Interventional procedures - introducing new procedures to the NHS in a safe and effective way
Our interventional procedures guidance aims to make sure new procedures are introduced to the NHS in a way that is both safe and effective.
Our guidance covers a wide range of treatments and some diagnostic tests such as:
- surgical operations
- endoscopic procedures,
- procedures carried out through arteries and veins,
- procedures carried out using ultrasound or X-ray.
We aim to support healthcare professionals who are in the process of introducing new procedures. We also aim to ensure patient safety is protected. The majority of the procedures we evaluate are new, but we also evaluate more established procedures if there is any uncertainty about their safety or how effective they are.
Improved process for developing guidelines
This year we updated the way we develop our guidance to increase the speed and efficiency with which new surgical techniques and other technologies can be safely introduced into the NHS.
Among the changes was the decision to more formally recognise the role that device manufacturers play in developing guidance.
Professor Bruce Campbell, former Chair of NICE’s Interventional Procedures Advisory Committee, said: “Our Committee needs as much information as possible about a procedure in order to make a recommendation to the NHS about whether it is safe enough and works well enough to use routinely.
“As well as looking at the published evidence on procedures we already get the advice of doctors and of patients. Many procedures involve using a new device, so our new process means that we now get additional information from manufacturers, to help our committee discussions and to make the most appropriate recommendations to the NHS.”
Mechanical clot retrieval for stroke
In February 2016, we published updated guidance for the NHS on a procedure to treat patients who have had a stroke.
Approximately 110,000 people have a stroke each year in England. It is the fourth single largest cause of death. It is also the largest cause of complex disability, and has limited available treatments.
An ischaemic stroke is a stroke that can be caused by a blood clot blocking an artery supplying the brain.
Currently the most common way of treating ischaemic stroke is by using drugs as soon as possible after the stroke. This helps dissolve the blood clot. However, the drugs must be given within 4.5 hours of the start of the stroke and only benefit around 1 in 7 people treated.
Mechanical clot retrieval can be used for blockages in large blood vessels. The patient first has a procedure using dye to see where the blood clot is. With the patient under sedation a catheter is then inserted through a large blood vessel, and moved forward to get pictures of the brain’s blood supply. The clot removal device is inserted through the catheter and positioned near the site of the clot.
Mirella Marlow, Programme Director – Device and Diagnostics Systems at NICE, said:
“When we originally looked at this in 2013 there was not enough evidence for us to advise that it worked well enough and was safe enough.
“At the time, we encouraged clinicians to collect more data to provide us with further evidence of the procedure’s long-term safety and effectiveness. We’re pleased that specialists took notice of our recommendation and recorded this information – this has contributed to NICE now being able to recommend this procedure with normal arrangements for clinical governance, consent and audit.
“We will also be exploring the potential for further NICE guidance on the devices used in the procedure.”
X-ray technique to cure rectal cancer
We published guidance on an X-ray technique for early stage rectal cancer in September 2015.
Rectal cancer is a common form of bowel cancer. The likelihood of developing it rises sharply with age. Common symptoms include rectal bleeding, and a change in bowel habit such as more frequent and looser stools, or stomach pain.
Low energy contact X ray brachytherapy, also known as the Papillon technique, aims to cure rectal cancer, or stop it spreading.
Patients usually have low energy contact X-ray brachytherapy as day patients.
A tube is inserted through the anus into the bowel to see the size and position of the tumour. An applicator containing an X-ray tube is then placed in contact with the tumour.
The X-rays only penetrate a few millimetres so damage to tissues that are not associated with the cancer is reduced. If the tumour does not shrink after contact X-ray brachytherapy, or if it comes back after treatment, surgery may be needed, if the person can have it.
Our guidance said the procedure is safe enough and works well enough for use in the NHS for patients who cannot have surgery. However, there is not much good evidence about how well this procedure works in patients who can have surgery, but have chosen not to.
Consequently, it should only be used if extra care is taken to explain the risks and extra steps are put in place to record and review what happens. More research on this procedure is needed and NICE may look at it again if more evidence is published.