Background
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 NHSBSP
5. enable comparisons to be made with other pieces of tested equipment
Disclaimer
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.
– 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.
| 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 |
