Rationale for Assessing Safety and Efficacy of Drug Candidates Alone and in Combination with Medical Devices: The Case Study of SpinalonTM

2017 ◽  
Vol 23 (12) ◽  
pp. 1778-1788 ◽  
Author(s):  
Pierre A. Guertin
Author(s):  
Ellen J. Bass ◽  
Justine S. Sefcik ◽  
Elease McLaurin ◽  
Rose Ann DiMaria-Ghalili

A prototype medical device and protocol that work well in a clinic would not necessarily work reliably in the home setting. The goal of this work is to identify factors to consider when translating a device evaluated in a clinic for use by home caregivers providing chronic wound care for persons living with dementia. One must consider the current device, the associated bundle, the protocol and how they may need to be modified. Semi-structured interviews with the research assistants who have applied a prototype device were conducted to generate a list of known issues with the current clinical protocol in terms of ultrasound application The researchers performed a set of specified tasks by following the current device protocol and explaining any difficulties with use\execution. They embellished the descriptions with details about what had happened with actual patients in the clinic. Using thematic analysis, analysts identified themes and subthemes. Issues potentially relevant to translating medical devices to the home are discussed.


2020 ◽  
Vol 29 (1) ◽  
pp. 37-43
Author(s):  
H Potockova ◽  
P Kusnierik ◽  
J Dohnal

Medical devices form a large heterogeneous group of products ranging from simple tools to medical testing and implants, the safety and efficacy of which are strictly regulated in all developed countries. Thanks to the health and cost benefits, medical devices have also found their way into veterinary medicine but, surprisingly, the regulation of these products is far less complex or, in some cases, missing altogether. Given the complexity and potential hazards of certain veterinary devices, the current state of affairs may lead to health and safety risks, both for animals and personnel involved. This review is the first to systematically map the current situation in the EU, revealing health and safety risks in practice for both animals and personnel involved and discussing them in a broader context. Only six out of the EU's 28 member states (Belgium, Croatia, Czech Republic, Germany, Hungary, and Slovakia) were found to have at least a degree of regulation of veterinary devices. As a result, a single product may be regulated as a veterinary medicinal product, a veterinary medical device or not be regulated at all, depending on the particular EU member state in question. As things stand, veterinary medicine makes use of all kinds of medical devices, including human products, regardless of their regulatory status and (pre-market) control. However, the use of such devices may influence the health and well-being of animals. Several measures are therefore suggested to attain the required levels of safety and efficacy surveillance for veterinary medical devices without creating excessive administration.


Author(s):  
Lukas Winter ◽  
Ruben Pellicer-Guridi ◽  
Lionel Broche ◽  
Simone A. Winkler ◽  
Henning M. Reimann ◽  
...  

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