Practical Evaluations

Mammographic equipment approved for use in the NHS Breast Screening Programme (“NHSBSP”) is subject to evaluation commissioned by NHS England and carried out by a number of breast screening services in England who undertake the practical evaluation of equipment using protocols provided by the NHSBSP.  These evaluations comprise a staged process as follows:
  1. A technical evaluation by the National Coordinating Centre for the Physics of Mammography (“NCCPM”) (the “Technical Evaluation”). 
  2. If the Technical Evaluation meets requirements, a subsequent practical evaluation is conducted by one of the breast screening services involved in the NHSBSP (the “Practical Evaluation”).
Technical and Practical Evaluations are undertaken to assess the use of equipment in a practical, clinical setting and are not intended to be clinical trials. Further information about the limitations of the Technical Evaluation and Practical Evaluations are set out below.
The purpose of the Technical and Practical Evaluations together are intended to:
  1. determine the suitability of the equipment for use within the NHSBSP;
  2. assist potential purchasers in making their choice of equipment;
  3. provide potential users with performance data about equipment;
  4. provide potential users with a record of the practical experience of using the equipment in the NHSBSP; and
  5. enable comparisons to be made with other pieces of tested equipment
Whilst NHSE commissions testing for the purposes outlined above, in order to provide further information and support to providers of screening services within the NHSBSP, it is for informational purposes only and such testing is subject to the limitations described below. No representation is made by NHSE in relation to the reports generated from the Technical Evaluation or the Practical Evaluation and, insofar as the law allows, NHSE accepts no liability arising from purchase or use of equipment by providers of screening services within the NHSBSP subjected to them.
Providers of screening services within the NHSBSP must ensure that all equipment purchased and used within the NHSBSP complies with all relevant requirements of the NHSBSP, the terms of their contracts in respect of the NHSBSP, and all other relevant obligations including but not limited to ensuring that such equipment:
  • complies with national equipment standards;
  • has been approved for use in the programme and is tested by appropriately trained staff and medical physics services, in accordance with NHSBSP guidelines;
  • is accredited for use within the NHSBSP and that image quality and radiation dose meet acceptable standards; and
  • is suitable for the usage intended in the breast screening unit.
Providers are reminded that they should carry out their own due diligence in respect of the above.

Practical evaluation
Testing undertaken during the Practical Evaluation is a balance between time, evaluation costs and depth. There are therefore limitations to the scope of the Evaluations undertaken on the behalf of the NHSBSP.
The Practical Evaluation is undertaken over a short time and does not include long term reliability or any subsequent updates to the system.
Evaluations are undertaken on systems in an assessment unit to test the full range of uses of a system. The usage may not reflect the usage required in other services or providers, in particular of a unit system solely used in a screening van or room. The technical image quality is shown in a separate report and must be acceptable before a Practical Evaluation is undertaken. The image quality of the final displayed image will be affected by the image processing and display. These are evaluated qualitatively in this evaluation, but it is not practical to evaluate clinical outcomes for the system.
The evaluation report does not absolve the provider of their responsibility during the procurement process to ensure the equipment is suitable for the usage intended by the provider. It is particularly advised that providers see example clinical images to ensure that they are satisfied with the image processing.

Further guidance and information on the NHSBSP services is online

Manufacturer Report Title  
Siemens Mammomat Revelation evaluation 12 August 2020
Hologic 3Dimensions in tomosynthesis mode 12 August 2020
IMS Giotto Class evaluation 12 August 2020
GE Healthcare Senographe Pristina DBT system 21 April 2020
GE Healthcare Senographe Pristina 2D system 2 March 2020
Siemens Inspiration PRIME system 2 March 2020
Hologic 3Dimensions in 2D mode 9 December 2019
Fujifilm Amulet Innovality DBT system evaluation 9 December 2019
Hologic Affirm Prone Biopsy system 27 March 2019
Fujifilm Fujifilm Innovality practical evaluation 24 February 2017
Philips MicroDose SI digital mammo 15 March 2016
GE Healthcare SenoClaire DBT system practical evaluation 29 January 2016
Hologic Affirm DBT biopsy system 30 December 2015
Hologic Selenia Dimensions DBT system 1 July 2014