A European regulatory pathway for Tidepool loop following clearance in the United States?

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application—based on an algorithm initially designed and developed by users —has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non‐profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future

Open Source Automated Insulin Delivery:Potential Pathways to Regulatory Approval

A note providing a broad overview of the regulatory pathways and processes that may be encountered by those seeking regulatory approvals for Open Source Automated Insulin Delivery apps/software in the United States, the European Union (including Northern Ireland), and Great Britain. It focuses on the distinctions in institutional structure, device classification, and processes for regulatory approval or conformity assessment in the three jurisdictions.The note is based on research presented in Laura Downey, Shane O’Donnell, Tom Melvin, and Muireann Quigley, “A European regulatory pathway for Tidepool loop following clearance in the United States?” Diabetic Medicine 2023;00:e15246. https://doi.org/10.1111/dme.1524

Open Source Automated Insulin Delivery: Potential Pathways to Regulatory Approval

A note note providing a broad overview of the regulatory pathways and processes that may be encountered by those seeking regulatory approvals for Open Source Automated Insulin Delivery apps/software in the United States, the European Union (including Northern Ireland), and Great Britain. It focuses on the distinctions in institutional structure, device classification, and processes for regulatory approval or conformity assessment in the three jurisdictions.The note is based on research presented in Laura Downey, Shane O’Donnell, Tom Melvin, and Muireann Quigley, “A European regulatory pathway for Tidepool loop following clearance in the United States?” Diabetic Medicine 2023;00:e15246. https://doi.org/10.1111/dme.1524

Proceedings of the 23rd annual Central Plains irrigation conference

Presented at Proceedings of the 23rd annual Central Plains irrigation conference held in Burlington, Colorado on February 22-23, 2011

Proceedings of the 21st annual Central Plains irrigation conference, Colby Kansas, February 24-25, 2009

Presented at the 21st annual Central Plains irrigation conference on February 24-25, 2009 in Colby, Kansas

Reducing the cost of pumping irrigation water

Irrigation accounts for a large portion of the energy used in Nebraska agriculture. The cost to pump irrigation water depends on the type of energy used to power the pumping unit. This document describes a method to estimate the cost of pumping water and to compare the amount of energy used to that for a well maintained and designed pumping plant. The results can help determine the feasibility of repairing the pumping plant

Heat Island Mitigation Assessment and Policy Development for the Kansas City Region

Lawrence Berkeley National Laboratory partnered with Mid-America Regional Council (MARC) to quantify the costs and benefits from the adoption of urban heat island (UHI) countermeasures in the Kansas City region (population 1.5 million), and identify the best regional implementation pathway for MARC. The team selected cool (high-albedo) roofs and increased vegetation as the two countermeasures to evaluate. For vegetation, there were two strategies: (1) planting new trees to shade building surfaces, and (2) increasing urban irrigation (a surrogate for the use of vegetation to manage stormwater) to increase evapotranspiration. Using the Weather Research and Forecasting (WRF) model we simulated selected weeks during summer time, across five years (2011 2015) representing a range of normal summer conditions. We also simulated six of the most intense heatwaves that occurred between 2004 and 2016. We found under typical summer conditions (non-heatwave) average daytime (07:00 19:00 local standard time) regional near-ground air temperature reductions of 0.08 and 0.28 C for cool roofs and urban irrigation, respectively. We calculated the building electricity, electricity cost, and emission savings that result from the reduction in outdoor air temperature (indirect savings) and found maximum regional annual indirect electricity savings of 42.8 GWh for cool roofs and 85.6 GWh for urban irrigationyielding maximum regional annual indirect electricity cost savings of $5.6M ($0.05/m2 roof) and $11.1M ($0.01/m2 irrigated land), respectively, and maximum regional annual CO2 savings of 43.4 kt and 80 kt, respectively.We next evaluated the building energy, energy cost, and emission savings from reducing direct absorbed radiation on the building surfaces using cool roofs and shade trees (direct savings). For cool roofs, we found regional annual direct energy cost savings of $10.9M ($0.15/m2 roof) with regional annual CO2 savings of 66.4 kt. For shade trees, the regional annual direct energy cost savings were $21M ($21/tree) with regional annual CO2 savings of 126 kt. We investigated cool roof cost premiums (the additional cost for selecting a cool roof product in lieu of a conventional roof product, estimated to be zero to $2.15/m2) and shade tree first costs (assumed to be$100 per tree). The regional cool roof cost premium was calculated using the regional roof area per roofing material type and the range of cool roof product premiums for each material type. The extra cost of selecting cool roofs across the region ranged from $4.33M to$87.1M, while the additional shade trees planted across the region were assumed to cost $102M. When we compared the regional annual direct cost savings to the regional cool-roof cost premium and the regional shade-tree first cost, we found regional simple payback times up to 8.0 years for cool roofs and 4.9 years for trees, respectively.Since this comprehensive assessment of UHI countermeasures is a valuable methodology for other local governments to apply, we developed a step-by-step guide for others to follow. Based on the benefits and costs of the UHI countermeasures, MARC will pursue the inclusion of these countermeasures in existing regional plans where they can complement other regional priorities for transportation, climate resiliency, clean air, and hazard mitigation. They hosted a local workshop in 2016 for stakeholders to introduce the topic and will continue to share these resources to further appropriate adoption of UHI countermeasures

Evidence from clinical trials on high-risk medical devices in children

BACKGROUND: Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. METHODS: Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0–21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. RESULTS: From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. CONCLUSION: Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity assessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details - which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081