New Royal College Meets, Studies Safety, Standards

Jean Lumley

The Faculty of Anaesthetists of the Royal College of Surgeons of England achieved Collegiate status in October 1988. The Annual Symposium held in November therefore became the first Symposiurn of the College of Anaesthetists and it was appropriate that the topic addressed was “Safety and Standards in Anaesthesia”.

The first speaker, Dr. I.N. Lunn from the University Hospital of Wales, commented that while the creation of standards for equipment for anaesthesia was not particularly easy, the matter of standards for anaesthesia organization and clinical matters had hardly yet been addressed. He went on to stress that surveys revealed the commonest source of mishap in anaesthesia is due to human failure.

Dr. E.C. Pierce from Harvard Medical School while reviewing critical incidents in anaesthesia, drawing attention to indications that anaesthesia related injuries, like aircraft accidents, do not usually result from isolated errors. Rather, anesthetic mishaps result from a combination of errors, system deficiencies, and predisposing influences that either help to create an environment conducive to error or a situation in which problems are not easily identified.

The medico-legal implications were discussed by Dr. M.J. Powers, Barrister at law, Temple. He suggested three means by which he believed that the numbers of medical claims could be drastically reduced. They were:

1. Recognition by the profession of the requirement for accountability to the patient, to the profession, and to the public.

2. A requirement for ongoing medical audit.

3. Introduction of minimal standards of anesthetic practice.

He congratulated the meeting on the way in which anaesthesia had led the way towards full medical audit with a degree of voluntary public accountability in the U.K.

Equipment Standards

The second session was devoted to a discussion of standards. Miss M.N. Duncan, Assistant Director, Safety and Quality Supplies from the Department of Health, talked about a decade of government activity in quality and standards. Since 1982, the government has pursued a policy of encouraging quality awareness in all sectors of industry, had taken part in a program of standards writing, and developed a registration scheme for manufacturers to be held to internationally recognized quality standards. She informed the meeting that for the next four years, a new goal in quality standards has been set in the decision to implement a single European market starting in 1992.

Dr. Peter Thompson from the University Hospital of Wales discussed the need for standards and described their history and development. He paid particular attention to the role of the International Electro Technical Committee (IEC) and the International Standards Organization OSO) in the standardization of anesthetic and related equipment. The role of the Test House run by the British Standards Institute in establishing test methods and reporting formats for electro-medical equipment was then discussed by Mr. N. Richardson, Principal Professional and Technology Officer, Department of Health. In addition to detailed testing and the preparation of formal reports, Test Houses offer half day consultations in which they have a thorough careful look at an item of equipment in conjunction with the manufacturer.

The third session was devoted to perspectives of design and function of anesthetic machines and ventilators. Dr. D. Wilkinson from St. Bartholomew’s Hospital reviewed the evolution of the anesthetic machine and Dr. P.L. Jones from the University Hospital of Wales addressed the topic of future developments in this field. Mr. John Mecklenburgh, also from the University Hospital of Wales discussed current design standards of safety for ventilators and the requirement for efficient alarm systems. Professor I.G. Whitwam from the Royal Postgraduate Medical School reviewed ventilation techniques which may be available in the 1990’s.

An interesting session was provided on electrical safety. The speakers were Mr. Mort Levin, previously with Hewlett Packard and Professor C.I. Hull from the Royal Victoria Hospital, Newcastle. It was stressed that achievement of safety is not a trivial task and concern was expressed that existing standards are not adequate. The second speaker discussed the implications of British Standards document 5724 which is concerned with the safe construction and operation of electro medical equipment. He compared the strengths and weaknesses of the standards by comparison with those adopted in other countries and stressed that safety can be maintained only by sensible use, constant of possible hazards, and an absolute refusal to “take chances” with faulty equipment.

The second day of the meeting opened with a session on essential monitoring with a talk given by Professor M.K. Sykes of the Radcliffe Infirmary, Oxford. He pointed out that two of the major tasks of the anaesthetist during an operation are 1) the monitoring of the function of the apparatus used to administer the anesthetic and 2) the monitoring of the patient’s condition.

Role of Monitoring

Although recognizing that there was still no conclusive evidence that the use of monitoring devices results in reduction in morbidity or mortality, he discussed the circumstantial evidence that their use can contribute to safety. He drew attention to the Faculty of Anaesthetists’ requirements for the provision of monitoring equipment in training establishments, published in 1987 and the Association of Anaesthetists’ recommendations for standards of monitoring during anaesthesia and recovery, published in 1988.

Mr. P.J. Schreiber from North American Draeger told the audience that the designer of medical equipment had three measures involving integration of electronic monitoring available to prevent injury to a patient due to operator error. The first measure is to design the equipment in such a way that a human error cannot occur. The second measure is to design the equipment so that no injury results in the event that a human error occurs. The third measure is to warn of the human error and its consequences. While the first measure provides the highest degree of safety, it cannot always be utilized due to the widely varying uses medical and specifically anaesthesia equipment are put.

The sixth session included a talk on Safety aspects of personnel selection of pilots. This was given by Captain A.I.I. Butler, Manager of Flight Crew Training for British Airways. The qualities which British Airways considered necessary for selection into a cadet pilot program were described and the methods of selection were discussed. The larger part of the talk was devoted to the basic operating standards which have been established and the training of pilots to meet those standards, the monitoring of performance, the recurrent training necessary, and the personnel and equipment used in the process of ensuring air safety through the training. In spite of all these safeguards, Captain Butler remarked that 80% of accidents have a human error element.

Psychology of Error

My-. 1. Chappolow from the RAF Institute of Aviation Medicine, talked about the psychology of human error; his analysis was based largely on investigations of aviation accidents. Fatigue was noted to play a part in only 9% of accidents and the effects of stress or personality and accident proneness are not clear cut. Mr. Chappelow said that 40% of human errors included equipment designed errors, inadequacy in training, and failure in administrative support or supervision.

The final session was devoted to equipment management. Mr. B.J. Love, Assistant Director from the Department of Health’s Procurement Directorate, described the purchasing strategies advocated by the Department of Health. He made a plea for buyers to be specialists in their knowledge of the marketplace and hoped that the development of national centers of responsibility for procurement would provide a national focus and locus for acquiring this expertise. In this way it was hoped that closer partnerships would be found between the National Health Service and its suppliers in both the technical and commercial field. Mr. L.F.G. Small, Principal Procurement Technical Officer to the Supplies Technology Division, Department of Health, talked of the investigations of equipment accidents which had been undertaken for more than 25 years. He mentioned a Health Equipment Information Bulletin on equipment management whose implementation has considerably reduced the incidents of equipment failure He stressed that the purpose of equipment management is to ensure that the right equipment is available when required in a safe and serviceable condition.

Dr. J. Lumley, from the Royal Post Graduate Medical School, talked of the acceptance procedures necessary when new equipment has been purchased. She also recommended that great care should be undertaken when accepting equipment back into service after maintenance, whether in-house or out-of-house servicing had been undertaken.

The final talk of the day was a lateral view of safety or risks and at what cost to the public by Mr. Anthony Smith, writer and broadcaster. Again a plea was made to the profession to educate the public. The overall theme which emerged from the meeting was that in terms of safety for patients, user (both physician and patient) education is all important.

Dr. Lumley is Consultant and Honorary Senior Lecturer, Royal Postgraduate Medical School, Hamnersmith Hospital, London.