Recently Published Documents
Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health
Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted.
Abstract Reusable medical devices are decontaminated and sterilized often many times by healthcare facilities across the globe. Reprocessing of medical devices comprises several processes and water plays an important role in some of these, including cleaning and steam sterilization. The water used is required to have certain qualities to ensure the effectiveness of the processes. In this short communication, we report findings of our study which measured quality parameters (pH, total hardness) for water used for medical device reprocessing in 13 primary and secondary care public hospitals in Nepal. The mean pH of water used for reprocessing of medical devices varied from 6.48 to 8.05 across the hospitals whereas the mean total hardness of water varied from 5.93 to 402.50 mg/L CaCO3. Although the range of the mean water pH across hospitals fell within the recommended range, many of the hospitals had mean total hardness higher than recommended for cleaning medical devices. None of the hospitals had mean total hardness suitable for using as feed-water for steam generation. Public hospitals in Nepal should have appropriate water treatment systems so that the recommended water quality can be achieved to ensure effective decontamination and reprocessing of medical devices.
A New Medical Device Modeling Framework for Predicting the Performance of Indwelling Continence Care Devices and Improving Patient Care
Abstract Computational models that incorporate human anatomy, tissue biomechanics, and experimental measurements from animals or cadavers to predict medical device performance have proven useful. Since implant choices made by clinicians and biological tissue properties can vary widely across patients, these models tend to suffer from a fundamental lack of information about such variations that impact the analysis. To demonstrate a new means of overcoming such paucity of input data, the authors focused on a tractable device concern (that of temporary continence care lead movement) and allowed input properties to vary within the bounds of experiment to generate many simulations that ultimately predicted device performance. The computational model results were then compared with experimental results to build confidence in the predictions. The results suggest that a new method considering intervals of poorly defined and highly variable biomechanical and structural modeling inputs can faithfully predict device mechanics as measured in a cadaver model. Moreover, both model and experiment suggest that a new basic evaluation lead can provide more reliable fixation compared to the predicate device.
In medical device industry the risk management plays a very vital role. There should be proper communication from each and every stakeholder related to risk management of each respective department, it can be Production, Design and Development or Quality Control and all other departments. In this current research work the role of risk analysis which had been done accordingly ISO 14971 for risk management of medical device using FMEA is implemented. FMEA (Failure Mode and Effects Analysis) plays important role in risk analysis by having several steps for mitigation of risk. Also it had been used for identifying hazard of each risk throughout the lifecycle of the medical device. Risk communication should be advanced so, that the risk identified can be easily controlled by taking appropriate risk control measures. In any medical device industry risk analysis should be done properly and as well the risk communication channel should be strong for proper and immediate action. In this research paper practically the role of Risk communication and risk analysis is covered. Risk management of any of the organization can only be effective if the risk analysis is done strongly and the communication related to risk is proper. In this research FMEA analysis for risk analysis is done on a medical device and also the communication from risk manager to the other entire stakeholders of the risk management from various departments are fully taken into the consideration.
Abstract On the medical device market there are several types of stationary and portable incubators that can be used in the care of infants. The prototype of a textile incubator made as part of this work consists of five material layers. The textile incubator is equipped with a functional heating and cooling mat, which is made on the basis of 3D channeled weft-knitted fabric. Its function is to generate heat and maintain it inside the textile incubator or to cool the baby's body while using therapeutic hypothermia. The mat is equipped with hoses transporting the heating or cooling medium. The mat, depending on variable input parameters, can emit heat in the range from 1.15 W to 86.88 W. In case of the cooling function, it can receive heat in the range from −4.32 to −27.96 W. This indicates a large adjustment range of the amount of heat supplied and received, which is a positive feature, and enables programming the heat balance to ensure comfort for the baby. The analysis of temperature measurements on the mat surface confirmed that maximum temperature differences do not exceed 1.6°C.
Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring
Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.