Medical Device Servicing ? What Terminology?

S

SteveK

#1
Medical Device Servicing – What Terminology?

As well as manufacturing Class IIa and IIb devices, we also service them for our customers (on-site) as part of a Planned Preventative Maintenance (PPM) programme. I would be interested on what terms and definitions of term other companies use. We indicate that our products are serviced annually either by ourselves or a hospital EBME department. Service terms that seem to be used are Inspection (but if a part is worn/damaged then replace – e.g. an O ‘Ring’), Minor service, Standard service, Major service etc. In the case of a mobile electrical suction unit, we currently recommend that an annual “Standard” service involves replacing filters, washers, external tubing and some parts on the receiver jar. We then recommend a “Major” service every 5 years. This involves the above plus stripping down and servicing the pump motor (with a service kit), replacing internal tubing etc. If anybody out there does this type of stuff I would be interested in some comments/suggestion on what should be the “correct” industry usage of such terminology.

Thanks!

Steve
 
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Marc

Hunkered Down for the Duration with a Mask on...
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#2
Re: Medical Device Servicing – What Terminology?

Any thoughts on this, folks? My Thanks in advance!
 
V

Vincnet

#3
Re: Medical Device Servicing – What Terminology?

Hi Steve,
I have no idea of what the standard wording is in the industry.

But I follow the idea as yours with my clients generally calling them Servicing level 1 Level 2 etc... as many levels as required by the type of product, and just defining in each level what needs to be done.

I know that in the automotive industry they do more or less do the same in defining what should be done for each servicing for my motorbike Honda has a very good web based database where they tell you what needs to be done for each servicing.i.e. 2000Km, 6000km, 12000km 18000km.

Vincent
 
V

Vincnet

#4
Re: Medical Device Servicing – What Terminology?

Just a quick update on this one Steve,

as we are in a strange small world, I just have this issue to deal with for a client. And digging the current regs, I would warn you to check with local and European laws regarding product and service both general and medical device related, and to the warranties and liabilities you will have to deal with in offering such services.


V
 
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