EBME Forums Forums Management Medical Equipment Management Out sourcing for medical equipment testing

Better apply some definitions there, Robert (before some smart alec jumps on here)!

"Bringing it to market":- does that include a repair (using the dreaded non-OEM part, of course) sold to a customer?

"Own organisation":- your hospital, your Trust ... or the wide NHS beyond?

Or are you thinking of a kludge knocked up "for indication only" never to leave the workshop?

No matter where the device is used if you go against the OEMs instructions during a repair or modification on any medical device, the liability lies with YOU! That being said if the company don’t specifically tell you that you can’t use non OEM parts in the service manual then use whatever will do the job.

CE marking just means the device has conformed to the relevant EU directive for its stated purpose, which also means if you use a device out with its original scope it is also not CE marked and hence the company will not be held responsible for any resulting altercations.

To modify medical devices it would be prudent to have ISO13485:2003 registration (along with the standard ISO9001)

We're straying from the topic a bit Martin, but here goes:-

No argument on your first point, except perhaps that I would use the word "responsibility" in lieu of "liability". Just like another other tradesman, the biomed must take responsibility for his own work and actions. Why should he not?

Reflecting upon my own experiences, how many times have I weighed up all possible options, and then "made the call" on equipment repairs in "unusual situations" (such as dealing with equipment donated for charity, that would otherwise remain un-repaired, and therefore of no use to man nor beast)? And how many times have I (with a heavy heart) heaved "beyond repair" kit into the skip? (not many times, actually, but ...) Someone has to make those sort of decisions.

That's an interesting remark about "manuals", by the way. Again, in my own experience, not having the manual is almost the default situation. But how could you "prove" that the manufacturer never issued any guidelines or directives?

OK ... here's what I do:- simply make a note of the Job Report (or whatever document is being used to record the work):- "no technical information available"* - signed and dated as usual, of course.

I agree with what you're saying about CE marking. It effectively licences the manufacturer to describe the equipment as [whatever] and then sell it as such within the EU. In practical terms, it means nothing at all (and I have never really understood why others on this forum sometimes get so excited about it).

On your final point:- yeah, right. In Big Firms like the NHS, maybe.

* As well as "equipment to be checked before use" (etc.), naturally. In other words, as you (I) have no control over where, how, by whom, and for what purpose the kit is going to be used, make it clear that liability is being passed on as the equipment itself changes hands (to be sold at auction, to a ward within a hospital somewhere, or the next container out to Africa, Kashmir or [insert your favourite country here]).

It may be worth looking at the government web page concerning the Electrical Equipment (Safety) Regulations 1994 . Here it states:

Modified and refurbished equipment are included within the scope of the regulations. Where equipment is refurbished to its original specification, it will be treated as second-hand equipment. However, if the refurbishment uses different types of components, it will be considered as modified electrical equipment.

So if you use the resistor from RS and it in some way different from the one you replaced you have to conform to all the requirements of the regulation.

CE marking is not always required but the regulations are law (via statutory instruments).

Over the years, I have seen some outstanding attempts at refurbishing kit ... sometimes even (claimed to be) by the original manufacturer. But close examination has always revealed it to be not quite "as new". So, again, I guess we're back to definitions. In this case:- "original specification".

So, are we saying that if the spec* hasn't changed (the normal case, I would have thought), we're home and dry. But if "different components" (definition required) have been used, then we're in ... er, deep water?

Let's be clear that I'm coming from a different perspective here (that is, not the default "NHS environment" assumed by many who visit the forum):- that of the "second-hand", donated, ex-medical (eg, veterinary) view of things.

So ... components meeting original specs? So like-for-like cannibalisation is OK, then? (phew)

And ... which regulations prevail when (or if) the kit is sent overseas?

* In this context, when we say "spec", do we really mean "performance"?

Bringing to the market - selling, leasing, renting, giving it away on a disposables contract etc.
Own organisation - the legal entity you work for i.e. the Trust who employs you.
Robert

I wonder if wrapping a probe in nurses tape is an approved modification or not?

All the legal stuff is a bit like the "voluntary" register we may all have to sign up to to be considered competent to swap one board for another as the manufacturer decrees.

If we are skilled professionals, we should be able to determine the effects of any "modifications" we make, if we are not aware of the effects of what we are doing, we should not be in a position to do it.

Using a "patent" part as a replacement is normal practice in most industries, why not in healthcare, the doctors prescribe "generic" drugs, why not generic batteries or probes?

But more realistically, the manufacturers want us to use them to maximise their profits, they are a business after all. The attempts to stop Techs swapping parts are all cynical attempts to gain the best results for their shareholders. But in reality the deeper the "gouge" the more we start to look at alternatives as we now are more accountable for our repair budgets.

I think I had better award that one "post of the week", Mithrandir.

If departments are so concerned about ongoing costs why did they not work out the total cost of ownership before buying a piece of equipment? It would be a simple process to include, in any tender, the need to provide prices for common spare parts, so the best overall life time costs could be compared and the need to use non original parts eliminated.

Using cheap non-OEM parts may seem like a good idea but are the parts really the same quality? Did the company supplying the parts obtain proper CE marking? Did they perform the required (MDD) compatibility testing?

Are all biomes really able to access the outcome of a modification? I doubt they really fully appreciate all the requirements, both technical and legal. Manufacturers employ teams of engineers and legal personnel to ensure they meet all the requirements across multiple world markets. It is easy to knock manufacturers high prices but without profits no R&D would occur.

Do those who provide cheap parts bring innovation to the market? Do 3rd parties and insurance companies design and develop new products? The answer is clearly not!

A generic drug only appears on the market after the patent has expired and only then after conforming to the required standard. This gives time for the original manufacturer to re-coup their investment and plough it back into new drugs. The manufacturers of medical equipment often do not have the luxury of a patent to protect their investment, so need spare parts income to fund investment in new products. How confident are you that the non-OEM parts you buy actually conform to the required standards?

As always in life things are not as simple as they first seem to be and the cheapest is not always the best!