Rapid Responses to:

EDITORIALS: Tom Dent, Sally Wortley, and Bruce Campbell New interventional procedures BMJ 2004; 329: 3-4 [Full text]

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Rapid Responses published:

New Interventional Procedures - inadequate guidance and regulation

Anton E Joseph   (8 July 2004)

Regulatory body for safety and efficacy of interventional procedures is an urgent priority

Anton E Joseph   (13 July 2004)

Naive call for more evidence on new procedures

Reiner Banken   (29 July 2004)

New Interventional Procedures - inadequate guidance and regulation 8 July 2004
Anton E Joseph, Consultant Radiologist, Mayday University Hospital, London Road, Croydon Surrey CR7 7YE Send response to journal: Re: New Interventional Procedures - inadequate guidance and regulation	It was rather disappointing to see that an editorial of such importance has had no rapid response at the time of this submission. Perhaps like me others too were planning a delayed response. I must admit that I was a little disappointed that like many dealing with problem areas the editorial proceeded to cover the problems very thoroughly but when the question was asked "What can be done?" The reply was the expresion of a few pious wishes. Perhaps the authors were influenced by the fact that they were employees of NICE. NICE after all claims to provide guidance and it would have gone against the grain of the institition to have said anything that might sound even remotely regulatory or dictatorial. May I illustrate the need for greater "control" with an example that I have been greatly interested in for some considerable time. This example illustrates vividly all the problems outlined in the editorial and perhaps justifies the solution which I will propose. Image guided biopsies or Fine Needle Aspirates have been around for a considerable period of time. At the time of its introduction it was clearly a technique to be embrassed with open arms since it was simple, easy to perform, accurate and provided the vital information required for proper treatment. Over the years tumour seeding along the needle track came to be recognised as a complication. In particular with the needles used for ultrasound guided procedures which had serrations of the needle tip to increase their detectability in tissues, there was an even greater hazard since these serrations were documented to trap cells and deposit them along the track and subcutaneously. This evidence was published but the sale of these needles continued without any restrictions. In fact more recently a needle with pits in a coating along the entire length of the needle has been introduced into the market. I must however emphaticaly state that I am not aware of any studies that have demonstrated any increased cell trapping or cell "dragging" with the use of this particular needle. Even the smooth neeedles as may be used with CT or ultrasound guidance have been shown to have cells adherent to the surface resulting in tumour seeding. It is clearly a retrograde step to entirely abandon this procedure. It is however essential that some form of regulation, not necessarily a dictatorial one be introduced to oversee this type of situation. It is fairly obvious to those who have been carrying out this procedure for a long time that there are means of virtually eliminating this complication by the use of a coaxial technique where by the biopsy or aspirating needle is passed down the lumen of another needle which could be placed at the margin of the lesion without penetrating the lesion. The biopsy needle can then be withdrawn without making any contact with the tissues. The editorial concludes that no clinical guidance can remedy the underlying reasons for the limited attention given to evaluating the procedures. This is precisely the situation that an authoritative body guided by experts could provide useful guidance rather than waiting for controlled trials etc.. It is not very pleasant perhaps demeaning for those in the interventional field to be identified as a group who for cultural and educational reasons do not find rigorius evaluation attractive. This attitude is not highly conducive to recognising at least some of the reasons why these procedures have not undergone evaluation. I would contend that it is not sensible to compare image guided biopsies with the old means of obtaining tissue surgically. What is very sensible is to compare the results and complication rates using the different types of devices and techniques in use. Manufacturers are not going to bend over backwards to subject their devices to careful scrutiny unless this is a requirement. It is therefore essential that there should be a body which is empowered on the basis of evidence and information to authorise or withhold the use of a procedure or permit its use on a limited basis till the necessary evidence exists. NICE has claimed a more benign mantle and hence perhaps it would be the function of an organisation such as the Medical Devices Agency or its current version. I cannot see why there should be any objections to such a requirement. After all as the editorial points rigorous controls are in place for the introduction of drugs. In the interest of patients it is not accptable to accept the adoption of new surgical, invasive procedures or medical devices without assessment of their safety and efficacy. Any body empowered with this task must be flexible enough to meet the clinical needs and the particular circumstances. After all there is a good model in NICE for it to emulate. Competing interests: I am involved in the development of a needle with improved detectability with ultrasound
Regulatory body for safety and efficacy of interventional procedures is an urgent priority 13 July 2004
Anton E Joseph, Consultant Radiologist Mayday University Hospital, London Road, Croydon Surrey CR7 7YE Send response to journal: Re: Regulatory body for safety and efficacy of interventional procedures is an urgent priority	Having submitted the rapid response to this editorial, I discussed the contents with my colleagues, who felt that I had not emphasised a very important aspect highlighted in the editorial. Hence my further submission. The editorial makes a shocking revelation that new surgical and invasive procedures enter clinical practice without assessment of their safety and efficacy. Even more significantly patients are offered treatments without adequate proof of the benefits or indeed harm to the patients, who are meant to have given their informed consent to undergo these procedures. This situation therefore raises a major moral and ethical issue in addition to the whole process of consent as currently practised. The authors should be highly commended for their willingness to bring this out into the open. Had it not been a publication from employees of such a prestigious organisation, I would have been submitting a rapid response asking the authors to provide proof before accepting these statements. I am surprised that the lay press have not picked on this and had not gone to town with it. We are supposed to be working in an environment of clinical governance with a plethora of organisations that are meant to ensure the safety of patients. Clearly the guidelines and the regulations covering this aspect of medical care is grossly inadequate. This poses a simple but vital question. Who is responsible for this state of affairs. Surely it must be the responsibility of the Department of Health and ultimately that of the Secretary of State for Health. I do not think that this is a matter that could be left in the hands of the medical profession or the manufacturers. Self regulation has clearly failed. In my previous submission I pointed out how in spite of evidence being available regarding the potential for a particular type of needle to increase the risk of tumour seeding, the manufacturers continued to promote it, clinicians continued to use it and there was no authoritative organisation that acted to question its use. Perhaps I was wrong in my judgment that my intervention would be misinterpreted in view of my competing interests. NICE clearly states that they would consider all matters brought to their attention, but this is grossly inadequate for this situation. There should be a requirement for anyone undertaking a new procedure to notify an organisation identified for this purpose. Approval must be obtained before the procedure is put into practice. There should be a requirement for the submission of progress reports. As for notification of drug reaction and side effects there should be notification of complications till the procedure is cleared for regular use and possibly thereafter. It is however an absolute necessity for the identification of an approved organisation with the necessary powers. Too much beaurocracy should be avoided at all costs. As I have pointed out before, NICE have shown the way to successfully handle problems of this nature. If pre-emptive action makes the case for going to war, patient safety also justifies and demands pre-emptive action. Competing interests: I am involved in the development of a device for use with ultrasound guided interventional procedures
Naive call for more evidence on new procedures 29 July 2004
Reiner Banken, Consultant in Health Technology Assessment Montreal, Canada Send response to journal: Re: Naive call for more evidence on new procedures	In their editorial Dent et al (1) call for greater efforts in evaluation of interventional procedures. Ressources needed to do these evaluations are however difficult to find. The transnational drug industry has ressources much greater than the fragmented medical device industry. More stringent requirements before devices can be sold will diminish innovations necessary for better treatments. Public money is therefore needed to improve our knowledge of the benefits and risks of interventional procedures, especially innovative procedures in surgery, which often do not require new devices from industry. While hoping for public money for evaluating interventional procedures we must find ways to make coherent decisions concerning new promising interventional procedures with insufficient evidence on effectiveness and safety. Claxton et al have proposed an economic model showing that that the amount and type of evidence required to support the adoption of a health technology will differ substantially between technologies with different characteristics (2). This type of framework may help in setting priorities for investing public resources for evaluating interventional procedures. As pointed out by Maynard et al (3) the effectiveness of both new and existing technologies should be assessed. Indeed new interventional procedures must be compared to the existing. Considering the limited evidence for many interventions (4) the call for greater efforts in evaluation of interventional procedures sounds naive from those in charge of NICE’s interventional procedures program. We do need more pragmatic and realistic discussions on the use and need of evidence on the effectiveness and safety of new interventional procedures than provided by this editorial. References 1. Dent, Tom, Wortley, Sally, and Campbell, Bruce. New interventional procedures. BMJ 329(7456), 3-4. 2004. 2. Claxton K, Sculpher M, Drummond M. A rational framework for decision making by the National Institute For Clinical Excellence (NICE). Lancet 2002;360:711-5. 3. Maynard A, Bloor K, Freemantle N. Challenges for the national institute for clinical excellence. BMJ 2004;329:227-9. 4. Cuervo, Luis Gabriel and Aronson, Jeffrey K. The road to health care. BMJ 329(7456), 1-2. 2004. Competing interests: None declared