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.
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As we were informed in the Minister’s useful briefing this morning, the NJR is able to capture details on patients, procedures, place or site, and the device with its product identification and unique identifier, thus allowing comparison with other devices that are underperforming. Amendment 100 adds four new paragraphs to Clause 16(2). They are subject to the patient’s consent and require that information about any medical device implanted in the human body is registered and retained in the information system outlined in Clause 16. The information system should be subject to expert review and, more importantly, patients should be empowered to enter reports of their experiences, following the use of medical devices in their treatment. The noble Baroness, Lady Cumberlege, identified this in her review and she will doubtless comment further.
In conclusion, I also support Amendment 101 in the name of the noble Baronesses, Lady Finlay and Lady Bennett. These amendments will give patients a voice and ensure that they consent to the information used about their care.