Acquisition of Medical Devices

Question 1

in terms of decontamination; what is a medical device

Answer 1

devices for the control or support of conception and products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in article 1(4) and other medical devices

[according to MDR 2017/745]

Question 2

what is a medical device according to the medical device directive (93/42/EEC)

Answer 2

The 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

Question 3

whos responsibility is it to produce medical devices in line with the recommendations

Answer 3

any supplier of medical devices

Question 4

what must suppliers be able to prove in terms of the recommendations or requirements listed in the directive

Answer 4

they must be able to prove that their 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 incorported to make sure that everything in use is safe

Question 5

what are the dentists obligations

Answer 5

to verify that any equipment you intend on using has gone through this rigour process so that you have verification that no danger to patients will arise from your use of any of these products
whether it is sterilisers, AWD or instruments

it even suggests that the operational software should be secure to avoid information from being susceptible to hacking or external influence, as well as demonstrating safety protocols for failed cycles and how they were developed

Question 6

what other considerations should we give to instrumentation

Answer 6

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 isnt a potential source of dangerous contamination