Latest evaluation report
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|From:||James Hall <email@example.com>|
In addition to previously listed evaluation reports on histology and
cytology equipment, the following report is now available from the Medical
Devices Agency address below:
The Tissue-Tek DRS 2000 Automatic Multiple Slide Stainer and marketed in
the UK by Bayer plc (Order Code: MDA/2000/28)
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 MicroMED U.R.M. Ultra Rapid Microwave Histoprocessor from Milestone and
marketed in the UK by CellPath plc (Order Code: MDA/99/59).
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).
The Shandon Varistain XY slide stainer (Order Code: MDA/98/28).
The Pathfinder Cytology System from NEOPATH and marketed in the UK by Bayer
plc (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.
Undergoing evaluation at the moment is the Sakura Linear Slide Stainer II
from Bayer. The report will be listed on the Histonet when published.
Published reports are available from:
Medical Devices Agency
Elephant and Castle
London, SE1 6TQ
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.
MDA Equipment Evaluator,
Department of Histopathology,
University College London Hospitals,
London, WC1E 6JJ.
Tel: 020 7679 6042
Fax: 020 7387 3674
Web Site: http://www.ucl.ac.uk/~rmkdhjh/index.htm
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