Chris Quinn, RGN, MBA, PG DMS.
Project Manager, National Patient Safety Agency; former Medical Devices Officer, Newcastle upon Tyne Hospitals NHS TrustInfusion devices are used by many thousands of patients every year, particularly in cancer treatment and diabetes. The National Patient Safety Agency (NPSA) has sponsored a project to detect the root causes of infusion device incidents and to identify ways to prevent their recurrence. The agency is piloting a number of solutions in six NHS trusts to test means of reducing adverse incidents and worrying experiences for patients using infusion devices.
Infusion devices are used by many thousands of patients every year, particularly in cancer treatment and diabetes. The National Patient Safety Agency (NPSA) has sponsored a project to detect the root causes of infusion device incidents and to identify ways to prevent their recurrence. The agency is piloting a number of solutions in six NHS trusts to test means of reducing adverse incidents and worrying experiences for patients using infusion devices.
These solutions were developed following a major review in response to growing problems in the use of infusion pumps that included extensive research into incident data and best practice and listening to patients' views.
What is the NPSA?
Most NHS care is delivered to a very high standard yet, in complex western health-care systems, even the most dedicated and professional staff can make mistakes. The NPSA (covering England and Wales) was set up in July 2001. Its creation stemmed from the publication of two reports on patient safety - An Organisation with a Memory (Department of Health, 2000), and Building a Safer NHS for Patients (Department of Health, 2001).
It was set up as a special health authority to create and manage a national reporting and learning system for patient safety incidents and near misses (NPSA, 2003). An essential part of its role is to create an open and fair culture in the NHS so that staff feel that they can report patient safety incidents; and patients' views and experiences are heard and acted on.
The main consequence is that management processes, systems and equipment are changed to 'design out' the potential for patient harm, wherever possible.
Why investigate infusion devices?
The Medicines and Healthcare products Regulatory Agency (MHRA) (covering the UK) - formerly the Medical Devices Agency and Medicines Control Agency - had noted an annual increase in reported patient safety incidences involving infusion devices.
In a 10-year review of such incidents covering 1990-2000 (Smith, 2002) it was established that in more than half of the reported incidents (1495: 53%) there was no fault found with the equipment and no cause established for the incidents. User error accounted for 19% of these incidents, which was almost three times the average rate for all other medical device groups (7%).
An academic literature review by Professor Peter Buckle, European Centre for Health and Medical Sciences at the University of Surrey (Buckle, 2003) did not point to any solutions but suggested more work was needed to take the human factor into account, particularly in the way the devices were used and the role of patients.
As part of the NPSA project 161 direct reports made to the agency about incidents associated with infusion were reviewed as part of its pilot national reporting work in 2002-2003 (Smith, 2002).
In 45 cases the incidents involved an 'over infusion' of a drug or solution. The most common reports involved drugs and solutions such as morphine, insulin, heparin, potassium crystalloid and parenteral nutrition. Themes that involved inadequate training, equipment management, policy adherence and end-user (staff and patients) involvement emerged as areas that required remedial solutions.
Nurses are so accustomed to the equipment available in hospitals that they may not stop to think much about it. For patients, however, the picture is very different: equipment may be both strange and the source of considerable fear of harm, some real and some imagined. This view emerges from research undertaken on patients' views of infusion pumps, commissioned by the National Patient Safety Agency (Richardson, 2003) as part of a major investigation into the safety of such pumps.
Little research has previously been carried out in this area and virtually no studies of patient views. The broad concern was to explore experiences of safety problems, together with information needs.
A short description of the nature and purpose of the study was prepared for those to be interviewed. A topic guide was used, covering the experiences of patients from their initial use of an infusion pump to the point of completion. Interviews were tape-recorded and transcribed verbatim. The information collected was carefully analysed as a whole and by type of use. A copy of the research report was sent to all people interviewed for comments.
Listening to patients
As part of the project the NPSA carried out in-depth interviews with 24 patients (Box 1). They were recruited through organisations for people with cancer or diabetes and had used an infusion pump in hospital for chemotherapy, intravenous feeding, to alleviate pain or symptoms, or for insulin control. The patients had experienced the use of an infusion pump during a stay in hospital within the past five years.
Of the 16 with cancer, most had used a pump for more than one purpose: 13 for chemotherapy and 11 for morphine or other pain relief following an operation. In one case a woman whose husband had died from cancer was interviewed. Seven people had diabetes, and one woman spoke on behalf of her child, who had diabetes.
Understanding the infusion pump
Reassuring patients through effective information should be an integral part of their treatment - it is not an add-on. When they understand the procedures, they are more likely to be in a relaxed state and it has been demonstrated that this leads to shorter hospital stays (Shuldan, 1999).
In her review of the patient interviews (Richardson, 2003) the researcher said that almost all participants felt that it was important to understand as much as possible about their treatment, including the infusion pump. But there was considerable variation in the extent to which they were informed (see study quote 1).
Most of those receiving chemotherapy said that nurses tended to provide a lot of information while setting up the pump. Typically patients reported: 'That's your time with them (the nurses), when you have an opportunity to talk about it all (infusion devices and treatment).'
Those who wanted information about the pump generally felt able to ask for it, and found nurses ready to answer questions. On the other hand, a few would have liked to have information earlier, as the first day of chemotherapy was 'not a good day to ingest that information'.
In contrast, those who used a pump for pain relief were often given little information or not at the right time. But they agreed that it could be difficult to find the right time for a discussion, as they had other worries immediately before an operation and were too drowsy afterwards.
A few said they were given no information at all and were shocked to wake up and find themselves attached to a pump.
The role of the booster button on some infusion devices in the use of morphine was an issue where clearer information was felt to be particularly important. Two participants were hesitant to use their morphine fully for fear of addiction. One woman was very worried that the supply might run out and therefore tended to under-dose herself: 'I was very nervous of using up my quota (of morphine) and then not having pain relief for a long time afterwards.'
Few participants could remember having been given any details on safety issues concerning the pump, such as the alarms, battery management or a need to avoid mobile phones (MDA, 1997).
Some said that they had seen notices about not using mobile phones because it could affect the equipment, but were not clear about the details. One patient said: 'We were never told which equipment. I thought it was for people on ventilators.'
Most participants felt their pump was well supervised. Nurses were said to respond fairly quickly when alarms went off, especially those on pumps providing chemotherapy. But some, particularly those using pumps for pain control, said alarms were often not responded to quickly. One woman, whose morphine had run out, was left in pain for several hours.
Patients varied in their willingness to question or refuse treatment from staff they regarded as less competent - a number wished to and some did. At least one patient did not question a member of staff because she did not want to give offence. But others did challenge their care (see study quote 2).
Many participants disliked the physical restrictions imposed by a cannula. One man described lying in bed 'like a statue' at first, because of fear of pulling it out.
Others talked about the difficulty of performing ordinary tasks, such as getting out of bed, eating or reading, where one needed to move the hand and arm. The pulling of the needle entailed in such activity could be the source of anxiety.
A number of patients found the pump's movable stand awkward to manoeuvre (see study quote 3).
Emotional needs and support
A number of patients felt that their emotional needs associated with the pump had been neglected. They stressed that finding themselves in need of such treatment was in itself difficult and the pump only served to underline the seriousness of their situation (see study quote 4).
One patient was scared when he saw an air bubble for the first time: 'I remember being totally petrified. I thought 'right, that is it - you are a goner!'.'
Several people were extremely concerned when they saw blood tracking back up into the pump. One man found it disconcerting that the pump faced away from him, as he felt himself connected to an 'alien' thing; this would have been eased if he could have seen it.
Perhaps the most worrying event was hearing the infusion pump alarm for the first time. This was not only annoying but could cause panic among those who assumed that it indicated a crisis. Moreover, the fact that they went off frequently raised a fundamental issue of patient safety because everyone began to ignore them (see study quote 5).
A few patients were more positive. Two said that they came to view the pump as a 'friend', because it was providing important pain relief or treatment.
Most of the patient safety incidents arose from human error. Two patients had had their lines severely pulled on or pulled out accidentally. In one case, a line was caught up in a vacuum cleaner by a cleaner, and in another a nurse trod on a crucial wire (see study quote 6).
Issues for regular insulin pump users
For regular insulin pump users with diabetes, the principal problem was not coming to terms with new equipment but getting the hospital staff to allow them to use their own pump while they were in hospital.
Four patients had managed to do so and appreciated the decision. One said: 'It was very much a case of 'you know what to do with your pump, so if you're happy, we won't mess about in any way, unless there is an emergency.''
These patients were, however, concerned about the ability of hospital staff to cope with their pumps, for instance if patients were under an anaesthetic, due to a lack of familiarity.
The participants with diabetes on regular insulin pumps argued that nursing staff needed to gain more familiarity with these pumps, possibly through more focused discussions with users. But they did note that clinical staff were eager to learn.
One participant had to use hospital equipment rather than her own pump during five separate hospital stays for operations. She ascribed this to ignorance on the part of hospital staff, and disliked having decisions made for her.
The most common recommendation from the research participants was that nurses needed better training on how to work with and around infusion pumps (Richardson, 2003).
It was suggested that all nurses, even those who would not normally handle a pump, should receive basic skills training, so they would know how to cope in an emergency.
Being on a pump is an unusual experience and patients can require considerable emotional reassurance. Nurses can overlook the intensity of patients' fears concerning pumps. One patient said that nurses should be required to experience patients' sense of confinement for a day or two 'just to see what it's like'.
The need for patients, and wherever possible the main carer, to have fuller information about the patient's disease and treatment was stressed by many participants. This should include the following information about the pump:
- Why patients were having one
- How it operates
- How long they would be having it
- The dosage
- Likely problems
- Details of the pump's use.
Participants also stressed that patients should be given ample warning about potential worries, such as air bubbles and the alarms.
The NPSA is piloting a toolkit, testing a range of measures to reduce the number of errors associated with the use of infusion devices.
It is now working with manufacturers, the NHS Purchasing and Supply Agency, MHRA and six NHS trusts - Hull and East Yorkshire; Blackpool; Epsom and St Helier; Cardiff; North Cheshire and Leeds - to test practical solutions to improve the way the devices are purchased, used, stored and maintained.
Different elements of the solutions are based on good practice that has already been identified in a number of hospitals.
For the elements that make up the toolkit see Box 2. The purpose of the pilot is to bring these elements together into a single package of solutions, to gather evidence on the effectiveness of each solution, and to ensure that they are practical to implement across the NHS. The results of the study will be used to inform both future purchasing decisions and manufacturers' design processes.
The NPSA is also promoting competency-based training for staff in rapidly advancing infusion device technology. A dedicated infusion pump website and a web-based training tool to support trusts in carrying out infusion device use training for staff is in development and should be available in the new year after testing.
As a consequence of the patient experience review, issues have been highlighted in two key areas - communication relating to treatment and patients' lack of confidence in staff training.
Clinicians need to hone their skills in informing patients by talking to them and using written material, based on an understanding of patient concerns. Information in plain English that is easy to understand and promotes a questioning, supportive and empowering experience for patients should help to reassure them in this technical and high-risk area.
The challenge is to provide information for patients that is an integral part of their treatment and not an afterthought or add-on. The NPSA is developing leaflets for patients on infusion devices and will be producing a pilot version for testing before distribution to the wider NHS.
The agency is working with patients to identify the information that they want and how to present it.
The patients interviewed generally felt a lack of confidence in the standard of staff training (or lack of training) in the use of infusion devices. Many were surprised that training was not regarded as mandatory by many trusts. They believed strongly that it should be compulsory and that trusts should not just pay lip-service to the need for training.
Training is a national concern and the NPSA is working to develop a national framework of competency standards to help trusts train staff. Patient views are expected to form a key part of the training programme on the use of infusion devices.
Study quote 1
'I was given no information on the first two pumps. I was told about the surgical procedures, not about how I would feel afterwards or what would be attached to me.'
- Toby, landscape architect, aged 40, a patient with cancer of the oesophagus, who had infusion pumps for pain relief and feeding and then later for chemotherapy
Study quote 2
'It's my life and I'm not having this (treatment) unless I'm one hundred per cent comfortable (with what was about to be done).'
- Sharon, age 47, a patient with aggressive non-Hodgkin's lymphoma. She refused treatment from a nurse after she queried a procedure that was about to be administered, and the nurse could not explain as she did not speak English well.
Study quote 3
'It was particularly difficult going to the toilet as a man and having to keep one hand free. It's a complete art form being able to walk around with one of those - any cancer survivor is a Fred Astaire by the end of it.'
- Andrew, age 66, a patient with colorectal cancer
Study quote 4
'Faced with these pumps and things (related to treatment), emotionally, it was a big shock ... I could see my life changing. You never think you're going to have to be wired up to one of these machines and have drugs pumped into you.'
- Susan, age 47, a patient with breast cancer
Study quote 5
'It could go wrong eight times in a night - you'd be just going back to sleep and it would bleep again; sometimes I felt like throwing the machine out of the window.'
- Annie, age 38, a patient with acute myeloid leukaemia
Study quote 6
'I've worked in TV as a producer, and there was a rule that no one ever stepped across a cameraman's cable; there should be a similar rule about stepping over any line connecting patients to equipment.'
- Lisa, age 39, a patient with non-Hodgkin's lymphoma, who had a Hickman line for chemotherapy. While three nurses were 'bustling' around the bed, one stepped on the line and pulled it out.
Buckle, P. (2003) Infusion Device Project Literature Review (unpublished NPSA document). London: NPSA.
Department of Health. (2000)An Organisation with a Memory. London: The Stationery Office
Department of Health. (2001)Building a Safer NHS for Patients - Implementing An Organisation with a Memory. Available at: www.doh.gov.uk/buildsafenhs
National Patient Safety Agency. (2003)www.npsa.nhs.uk
Medical Devices Agency. (1997)Electromagnetic Compatibility of Medical Devices with Mobile Communications (DB 97 02). London: DoH.
Smith, A. (2002)A Review of Infusion Device Incidents Reported to the Medical Devices Agency (MDA) between 1990 and 2000 (unpublished NPSA document). London: NPSA.
Richardson, A. (2003)Infusion Pumps: The experiences and views of patients (unpublished NPSA document). London: NPSA.
Shuldan, C. (1999)A review of the impact of pre-operative education on recovery from surgery. International Journal of Nursing Studies 36: 2, 171-177.