EBME Forums Forums Management Training DB 2006(5) Training

Having looked at the new Medical Device Management document DB2006(5) the section on training gives me some cause for concern.

the section reads as follows "

5.4 Training for repair and maintenance service providers

Individuals providing repair and maintenance services need to be adequately trained and appropriately qualified. This applies to directly employed staff, contracted services or others. For simple mechanical devices a qualification at NVQ level 2 may be appropriate. For more complex devices a qualification at NVQ level 3 or above may be required. The level of qualifications and training required for each individual should be stipulated in all service contracts provided by external contractors or in house services."

Looking at the profiles for an entry level Medical Engineering Technician - band 4 the KTS factor 2 requires "Professional electronics knowledge acquired through BTEC/ONC +
short courses, & regular updating"

It is somewhat disheartening that our guiding body - namely MHRA - sets our standards so low.

Get your gradings agreed now before AfC pick it up and downgrade everybody - degree or equivalent - who do we think we are ??

I only wish I had read that before going to the MHRA MDLO conference yesterday - might have livened it up a bit !!

Perhaps we need to contact the MHRA and ask for their evidence that supports this statement on training.

I'd be interested to know what any training organisation's thoughts were on this (Capital Medical, Services etc) also any of our overseas colleagues as to the qualifications required by their organisations.

Brian

The question that needs to be asked is what do the MHRA describe as complex? The line "For simple mechanical devices" would in my opinion apply to something like trolleys and then the line "For more complex devices" seems to imply that anything more complicated than a simple mechanical device would be complicated. So I suppose in theory you could then claim that according to this a nebulizer is complex and something like a syringe driver is specialist! Doesn't really work without a clean definition of complex.

Then again the MHRA has been coming out with some dubious advise recently so I take it you have to take this with a pinch of salt.

Mr R J Ling
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Member # 301


posted 08 November, 2006 07:21 PM
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Seriously; I was asking about what people consider to be "complex" because I think that MHRA raises potentially very contentious issues when trying to suggest a level of qualification for individuals servicing "complex" equipment (not like their usual impartial, fence-sitting nature, when considering their protection of commercial "sensitivities" I might add).

What I was referring to when I mentioned technicians qualified to L3 fixing "complex" equipment, and trying to find out from others what "complex" might mean to them, is that this is very subjective depending upon the level individuals are already experienced working at and who employs them.

It's all right for MHRA to state that L3 qualified individuals work on "complex" kit but the educational requirements of AfC and KSF (the things that determine salaries in the NHS) mean that it's possible that employers could actually use this guidance to justify employing individuals in the NHS who're on lower bands, hence lower salaries, to work on more complex equipment than they should be expected to considering the rate they're paid, the skills and knowledge they're expected to pick up on the job.

To me "complex" equipment could mean stuff fixed by a "specialist" - read into that as you will but as a "specialist" on band 6 I wouldn't want a lower graded technician i.e Band 4/5 (due to L3 qualifications or equivalent) to be expected to work on the same "complexity" of equipment as me, as suggested by the MHRA, and not earning a comparable wage. Neither do I relish the thought that this person might never be able to get out of this "trap" because VRCT/HPC will never consider them "fully qualified" until they get piece of paper and letters after their name.

However there has to be a line drawn somewhere. Qualifications, skills and experience translate to hard cash in the pocket, to some extent. I just don't think MHRA should have made statements about the level of qualification required to work on "complex" equipment without being able to specify or give examples what's meant by "complex" or even give the type of qualifications or basic training required, in general.

What's this tripe from DB2006(05) mean then?


quote:
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Individuals providing repair and maintenance services need to be adequately trained and appropriately qualified. This applies to directly employed staff, contracted services or others. For simple mechanical devices a qualification at NVQ level 2 may be
appropriate. For more complex devices a qualification at NVQ level 3 or above may be required. The level of qualifications and training required for each individual should be stipulated in all service contracts provided by external contractors or in house services.

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Meaningless codswallop! Be interested to know who contributed this - is this actually meant to be guidance that is taken seriously?

As others have stated before - all these organisations are chipping-in about levels of required skills, qualifications and experience but there's no consistency or coordination with each other. They're not getting into the politics or discussing what they're publishing - it just seems to me that the whole lot of them, AfC panels, KSF panels, NOS groups, VRCT, IPEM, MHRA, NHS, DoH are just sending mixed messages about what's required to do the job.

I think that as a government agency that's always seemed, to me, keen to be seen to protect the interests of medical equipment manufacturers, in particular, (and their "commercial sensitivities") that the MHRA would have stayed out of the "required qualifications" political debacle.

Even if every medical device was classed as complex, it still means that the educational requirement is NVQ level3. Not degree level as required by VRCT.
Or does this mean that a Registered Technologist is the responsible person and oversees a lesser qualified technologist?

Does anyone know who has been consulted in the drawing up of this DB? It is normal for things like this to go out for consultation and ammendment prior to publication.

Robert

It means that if a device isn't considered complex then qualifications of less than L3 could be justified, based on guidelines, by employers, e.g. GCSE. Not specifying or giving examples of the level complexity they're talking about or the type of qualification in guidance gives a ridiculous amount of leeway, to a variety of employers, in my opinion.

Perhaps the MHRA should look at what IPEM, VRCT and NHS careers (see below) currently have to say about qualifications for individuals working as "Clinical Technologists" - plus look at the medical engineering job advertisements that are posted on this site every day (the de-facto requirements of healthcare):

That's the NHS view on it. MHRA is not helping the situation by potentially giving non-NHS employers e.g. lesser-reputable 3rd party maintenance organisations in particular, in my opinion, a lot of leeway (based on official guidelines) RE: minimum qualifications and the training required to come into a hospital near you and have a go at fixing medical devices.

Unfortunately this guidance is based on other MHRA advice to non-technical individuals, working in healthcare organisations, who are in a position to decide where the money is going to be spent on medical equipment maintenance. GCSES (Grades A-C) are L2 qualifications, L3 is ONC.