Medicines and Medical Devices Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.

First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too

“few and far between and all too often prompted by catastrophe”. 

The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.

Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.

Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake. 

Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it

“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.

Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.

First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.

Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.

The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.

Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.

The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:

“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”


That surely is the goal to which we must all aspire.

I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.

I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.

This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.

[Lord Ribeiro (Con) [V]]

My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to

“improve surgery through learning from best practice, and … improve the quality of care to patients.”

The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.

Medicines and Medical Devices Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

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

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.

My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.

This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.

What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:

“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”


The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.

The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.

Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.

I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.

For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.

I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.

[Lord Ribeiro (Con) [V]]

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.