Is Innovation being stifled in the National Breast Screening Programme through overly complex processes?
17 June 2019
The NHS Five Year Forward View references the importance of “Leveraging the potential of Technology and Innovation” to improve efficiency and patient outcomes. It also states that improving cancer outcomes is one of the top priorities for the NHS. Which is why it is appropriate to focus on early detection of cancer through screening programmes that enable cancer to be identified and treated in the early stages, when outcomes are often far better for the patient and the cost burden much less.
Yet the current, increasingly complex and burdensome process is delaying the realisation of potential benefits from new technology within the Breast Screening Programme.
The Breast Screening Program was introduced into the UK in 1988 and has arguably saved thousands of lives using Mammography equipment that performs a low dose X-ray examination of the breast. In the past few years, the age of women invited for screening has been extended so that now it covers those aged between 47 to 73 years (previously 50 – 70). As a result, there are more than 2.6 million women invited for screening each year. With over 2 million Mammograms carried out each year it is vital the service is as efficient as possible and has access to the best and latest technology that can provide the lowest patient dose, highest quality imaging and the most efficient and appropriate examinations.
The Mammography equipment that is used in Breast screening, like all other Medical Imaging equipment must adhere to stringent guidelines and regulations and be tested and certified with CE approval. As the Breast screening program carries out examinations on most people who are assumed to be completely healthy (and therefore not patients), the Breast Screening Programme (BSP) in England decided to introduce additional level of checks and tests before allowing Mammography equipment to be used for Breast Screening. This is not the case in the National Breast Screening Programmes in Scotland, Wales and Northern Ireland and in many other countries in Europe where it is deemed that the CE certification and other regulations (like EUREF) provide the requisite assurance that the equipment meets the necessary standards. These additional steps were previously a combined Medical Physics test (“Technical Evaluation”) and a “Usability Test” (to check that the dose rate and image quality met the stringent quality requirements of the BSP and checking additional issues such as the ergonomics impacting the operator and the recipient of the test). In recent years, these two tests have been split with an initial Medical Physics tests and then a “Practical Evaluation” where a nominated Breast Screening centre in England assesses the equipment’s suitability for use in the BSP. This is performed by carrying out over 500 examinations (the amount appears to vary due to a lack of guidance on the required statistical number) and thereafter providing a report that is checked and published by Public Health England to provide guidance for other centres in the BSP. The actual publication of the report, in some examples, has taken in excess of 18 months after completion by the evaluation site, thus adding further delays.
This dual step approach combined with limited resources within the BSP and Public Health England often means that there is a considerable time delay from when a manufacturer introduces new technology into the market with the appropriate CE and regulatory approval, and the point at which the above tests are completed and the technology is made available within the English Breast Screening Programme. In many cases the time delay can be measured in years, due to lack of guidelines, support and in some cases variability in guidance provided to both suppliers and the sites performing the evaluation. It’s also clear that the same lack of resources has led to variability of treatment and prioritisation between suppliers, conflicting and sometimes less stringent guidance on areas like selection of evaluation sites, all of which ultimately lead to a significant variance in the delay between suppliers. While it is understood that the Breast Screening Programme wish to maintain high quality and safety standards it seems that the current process is overly complex, too lengthy, lacks resources and is acting as a barrier to the timely adoption of innovations which could be beneficial to those being screened and the staff that provide the service. Is it not time to adopt a different approach?
Against the backdrop of the recent challenges faced by the English Breast Screening Programme in the media, it is AXREMs determination to speed up the Breast Screening Programme’s access to modern technology through timely evaluation and implementation of technologies which benefit those working in the Breast Screening Programme and the recipients of the service.