e r t n e C g ) n M i t P a NHS Breast Screening ProgrammeC n i C d Equipment Report 1602 r N o Practical evaluation of Fuj-ifilm A(MULET o y C h Innovality digital mammography system p l a a n r February 2017 g o o i t m a Public Health England leads theN NHS Scremening Programmes a e M h t f m o o s r c f i e s y l b h a P l i a e v h A t r o f Practical evaluation of Fujifilm AMULET Innovality digital mammography system About Public Health England e Public Health England exists to protect and improve the nation's health and wellbeing, r t and reduce health inequalities. It does this through world-class science, knowledge and n e intelligence, advocacy, partnerships and the delivery of specialist public health services. C PHE is an operationally autonomous executive agency of the Department of Health. g ) Public Health England, Wellington House, 133-155 Waterloo Road, London nSE1 8UG M Tel: 020 7654 8000 www.gov.uk/phe i t P a Twitter: @PHE_uk Facebook: www.facebook.com/PublicHealthEngland C n i C d About PHE Screening r N o ( - Screening identifies apparently healthy people who may obe at increaysed risk of a disease C h or condition, enabling earlier treatment or better informed decisions. National population p screening programmes are implemented in the NHlS on the advice of the UK National a a Screening Committee (UK NSC), which makes independent, evidence-based n r g recommendations to ministers in the four UoK countries. The Screening Quality Assurance o Service ensures programmes are safe aind effective by checking that national standards t m are met. PHE leads the NHS Screeninag Programmes and hosts the UK NSC secretariat. N m PHE Screening, Floor 2, Zone B, Skipton Haouse, 80 London Road, London SE1 6LH e www.gov.uk/topic/populationh-screening-Mprogrammes Twitter: @PHE_Screeningt Blog: phescreening.blog.gov.uk f m o Prepared by: J Clarok, EHL Mun gutroy s For queries relatring to this dcocument, please contact: [email protected] f The images o n pages 8, i9 and 10 are courtesy of Fujifilm e s © Crown copyright 20y17 l b h You may re-use this information (excluding logos) free of charge in any format or a P medium, under the terms of the Open Government Licence v3.0. To view this licence, l i viasit OGL or eemail [email protected]. Where we have identified any third vparty copyhright information you will need to obtain permission from the copyright A holderst concerned. r o fPublished February 2017 PHE publications gateway number: 2016633 2 Practical evaluation of Fujifilm AMULET Innovality digital mammography system About this document e Acknowledgements r t n e The author is grateful to all the staff at the Breast Imaging Unit at Barnsley Hospital, for their C co-operation in the evaluation of the system. g ) Document lnformation n M i t P Practical evaluation of aFujifilm Title C AMULET Innovality dnigital mammography sdyistem C r N o Policy/document type Equipment Report 1602 ( - o y C h Electronic publication date February 2017 p l a a n r Version 1 g o o i t m a Superseded publications None N m a e Review date None M h t f Author/s m o J Clark, EHL Mungutroy o s r c Ownerf NHS Breast Screening Programme i e s y l b h Document objective To provide an evaluation of this a P l (clinical/healthcare/social equipment’s suitability for use within i a queestions covered) the NHSBSP v h A tPopulation affected Women eligible for routine and higher- r risk breast screening o f Target audience Radiologists, radiographers, programme managers, physicists Date archived Current 3 Practical evaluation of Fujifilm AMULET Innovality digital mammography system Contents e r About Public Health England 2 t n About PHE Screening e2 C Executive summary 7 1. Introduction g 8 ) n M 1.1 Evaluation centre and timeline i 8 t P a 1.2 Equipment evaluated 8 C n 1.3 Objectives i C 11 d r N 2. Acceptance testing, commissioning and performance testing 12 o ( - 3. Routine quality control 12 o y 3.1 Daily QC tests C h 13 p 3.2 Weekly QC tests al a 15 3.3 Monthly QC tests n r 17 g o o 4. Data on screening carried out i 20 t m a 4.1 Clinic throughput 20 N m 4.2 Clinical dose audit 20 a e 4.3 Imaging times h M 21 t 4.4 Image quality 21 f m o 5. Data on assessment con ducted 25 o s 6. Equipmenrt reliability c 25 f i 7. Electreical and meschanical robustness 25 y l b 8. Radiographehrs’ comments and observations 26 a P 8.1 lOperator manual 26 i a e 8.2 Training 26 v h A 8.3 Etase of use 26 r 8.4o Exposure times 27 f 8.5 Setting radiographic views 27 8.6 Setting the position of the breast support table 27 8.7 Range of movements 27 8.8 Effectiveness of brakes and locks 27 4 Practical evaluation of Fujifilm AMULET Innovality digital mammography system 8.9 Environmental conditions 27 8.10 Compression 27 8.11 Comfort level of women 28 e r 8.12 Range of controls and indicators 28 t n e 8.13 Choice of paddles/collimators for spot compression 28 C 8.14 Time elapsed before the image appears at the AWS 28 g ) 8.15 Image handling and processing at the AWS 28 n M 8.16 Overall image quality at the AWS ti P28 a 8.17 Ease of transfer of images n C 29 i C 8.18 Level of confidence in the Innovality d 29 r N 8.19 Hazards o 29 ( - 8.20 Equipment cleaning o y 29 C h 8.21 Patient and exposure data on images 29 p l 8.22 Did the performance of the system limit paatient througahput? 29 n r 8.23 Magnification g 29 o o i 8.24 Additional comments on performtance m 30 a 9. Radiologists’ comments and Nobservationms 30 9.1 Reporting workstation a 30 e M h 9.2 Image quality 31 t 9.3 Use in assessmemnt f 31 o 10. Confidentialioty 31 s r c 11. Securityf issues 31 i e s 12. Training y 32 l b h 13. aDiscussion 32 P l 13i.1 Equipm ent and practical considerations 32 a e v13.2 Phhysics testing and routine QC 33 A t 13.3 Screening 33 r o 13.4 Clinical assessment 33 f 13.5 Radiographers’ and radiologists’ views 34 14. Conclusions and recommendations 34 References 35 Appendix 1: Physics report 36 5 Practical evaluation of Fujifilm AMULET Innovality digital mammography system Appendix 2: Clinical breast dose survey 41 Appendix 3: Radiographers’ answers to questionnaire 42 Appendix 4: Manufacturer’s comment 48 e r t n e C g ) n M i t P a C n i C d r N o ( - o y C h p l a a n r g o o i t m a N m a e M h t f m o o s r c f i e s y l b h a P l i a e v h A t r o f 6 Practical evaluation of Fujifilm AMULET Innovality digital mammography system Executive summary e The purpose of this evaluation was to assess the practical performance of the Fujifilm r t AMULET Innovality digital mammography system, in 2D mode. It was found to be n e suitable for use in the screening and assessment of women within the NHS Breast C Screening Programme (NHSBSP). g ) The evaluation was carried out between March and July 2014. The system was reliable n M throughout this period; Quality control (QC) results were stable and withini limits. The t P system was fully integrated with the breast unit’s PACS and with the Naational Breast C n Screening System (NBSS). i C d The Innovality performed well and the radiographers found it erasy to use aNfter their o initial applications training. They particularly liked the special Fit Sweet paddle, which ( - was comfortable for women, and the iAEC which made ito very easy yto image breasts with implants. Some difficulties were reported with chaCnging the phaddles and with p increasing compression slowly enough. Screening times averaged 6 minutes per l a a woman, and could have been shorter if changing facilities were available. n r g o Image quality was assessed as good or excellent for othe majority of screening and i assessment images, with none poor or tinadequatem. a N m A dose survey was carried out as part of this evaluation. The average mean glandular dose for 50-60mm breasts wase 1.18mGy, wahich is well within the national diagnostic M reference level. h t f m o o s r c f i e s y l b h a P l i a e v h A t r o f 7 Practical evaluation of Fujifilm AMULET Innovality digital mammography system 1. Introduction e 1.1 Evaluation centre and timeline r t n e The Breast Unit at Barnsley Hospital serves a population of approximately 38,000 C women, of screening age between 47 and 70, every year. The unit is a dedicated static site which provides services for breast screening and assessment as well as forg ) symptomatic imaging. Assessment of recalled screening women is carried ount on site M i every week. t P a C n The evaluation of the Fujifilm AMULET Innovality digital mammography system took i C place over the period of April to July 2014. It was carried out followding the guidelines published by the NHS Breast Screening Programme1. The Innorvality has tNomosynthesis o capability, but only the 2D mode was evaluated at Barnsley-. ( o y C h 1.2 Equipment evaluated p l a a 1.2.1 X-ray set and workstation n r g o o The Innovality was installed by Fujifilm oni a loan basis for the duration of the evaluation. t m a Fujifilm agreed to indemnify the equipment and provided both technical and applications N m support over the evaluation period. a e The mammography gantry cohmprises of Man automatically controlled C-arm with push button controls on either stide. It also has foot pedals to adjust the gantry height and f compression plate heighmt. Integratoed ambient lighting at the rear of the gantry is intended to help provide a relax ed environment during operation. o s r c Additional operaftor controls are located on the C-arm, together with a display showing i e s the compression force, compressed thickness and selected angulation. An additional y l display abt the foot ohf the gantry shows the patient demographics. It changes a automatically to sPhow the compression force, compressed breast thickness and l seliected angu lation when the foot controls are operated. a e v h The Innovality is powered by a single phase voltage of 220/240V with a separate A t genera tor to the gantry. It has an amorphous selenium detector housed within a r o moulded carbon fibre casing, utilising optical switching technology. It uses a tungsten f target with rhodium and aluminium filters but only rhodium is used for 2D operation. The acquisition workstation (AWS) consists of two 3MP monitors mounted on swing arms, with a keyboard and a separate control pad. It has an integrated radiation shield within the console. A footswitch for exposure at workstation was provided. This operated satisfactorily, but was rarely used in the evaluation. 8 Practical evaluation of Fujifilm AMULET Innovality digital mammography system A “sleep” mode, operated by a sliding on/off button, was enabled for day-to-day operation. There was also a facility for shutdown which could be used if necessary. e r t n e C g ) n M i t P a C n i C d r N o ( - o y C h p l a a n r g o o i t m a N m a e M h t f m o o s r c f i e s y l b h a P l i Fiagure 1. Fuejifilm AMULET Innovality X-ray set v h A 1.2.2. Ptaddles r o Tfhree standard-size compression paddles were available for use with the equipment as well as specialist paddles for use in assessment. All the different paddles were automatically recognised by the Innovality once they were in position on the gantry. The 24cm x 30cm Fit Sweet paddle, shown in Figure 2, was in routine use. This paddle is somewhat flexible and compresses the breast in 2 planes – posterior to anterior 9 Practical evaluation of Fujifilm AMULET Innovality digital mammography system (chest wall to nipple) and lateral to medial aspect. It is designed to maintain good compression while minimising pain. The 18cm x 24cm shifting paddle was generally used for the smaller breasts. When e r used in the oblique position, the paddle shifted to the appropriate side. t n e A 24cm x 30cm fixed paddle with a high edge was also available. C Specialist paddles, such as a 9cm x 10cm magnification paddle and a spot comp ression g ) paddle, were also provided for the evaluation. n M i t P a C n i C d r N o ( - o y C h p l a a n r g o o i t m a N m a e M h t f m o o s Figure 2. Fit Sweret paddlec f i e s 1.2.3 Accessories y l b h a Different accessoPries were available for the evaluation. These included wall mounting for the l paadidles and ea magnification table which provided 1.8x magnification. v h A 1.2.4 Automatic exposure control t r o The automatic exposure control (AEC) for the Innovality operates in two different f modes: AEC and iAEC. Three different dose settings can be used with either mode: N (Normal), L (Low) and H (High). Exposures under both AEC modes are determined by a pre-exposure which does not contribute to the image and is excluded from the post- exposure mAs. 10