decontamination sciences - acquisition of medical devices Flashcards
what is a medical device
any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes
* diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
* diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
* investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
* providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
* devices for the control or support of conception
* products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point
Medical Device Regulation (MDR) 2017/745
description covers any of the instrumentation used for carrying out procedures on humans and also covers any of the equipment that we use to re-process this instrumentation, even down to the software that is used to operate and control equipment
The MDR replaced the Medical Device Directive (93/42/EEC)
who is resposible to ensure devices are in alignment with any of recommendations/requirements needed of MDs
suppliers of medical devices
they must be able to prove that the equipment and all associated components are in compliance with the directive, prove the rational of how they reached this decision and prove the methods they incorporated to make sure that everything in use, is safe.
dentist obligations in regards MDs
need to verify that any of the equipment you intend on using, has gone through this rigorous process so that you have verification that no danger to patients will arise from your use of any of these products
Whether it be a Sterilisers, AWD or instrumentation.
It even suggests that the operational software should be secure to avoid information being susceptible to hacking or external influence, as well as demonstrating safety protocols for failed cycles and how they were developed
instrumentation should be
Procurement of instrumentation should always be from a reputable company that can prove the source of their manufacturing is in compliance with any relevant directives or standards.
As well as being CE marked
* This gives you assurance that the materials the equipment is made from are of the required grade/standard and that the manufacturing environment isn’t a potential source of dangerous contamination
