Aidan and the list

Perhaps I should clarify.

My point was that it would be difficult to contravene the essential
requirements (safety, function etc) of any directive (I am an electronics
engineer) with a mod like this.
 I assumed that an engineer would be doing the mod.  I had also assumed
that the patient had been referred to you/ your trust.
If the device could not be regarded as a "medical device" then you don't
need to "place it on the market" to come under the EMC (etc) directive, you
just have to commission it!
That is why regarding it as a one off medical device is an advantage - it
lets you off the paperwork - but not the essential requirements.
You would obviously take on liability and void any warrantys - but that's
what engineering is about!

Barry Taylor, Clinical Scientist
Bioengineering Department
Tulley Medical Physics Building, Hull Royal Infirmary
Anlaby Road, Hull HU3 2JZ, UK
Tel 01482 675928, fax 01482 675750

-----Original Message-----
From:   Aejaz Zahid SRCS [SMTP:[log in to unmask]]
Sent:   28 June 2001 17:04
To:     [log in to unmask]
Subject:        FW: Message for Assistech list Re: Adapting Answerphone



-----Original Message-----
From:   p=NHS NATIONAL
INT;a=NHS;c=GB;dda:RFC-822=Rob.Strachan(a)sth.nhs.uk;
Sent:   Thursday, June 28, 2001 3:35 PM
To:     p=NHS NATIONAL
INT;a=NHS;c=GB;dda:RFC-822=ASSISTECH-request(a)JISCMAIL.AC.UK;
Subject:        Message for Assistech list

I tried to send this message to the discussion list, but my mail account is
not compatible with your server, and it was rejected.  Could you post it
for
me please?

Rob Strachan

The message:  re  Adapting answerphone

Barry,

You say: 'If this could be regarded as a medical device (a special for one
patient)
> then you would not infringe anything.(?)'
>
If its a medical device for a named patient then the Essential Requirements
of the Medical Device Directive DO still apply and so there would be an
infringement if the adaptation did cause EMC problems (of which I have no
idea: I'm a mechanical engineer...), unless the patient is referred for
treatment to your legal entity, Aiden, and then the Regulations do not
apply, and there could be no infringement, as the device is not 'placed on
the market'.

The only difference between medical devices for a named patient and medical
devices for general use, when they are to be used externally to your legal
entity is that third party involvement is reduced, and some of the up-front
documentation.  The Essential Requirements are still just that: Essential.
it would also be reasonable to work to them for in-house stuff too, as they
establish best practice, and to work to a lower standard could then leave
you in jeopardy from consumer protection law.

Rob


Rob Strachan B.Eng MIPEM AMIMechE C.Eng SRCS
Clinical Engineer
Medical Engineering Section
Directorate of Medical Physics and Clinical Technology
Royal Hallamshire Hospital, SHEFFIELD  S10 2JF     Tel 0114 271 3138  Fax
3137
e-mail  [log in to unmask]

Clinical Engineer
The Gait Laboratory
Ryegate Children's Centre, Tapton Crescent Road
SHEFFIELD  S10 5DD    Tel 0114 271 7629


> -----Original Message-----
> From:   Barry Taylor [SMTP:[log in to unmask]]
> Sent:   Thursday, June 28, 2001 11:42 AM
> To:   [log in to unmask]
> Subject:   Re: Remotely operated telephone answering machines
>
> Aidan
> Maybe I'm nit picking, but what CE legislation would you infringe by
> modifying an ansaphone?
   If this could be regarded as a medical device (a special for one
patient)
   then you would not infringe anything.(?)
> Otherwise, I suppose you might be in danger of infringing the EMC or
> telecoms directives but if it works in the patients home without
> transmitted or received interference, I can't see that EMC would be
> "policeable" or even against the spirit of any legislation.  It would be
> difficult to make such a mod affect the characteristics of the phone line
> connection.
> It comes down to the risk assessment. Or perhaps others take a different
> view?
>
> Barry Taylor, Clinical Scientist
> Bioengineering Department
> Tulley Medical Physics Building, Hull Royal Infirmary
> Anlaby Road, Hull HU3 2JZ, UK
> Tel 01482 675928, fax 01482 675750
>
> -----Original Message-----
> From:   Aidan Negus [SMTP:[log in to unmask]]
> Sent:   27 June 2001 16:15
> To:     [log in to unmask]
> Subject:        Remotely operated telephone answering machines
>
> I wonder if anyone has any experience or knowledge of any systems which
> can
> be used to remotely (by IR, RF or an adapted switch) access a digital
> answering machine. I have a client who has Motor Neuron Disease and who
> would like to be able to play back phone messages by pressing a single
> switch.
>
> We have tried using a Gewa Prog and VoiceMail, but this proved too
complex
> for the client. Additionally, we are unable to switch adapt commercially
> available devices as this would infringe CE legislation.
>
> Please reply to assistech and / or directly to my email address:
> [log in to unmask]
>
> Thank you
>
> Aidan Negus
> Occupational Therapist
> Access to Communication and Technology
> Oak Tree Lane Centre


Rob Strachan B.Eng MIPEM AMIMechE C.Eng SRCS
Clinical Engineer
Medical Engineering Section
Directorate of Medical Physics and Clinical Technology
Royal Hallamshire Hospital, SHEFFIELD  S10 2JF     Tel 0114 271 3138  Fax
3137
e-mail  [log in to unmask]

Clinical Engineer
The Gait Laboratory
Ryegate Children's Centre, Tapton Crescent Road
SHEFFIELD  S10 5DD    Tel 0114 271 7629



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