EUROPEAN PRESSURE ULCER ADVISORY PANEL

During an excellent conference such as this one expects to hear cool, professional presentations of scientific papers, not an emotional outburst from the association's President. But that is precisely what I will now make! First let me establish my right to make this promised outburst. While my day-to-day work is primarily involved in cardiac medicine, I have some experience with the subject of this conference, namely pressure ulcers. In particular I have been intrigued by the changes in practice that have arisen as the evidence base has grown. Back in 1996, the impact of the available science was not so impressive but this has changed in more recent years. Some interventions we have discarded, for example we no longer use hot air and ice anymore when treating ulcers, nor do we use ultrasound anymore in treatment since prospective, double blind and placebo controlled studies showed that it did not work! Perhaps the greatest challenge now lies not in finding out what interventions work, but to enable the diffusion of these findings to doctors and nurses in all care settings throughout our national countries, both in the cutting edge centres of excellence and in the geographically remote care providers. Regardless of this challenge of ensuring the appropriate diffusion of good practice, let me be clear that in 2001 it is not acceptable anymore either in medicine or nursing that procedures are followed that have not been adequately evaluated.

Making sure that such evaluations occur would appear to be a simple matter of legislation, especially in today's climate of the developing European 'super-state'. But this may not be so; although 'Europe' today may be synonymous with organisation and regulation, for many European citizens this new bureaucracy appears to have side-stepped the democratic process and so may frighten more than it reassures. For example, the introduction of the Euro in place of national currencies was not decided by the European people, but organized by politicians. Most certainly no-one asked for my advice before the Guilder was scrapped! Despite these feelings of alienation from decision-making processes, the new Europe has produced some good results, not least when considering the concept of 'quality'. A European mother can be confident that the yellow toy of her child does not contain cadmium. Visitors to the Royal Box in Ascot can be sure that their strawberries are not treated with pesticides and that the champagne does not contain sulphur. These are examples of quality in action through the imposition of a minimal quality standard (or mark), in this case the CE Mark. This quality mark impacts upon each of us in our daily lives, but just exactly what does it mean? In many cases it may simply note that minimal quality control standards have been imposed with self-certification by the manufacturer. Few realise that there are differing levels of conformity to the CE mark, but that only two levels of attainment really denote strong control of quality within the manufacturing process.

What about quality marks in health care? Patients, regardless of their disease or condition can be assured that they are most unlikely to develop serious side-effects from their medications. There is a clear and consistent path to bringing a new medicine to the market-place - controlled clinical trials following a battery of toxicity testing. These procedures consume lots of time and money, explaining at least in part the high prices of drugs! Few would disagree with the need for such caution when developing a new medicine. Few would also disagree with the need for monitoring once a drug is in use to identify unexpected problems and take swift action is problems arise. For example it became evident that the use of cerivastatin, a cholesterol lowering drug, had been implicated in the death of at least fifty-two patients. That is fifty-two out of the more than fifteen million patients using it. The drug was withdrawn and the manufacturer's value in the stock market was significantly reduced. It is perhaps evident that where drugs are concerned quality can be introduced and maintained.

It is evident to me that the system that works for medications should also apply for all aspects of health care, including pressure ulcer care. Static support surfaces - and especially powered support surfaces - should only be used when they have proven to be safe and to be effective following very thorough clinical investigations to the same rigour of drug trials. That is my view which looks simple but this is not the case. Currently, probably the majority of support surfaces used in pressure ulcer care are self-certificated by their manufacturer as being a Level 1 Medical Device. Such a registration under the CE mark scheme does not call for independent evidence of either safety or effectiveness. It remains possible to both introduce and use support surfaces that may be ineffective or even dangerous. Is this what we want to see in pressure ulcer care? Perhaps you could say that medical devices such as a mattress are inherently less dangerous than a drug and so the processes required to bring both to market should differ? But is this true? The costs of complications such as pressure ulcers can be very high indeed and the use of ineffective interventions will fail to reduce the drain on health service resources. This argument has not yet been explored by our political masters!

Why does the current inequality between the development of drugs and devices continue? Perhaps because device manufacturers are 'poorer' than the drug companies with less money, and smaller returns to be made upon any investment in clinical research? This of course leads to new devices being introduced without prior clinical trials. Perhaps, and let me be controversial, less evidence is demanded from nurses, the purchasers of many of the pressure-redistributing support surfaces? I can only back this up with an observation from my own country, the Netherlands, where a pressure-redistributing overlay was marketed based upon its inclusion within a chapter of a PhD thesis. The data did not support the device as being more effective than the control intervention. However, many nurses were apparently impressed with the concept that a PhD thesis had considered the use of the overlay. Perhaps this reflects a lack of training for nurses in the evaluation of studies, and in particular their statistical tests and conclusions? See I did promise to be controversial in this presentation!

It is evident that European regulations should apply to all pressure-redistributing support surfaces, such a conclusion is logical for the deployment of effective devices should control, or even reduce the costs of pressure ulcer care. EPUAP must play an important role in this process of developing appropriate regulations. However, the role for the EPUAP lies not only in bringing the case for regulations to governments but also in helping manufacturers. We must help our colleagues in industry by agreeing the scientific standards which clinical studies of mattresses and other devices should meet. EPUAP should also facilitate these clinical studies but assisting multi-national trials to be planned and executed. Finally we should be clear that groups such as the EPUAP expect medical devices and drugs to meet common standards for safety and effectiveness.

Perhaps the EPUAP could go one step further and instigate its own quality mark? In an ideal world I could see new devices being approved, or not, by a quality approval process controlled by the EPUAP. Why not? We could become a recognised test centre where manufacturers would bring new devices, pay for the clinical studies conducted by EPUAP and at their conclusion be awarded the 'EPUAP quality mark' or not. It is as simple as that.

We, the EPUAP, have grown from a group of enthusiastic people perhaps without much real knowledge to a group of enthusiastic people with scientific knowledge and we should behave accordingly. We must be prepared to state what is important and in line with our scientific knowledge regardless of all the special interests and hidden agendas that surround all human activity. One of these important statements is that pressure-redistributing support surfaces need to be evaluated in a transparent, consistent manner. Knowledge of their effectiveness is required prior to, and as a condition, of their entry into the marketplace. Perhaps we should start our quality mark now without delay. It could be a real success: the EPUAP-mark.

Editor's comment
Dr Haalboom's call for rigorous evaluation of new pressure-redistributing support surfaces will be welcomed by all members of the European Pressure Ulcer Advisory Panel. Perhaps before setting ourselves up as a testing centre for new products we need to be clear just exactly what we should measure, and how these measurements should be made and reported. The next article from the EPUAP Support Surface Working Group provides a draft statement that may help us deal with the often-misused concept of measurements of the pressures exerted between mattresses and human tissue. The draft report from the Working Group also marks a positive collaboration between academic and clinical researchers within and beyond the health care industry. Perhaps it is only through such dialogue that we, the EPUAP and the industry, will clearly see the shape of the minimum standards required to help establish the quality mark suggested by Dr Haalboom.