by Mr Chris Quinn RGN, MBA, PgDMS, FETC, ENB 100, ENB 998
Medical Devices Officer, Royal Victoria Infirmary & Associated Hospitals NHS Trust
Newcastle Upon Tyne
The development and impact of technology has never been more apparent than in today's health care environment. This is particularly evident in the nursing and midwifery professions. Sophisticated procedures, techniques and risk management requirements have led to the continued development of all types of devices.
There has been an emphasis shift whereby many device functions have moved from being one of supporting clinical practice to that of being an integral requirement in treatment delivery. The ability to reduce hospital mortality is associated with the amount of technology available (Bastos et al 1996). Clinicians are at a stage that without the use of the many available devices procedures could not be carried out safely. "Remarkable progress in improved outcomes from some conditions, particularly when severely ill patients, are treated in well equipped and well managed intensive care units (ICU) which have clear directorship and comprehensive management guidelines and protocols" (Zimmermann et al, 1993).
This however, is a double edged sword because as devices become more complex the associated risks also increase and as such also need to be managed. It is clear that improved training is an integral part of any good risk management strategy (Cooper 1994; Orser & Oxorn 1994). How many nurses or doctors can claim that they have had comprehensive competency based training on the devices they use, the author suspects not many. It is also increasingly evident that unless NHS Trusts start to address risk management issues significant financial penalties may be incurred through an ever increasing trend towards medical negligence claims ( Bourn 1997).
This article focuses on the steps taken by one Trust to minimise the risks associated with the use of intravenous infusion devices through the development and introduction of a quality training strategy.
The Risks Associated With The Use Of Infusion Devices
Infusion devices facilitate the administration of both simple and complex pharmacological regimes. The evolving complexity of these devices and a need for training is highlighted in the Health Equipment Information document HEI 98, the "Management of Medical Equipment And Devices", from the Medical Devices Agency (MDA), an arm of the Department Of Health. Evidence suggests from the adverse incident reports that the MDA receive that many incidents occur as a result of inadequate training of the user, or service personnel. In the financial year ending March 1996 over 4,000 adverse incidents were reported to the Medical Devices Agency with over 400 relating to infusion devices ( MDA DB 9701, 1997). This report indicates that a significant portion of these adverse incidents are related to syringe pumps and that nationally there has been a steady increase in the numbers of incidents reported over the preceding five years. The worrying aspect of these figures is that the MDA estimate that only around 10 - 20% of incidents get reported. This figure is based on anecdotal evidence obtained by MDA personnel asking people during field visits and manufacturers perceptions when they do a recall on equipment and start asking people if they've been having problems. If this is correct then it represents a gross under reporting. It is the authors belief that under reporting is possibly related to the "fear factor" experienced by staff who may be wary of disciplinary action, a pathway traditionally used by many Trusts. Another consideration is that many device related errors are attributable to "human error" and are dealt with at local level and as such do not need to be reported to the MDA.
One of the main areas where human error is common is during the drug calculation process. A study by Rolfe and Harper (1995) found that out of 42 clinicians who felt that they were adequately prepared to calculate drug doses, only 19 answered all the questions correctly during a calculation test. This study concludes that "drills and experience in clinical practice have an important effect on clinicians to calculate drug doses accurately". Baldwin (1995), reviewing the above article, also writes that many undergraduates despite having passed 'A' level math's could not perform simple calculations. Adams and Duffield (1991) also concluded that drills and experience in clinical practice have an important effect on nurses ability to calculate doses accurately and that after a relatively short break from this practice nurses skills deteriorated rapidly. The frequent recurrence of similar incidents is also a worrying trend for the MDA, " A particularly disturbing feature has been the recurrence of accidents with similar causes, in spite of earlier warnings describing such accidents in considerable detail and containing suggestions on how they may be avoided" (Health Equipment Information Bulletin No.98 ,HEI 98, 1991).
There is no doubt in the authors mind that one of the main reasons for accident recurrence is related to the general lack of ownership at management level to ensure that the many safety action bulletins and hazard warnings issued by the MDA are followed through appropriately. The information related to the financial cost of clinical negligence related to infusion device error is not readily available although a report from the National Audit Office (Bourn J: Comptroller and Auditor General, 1997) estimates that overall; "the cost of clinical negligence to health authorities and NHS Trusts was approximately £200 million, in cash terms, in 1995 - 96, and the cost of claims was likely to rise by 25% p.a. over the next 5 years. The NHS summarised accounts for this period contain provision totaling £80 million and identify contingent liabilities of some £1.6 billion". High risk procedures, such as in the use of infusion devices, will probably provide an increasing focus for negligence claims when things go wrong. These escalating figures cannot go unchecked and should prompt urgent action to develop management strategies that minimise clinical risks to patients, clinicians and Trusts. The likelihood of litigation against health service organisations and individuals increasing is very real, "an increase in medical negligence litigation,.... as patients come to expect more of their health care and are at the same time becoming more aware of their legal rights patients will want a full explanation and very often the possibility of compensation, but often a desire for the allocation of blame will provide the motivation to approach a solicitor" (Spring & Price 1995).
Contributing factors that lead to the reporting of adverse incidents are inadequate training or knowledge, lack of awareness, inferior quality equipment, inadequate servicing arrangements, use of unsuitable equipment and inadequate documentation and record keeping ( MDA DB 9504, 1995). Health Equipment Information bulletin No. 98 (MDA 91) highlights where the responsibility for addressing the issues rests; "The importance of ensuring safety in the use of equipment is stipulated in the Health And Safety At Work Act (1974) and the Consumer Protection Act (1987) which places a clear obligation upon all employers and employing authorities to safeguard the health, safety and welfare of patients and employee's who may be working or, visiting the premises". As well as statute there is a myriad of recommendation made by the Medical Devices Agency on the management of medical devices. These are available free of charge to NHS organisations. Examples of Infusion Device information can be found in the documents, The management of infusion systems (MDA DB 9504) , Infusion Systems (MDA DB 9503) and The Management of Medical Equipment and Devices (HEI 98), these contain all the information required to develop appropriate risk management strategies in the use of medical devices. It is the authors view that the information above may not be receiving as much attention as it should . This view is supported by the continued increase in the reporting of adverse incidents and increasing litigation costs.
Developing A Training Strategy
The Royal Victoria Infirmary & Associated Hospitals Trust, Newcastle, decided to address the training issues discussed above and appointed the author on a one year seconded post. The focus of the role was to raise awareness into the use and management of medical devices across the Trust with a particular focus on infusion and monitoring devices. The objectives covered implementing an educational and training program which addressed;
Because of the limiting time scale a Medical Devices Project Group was established, led by the author, to facilitate the process. This group comprised nursing membership from the seven directorates within the Trust.
As part of the process the following activities were facilitated; the supply of device information packs to all wards; risk assessment of at least three wards and departments in each directorate; the adaptation of nursing practice to meet national recommendations; the training of project group members to cascade and continue the awareness sessions within their directorates at the end of the project period; and, most importantly the piloting of a national training scheme for infusion and monitoring devices, called "Finger On The Button" (FOTB).
Very early on in the project it became evident that Training would become the biggest issue in addressing the problems above. The awareness sessions identified that staff knowledge was limited regarding device management, and that they had received little or no training in using infusion or monitoring devices. Other areas for concern that were highlighted were that many staff could not perform simple drug calculations. It was clear that national trends relating to the above were reflected within the authors organisation.
It was also clear that any training undertaken needed to be comprehensive and should include the deficits highlighted. The design of the national pilot training scheme "Finger On The Button ", appeared to meet these needs.
Finger on The Button (FOTB) Training
This training program was developed, launched autumn 1996, following three years preparatory work by pharmacists, clinical staff, scientists and trainers working in the health service, experienced training consultants and equipment manufacturers from the private sector. The program design comprises, open learning, study days, skills training and competence assessment.
FOTB training initially focuses on two key families of equipment, infusion and monitoring devices, each family having it's own learning pack. The main benefit of this system is its flexibility of use. The training program has been developed as a direct result of the experience of staff at the Hammersmith Hospital, London, who went through a risk management exercise culminating in the development of a strategy for the management of medical devices. Addressing training issues was seen as one of the main focus areas in responding to the risk assessment recommendations. At each stage in the program individuals are tested, who need to pass before moving through each stage. The result is a training program which has been designed to meet particular training objectives and satisfy operational requirements of staff working day to day with electronic medical equipment. Both packs cover four main phases of training;
- Preparation : this covers basic theory and operation, self assessment (diagnostic) and preparatory knowledge e.g. drug calculations and interactions.
- Study day : this includes an assessment to test self directed learning, universal housekeeping and safety issues and Device function issues.
- Equipment Training : this again includes demonstrations, supervised assembly, practice and assessment of learning.
- An on the ward assessment (OTWA) : Staff competencies are assessed in individuals' areas of work.
In evaluating the pilot at the Royal Victoria Infirmary, Newcastle, all participating staff found the learning process to be positive, in particular the design of the packs, which provide instant feedback and remedial suggestions. It was described as "user friendly" and "non threatening", apart from the evaluatory test on the study day, and was said to be "a very useful resource". Following the Pilot evaluation the Trust has decided to implement the FOTB training for all staff as part of a risk management drive.
There is no doubt that the FOTB training helped focus staff on a number of issues. Staff were unaware of the various classifications of IV devices, e.g. Neonatal, High and Low Risk Devices, and the significance of such. Devices are still appearing in circulation that are obsolete, and have had to be removed. The use of such devices would certainly increase the risk to patients if used inappropriately e.g. low risk classification devices used for high risk drug applications. Training has raised the awareness of staff in this respect. During the company training element of the FOTB training it became evident that staff did not fully understand the functions of one particular volumetric pump and the effect that it had on a pressure occlusion alarm. One nurse did not understand the anti free flow function on another, they thought that it was just a simple line clamp and in practice did not fit it to the pump. There is no doubt that these sessions highlighted that staff knowledge prior to training was incomplete.
The fact that a focus has been given to staff through training has led them to question other aspects of their practice in relation to national and local guidelines. Listed are some of the initiatives that the project group are addressing in relation to the recommendations being made. Medical Devices Agency DB 9504 (The Scottish Office Home and Health Department) "The Management of Infusion Systems" Appendix 7 of this report summarises the recommendations of details to be recorded at the start of an infusion, and at each check. The project group looking at how best to address this, agreed that where possible current practice should be adapted rather than introducing new practices. To this end the current additive label was redesigned with the introduction of a carbon copy top piece which can be placed in the patient records as an auditable record of both device and drug.
Clinical negligence is costing the NHS over £2m per year and will increase by 25% per year over the next 5 years ( Bourn 1997). The risks associated with the use of high tech devices, in the presence of poor training, are great. The medical devices agency received over 4,000 adverse incident reports in the year 1995-96, this figure has increased every year for the past 5 years ( MDA DB 9701, 1997).
Lack of training is identified as a significant cause of infusion device related adverse incidents. Training in many areas is either little or non existent and tends to be experiential and not competency based. The need to develop appropriate training strategies is needed if the 'bleeding vein' of clinical negligence payments is to be arrested.
This author believes that training should be facilitated, structured, coordinated and competency based otherwise it runs the risk of fragmentation and becoming ineffective. The appointment of a Medical Devices Officer is a cost effective way of addressing the issues highlighted in this paper as well as implementing local and national issues and should be explored in other similarly sized Trusts.
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