scholarly journals Building a Reliable Wireless Medical Device Network

Author(s):  
David Hoglund ◽  
Vince Varga

How to design and test the most effective and secure wireless medical device connectivity applications that will provide the true mobility experience that is needed in the 2018 healthcare marketplace. Today’s medical devices will need to be connected to provide the data to the electronic medical record. This connectivity will be either real time or on a non real time basis. In either case; the majority of this data transfer will move toward a wireless medium from a legacy wired connection. The following will discuss best practices for wireless network design based upon application requirements; but also the protection of any data regarding cybersecurity requirements. The author has over three decades of medical device knowledge sense but also two decades of wireless and security integration knowledge sense. The take away is to understand the best practices and how to apply this to product design and the overall enterprise implementation into the healthcare ecosystem of connected devices.

2018 ◽  
Vol 63 (1) ◽  
pp. 81-93 ◽  
Author(s):  
Jonas H. Pfeiffer ◽  
Martin Kasparick ◽  
Benjamin Strathen ◽  
Christian Dietz ◽  
Max E. Dingler ◽  
...  

Abstract Today’s landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).


2021 ◽  
Author(s):  
Abdulmalek Aljafari

Abstract Background Country level comparative studies on the performance and experiences of medical device procurement systems, in terms of both quality and efficiency, particularly during COVID-19 are lacking. Objective To evaluate the impact on healthcare cost and efficiency of four national models of medical device procurement. Further, to propose procurement system "best practices" using the response to COVID-19 as a reference. Methods A review of qualitative data drawn from public and private sources was conducted, as well as various studies related to national procurement systems in four G20 countries, to (1) identify differences, strengths and weaknesses; (2) evaluate how each system responded to the COVID-19 crisis; and, (3) identify best practices for policy-makers. Results While some governments have centralized the procurement of medical devices, developing a national scheme for tendering and purchase, other countries have deployed a decentralized approach where regions or even individual hospitals are responsible for all or some aspects of procurement. This dichotomy has led to a variety of efficiency and quality of service outcomes, with models implementing national uniformity achieving greater cost-savings. Furthermore centralized systems of procurement performed better during times of health crisis. It remains unclear whether these short-term savings lead to long-term efficiencies achieved through improved patient outcomes as data is lacking. Conclusion The available data indicates that countries that have adopted a centralized approach to the procurement of medical devices tend to have an advantage during times of crisis, as well as in the normal provision of healthcare services.


Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.


2021 ◽  
pp. 193896552199308
Author(s):  
Kathryn A. LaTour ◽  
Ana Brant

Most hospitality operators use social media in their communications as a means to communicate brand image and provide information to customers. Our focus is on a two-way exchange whereby a customer’s social posting is reacted to in real-time by the provider to enhance the customer’s current experience. Using social media in this way is new, and the provider needs to carefully balance privacy and personalization. We describe the process by which the Dorchester Collection Customer Experience (CX) Team approached its social listening program and share lessons to identify best practices for hospitality operators wanting to delight their customers through insights gained from social listening.


2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.


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