Biomedical Engineering Reference
In-Depth Information
Postmarket Surveillance
12.1 Introduction
It is not the aim of this chapter to teach you how to set up your vigilance system; this is left
to other texts and documents. It is enough to say that if you do not have one in place then you
are either a Class I exempt manufacturer who has never been audited or you are not a medical
device manufacturer. In all cases, no matter what class of device, you must have a postmarket
surveillance , complaints, and vigilance system in place. Those of you who have them
working probably think of them as an annual pain when audit time comes round. However, to
the designer they are the fountain of all knowledge - really!
In this chapter, therefore, we shall be looking at PMS (postmarket surveillance) differently to
how an auditor would - we shall be using it as a quality tool. Remember, many chapters ago,
I introduced you to the film Chitty Chitty Bang Bang and its song:
“From the ashes of disaster grow the roses of success.”
Recall also the wonderful quote of Edison:
“Genius is 1% innovation and 99% perspiration.”
There is so much knowledge associated with hindsight that proverbs and sayings abound:
“Three failures and a fire a Scotsman's fortune make.” (anon)
“We often discover what will do, by finding out what will not do; and probably he who
never made a mistake never made a discovery.” (Samuel Smiles)
What is it we learn from these quotes? Firstly we will make mistakes, but these mistakes
only help to make our designs better. Secondly, people will find fault with our designs, but
these will lead to improvements and even new products. What is it we learn? We learn that
everyone is an expert designer and they will always give you design suggestions - even when
you do not want them. Some will do this nicely; others will do this using your complaints
procedure. However they do it you, as the designer, you must capture people's design
suggestions. To this end this chapter is all about capturing the information; and this is not as
easy as you think!
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