flow-meter™ | Safety and the environment in relation to medical devices - part 4

Once medical devices are placed on the market and made available to operators, they take on the specific connotation of work equipment. This aspect, often underestimated or disregarded, is addressed by the Regulation through the manufacturer's obligation to demonstrate the usability of the device and, therefore, its safe application and its capability to limit the risk of reasonably foreseeable human error. The need to link the general safety and performance requirements of medical devices with the essential safety requirements of the Machinery Directive or with the general safety and performance requirements of Personal Protective Equipment, is also an innovative fact introduced by the Regulation and not considered in the previous regulatory framework. During the pandemic event, this aspect became very important, especially when defining the requirements that had to be present for respiratory protective masks. Were they to be PPE or medical devices? Did their use have to follow the rules of 3rd category PPE, or could they still be considered suitable for protecting bystanders and wearers even if they were worn according to different criteria from those previously set for PPE and then disregarded when reused? Specific guidelines and common positions came and went during the period 2020 - 2021, with contradictory answers.
At a critical time like the present, when the focus is on an increasing sensitivity to reducing plastic consumption and product reuse, should the advantages of the single-use device, i.e. disposable after the first application, prevail, or can concepts such as the single-patient device, i.e. intended for the continued treatment of the individual case, thus reducing the requirement for repeated replacement within the duration of a specific therapy, come into play? These are questions that need to be asked when considering the development of a new product. The use of the life cycle concept and scenario and application context analysis must therefore be a strong driver for the identification of new, reliable, safe and innovative solutions, for which the determination of the risk/benefit assessment ratio is a driving force.
More information:
www.flowmeter.it/
/ flow-meter-s.p.a.