My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.
In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.
In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately
notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.
In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.
I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.
To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.
In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.