Division of Neuroradiology and Neurophysics
MR and Medical Devices
Notes from the Second meeting of the working party on April 21st 2005
Present: Paul Tofts (chair), Dan Tozer (MS), Ralph Deichmann (FIL), Louis Lemieux
(epilepsy)
1. Two groups (high field and NHNN) had dropped out for the moment, although
they remained interested.
Group
Epilepsy
FIL
High field
MS
NHNN
person
LL
RD
DThomas
D Tozer
LM/JT
device
MREG
MDEFT
Scanner unavailable
Texture analysis
No device in mind
Type
analysis
Sequence
analysis
2. PT hoped we could
a. Get feedback on his 4 documents (on the Division website)
b. Give a tangible product to the Division at its next meeting (Monday May
16th)
c. Maybe (eventually) write a paper, perhaps for Magma
3. Re: physicists’ potential liability for devices, PT reported that a new aspect had
arisen. Instead of a route through employer’s liability, an alternative is that all
new projects, in addition to needing ethics permission, need a ‘sponsor’, who
would normally be UCLH. He will investigate further. [since then an equivocal
response from Mr Mick McNally at UCLH has been received]
4. DT’s texture analysis device: He is broadly happy with PT’s documents. The
device-specific response should be approved by someone else (other than the
author). He suggested giving the device developer a Roadmap:
a. See which essential requirements (ER’s) apply
b. Fill them in
c. Get the document approved/reviewed by someone else.
PT will put these into one of the documents. Dan will consider asking someone to
review his document (? JT or DThomas?)
5. RD’s sequence device. He is also happy with PT’s documents. He has written a
‘data sheet’, to include a disclaimer. He proposed that by starting with writing the
instruction manual, bearing in mind the requirements mentioned in PT’s
documents, then the bureaucratic requirements would be met naturally. He will
show his manual to the radiographic users, then send for Divisional use.
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6. LL, writing up his MREG device, had encountered difficulties, and is still
working on this. Not clear how much of the device to write up and attempt to
validate. GR20-22 do not refer to any specific ER’s. (PT will sort this). He will
finish manual then show to users of MREG.
7. The two general approaches seemed to be:
a. Give detailed responses to the ER’s or
b. Write a comprehensive manual (this is a more friendly approach).
8. There was a general discussion on how this MDD work will evolve, how it will
‘live’
a. Up to each group to decide how to use it
b. Suggested a new device should include MDD compliance, as well as
ethics permission, before being used on patients.
c. What constitutes a ‘new device’?
9. Another MDD error had been uncovered recently:
a. Dispim volumes had been used by an enterprising radiographer to measure
tumour volumes
b. The results seemed ‘reasonable’
c. Oblique slices are incorrectly handled (the inter-slice distance is wrong)
d. Dispim volumes are underestimated by a variable amount, depending on
the angulation; could be up to 30% error.
e. Detailed analysis of volumes had been carried out, and a paper prepared.
f. Now (with hindsight) some basic volume measurements on bottles are to
be made.
10. Blanket ethics permission for normal controls:
a. RD has this for the FIL
b. Mara Cercignani is in the process of making an application for the MS
group.
Paul Tofts May 4th 2005
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