HSSIB: Risks to medication delivery using ambulatory infusion pumps – design and usability in inpatient settings (15 November 2023)

Summary

Ambulatory infusion pumps are small, battery powered devices that 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.

Despite having audio and visual warning alarms to notify when medication is not being delivered as it should be, there is a risk that alarms can go unnoticed, particularly by healthcare staff in inpatient settings.

The patient case in the Health Services Safety Investigations Body (HSSIB) investigation report is Stephen, a 45-year-old cancer patient on palliative care in hospital, who did not receive his pain relief medication for six hours. Over the course of six hours, there were eight warnings.

Content

The investigation

An investigation was carried out to explore factors that can affect the ability of patients to reliably receive their medication via an ambulatory infusion pump. The focus was on this specific type of device as they are used widely across healthcare providers in England for patients receiving palliative care. The investigation uses ‘hazard’ to describe something that has the potential to cause harm or have an adverse effect on a patient. A ‘control’ is a measure put in place to reduce the risk of a hazard occurring.

The investigation focused on:

• Equipment controls that enable effective delivery of medication.
• Environmental and staff factors that can influence the monitoring of medication delivery via ambulatory infusion pumps.

Findings

• 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 the Medicines and Healthcare products Regulatory Agency (MHRA) data standards.
• The main factors that affect staff’s 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.

Safety recommendations

• HSSIB recommends that the British Standards Institution engages with appropriate stakeholders to develop national human factors guidance, including consideration of usability and environment of use, for medical devices. This is to support international medical device standards and help manufacturers and healthcare staff to recognise these elements for the improvement of patient safety.
• HSSIB recommends that the British Standards Institution engages with international standards committees to influence the inclusion of human factors, including usability and environment of use requirements, in medical device and medical electrical equipment standards.
• HSSIB recommends that NHS England and the Medicines and Healthcare products Regulatory Agency work together to develop an effective mechanism for sharing medical device related incident data, including where devices function as designed.

Safety observations

• Palliative care providers can improve patient safety by reviewing their ambulatory infusion pumps checks to determine whether they are in line with the Palliative Care Formulary guidance and the minimum expectations of NHS England.
• Ambulatory infusion pump manufacturers can improve patient safety by considering new technology to develop improved methods of alerting staff to hazardous situations.
• Care providers can improve patient safety for inpatients who are given medication using ambulatory infusion pumps by providing safety netting advice about alerting nursing staff to alarms, appropriate places to put ambulatory infusion pumps, and the consequences of patient interaction with the device.