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Millions of Australians use the private health system every year. They should receive safe, high-quality, value-based care. However, poor policy and inadequate regulation of medical technology is driving low-value care at great expense to consumers and the broader health system. Key drivers include the Prescribed List of Medical Devices and Human Tissue, gaps in quality and safety controls for devices being used, and marketing and conflicts of interest. All of these should be addressed to reduce low-value care in Australia's private health system, so consumers are protected from harm and limited health budgets are used effectively. What is known about the topic? With health expenditure rising unsustainably, there is a growing focus on ways to reduce low-value care to improve health outcomes and eliminate unnecessary costs. What does this paper add? This paper details drivers of low-value care in Australia's private health system and recommendations to overcome them. Drivers include the Prescribed List of Medical Devices, gaps in safety and quality controls, and conflicts of interest and marketing. What are the implications for practitioners? These insights are relevant to clinicians, researchers, policymakers, consumers and health business leaders with an interest in low-value care. This article belongs to the Special Issue: Value-based Healthcare. [ABSTRACT FROM AUTHOR]

Activity reporting of Pastoral Care Coordinators (PCCs) is often inadequate within care settings because of suboptimal analog data collection methods. This study aims to render pastoral care activity reporting more efficient through digitizing data collection in pastoral care settings. A one-year feasibility (pilot) study of a digital tool, the "Pastoral Care Activity Tracker" (PCAT) was conducted between June 1, 2020 and May 31, 2021 at HammondCare, an Australian nonprofit healthcare organization. Feasibility was measured using electronic activity logs collected by the tool and user feedback surveys by PCCs. Of the 43 PCCs working in the organization, 42 (97.7%) used the PCAT tool to complete the logging of 66,298 pastoral care activities (M [SD] = 1,578.5 [827.8] activities per PCC). Most activities were logged successfully (98.3%) and took less than one minute (89.5%). Survey responses (n = 20, 46.6%) indicated many PCCs found the PCAT more convenient (n = 15, 75.0%) and easier to use (n = 10, 50.0%) than paper-based method. PCCs found the PCAT to be feasible, favorable, and easier to use for report generation compared to paper-based methods. The feasibility of the PCAT improved pastoral care activity data capture, as perceived by PCCs. [ABSTRACT FROM AUTHOR]

This paper aims to highlight how to reduce medication errors through the implementation of human factors science to the design features of medication containers. Despite efforts to employ automation for increased safety and decreased workload, medication administration in hospital wards is still heavily dependent on human operators (pharmacists, nurses, physicians, etc.). Improving this multi-step process requires its being studied and designed as an interface in a complex socio-technical system. Human factors engineering, also known as ergonomics, involves designing socio-technical systems to improve overall system performance, and reduces the risk of system, and in particular, operator, failures. The incorporation of human factors principles into the design of the work environment and tools that are in use during medication administration could improve this process. During periods of high workload, the cognitive effort necessary to work through a very demanding process may overwhelm even expert operators. In such conditions, the entire system should facilitate the human operator's high level of performance. Regarding medications, clinicians should be provided with as many perceptual cues as possible to facilitate medication identification. Neglecting the shape of the container as one of the features that differentiates between classes of medications is a lost opportunity to use a helpful characteristic, and medication administration failures that happen in the absence of such intentional design arise from "designer error" rather than "user error". Guidelines that define a container's shape for each class of medication would compel pharmaceutical manufacturers to be compatible and would eliminate the confusion that arises when a hospital changes the supplier of a given medication. [ABSTRACT FROM AUTHOR]

Background: Current evidence shows that medical device‐related pressure injury (MDRPI) has a high prevalence (10%) and incidence (12%), and much research has been done to prevent MDRPI in recent years. However, to our knowledge, there is limited systematic review available on interventions and strategies to prevent MDRPI. Aim: To synthesise research evidence on interventions and strategies used to prevent MDRPI. Methods: This systematic review adhered to the PRISMA Guidelines. We searched six databases including Medline, CINAHL, EMBASE, Cochrane library, Web of Science and ProQuest with no restriction to year of publication. Data were extracted and checked by two authors independently. A narrative summary technique was used to describe the findings. Implementation strategies were grouped into six classifications: dissemination/implementation process/integration/capacity building/sustainability/scale‐up strategies. Results: Twenty‐four peer‐reviewed papers met the inclusion criteria, which comprised of 11 quality improvement projects and 13 original research. Types of devices included respiratory devices (non‐invasive ventilation mask, CPAP/BiPAP mask, endotracheal tube), gastrointestinal/urinary devices and other devices. Interventions used included the use of dressing, hyperoxygenated fatty acids, full‐face mask, training, and/or multidisciplinary education, use of special securement devices or tube holder, repositioning, application of stockinette, early removal and foam ring use. Common implementation strategies included ongoing staff education, audit and standardising documentation or guideline development. Conclusion: Much work on MDRPI prevention strategies has been undertaken. There were a variety of devices reported, however, it is evident that higher quality research is needed. Relevance to clinical practice: Current evidence shows that interventions including use of dressing or special securement device, repositioning, and training/multidisciplinary education can be beneficial for MDRPI prevention. High‐quality research, such as randomised controlled trials are needed to test the effectiveness of the interventions and their implementation strategies. No patient or public contribution. [ABSTRACT FROM AUTHOR]

Background: Improving the design of technology relies in part, on the reporting of performance failures in existing devices. Healthcare has low levels of formal reporting of performance and failure of medical equipment. This paper examines methods of reporting in the car industry and healthcare and aims to understand differences and identify opportunities for improvement within healthcare. Methods: A literature search was carried out in Pubmed, Medline, Embase, Engineering Village, Scopus. NHS England and MHRA publications and guidelines were also reviewed. Focus was placed on the current system of reporting in both industries, known degree of patient harm, initiating factors, barriers, quality and methods of incident investigation and their validity. The findings were used to compare error reporting system in the two industries. Results: Derivation of healthcare incident data from different sources means the full extent of patient harm is not known. For example, in 2012 there were 13,549 and 38,395 incidents reported by MHRA and NRLS (National Reporting and Learning System) respectively leading to uncertainties on the extent of the problem. The car industry emphasises the role of reporting source in ensuring data quality. Utilising some aspects of this approach might benefit healthcare reporting. These include a specific reporting system that stresses the importance of organisational learning in improving safety and recognises the limitations of root cause analysis. Conclusions: Learning from reporting systems within the car industry may help the healthcare sector improve its own reporting, aiding healthcare performance. [ABSTRACT FROM AUTHOR]

In recent years, X-ray irradiators have been introduced as an alternative to gamma irradiators due to the problems with the acquisition, transport and security of radioactive sources. Self-shielded low energy X-ray irradiators (such as the RS 2400) were developed to complement and eventually replace gamma sources. These irradiators are quite suitable for sterilizing insects for SIT applications, as well as for research on quarantine treatments of food and phytosanitary applications. During the irradiation of an agricultural product the absorbed dose inside the canister must be controlled to ensure that the desired effect is achieved without deleteriously affecting the product. The focus of this paper is to describe the Dose Assurance Service offered by the Insect Pest Control Laboratory of the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture using an alanine-EPR dosimetry system as a transfer standard for low energy X-radiation. All the administrative and technical issues are now finalized and the dose assurance service is ready for operation. The purpose of this Service is to help facilities using such irradiators to check the quality of their dosimetry systems. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this paper was to evaluate how uncertainty has been accounted for in the cost-effectiveness analyses (CEAs) submitted by manufacturers to the French National Authority for Health (HAS) and to identify recurring concerns in these submissions.Methods: We used a cross-sectional design to evaluate manufacturers' submissions from the beginning of the evaluation process in October 2013 to the end of May 2015 (n = 28). The sources of uncertainty attached to these CEAs were categorized and assessed. Relevant data were extracted independently by two assessors.Results: Adherence to the HAS reference case was generally considered to be acceptable. Methodological uncertainty and parameter uncertainty were the sources of uncertainty that were most frequently explored by manufacturers. The quality of reporting of deterministic sensitivity analysis and probabilistic sensitivity analysis varied substantially across submissions, with a frequent lack of justification of the plausible range of parameter point estimates in 12 submissions (43 %). Structural uncertainty was explored much less frequently. Concerns related to omission of either important clinical events or relevant health states or extrapolation of the effects of the technology beyond the time horizon of the clinical trials were identified in 16 submissions (57 %).Conclusions: This study presented a characterization of the treatment of uncertainty for the first 28 manufacturers' submissions to the HAS. This work identified important concerns regarding the exploration of sources of uncertainty. The findings may help manufacturers to improve the quality of their submissions and may provide useful insights for extending guidelines on uncertainty analysis in CEAs submitted to the HAS. [ABSTRACT FROM AUTHOR]

This paper describes and discusses the role of unmet needs in the innovation of new medical technologies using the National Institute for Health Research Devices for Dignity (D4D) Healthcare Technology Co-operative as a case study. It defines an unmet need, providing a spectrum of classification and discusses the benefits and the challenges of identifying unmet need and its influence on the innovation process. The process by which D4D has captured and utilized unmet needs to drive technology innovation is discussed and examples given. It concludes by arguing that, despite the challenges, defining and reviewing unmet need is a fundamental factor in the success of medical technology innovation. [ABSTRACT FROM PUBLISHER]

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. [ABSTRACT FROM AUTHOR]

Background: Central venous catheters are used frequently in the intensive care unit (ICU). However, there is an associated morbidity, mortality and cost derived from their infectious and mechanical complications. The Scottish Patient Safety Programme (SPSP) has developed a multi faceted care bundle, with the aim of reducing catheter-related blood stream infections. Aim: This paper aims to identify and describe the experience and challenges in implementing the SPSP central line insertion bundle in one adult ICU, in a large inner city teaching hospital. Interventions:'Plan-Do-Study-Act' cycles, checklists for insertion and a standardized trolley were adopted to implement the central line insertion bundle in clinical practice. Conclusion/Implications: Improving the reliability of the central line insertion bundle has reduced infections. Key steps in the process were setting clear aims and ensuring staff understand the change process and measurement of results. This is fundamental to the success of any quality improvement process. [ABSTRACT FROM AUTHOR]

Despite infrastructure and capacity challenges in Africa, significant development has been made in the number of laboratories supporting immunological and safety studies required for large-scale HIV/AIDS vaccine or intervention trials. In Uganda, cohorts participating in HIV intervention trials are often recruited from rural areas. To avoid transporting samples from intervention trial areas over long distances (120 km) to central laboratories in Entebbe, we set up a standardized peripheral blood mononuclear cells (PBMCs) processing laboratory at a field station in Masaka, southwest Uganda. The laboratory was well equipped and enrolled into the International AIDS Vaccine Initiative (IAVI) Quality Assurance (QA) program. Staff was trained in laboratory techniques and Good Clinical Laboratory Practice (GCLP). The laboratory received IAVI and GCLP accreditation in 2008. In this paper we describe the process and achievements of measures taken to overcome challenges, to build staff capacity, and to optimize the quality of the cells yielded. [ABSTRACT FROM AUTHOR]

In April 2008, the Building and Construction Authority of Singapore releases design guide BC 1: 2008 to the industry and alternative steel materials which are manufactured to non-BS standards are now permitted in building structural steelworks designed to BS 5950. This paper examines the BC 1 requirements for material performance and quality assurance vis-á-vis the use of such alternative steel materials in design. A list of certified alternative steel materials complying with the minimal essential material performance requirements is compiled. These certified materials are treated as per normal without any restriction or downgrading in design if they are produced by steel mills who can meet the quality assurance requirements. Emphasis is now placed on our stockholders and traders to source and import into Singapore steel materials from audited mills that have in place stringent factory production control system and proper mill test certification. All key stakeholders - manufacturers, stockholders, traders, auditors, fabricators and engineers have a duty and are expected to play a role in maintaining quality in material usage in Singapore's steel construction industry. [ABSTRACT FROM AUTHOR]

Background: The Every Newborn Action Plan (ENAP) and Ending Preventable Maternal Mortality targets cannot be achieved without high quality, equitable coverage of interventions at and around the time of birth. This paper provides an overview of the methodology and findings of a nine paper series of in-depth analyses which focus on the specific challenges to scaling up high-impact interventions and improving quality of care for mothers and newborns around the time of birth, including babies born small and sick.Methods: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the ENAP process. Country workshops engaged technical experts to complete a tool designed to synthesise "bottlenecks" hindering the scale up of maternal-newborn intervention packages across seven health system building blocks. We used quantitative and qualitative methods and literature review to analyse the data and present priority actions relevant to different health system building blocks for skilled birth attendance, emergency obstetric care, antenatal corticosteroids (ACS), basic newborn care, kangaroo mother care (KMC), treatment of neonatal infections and inpatient care of small and sick newborns.Results: The 12 countries included in our analysis account for the majority of global maternal (48%) and newborn (58%) deaths and stillbirths (57%). Our findings confirm previously published results that the interventions with the most perceived bottlenecks are facility-based where rapid emergency care is needed, notably inpatient care of small and sick newborns, ACS, treatment of neonatal infections and KMC. Health systems building blocks with the highest rated bottlenecks varied for different interventions. Attention needs to be paid to the context specific bottlenecks for each intervention to scale up quality care. Crosscutting findings on health information gaps inform two final papers on a roadmap for improvement of coverage data for newborns and indicate the need for leadership for effective audit systems.Conclusions: Achieving the Sustainable Development Goal targets for ending preventable mortality and provision of universal health coverage will require large-scale approaches to improving quality of care. These analyses inform the development of systematic, targeted approaches to strengthening of health systems, with a focus on overcoming specific bottlenecks for the highest impact interventions. [ABSTRACT FROM AUTHOR]

Background: Flexible nasolaryngoscopy is an essential component of the otolaryngological physical exam. Historically, the ability to create and share video recordings of these endoscopic exams has been limited by poor mobility of fixed endoscopy towers. The advent of smartphone endoscope adapters has allowed physicians to create and share video recordings of endoscopy in a wide variety of locations that would not have previously been feasible. This paper sought to review the literature on the effect of smartphone endoscope adapters on patient care, patient satisfaction, and resident learning. Methods: This systematic review was conducted according to PRISMA guidelines. A systematic literature search was performed for all relevant English language studies (1946–2017) using Ovid MEDLINE, PubMed, and EMBASE. The study protocol was registered with the PROSPERO database. Results: A total of 91 abstracts were identified and screened by two independent reviewers. Based on inclusion and exclusion criteria, three studies were selected and subjected to full-text extraction as well as quality assessment. These studies demonstrated high diagnostic accuracy and quality of smartphone adapter-recorded videos, and a benefit of these devices on resident education. Due to the heterogeneity of included studies' methods and measures, a meta-analysis was not possible, so a qualitative synthesis of the literature results was performed. Conclusion: Despite a paucity of data on the subject, the present study provided a comprehensive review of the literature, and suggested overall high diagnostic accuracy, quality, and enhancement of resident education with the use of smartphone endoscope adapters for flexible nasolaryngoscopy. Trial registration: CRD42018086714. [ABSTRACT FROM AUTHOR]