Evaluation reports

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From:Jim Hall <rmkdhjh@ucl.ac.uk>
Date:Wed, 19 May 1999 11:28:40 +0100
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Fellow Histonetters,

In addition to previously listed evaluation reports on histology equipment
(and now Cytology equipment), the following report is now available from
the address below:

Pathfinder Cytology System from NEOPATH (Order Code: MDA/99/13).  This
report was compiled in conjunction with Dr E McGoogan and MR Derek Bishop
from the Department of Pathology at the University of Edinburgh Medical School

Available reports previously listed:

The Leica Jung TP1050 enclosed tissue processor  (Order Code: MDA/95/05).

The Tissue-Tek VIP E300 enclosed tissue processor (Order Code MDA/95/61) .

The Merck DS-50 Mirostainer X-Y slide stainer (Order Code MDA/96/06)
manufactured by Mercer Scientific, New Jersey.

The Shandon Pathcentre enclosed tissue processor   (Order Code: MDA/96/55).

The Leica CV5000 robotic coverslipper   (Order Code: MDA/96/80).

The Leica Autostainer XL automated slide stainer   (Order Code: MDA/97/19).

The Shandon Consul Automatic coverslipper  (Order Code: MDA/97/75).

Shandon Varistain XY slide stainer  (Order Code: MDA/98/28).

Undergoing evaluation at the moment is the MicroMED U.R.M. Ultra Rapid
Microwave Histoprocessor.  The report will be listed on the Histonet when

Published reports are available from:

Orders Department
Medical Devices Agency
Room 1207
Hannibal House
Elephant and Castle
London, SE1 6TQ
Tel:  0171-972-8181
Fax:  0171-972-8105
E-mail:  dep@medical-devices.gov.uk

May I take this opportunity to remind UK members of the National Health
Service that all of the evaluation reports are available to them for

The basic objectives of  the evaluations are to substantiate the claims
made by the manufacturers, evaluate performance under workloads found in a
routine histopathology laboratory, ensure that the instrument conforms to
certain safety standards, and to carry out a survey of users and publish
their views and experiences.  A report on solvent vapour emissions by an
independent consultant in Health and Hygiene is now included.   Long term
reliabilty cannot be assessed as the instruments are only in-house for
approximately 4 weeks, this being the average time a manufacturer will part
with their instruments for free.  The reports are not WHICH type reports,
are unbiased and follow similar protocols.

The cost of the evaluations has been met by the UK Department of Health
primarily for the benefit of members of the UK National Health Service.
The published reports are available to non National Health Service members,
but they are required to purchase the reports.  A catalogue and price list,
on all evaluations carried out to date, is available from the above
address, free of charge, or can be downloaded from the MDA web site on
http://www.medical-devices.gov.uk   You may be interested to know that
reports are available on a multitude of medical devices from Latex
Sensitisation (use of  latex gloves) to transport for the disabled to CT
scanners.  The Pathology section encompasses all disciplines and reports
are available on, for  example, the Abbott AxSYM immunoassay analyser, the
TechniconH*3 haematology analyser, the efficacy of thirteen chemical
disinfectants against Human Immunodeficiency Virus (HIV), fifteen HBsAG
screening assays, etc., etc.

The primary task of the Medical Devices Agency, an Executive Agency of the
Department of Health, is to help safeguard public health by working with
users, manufacturers and legislators to ensure that medical devices meet
appropriate standards of safety, quality and performance and that they
comply with relevant Directives of the European Union.


Jim Hall,
MDA Equipment Evaluator,
Department of Histopathology,
University College London Hospitals,
Rockefeller Building,
University Street,
London, WC1E 6JJ.
Tel.No. 0171 209 6042
Fax 0171 387 3674

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