EBME Forums Forums Management Medical Equipment Management Biomed processes around the world?

Hi,
I am just wondering how medical devices services are organised around the world in terms of legal and practical issues.
Now I work in Poland, we have here brand new regulation that forces (shortly) as following:
1. medical equippment manufacturers/distributors/importers give list of authorized services companies and list of devices maitenance activities (caliration, check-ups, updates, ....), and service parts(!!!!).
2. hostpitals are not obliged to obey that rules but when patient makes oficial complain to a court, it can not be now defended. in my opinion that medical devices distributors monopoly has been just became legal. I dont belive that they (distributors,..) will be eager the share their cake part. For example simple 16uF capacitor would be labelled XYZ3432356456 for 150$/ea, and replacemet of it costs 2 workhour 200$ each + transport costs + VAT.
periodical checkups also are few times more expensive when done by authorized service.
in practice some hostpitals make their own service (if possible) of low to medium risk devices (like CTG, ECG, cardiomonitors, infussion pumps, defirillatots,...) with menttioned patient complain or in worse situation patient safety issue risk.
what about in different counties? for example biomedical engineer from hostpital does safety and functional periodiacal test of ECG device, can this activity be made ISTEAD of ECG authorized perdiodical service check-up? does the engineer should have special certificate from that company?

3. all service documentation should be kept for 5 (!!!!) years and for implantable parts for 15 (!!!) years AFTER stopping the device usage. Asuming that we are using Philips DuoDiagnost X-ray machine since 2001 and we will stop using it next year we should keep service documentation till 2016. is that similar in more normal countries?

Isn't Poland in the EU these days?

Where are the major equipment manufacturers based?

There are your main clues right there.

Yes, Poland is in the EU.
I heard that mentioned new regulation was done to meet with EU medical devices directives. But it does not mean that medical devices services should be organised in totally the same way in every EU country, I wrote what bothers me the most, and I am curious if You have similar problems.
Major devices manufactures are based in EU, USA, Japan and South Korea.
I don't understand Your clue Geoff, maybe my English is the root cause...

Dare I suggest that you have yet to grasp what the EU is all about (clue:- that is exactly what it means ... not only for medical equipment, but also each and every micro-managed aspects of our lives).

Meanwhile, the medical device industry is heavily regulated. It always has been, and probably needs to be. But (in retaliation, perhaps), those who lobby on behalf of the manufacturers have strong voices.

Do I need to say any more?

Yes, many in the so-called Western World labour under constraints similar to those you have mentioned. Many (of us) continue to fight a rearguard action (a losing battle, if you like) against (on the one hand) bloody-minded government bureaucracy (and, let it be said, corruption) and (on the other) the blatant gouging by many of the "main player" manufacturers.

OK Michal (sitting down now with a cup of tea) ... to address your three points briefly, one by one:-

1) This is a good thing ... as it forces manufacturers, distributors et al to face up to (and document) their maintenance commitments (otherwise they are let off the hook completely). Whether you want to follow their guidance is up to you, and the people you work for.

2) Again, whether you submit to gouges is up to you, etc. If your employer and/or customers are happy with your work, I reckon that should be enough. If they want bits of paper, ask if they are prepared to pay to send you on the necessary course(s).

3) I'm not sure why anyone should insist on records being archived like that ... but at least it presupposes that maintenance records do exist in the first place!

For some reason I am reminded here of my years in Saudi Arabia. The MoH there brought out many such rules and regulations. Some were sound, some were not ... but many were ignored regardless. Then as now, and as far as possible, we simply got on with the work.

What is of interest to me is ... how is the biomed scene in Poland? Is healthcare provided largely through government hospitals (as in the UK), or is there a strong private hospitals sector? And, do hospitals have their own biomeds (and biomed departments), or do they rely mostly on manufacturers and their agents? And (lastly) are there many ISO's (Independent Service Organisations ... private biomed companies)?

Geoff,
My understanding of the EU is that the Organization gives guidelines, that each coutry must follow. the guidelines can be of course more or less detailed. I understand now that for medical devices market it is rather more detailed....
When mentioned regulation have been intdroducing, there was really big lobby of manufacutrers, that's the reason I think something is not fair here. Another example from reguation, that the manufacturer/distributor specifies life cycle of their product. It is not hard to imagine that for example anesthesia machines manufacurer will say, that XXX device can be used only for 6 years. After that time hospital will get decent dicount for new one.
You say: . What happens if patient is hurt when using device repaired by no authorized biomed? You should proove in court that Your company meets standards (given by manufacturer?) which is obvoisusly not true. Problems, problems, no doubt.

Poland is similar to UK in that matters. Most of hospitals are public. Private centers concentrate on ambulatory and dental services. Public hospitals hire usually medical devices specialists deparatement, but now they work on the edge of braking rules and reuguations. Of course that is hospital top management responsibiliy but can be easily transferred into 'poor' engineers. When this situation goes further, after some time biomedical engineers in hospitals and third parites will not be nessesary...
For now there is very few ISO's in Poland.

All your points are well taken. This stuff is what we all grapple with every day.

It sounds to me that what Poland needs is more ISO's. Competition is always healthy ... after all, that's what the so-called "Free Market" idea is supposed to be all about.

So, start up you own servicing company ... then get in touch!

Speaking from North America the regulations are similar.

Michal1 Forgive me but that last sentence(is that similar in more normal countries?) in your opening post is quite humorous. Isn't Poland a 'normal' country?

in some meaning this sentence was made on purpose. It does not mean that Poland is not normal country, but there are some places where is more normal than here (especially in some places on the west and north of Poland). mentioned new regulation about medical devices are an example of something that could have been done better, in my opinion.

It's all relative. When all the so-called "emerging nations" have finally, er, emerged ... and all the so-called "developing nations" have ... well, I expect you catch my drift ... where will all the other nations be at that point? Stood still?

Count your blessings, Michal ... the grass ain't always greener, believe me.

The regulation of medical devices could and should be organised in a better fashion, for sure. I don't think it really matters too much where you are. The whole thing is driven by a cartel of manufacturing heavyweights, after all.