Medicines and Medical Devices Bill Debate

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Department: Department of Health and Social Care

Medicines and Medical Devices Bill

Baroness Redfern Excerpts
Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020

(3 years, 4 months ago)

Grand Committee
Read Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-V Fifth marshalled list for Grand Committee - (6 Nov 2020)
Baroness Walmsley Portrait Baroness Walmsley (LD) [V]
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My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.

It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.

There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.

I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.

Baroness Redfern Portrait Baroness Redfern (Con) [V]
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My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.

I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.

This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, we support the amendments in the names of the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, and Amendment 103 in the name of the noble Baroness, Lady Cumberlege. Registers are a tool that helps clinicians to track devices and those who have the devices fitted or implanted, and to use the data for research and to aid patients to seek redress.

The noble Baroness, Lady Finlay, explained clearly how the amendment would work to help to change a medical device that no longer functions. By citing the recall mechanism for a faulty domestic product, she illustrated what is required of a device register.

The amendments in this group relate to the tracking of medical devices, and the information stored. Amendments 86, 88 and 102 would allow regulations to provide for the tracking of all devices, as they are used, via a unique device identifier, with the information recorded either in registries or through hospital episode statistics data.

Amendment 103 is an important amendment, tabled by the noble Baroness, Lady Cumberlege, that seeks to clarify which information held by the healthcare system requires the consent of the relevant patient. Data is powerful, and should be kept appropriately. The governance of data has been a key issue in the NHS for more than 20 years.