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.