A Hazard Analysis of Class I Recalls of Infusion Pumps.

BACKGROUND: The adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals. OBJECTIVE: This study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device. METHODS: The authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors. RESULTS: The proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively. CONCLUSIONS: The proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use.

The Conceptual Modeling of Interoperability Framework of Heart Sound Monitor in the Context of an Interoperable End-to-End Architecture.

Background: Heart sound monitor (HSM), a device suitable for home-use, can be used to acquire heart sounds. It enables the telemonitoring of cardiac function, which has been largely evolved and widely used in recent years. Nevertheless, the designers paid little attention to the consistency of information model and data interaction of HSM, thus the data could not be shared and aggregated among healthcare systems. Consequently, the device's development and its application in person-centered telehealth are hindered. Objective: To solve this problem and to build interoperability for HSM, this article proposes a HSM interoperability framework that is constructed by using standardized modeling methods. Methods: The authors collected the common device-output information of HSM involved in telemonitoring, leveraged the standardized interoperability framework defined in ISO/IEEE 11073 Personal Health Device (11073-PHD) standards to model the static data structure and dynamic interaction behaviors of HSM. Results: Via a meta-analysis, the HSM device-output information includes collected data (heart sound measurement), and derived data (e.g., device status). Based on such information, an 11073-PHD-compliant domain information model has been successfully created. This enables the interoperability between HSM and aggregation device, allowing inter-device plug-and-play using the service model and communication model. A prototype of this design has been implemented and validated via Continua Enabling Software Library. Conclusions: The ISO/IEEE 11073-PHD standard framework has the potential to accommodate the HSM, which implicate HSM can be integrated into the interoperable ecosystem to achieve holistic health solution. Findings in this article may be taken as a reference for standard developing organizations to establish a standardized interoperability framework for HSM.

Information and Communication Technology-Powered Diabetes Self-Management Systems in China: A Study Evaluating the Features and Requirements of Apps and Patents.

BACKGROUND: For patients with diabetes, the self-monitoring of blood glucose (SMBG) is a recommended way of controlling the blood glucose level. By leveraging the modern information and communication technology (ICT) and the corresponding infrastructure, engineers nowadays are able to merge the SMBG activities into daily life and to dramatically reduce patient's burden. Such type of ICT-powered SMBG had already been marketed in the United States and the European Union for a decade, but was introduced into the Chinese market only in recent years. Although there is no doubt about the general need for such type of SMBG in the Chinese market, how it could be adapted to the local technical and operational environment is still an open question. OBJECTIVE: Our overall goal is to understand the local requirements and the current status of deploying ICT-powered SMBG to the Chinese market. In particular, we aim to analyze existing domestic SMBG mobile apps and relevant domestic patents to identify their various aspects, including the common functionalities, innovative feature, defects, conformance to standards, prospects, etc. In the long run, we hope the outcome of this study could help the decision making on how to properly adapt ICT-powered SMBG to the Chinese market. METHODS: We identified 289 apps. After exclusion of irrelevant apps, 78 apps remained. These were downloaded and analyzed. A total of 8070 patents related to glucose were identified from patent database. Irrelevant materials and duplicates were excluded, following which 39 patents were parsed to extract the important features. These apps and patents were further compared with the corresponding requirements derived from relevant clinical guidelines and data standards. RESULTS: The most common features of studied apps were blood health data recording, notification, and decision supporting. The most common features of studied patents included mobile terminal, server, and decision supporting. The main difference between patents and apps is that the patents had 2 specific features, namely, interface to the hospital information system and recording personal information, which were not mentioned in the app. The other major finding is that, in general, in terms of the components of the features, although the features identified in both apps and patents conform to the requirements of the relevant clinical guidelines and data standards, upon looking into the details, gaps exist between the features of the identified apps and patents and the relevant clinical guidelines and data standards. In addition, the social media feature that the apps and patents have is not included in the standard requirements list. CONCLUSIONS: The development of Chinese SMBG mobile apps and relevant patents is still in the primitive stage. Although the functionalities of most apps and patents can meet the basic requirements of SMBG, gaps have been identified when comparing the functionalities provided by apps and patents with the requirements necessitated by the standards. One of the most important gaps is that only a small portion of the studied apps provides the automatic data transmission and exchange feature, which may hamper the overall performance. The clinical guidelines can thus be further developed to leverage new features provided by ICT-powered SMBG apps (eg, the social media feature, which may help to improve the social intervention of patients with diabetes).

Child development at 5 years of age predicted mathematics ability and schooling outcomes in Malawian adolescents.

AIM: This study aimed to examine the association between child development at 5 years of age and mathematics ability and schooling outcomes at 12 years of age in Malawian children. METHODS: A prospective cohort study looking at 609 rural Malawian children. Outcome measures were percentage of correctly answered mathematics questions, highest school grade completed and number of times repeating school grades at 12 years of age. A child development summary score obtained at 5 years of age was the main exposure variable. Regression analyses were used to estimate the association and adjust for confounders. Sensitivity analysis was performed by handling losses to follow-up with multiple imputation (MI) method. RESULTS: The summary score was positively associated with percentage of correctly answered mathematics questions (p = 0.057; p = 0.031 MI) and with highest school grade completed (p = 0.096; p = 0.070 MI), and negatively associated with number of times repeating school grades (p = 0.834; p = 0.339 MI). Fine motor score at 5 years was independently associated with the mathematic score (p = 0.032; p = 0.011 MI). The association between child development and mathematics ability did not depend on school attendance. CONCLUSION: Child development at 5 years of age showed signs of positive association with mathematics ability and possibly with highest school grade completed at 12 years of age.

Regulatory barriers blocking standardization of interoperability.

Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD WG) and Continua Health Alliance, are striving for this purpose. However, factors like the medial device regulation, health policy, and market reality have placed non-technical barriers over the adoption of technical standards throughout the industry. These barriers have significantly impaired the motivations of consumer device vendors who desire to enter the personal health market and the overall success of personal health industry ecosystem. In this paper, we present the affect that these barriers have placed on the health ecosystem. This requires immediate action from policy makers and other stakeholders. The current regulatory policy needs to be updated to reflect the reality and demand of consumer health industry. Our hope is that this paper will draw wide consensus amongst its readers, policy makers, and other stakeholders.

Height gain during early childhood is an important predictor of schooling and mathematics ability outcomes.

AIM: To examine the association between height gain at different stages of early childhood and schooling and cognitive outcomes in 12-year-old Malawian children. METHODS: A prospective cohort study looking at the growth and development of 325 rural Malawian children. Main outcome measures were highest school grade completed, number of times repeating grades and percentage of correctly answered mathematical questions at 12 years of age. Height-for-age at 1 month and conditional height gain for 6, 18 and 60 months were used as predictors. Ordinal logistic and linear regression analyses were used to estimate the association and adjust for confounder. RESULTS: The conditional height gain during 18-60 months was positively associated with mathematics test results (p=0.003) and negatively associated with number of times repeating grades (p=0.011). It was not significantly associated with highest grade completed (p=0.194) if those who never attended school were included as having completed zero grade, but was positively (p=0.049) associated with this outcome among those who ever attended school. CONCLUSION: Height gain during the 18-60 months period of age was related to schooling and mathematics ability at age 12 years. The importance of promoting catch-up growth after the period when stunting is common should receive attention.

Comparison of four statistical approaches to score child development: a study of Malawian children.

OBJECTIVE: Assessment of child development often results in a multitude of binary outcome data. There is no agreed way to use them to score the developmental status of children. Conventional methods include age-standardized Z-scores and simple sum of number of passes. Recently two approaches based on the Rasch model and the concept of 'developmental age' have been proposed. This study aims to compare the performance of the four approaches. METHODS: In a longitudinal study, 473 Malawian children were measured for growth status at age 36 months and administered a new test of developmental milestones between age 3 and 6 years. The test consisted of four domains: gross motor (GM), fine motor (FM), social and language development. The four approaches were used to score the developmental level of each child in each domain, and the results compared. RESULTS: In this sample, the approach based on the Rasch model provided development scores that were more normally distributed than the other approaches did. The four sets of scores were highly correlated with each other. They gave similar estimates of the effect of height-for-age on GM, social and language development. In FM development, the maximum difference in the effect size estimates was only 0.04 standard deviation despite its statistical significance (P = 0.009). CONCLUSION: The four approaches were practically equivalent in the context of the estimation of an intervention effect or association. Their relative advantages and disadvantages are discussed. None of them can be universally recommended.