This is the main finding set out in our latest report charting an investigation focused on the delivery and monitoring of medication via what is known as ambulatory infusion pumps.
Ambulatory infusion pumps are small, battery powered devices which allow patients to carry out day-to-day activities while receiving medication. They are used for many healthcare needs, including symptom relief during palliative care, and in different settings including hospitals, hospices, and patients’ homes.
Exploration of hazards and controls
Through our investigation, we concluded that even when a device is fully functional and providing audible and visual alerts, there is a risk that staff may not pick up that medication is not being delivered. Under the theme ‘exploration of hazards and controls’ the investigation highlights three main hazards:
- staff checks delayed or not carried out
- patient ability to interact with equipment while the alarm is activated
- ambulatory infusion pump alarms not heard/responded to by healthcare staff.
Some of the safety risks identified in the investigation were seen in the patient case we examined. Stephen, a 45-year-old cancer patient on palliative care in hospital, did not receive his pain relief medication for six hours. This happened on his seventh day as an inpatient on the oncology ward. There was a medication blockage issue, and whilst the device provided an audible alarm, a red light, and a warning message on the device screen, staff were not aware that his medication was not being delivered.
Over the course of six hours, there were eight warnings. The investigation highlighted that when the blockage alarm sounded there was an opportunity for Stephen to interact with the device and intermittently silence the alarm. It also showed that Stephen’s syringe pump was out of the line of sight, and out of audible range, of the nurses’ station due to the hospital infrastructure and working environment.
The report sets out key findings in four theme areas. As well as exploration of hazards and controls (as above), they looked at; ambulatory infusion pumps – national overview; inpatient knowledge and awareness of medical devices and post-market monitoring and surveillance of medical devices.
The findings provided the basis for three safety recommendations and three safety observations. The three safety recommendations are focused on developing national human factors guidance, ensuring that human factors is considered in international medical device standards and developing a mechanism for sharing medical device incident data, including where devices function as designed.
Craig Hadley, Senior Safety Investigator at the Health Services Safety Investigations Body (HSSIB), says: “Our investigation brought human factors squarely into focus when it comes to the medication safety risk around ambulatory infusion pumps. We found that there are issues relating to the design and usability of the device, and factors within the environment of a busy ward that make it more challenging to spot when medication is not being delivered as it should. We considered the hazards and looked at the safety controls in place to manage them and why that might not be effective – for example staff routines, capacity, and perception of risk, contribute to the risk that 4-hourly checks of the infusion pump may be delayed or not happen at all.
“It is important that the safety risks are addressed because, as we saw in Stephen’s case infusion pumps are often used to provide crucial pain relief medication for people with advanced or terminal illness. These devices are often used in settings where patients could be very unwell, on palliative care or are vulnerable and it is vital that there is no gap or delay in the management of their symptoms. The recommendations and observations we have made are aimed at supporting the safe use of infusion pump devices and preventing future occurrences of patients not receiving intended medication.”
Findings in full
- Current ambulatory infusion pump alarms may not effectively notify staff of hazardous situations (situations where intervention by a healthcare professional is needed because there is potential for harm to a patient). Alarms may occur, but if staff are not alerted to them, the required interventions may not take place.
- Current national reporting systems are complicated and do not support the capture and sharing of medical device related incidents across appropriate national bodies.
- To enable the effective cross organisational sharing of incident data local incident reporting systems, which feed into the NHS England Learn from Patient Safety Events service, would need to meet Medicines and Healthcare products Regulatory Agency (MHRA) data standards.
- The main factors that affect staff ability to hear an alarm and intervene in a hazardous situation are the infrastructure and working environment in which infusion pumps are used.
- When staff cannot hear or see an alarm, outside of the 4-hourly infusion pump staff checks, they are reliant on patients or families to alert them to issues with an ambulatory infusion pump. This is not always possible when the patient is unwell.
- International standards used by manufacturers of medical devices do not fully consider the environment in which the equipment is used.
- NHS staff are not always given guidance on how to use specific medical devices in the context of their varying environments, and how this may affect patient safety.
- The inability to access the Palliative Care Formulary (a best practice guide for medication prescribers), as a free resource, may have an impact on patient safety. This can be both in the palliative care specialism and across the wider healthcare system.