Safety matters

Over the past few years, problems of anaesthetic safety referred to the safety committee of the Association of Anaesthetists have been fairly low key and generally easily resolvable. Recently, however, several more important safety issues have come to the fore, some of which are not so easily resolvable. It is important to know what these are and how the Association is helping to tackle them. Some issues, as will be discussed later, are a result of recent medical disasters or near disasters, whilst one of the main issues at the moment involves prevention of a perceived problem. In August last year, the Medical Devices Agency (MDA) issued a bulletin on single-use medical devices [1]. Key to this document was the statement that devices designated for ‘single use’ must not be reused under any circumstances and the bulletin warned of the legal consequences of so doing. Although the bulletin encompassed other issues, the driving force behind it was the Department of Health's almost obsessive preoccupation with preventing transmission of prion disease, particularly variant Creutzfelt–Jakob disease (vCJD). In anaesthesia, transmission could theoretically occur by not changing all disposable items that come into contact with the patient or patient's breath. This could include the anaesthetic circuit and other parts of the anaesthetic breathing system (such as the carbon dioxide absorber) as the manufacturers of the majority of anaesthetic filters would not guarantee that prions could not pass through the filter. The majority of anaesthetic departments in the UK use a single-use anaesthetic circuit separated from the patient, at the patient end, by a bacterial/viral filter. Common practice is to discard the filter after single usage. The same does not apply to anaesthetic tubing. Departments tend to discard the tubing after each list, after each day's operating or after a week or even longer. Most of these anaesthetic breathing circuits are marked for ‘single use’ only. Some countries do in fact throw the circuits away after each case. The dilemma is clear. Is it now necessary to discard the anaesthetic breathing circuit after every case or should we continue with current practice? If the circuits have to be thrown away after each case, what of other items coming into contact with the patient or the patient's breath such as laryngoscope blades, laryngeal masks, soda lime and so on? It is important to look more closely at the issues. In January of this year, the Department of Health singled out tonsillectomy as a particular area of concern. This was because prions are detectable in reticuloendothelial tissues. The Department issued guidelines on the use of disposable surgical instruments for tonsillectomy. The implications for anaesthesia were concisely presented in the May issue of the Royal College of Anaesthetists Bulletin[2]. There was a statement that for all other procedures normal practice should continue. Normal practice, however, as described previously, is in some conflict with the MDA bulletin. Does ‘single use only’ on an anaesthetic circuit really mean single use? It would be stretching credulity a little far to suggest that single use relates to a time period rather than an individual patient, but there is another facet to this. If a manufacturer stamps ‘single use only’ on a product then that absolves the manufacturer from having to describe how the item can be prepared for reuse with all the legal implications thereof. Reuse in these circumstances may be difficult as prions are notoriously difficult to eliminate by any method of decontamination. There is a view that the manufacturers could be more specific about reuse of their breathing circuits. This may not be in the manufacturers best financial interest in the short term but as this edition goes to press, one manufacturer is indicating that as prions pass through breathing system filters in water and their filter does not let water pass through, aerosolised prions would be removed with an efficiency in the 99.999% range – progress indeed! This may well be a way forward. The alternative is destruction of the circuit and other items described above for each individual case. The cost is high both financially and in terms of storage space. One large Trust has put the annual cost at a conservative £250 000. The environmental cost of destroying large numbers of disposable items may also be substantial. The risk of an individual contracting vCJD from anaesthetic tubing must be remote. The likelihood of any legal action against a Trust or individual being successful in the future must be even more remote. In response to the MDA bulletin, the Association has asked the Department of Health for clarification. The Department has suggested that the AAGBI should meet with representatives of the manufacturers (BAREMA) and the Medical Devices Agency. This has been done and we are now seeking a meeting with the Chief Medical Officer to discuss this and other safety concerns. It is hoped that some interim advice will be available to members shortly. Two incidents have occurred this year involving epidural/intrathecal and intravenous connections. In one incident, it is understood an epidural drug was given intravenously and in the other a drug intended for intravenous use was given intrathecally [3]. Although this latter incident was not related to anaesthesia, the inferences drawn in the extensive report on the incident have repercussions for us. Sadly, both incidents had tragic consequences. Interest in the causes of medical accidents over recent years has focused on systems failures. If every part of a system goes wrong at once on a particular day, an incident occurs, the so call ‘Swiss Cheese’ effect. The report on the inadvertent intrathecal injection describes in detail the safety aspects of protocols, communications, operational practices and so on. Of interest to anaesthetists is that the report suggests that different fittings and connectors should be used so that intravenous fittings are separate from intrathecal/epidural fittings and the two cannot be cross-connected. At present, of course, most syringes and giving sets can cross-connect both areas. The Association is aware of a variety of interesting ways to prevent cross-connection: altering male/female connections, anticlockwise locking systems and so on. The difficulty will be trying to bring these ideas to manufacture. Very few companies making medical plastics are now based in the UK and it would require a European, if not global, standard in order to begin manufacture, which takes time. Nevertheless, the Japanese, after an intravenous/enteral feed misconnection did manage in a short time to manufacture different connectors for the two systems. Labelling of drug ampoules and the labelling of syringes in the anaesthetic room are two other areas where there are safety concerns. There are an increasing number of enquires to the Association concerning the issue of labelling. Drugs are made by a variety of manufacturers and different drug ampoules containing the same drug can be labelled very differently and this may lead to confusion and error. Syringe labels are also variable throughout the UK. Some are black on white, others colour coded for different types of drug. Each manufacturer's colour codes may be different and lead to confusion when, for example, a trainee moves to a different centre. Some take the view that to make ampoules and syringe labelling more uniform may increase the likelihood of a drug error, as the anaesthetist may not read the ampoule or label. Drug errors have been reported where the wrong drug has been given despite clear labelling on the syringe. The majority view would be that creating uniformity, although never eliminating entirely the possibility of error, would go someway to help the situation. For this reason, working groups have been started by the Association, both alone and with other organisations to look at this area. It may be easy to go to a uniform standard of syringe labelling but not so easy to encourage the manufacturers to make ampoule labelling uniform. Needlestick injuries are of increasing concern to all health workers. Viral illnesses contracted as a result may have a devastating effect on a career. Doctors are injured about half as often as nurses but we do not have accurate data for the number of anaesthetists incurring injury, contaminated or not. We are trying to obtain such data. Some departments have now moved away from using sharp needles to draw up drugs and there is now a range of self-sheathing needles available in the UK. Further information on needlestick injury is available on the website ‘needlestick forum.net’. Finally, in another major incident this year, a child was inadvertently given 100% nitrous oxide in an A & E Department. The Association and BAREMA have sent a letter to all Chief Executives and stated that all anaesthetic machines should have an oxygen analyser attached immediately and that plans need to be made now to ensure that all machines within their Trust are fitted with a hypoxic guard. There are other safety issues with which the Association are at present dealing but the above is an outline of the present important areas under discussion. They are all at varying stages of resolution; the important point is that the Association is active in its involvement in these areas of safety and will continue to be so.