Variant CJD and Surgery

Debate between Baroness Blackwood of North Oxford and Paul Beresford

Tuesday 29th November 2016 Commons Chamber

[The Parliamentary Under-Secretary of State for Health (Nicola Blackwood)]

I congratulate my hon. Friend the Member for Mole Valley (Sir Paul Beresford) on securing this important debate on variant CJD and surgery. It is clearly an area on which he has a great deal of knowledge. I recognise that prion disease is the causative agent of transmissible spongiform encephalopathies such as variant CJD. It remains in many ways obscure and there are many aspects of these rare diseases that we are still in the early stages of researching. However, one thing I am confident about is that the UK system for ascertaining CJD case numbers has been for the past 20 years reliable and accurate. Our national CJD research and surveillance unit, which is based in Edinburgh and funded by the Department and the Scottish Government, leads pan-European work and has leadership from expert clinicians and scientists who, in 1996 following BSE, were the first to identify variant CJD as a separate form of the condition.

The Department recognises the potential seriousness of secondary—person-to-person—transmissions of vCJD and has since the late 1990s introduced a series of measures to reduce the risk of such spread, whether by blood transmission or by surgery. We are reassured that there have to date been no cases attributable to surgical transmission and only three cases of clinical disease attributable to blood transfusions, all of which occurred in or before 1999. However, our risk assessment models, which we use in our impact assessments of potential risk reduction measures, continue to take into account the potential for secondary—person-to-person—transmissions by both routes, in people with all genotypes and over potentially very long incubation periods, which my hon. Friend mentioned. This is why the scientific advice we have is that the surgical instrument measures in place are sufficient irrespective of the genotype.

My hon. Friend was right to mention the recent case. It was always anticipated on the basis of a wide body of published scientific work that, following the BSE epidemic, further cases of vCJD, including MV cases, might arise from time to time. We have seen that with similar diseases, such as kuru in Papua New Guinea, and studies suggest MV cases could be seen in small numbers for more than 30 years after exposure. Having reviewed the information about the case of vCJD in a patient with MV genotype, the Advisory Committee on Dangerous Pathogens has advised that no changes in the current risk reduction measures are needed at present. It advises that the measures in place are sufficient, irrespective of genotype, although of course the matter will remain under review.

It is important to stress that modern surgical equipment in the UK is very safe and that robust guidance is in place for the NHS on procedures and practices to reduce the risk of contamination of any kind, including the use of single-use instruments where possible and of decontamination practices. Where it is not possible to use single-use instruments in higher-risk procedures, there are processes in place to track the use of specialist equipment. As my hon. Friend will know far better than I do, there is a potential risk of vCJD transmission via dental surgery, and this has been recognised by the UK’s chief dental officers. In 2007, they issued letters to all dentists to advise that endodontic root canal reamers and files should be used as single-patient or single-use instruments.

[Sir Paul Beresford]

I am a little worried that the Minister appears to accept that surgical procedures are as good as they can be, given that the Department is inviting research to find a RelyOn equivalent, to improve the situation. The Department must therefore see a flaw in what we have at present.

[Nicola Blackwood]

My hon. Friend anticipates my next words as only an experienced Member of Parliament can do. I think it is right to say that there has so far been no evidence of any secondary, person-to-person, vCJD transmissions via surgery or dentistry. Nevertheless, we are maintaining and updating our precautionary approach. Surgical instruments guidance has recently been refreshed to support health organisations in delivering the required standard of decontamination of surgical instruments and to build on existing good practice to ensure that high standards of infection prevention and control are developed and maintained. My hon. Friend mentioned a number of these points.

The major change in this latest revision takes account of recent changes to the Advisory Committee on Dangerous Pathogens transmissible spongiform encephalopathy subgroup’s general principles of decontamination. This establishes a move towards in-situ testing for residual proteins on instruments. Residual protein is important because of the potential risk of the transmission of prions, though vCJD has not been shown to have been transmitted person-to-person in this way. The guidance provides information on how sterile services departments can mitigate the patient safety risk from residual protein with the objective of reductions in protein contamination levels through the optimisation of decontamination processes.

The ambition is that all healthcare providers engaged in the management and decontamination of surgical instruments used in acute care will have implemented this guidance by 1 July 2018. However, providers whose instruments are likely to come into contact with higher-risk tissues—for example, neurological tissue—are expected to give the guidance higher priority and to move to in-situ protein detection methodologies by 1 July 2017.

The chief medical officer has also recently written to NICE supporting the need to update its guidance on patient safety and the reduction of risk of transmission of CJD via interventional procedures, to ensure that it is fit for purpose, appropriately targeted, and can command the confidence of those who use it. We would expect this to take account of available evidence, including decontamination methods that are safe and effective against human prions; the epidemiology of CJD, including data on the prevalence of vCJD infectivity in the UK population from the appendix prevalence studies; and the availability and performance of single-use instruments in high-risk specialties. We would also expect the guidance review to be considered in the context of the latest research on prevalence, particularly for those born after 1996, who are currently considered unlikely to have been exposed to the BSE agent.

My hon. Friend is right, however, to say that adopting the precautionary principle alone is not sufficient. That is why successive UK Governments have been supportive of the development of new measures that might help in vCJD risk reduction. The Department of Health has provided over £70 million for CJD-related research in the last 15 years. That research has focused on infectivity, pathogenesis and transmission risk; decontamination of surgical instruments and the development of more sensitive methods to detect residual proteins to improve instrument cleaning; test development, treatment and diagnosis; and surveillance, screening, epidemiology and case finding.

[Sir Paul Beresford]

I accept everything that my hon. Friend says. However, a test solution is on the market and waiting to come through. The prion unit test has reached the point at which it just needs a final run to ensure that it does come through. I hope that I can count on the Minister to back me in persuading the MRC to support that last round of testing. If we could test blood, we would not have to import blood products from overseas. We could separate out the one in 2,000 or whatever the figure is and cut down on the costs of instrument storage.

[Nicola Blackwood]

That is one reason why the Department has continued in difficult financial times to ring-fence £5.5 million a year for CJD-related research. We are keen to see safe, evidence-based, cost-effective measures to reduce the risk of vCJD. At the moment, however, there is no validated diagnostic blood test that can be used before the onset of CJD symptoms to diagnose whether someone is infected or incubating the disease. We will of course take advice from the ACDP and the Advisory Committee on the Safety of Blood, Tissues and Organs on the use of any potential test in any proposed Department of Health-funded research study or deployment by UK blood services, but there are established systems for applying for research funds. We have put such funds out there, and any applications for those funds must go through the standard processes. To do otherwise would be to undermine the reputation for research excellence that the UK scientific community has fought hard to establish.

To that end, we recently launched an open competition, inviting proposals for research to further inform our risk-management and health-protection measures, including our understanding of vCJD infection in the UK population, the development of a test able to detect pre-clinical levels of infection in blood, and the development of decontamination technologies for reusable medical instruments. I understand that Professor Collinge’s RelyOn is one application that is currently going though that process, so it would be inappropriate for me to intervene.

I assure the House that the Department recognises the fatal consequences of all forms of clinical CJD and the devastating cost to individual patients, their families and carers, which my hon. Friend described movingly. That is why we set up the vCJD Trust in 2001 in recognition of their wholly exceptional situation and the fact that the Government are their last resort for help. The trust provides a no-fault compensation scheme for vCJD patients and their families, providing payments to be made in respect of 250 cases from a trust fund of £67.5 million. Over £41 million has been paid out by the trust to date.