July 09, 2020 Industry news
Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review (IMMDR), also referred to as The Cumberlege Review, published on 8 July, presents the sector with a devastating reminder that despite best efforts, there is still more that can be done to deliver improvements to patient safety.
It has forced the entire healthcare industry to pause and reflect on some of its current operations, and strive to find ways to prevent such instances from arising in the future.
And if anything could present a case strong enough for the need for end-to-end traceability, the Cumberlege review does so.
One of the most prominent recommendations that would, in part, stand as a catalyst for traceability is the proposal for a patient-identifiable database. Highlighted as recommendation seven in the review the recommendation states: “A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”1
In reviewing the three specific medical interventions over which concerns have been raised, Review chair Baroness Cumberlege has noted that “had such a database existed before now some of the avoidable harm that has happened could in all likelihood have been prevented”.2
A national registry at this scale, will need to be underpinned by interoperable open standards and unambiguous data, which can all be shared seamlessly across the healthcare system. With all data captured in a standardised format, reporting trends can be identified in a timely manner, and on a widespread scale, reducing the likelihood of extended risk to the patient population.
Secretary of state for health and social care, Matt Hancock, has already issued a ministerial direction mandating the collection of such information in a national database and this has recently been supported through the amend to the Medicines and Medical Devices Bill announced by the Department of Health and Social Care.
A key part of the new bill – which covers the whole of the UK, and both private providers as well as NHS providers – will centre on the introduction of a Medical Devices Information System.
This intended database for medicines and medical devices “will facilitate tracking medical devices by their unique identifier, to a patient’s individual record. It will facilitate the capture and use of patient and procedure data on implanted medical devices to create over time a future system of clinical registries. Such a system would monitor the performance of devices and ensure patient outcomes can also be tracked.”3
But at six acute trusts in England, this type of database already exists. Via the Scan4Safety programme[1], these organisations have introduced barcode scanning at the point of care. This captures details of every person, every product, and every place, to give complete visibility and end-to-end traceability, of what has been done to which patient, when, and where.
And having visited University Hospitals of Derby and Burton NHS Foundation Trust, Baroness Cumberlege was able to see tangible evidence of such a database, where procedure related data could be seen for historic mesh surgery.
The full report detailing the evidence, and lessons learnt from the two-year Scan4Safety demonstrator site programme will soon be published including the improvements to patient safety outcomes and savings that resulted. It will also include a step-by-step guide which leaders can use to implement point-of-care scanning in their own organisations.
In the interim, however, we are keen to give a sense of specific learnings relating to procedure databases and product recall. We feel that these are particularly relevant at this time given the recommendations presented in The Cumberlege Review.
The creation of procedure databases at Scan4Safety trusts
- All patients have a barcode on their wristband – a unique patient identifier – which is scanned before a procedure
- All equipment used for the procedure – including implantable medical devices – is scanned before use and recorded against that patient
- The location in which the procedure is to take place also has a barcoded identifier which is scanned
- At some trusts, staff also have barcodes on their badges which they scan prior to a procedure, which makes it possible to identify which clinicians were involved in which procedures.
- All of this information is automatically recorded within a database which can subsequently interrogated, making it possible to immediately trace what has been done to which patient, where, when, by whom and with what.
This meets Baroness Cumberlege’s recommended standards for a database – and could quickly be rolled out across a full range of procedures. While software clearly needs to be installed, the basic principle of scanning is familiar to all via self-service checkouts and no more complicated. It is also worth noting that GS1 standards are globally unique and entirely system and device agnostic which meets the national interoperability agenda.
In the specific example of mesh surgery which Baroness Cumberlege has been exploring, Scan4Safety trusts are able to identify patients who have undergone such procedures with speed and ease, as all details are captured in real time at the point of care.
Product recall at Scan4Safety trusts
Swifter product recall when a problem does emerge is an important related benefit to the creation of a procedure database.
- In a review at the end of the Scan4Safety programme, the team at Salisbury NHS Foundation Trust concluded that product recall was “a relatively easy area to implement improvements in” – simply by introducing a new inventory management system and scanning of barcodes at the point of care.
- At Leeds Teaching Hospitals NHS Trust, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes following Scan4Safety.
- Leeds also reported £84,411 of staff efficiency savings on recall from January 2016 to December 2017 alone. And in December 2019 there was clear evidence of the strength of the approach: a series of implantable devices were identified, surgical lists checked to ensure that patient care wasn’t compromised by them being within, the affected items placed in physical quarantine and the deputy chief medical officer informed the process was complete. This all happened within an hour and 45 minutes, across multiple trust sites.
Conclusion
Two themes that come to mind from the report are ‘collect once and use often’ and ‘collecting what matters’. These two stand as testament to the value of accurate data capture to improve visibility, interoperability, and traceability across the system.
The evidence lies in the experiences of the Scan4Safety trusts, and we firmly believe that introduction across the NHS of point-of-care scanning would meet this requirement.
The full Scan4Safety evidence report will be published next week, and we look forward to providing greater detail then.
With best wishes,
Glen
Footnotes:
[1] The Scan4Safety programme was launched in 2016 but the Department of Health and Social Care. Six trust demonstrator sites were each given a proportion of £12m to implement GS1 standards and point-of-care scanning into their organisation. Find out more on the Scan4Safety website at: https://www.scan4safety.nhs.uk/
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