More safety checks on new surgical techniques
By Jeremy Laurance, Health Editor
19 February 2003
Surgeons who try out new operations without authorisation are for the first time to be subject to safety checks to prevent patients being used unknowingly as guinea pigs.
The National Institute for Clinical Excellence, which assesses new drugs and medical devices, is to extend its remit to checking the safety of all new procedures involving making a cut or hole in the body and the use of X-rays, lasers or ultrasound.
The aim is to prevent patients being used unwittingly for experimental procedures that have not been assessed. Under the new programme, any surgeon wishing to try a new procedure will first have to notify Nice and follow any guidance available or gather data so that guidance can be produced. Patients will also have to be informed about the risks and benefits of the proposed treatment and that it is untested.
The move follows the débâcle over key-hole surgery, introduced in the early 1990s, which was widely taken up by surgeons before the risks and benefits had been assessed. The new technique called for different skills from conventional surgery and patients were injured, some seriously.
A register was set up by the royal medical colleges in 1996 with the aim of banning unsafe procedures and limiting unproven ones, but it fell into abeyance because of lack of funding. Reacting to a recommendation in the Bristol Royal Infirmary inquiry report, Nice is to take over its programme and will issue its first guidance next month.
Among the first procedures likely to be covered are uterine artery embolisation, a treatment for fibroids in the womb that offers an alternative to hysterectomy and is growing rapidly in popularity, an operation to correct a chest deformity in children and a less invasive treatment for abnormal menstrual bleeding in women.
Later advice will cover laser treatment of the eye, widely provided by commercial clinics for the treatment of short sight. They were criticised by the Consumers' Association last week for underplaying the risks.
Professor Sir Liam Donaldson, the Government's chief medical officer, said the absence of a mechanism for protecting patient safety when new techniques were being tried was a "gap that needed to be closed". Inno-vations that could bring medical advances of huge benefit must not be stifled, Sir Liam added.
Sir Peter Morris, president of the Royal College of Surgeons, said the real test would be whether the new programme curbed innovation. He welcomed the plan to subject new procedures to rapid assessment.
Referring to an operation on the carotid artery in the neck developed in the 1950s to reduce the risk of stroke, but not assessed in trials until the 1980s, he said: "We had to wait 30 years before we really knew if it was the sort of thing we should be doing."
Five new procedures are expected to be notified to Nice each month. Professor Bruce Campbell, chairman of the Interventional Procedures Committee, said: "We all know very few procedures are completely safe. The question is whether they are safe enough and work well enough to be used. The fundamental aim is to reassure patients and their carers that they are providing benefit without undue risk."
2 March 2003 20:43
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