Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee.

  • Great Britain. Parliament. House of Commons. Select Committee on Science and Technology.
Date:
2006
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Licence: Open Government Licence

Credit: Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee. Source: Wellcome Collection.

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    APPENDIX 3 Memorandum from Dr Alan M Calverd INTRODUCTION I write in my personal capacity, but with the particular experience knowledge and interest acquired in my capacity as the EU Authorised Representative for the FONAR Corporation, Melville, Long Island, USA, and as Technical Manager of one of its customer Companies operating clinical MRI systems in the UK. In view of the short time available to me for comment, these notes have been prepared in good faith but have not been cleared by FONAR or any other Company or group with which I am associated. They represent my personal opinion only. THE FUTURE OF INTERVENTIONAL RADIOLOGY I have been privileged to work in the past with Prof Louis Kreel and a number of other innovators in the field of realtime x-ray-guided surgery and angioplasty. The benefits of these minimally intrusive, low-risk and low-cost procedures compared with open surgery are manifest, and they have taken their place in the routine armamentarium of most hospitals. The next logical stage in the development of such procedures is clearly to explore the benefits of MRI, which permits better visualisation of soft tissues without the use of toxic contrast agents, and can be used to characterise the chemical status of a region infused with a cytotoxin, or the physical state of a polymerising resin. In principle this allows us to, say, precisely ablate a tumour with negligible damage to surrounding tissues, or to effect exquisitely controlled repairs of fractured or collapsed bone. BRITAIN AT THE LEADING EDGE—FOR Now The key to image-guided interventions is the ability of the surgical team to access the patient close to the surgical site, and to carry out anaesthesia and intraoperative monitoring safely and efficiently. To this end, FONAR have developed the OR360 “operating theatre in a magnet”, currently the only MRI system that allows unrestricted access to the patient, and among the most powerful (thus fastest and most precise—ie safest) open MRI systems on the market. The first commercial OR360 in the world is now nearing completion at the Oxford Nuffield Orthopaedic Centre, where it will be used, with considerable support from the manufacturers, to explore its potential for high-throughput routine imaging and in truly “hands on” interventional procedures. ONOC was particularly favoured for this work on account of its established reputation in orthopaedic radiology and the unique enthusiasm and expertise of its clinical research and development teams. Development of intraoperative imaging in this, the likely precursor of a new family of MRI equipment, clearly encourages operators to work close to and even inside the primary magnetic field and gradient fields, which are confined between the pole pieces above and below the patient. The optimum positioning of, say, a surgeon’s hand, is determined by the patient’s anatomy: there is no substitute for tactile sensation in medicine, and the OR360 uniquely permits the combination of direct contact through a surgical tool, with the ability to visualise anatomy and chemistry deep inside the patient. The proposed EU restriction on operator exposure to time-varying gradient fields will severely restrict the scope of work that can be legally done in such machines, and will place severe limits on the development of both the equipment and its applications. I fear that clinical research in interventional MRI will be effectively curtailed in the UK, and British patients will be denied the benefits of those techniques that have been developed. If the future of close-contact interventional MRI in the UK is is doubt, there seems little point in putting the machine into use at all, and several million pounds of NHS capitai expenditure may as well be written off before it is switched on. CRITIQUE OF THE EU DIRECTIVE The “precautionary principle” is, reductio ad absurdam, the antithesis of any form of progress or innovation. It is an anomalous basis for legislation in a rational society that generally prefers evidence to superstition or ignorance, and it sits ill with the British courts’ insistence on proof of actual harm in determining real cases. Until the 20th century, no human had been subjected to an acceleration in excess of lg, or travelled faster than a horse. Adoption of the precautionary principle in, say, 1900, would have prevented the development of the aeroplane or the motor car. The supposed basis of the Directive’s exposure limits to time-varying magnetic fields is an arbitrary multiplier applied to a reported threshold for some subtle, transient physiological effects. If the same arithmetic were applied to such transient effects as hearing or vision it would be illegal to speak or switch on a light.