access to the patient). Conclusion. MDIDS for externally controllable medical devices can provide a solid basis to improve the safety and interoperability of medical device remote control technologies in the tele-critical care context. They can also benefit the research, development, and testing of physiological closed-loop control systems. We applied the MDIDS methodology to infusion pumps and ventilators to support the integration of these devices to the U.S. Army Telemedicine & Advanced Technology Research Center (TATRC) National Emergency Tele-Critical Care System.

Demonstration of Remote Control of Critical Care Ventilators and the Integrated Clinical Environment

Introduction: The COVID-19 pandemic posed numerous challenges to patient care, including extensive PPE use, patient care in isolation rooms, inadequate numbers of intensivists particularly in rural communities, use of unfamiliar ventilators that would be partially remedied by the ability to remotely control lung ventilation. The goals of the project were to study the intended use, risk management, usability, cybersecurity for remote control of ventilators and demonstrate the use of a single interface for several different ventilators. Method(s): Clinical scenarios were developed including remote control of the ventilator from an antechamber of an isolation room, nursing station within the same ICU, and remote control from across the country. A risk analysis and was performed and a risk management plan established using the AAMI Consensus Report--Emergency Use Guidance for Remote Control of Medical Devices. A cybersecurity plan is in progress. Testing was done at the MDPNP laboratory. We worked with Nihon Kohden OrangeMed NKV-550, Santa Ana, CA, and Thornhill Medical MOVES SLC, Toronto, Canada. Both companies modified their devices to allow remote control by and application operating on DocBox's Apiary platform. Apiary is a commercially available ICE solution, DocBox Inc, Waltham, MA. An expert panel was created to provide guidance on the design of a single common, simple to use graphical user interface (GUI) for both ventilators. Manufacturers' ventilation modes were mapped to ISO 19223 vocabulary, data was logged using ISO/IEEE 11073-10101 terminology using AAMI 2700-2-1, Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Requirements for forensic data logging. Result(s): We demonstrated that both ventilators can be controlled and monitored using common user interface within an institution and across the country. Pressure and flow waveforms were available for the NKV-550 ventilator, and usual ventilator measurements were displayed in near-real time. The interface allowed changing FiO2, ventilation mode, respiratory rate, tidal volume, inspiratory pressure, and alarm settings. At times, increased network latency negatively affected the transmission of waveforms. Conclusion(s): We were able to demonstrate remote control of 2 ventilators with a common user interface. Further work needs to be done on cybersecurity, effects of network perturbations, safety of ventilator remote control, usability implications of having a common UI for different devices needs to be investigated.

Human-Centered Design in Response to a Pandemic: A Health System and Innovation Center Collaboration

Purpose of Study In the spring of 2020, the coronavirus pandemic brought new challenges to healthcare systems as the rising demand for protective equipment led to product and resource inequalities around the globe. The inability to safeguard workers led to increased infection rates and deaths of healthcare professionals worldwide. The purpose of this study is to evaluate the response of an in-house innovation committee to meet the unforeseen needs faced by healthcare systems during an acute medical crisis. Methods Used Housed directly within the University of Utah's health system (U Health), The Center for Medical Innovation (CMI) teamed up with the hospital's administration, BME, COVID task force, and occupational health to create an innovative think-tank to tackle the challenges brought in by the coronavirus pandemic, with the purpose of stratifying clinical needs based upon acuity, frequency, and urgency. While prioritizing equipment needs, CMI used human-centered design to analyze common industry practices, engineer comparable solutions from commercially available materials, test reimagined products against known gold-standards, and create open-source assembly guides that allowed others facing similar shortages to do the same. Summary of Results The close-working relationship between CMI and U Health allowed for the rapid identification, innovation, and engineering of products that met the needs of healthcare workers during the months following the COVID pandemic. Many of these were directly adopted in clinical settings, including aerosol containment tents, powered air-purifying respirators, and self-testing stations. Additionally, CMI identified and engineered 20 additional readily producible, rapid-response products in anticipation of future needs, such as a bubble CPAP, containment boxes, and re-usable PPE. From these, dozens of open source, 'Improvised Personal Protective Equipment' manuals were shared with global partners to address the inequality of medical equipment in lowresource settings. Conclusions The rapid development of easily-producible, lowcost solutions for acute clinical needs-especially those faced by the equipment shortages seen during a pandemic-is improved via the partnership between health systems and a center for medical innovation.

Utilization of Health Resources During the Coronavirus Pandemic in Israel: Meuhedet Health Services' Real Data Analysis and Future Conclusions

Aim: This study aimed to examine the utilization of health resources during the first year of the COVID-19 pandemic in Israel through the analysis of Meuhedet Health Services' real-world database. Background(s): The history of COVID-19 in Israel comprises three waves: from February to May 2020, from May to November 2020, and from November 2020 to April 2021. Restrictions imposed on the Israeli population included travel limitations and even lockdowns. Meuhedet Health Services, the third largest health management organization in Israel, manages all its medical data through computerized electronic files and has collected various types of health services data from 2018 to 2020. This paper compared the consumption of Meuhedet Health Services over two consecutive years of the pandemic using a real-world database. Method(s): Electronic medical records from primary care physicians, laboratory tests, hospitalization medical histories, treatments in hospitals and institutes, visits to and treatments by community physicians, and prescriptions and medical equipment consumption were collected from 2018 to 2020. This research used aggregated, non-personalized, and decoded data from a cohort of insured individuals, and the research was approved by all the relevant institutional Helsinki Committees. The data analysis compared the corresponding data in a chosen month of the year with the data in the same month of the previous year. The differences were then scaled by the data corresponding to the month of the previous year, and the result was multiplied by 100 and plotted. To analyze drug consumption, we used the fixed price of every drug in a year multiplied by the difference in consumption of the drug in question between the month of the current year and the same month of the previous year, multiplied by 100. Result(s): A significant decrease was noted in hospitalization days, general hospital outpatient clinic visits, general hospital emergency room visits, and total numbers of visits to community physicians during the first lockdown in the first wave of the pandemic in comparison to 2019. At the end of the lockdown, however, a compensatory increase was noted in all services. In terms of drug consumption, the data showed no differences in the effects of the different waves. Our findings revealed that the first wave of COVID-19 was a shock, with a significant reduction in the consumption of health services, but this decrease attenuated with the second wave due to immediate management interventions and safety rules implemented in hospitals and clinics. Conclusion(s): People shun medical services during a fast-spreading epidemic that causes significant mortality. Since new variants of COVID-19 could be part of our lives for the next few years, we should learn how to continue living with the pandemic and develop alternative medical services to maintain healthy states. Digitization, remote services, telemedicine, and home care, including home hospitalization, should be part of the health services to cope with pandemic situations.Copyright © 2023 Klang et al.