Marketing authorization of medical devices in China

Medical device regulations across the globe have significant variations. The Chinese medical device market, like China’s economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting

Scheduling Accessory Assists Patients with Cognitive Disorders

Recom Technologies Inc. received initial funding from NASA to research the commercial potential of an artificially intelligent planning reaction model to serve as a tool to help individuals suffering from various forms and levels of brain impairment. In 1993, the chief of the Artificial Intelligence Research Branch at Ames Research Center suggested collaborative research with Santa Clara Valley Medical Center. This partnership led to further development of the technology and funding to support clinical research from the U.S. Department of Education's National Institute on Disability and Rehabilitation Research. In 1996, Attention Control Systems Inc. was founded to market the finished device, called the Planning and Execution Assistant and Trainer (PEAT). PEAT is a pocket-sized PDA-like device with a graphical display, touchscreen controls, an electronic calendar, an address book, and a built-in phone, that cues users to start or stop scheduled activities, monitors their progress, and adjusts schedules as necessary in response to delays or calendar changes. It uses an automatic planning model developed for NASA to adjust daily plans when a situation changes. PEAT is sold as a complete system that includes software, hardware, documentation, and technical support. In addition to the flagship Pocket PEAT device, there is PEAT Phone, PC PEAT, and PEAT Link. Clinical studies of PEAT continue at Santa Clara Valley Medical Cente

The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare?

Background: Policies for health technologies such as medical devices are essential and contribute to improved quality of healthcare. The regulation, assessment, and management represent important functions of medical devices. Insufficiently developed interactions between these functions impact the quality of delivered healthcare. To date studies lack to analyse these functions in a broad way. The aim of this study is to analyse the regulation, assessment, and management of orthopaedic medical devices in Mexico and how they shape healthcare. Methods: This qualitative study included 42 stakeholders involved directly or indirectly in the regulation, assessment, or management for orthopaedic medical devices in Mexico. Results: The fragmentation of responsibilities for medical device functions may be a central aspect of our findings concerning challenges reported by interviewees. Strengthening technovigilance based on improved reporting across health care institutions emerged as pathway to improve medical device regulation. With regard to improving the medical device assessment, a comprehensive update of the standard list represents a relevant opportunity. Integrating advanced quality attributes into procurement processes regarding decision-making, purchasing strategy, and procurement agent is needed to fostering the management. Conclusions: This study provides a broad analysis of medical device functions within a health system and highlights in this specific context how improvements might be achieved. It addresses a broad range of interest groups represented by policy makers, health service providers, managers and administrators of healthcare facilities, and doctors with an interest in health technologies. In this paper we highlight important themes that influence outputs and outcomes of the regulation, assessment, and management and discuss strategies in fostering these areas. To date, the regulation, assessment, and management of medical devices are rarely analysed in a broad way, even though these functions importantly contribute to the successful implementation of health technology policies. The quality of delivered healthcare is influenced by the performance between and within these functions. In Mexico, little discussion has been raised on challenges of the regulation, assessment, and management of medical devices. Changes to current processes and practices can improve outputs and outcomes of these functions and positively influence the quality of delivered healthcare. Stakeholder involvement and commitment is essential to this

Underwater near-infrared spectroscopy measurements of muscle oxygenation: laboratory validation and preliminary observations in swimmers and triathletes

The purpose of this research was to waterproof a near-infrared spectroscopy device (PortaMon, Artinis Medical Systems) to enable NIR measurement during swim exercise. Candidate materials were initially tested for waterproof suitability by comparing light intensity values during phantom-based tissue assessment. Secondary assessment involved repeated isokinetic exercises ensuring reliability of the results obtained from the modified device. Tertiary assessment required analysis of the effect of water immersion and temperature upon device function. Initial testing revealed that merely covering the PortaMon light sources with waterproof materials considerably affected the NIR light intensities. Modifying a commercially available silicone covering through the addition of a polyvinyl chloride material (impermeable to NIR light transmission) produces an acceptable compromise. Bland-Altman analysis indicated that exercise-induced changes in tissue saturation index (TSI %) were within acceptable limits during laboratory exercise. Although water immersion had a small but significant effect upon NIR light intensity, this resulted in a negligible change in the measured TSI (%). We then tested the waterproof device in vivo illustrating oxygenation changes during a 100 m freestyle swim case study. Finally, a full study compared club level swimmers and triathletes. Significant changes in oxygenation profiles when comparing upper and lower extremities for the two groups were revealed, reflecting differences in swim biomechanics

A new mini-navigation tool allows accurate component placement during anterior total hip arthroplasty.

Introduction: Computer-assisted navigation systems have been explored in total hip arthroplasty (THA) to improve component positioning. While these systems traditionally rely on anterior pelvic plane registration, variances in soft tissue thickness overlying anatomical landmarks can lead to registration error, and the supine coronal plane has instead been proposed. The purpose of this study was to evaluate the accuracy of a novel navigation tool, using registration of the anterior pelvic plane or supine coronal plane during simulated anterior THA. Methods: Measurements regarding the acetabular component position, and changes in leg length and offset were recorded. Benchtop phantoms and target measurement values commonly seen in surgery were used for analysis. Measurements for anteversion and inclination, and changes in leg length and offset were recorded by the navigation tool and compared with the known target value of the simulation. Pearson\u27s Results: The device accurately measured cup position and leg length measurements to within 1° and 1 mm of the known target values, respectively. Across all simulations, there was a strong, positive relationship between values obtained by the device and the known target values ( Conclusion: The preliminary findings of this study suggest that the novel navigation tool tested is a potentially viable tool to improve the accuracy of component placement during THA using the anterior approach

Explant Analysis of Total Disc Replacement

Explant analysis of human disc prostheses allow early evaluation of the host response to the prosthesis and the response of the prosthesis from the host. Furthermore, early predictions of failure and wear can be obtained. Thus far, about 2-3% of disc prostheses have been removed. Observed wear patterns are similar to that of appendicular prostheses including abrasions/scratching, burnishing, surface deformation, fatigue, and embedded debris. Chemically the polymeric components have shown little degradation in short-term implantation. In metal on metal prostheses the histologic responses consist of large numbers of metallic particles with occasional macrophages and giant cells. Only rare cases of significant inflammatory response from polymeric debris have been seen